Download To Reduce Blood Pressure in African American Males

HYPERTENSION
1
Evidence Based Practice: To Reduce Blood Pressure in African American Males
Pierre Nkurunziza RN, BSN
Neeta Monteiro RN, BSN
David Buchanan RN, BSN
Sarah Fisher RN, BSN
Wright State University-Miami Valley College of Nursing and Health
NUR 788 – Spring 2012
HYPERTENSION
2
Table of Contents
Cover page...………………………………………………………………………………………………….………..1
Abstract……………………………………………………………………………………………….…………………3
Problem Statement ……………………………………………………………………….…………………………4-6
Planning the Practice Change Team ……………………………………………………………………………..6-8
Critical Appraisal of Evidence ……………………………………………………….……………………………8-10
Plan a Pilot Test of the Change ………………………………………………….……………………………..10-15
Evaluation ………………………………………………………………………………………………………...15-18
Human Subjects Concerns ………………………………………………………….…………………………..18-19
Budget …………………………………………………………………………………………………………………19
Conclusion……………………………………………………………………….………………………………..19-20
References ……………………………………………………………….……………………………………….21-23
Appendices……………………………………………………………….……………………………………….24-29
Appendix A ………………………………………………………..24
Appendix B ………………………………………………………..25
Appendix C … (refer to a separate document)………………..25
Appendix D ………………………………………………………..26
Appendix E ………………………………………………………..27
Appendix F………………………………………………………...28
Appendix G ………………………………………………………..29
Abstract
According to the Centers for Disease Control and Prevention (2012), African Americans
[AA] (44.4%) have the highest prevalence of hypertension (HTN) when compared to Whites
(32.6%) and Mexican Americans (28.3%). The research team proposed a culturally-sensitive
educational intervention via tele-monitoring, delivered by Advance Practice Nurses (APNs) in a
private family practice setting. The goal is to reduce blood pressure (BP) readings in AA males
aged > 40 years to within normal range of < 120/80 mmHg over a six-month period. Stakeholders
include patients, family members, physician, APNs and private practice staff. Resistance may
come from staff and APNs because of additional work responsibilities in managing patients.
Strengths of change include decreasing BP and reducing the sequelae associated with HTN.
Following a rigorous and comprehensive search of the evidence since 2001, a total of 12 studies
were identified. One study was a meta-analysis, while the remaining eleven studies were
Randomized Control Trials. Evidence across the studies supported the utilization of APNs and
tele-monitoring to reduce HTN amongst AA men aged 40 years and older.
Rosswurm and Larrabee’s framework was chosen to guide the EBPCP. The setting will be
a medium size solo family practice office. A purposive sample of 60 AA men will be recruited by
two APNs during a routine family practice visit encouraging participation in the intervention. The
EBPCP will consist of a tailored, culturally sensitive educational intervention incorporating telemonitoring by APNs. The intervention will be measured using various instruments, including BP
and weight via anthropometric measures, exercise pattern (Lorig et al., 1996), diet type and
frequency (ordinal scale), medication adherence (Morisky’s scale), smoking and alcohol
consumption (self-reported on a nominal scale) and patient satisfaction (investigator-developed
open-ended questionnaire). These will be measured at baseline, and again at one month, three
months and six months. Donabedien’s evaluation model will be used to evaluate the intervention.
Problem Statement
The problem of interest for the proposed practice change is hypertension (HTN). HTN is
the number one silent killer among adults in the United States (US). According to the Centers for
Disease Control and Prevention [CDC] (2012), African Americans [AA] (44.4%) have the highest
prevalence of HTN compared to Whites (32.6%) and Mexican Americans (28.3%). The World
Health Organization [WHO] (2011) attributes HTN as the leading cause of cardiovascular mortality
worldwide. In 2008, the prevalence of HTN among adults aged 18 years and older was 68 million
(31%) and has shown no improvement in the past decade. Less than half of those with HTN have
their condition under control. It affects one in three adults in the US and contributes to one out of
every seven deaths and nearly half of all cardiovascular disease--related deaths in the US. In the
state of Ohio, HTN is more prevalent among men (33.1%) compared to women (30.4%); when
considering races AAs have a higher prevalence (40.4%) compared to whites (31.1%). In 2010, the
related health care cost of HTN in the US was about $76.6 billion (CDC, 2011). The American
Heart Association, Institute of Medicine, WHO and Healthy People 2020 aim to reduce the
prevalence of hypertension by assessing high risk factors, providing education and eliminating
gaps in the treatment plan. Although research on treatments is advancing, disparities in HTN
exists among AAs which indicates a need for more evidence based research to close this widening
gap.
Healthy People 2020 have included HTN reduction among its objectives. The baseline rate for this
decade was 29.9%. The target rate is projected to be 26.9% with an estimated 10% improvement
(Department of Health and Human Services, 2012). This goal cannot be accomplished without turning the
focus onto the population group with the highest prevalence of HTN in the US which is largely constituted
by AA males, aged 40 years and older. AAs develop high blood pressure (BP) more often, and at an earlier
age, compared to whites and Mexican Americans (CDC, 2012).
The American Heart Association (2012), describes HTN as an abnormal high measurement of the
force exerted on the arterial walls by the blood pumped from the heart. Optimal blood pressure is less than
120/80 mmHg. HTN is defined as a consistent elevation of the systolic BP above 140 mmHg and a diastolic
BP above 90 mmHg. Consequently when HTN is left untreated after a while, sequelae can be detrimental
and multiple systems can be affected such as cardiovascular, neurology, renal, ophthalmology,
reproductive, and respiratory. High risk factors for high BP are advancing age, obesity, males, AA heritage,
family history of hypertension, atherosclerosis, diabetes, smoking, high-salt diet, excessive alcohol
consumption and emotional stress (National Institute of Health, 2012).
The possible interventions to encounter HTN are: (1) The Dietary Approaches to Stop
Hypertension (DASH) eating plan. DASH is a simple heart healthy diet that can help prevent or lower high
BP. This diet is low in sodium, cholesterol, saturated and total fat, and high in fruits and vegetables, fiber,
potassium, and low-fat dairy products. (2) Monitoring BP is important because high BP often has no
symptoms. One way to improve BP is by tele-monitoring patients in the convenience of their homes.
Interventions that use home BP tele-monitoring linked with patient feedback and medication titration can
enhance access and improve outcomes for adults with HTN (Bosworth, 2011). (3) Education regarding
lifestyle modification such as eating a healthy diet, maintaining a healthy weight, calculating and
maintaining body mass index (BMI) within normal range, engaging in moderate physical activity, smoking
cessation, limiting alcohol and medication adherence. (4) Preventing and managing diabetes. (5) Treating
high BP with medications and stressing the importance of medication adherence (CDC, 2012).
The principle goal of treating HTN is to reduce the sequelae associated with HTN and to prevent
multiple system damage. Although the recommended intervention varies and is dependent on the patient’s
age and severity of HTN, experts believe that innovative, tailored, culturally sensitive educational
interventions via tele-monitoring are most effective in reducing high BP. Based on these recommendations,
we propose a six-month tailored, culturally-sensitive educational intervention incorporating tele-monitoring
by APNs employed by a private practice. The educational intervention will include diet management,
engaging in moderate physical activity, weight control, medication adherence, and assessment of lifestyle
changes (smoking cessation and limiting alcohol consumption) in comparison to standard educational
intervention of blood pressure management by APNs. The proposed practice change delivered over a sixmonth time period will be guided by asking clinical questions in PICOT format [P: population of interest; I:
intervention or issue of interest; C: comparison of interest; O: outcome expected; and T: time for the
intervention to achieve the outcome] (Melnyk & Fineout-Overholt, 2011).
The purpose of this EBPCP delivered by APNs is to provide adequate management of HTN
resulting in decreased HTN among AA males aged 40 years and older. Based on these recommendations
our PICOT question is: In hypertensive AA males aged > 40 years (P), what is the efficacy of a tailored,
culturally-sensitive educational intervention via tele-monitoring by APNs employed by private practice (I) in
comparison to standard educational intervention of blood pressure management by APNs (C) in reducing
blood pressure readings within normal range of < 120/80 mmHg (O) over a six month period (T)? (see
Appendix A).
Planning the Practice Change Team
There are several disciplines that must be included in planning this practice change. The APNs,
physician, staff nurses, nursing assistants, billing and clerical staff all need to have input into the best way
to integrate the proposed practice change into the patient’s plan of care. By including all levels of staff in
the planning the best methods of implementing and monitoring alternate BP measurements can be
determined.
The key informants in implementing this practice change will include all levels of staff within the
primary care practice. The APN’s salary which is approximately $92,000 per year will be prorated for one
day/week to oversee the proposed practice change from the onset to conclusion, and to maintain the
integrity of data collection and data analysis/interpretation. The APN and physician need to give guidance
on clinically acceptable BP readings and pharmacological management of HTN. The staff nurses need to
provide information on the techniques on BP monitoring as well as support staff teaching. Clerical staff and
nursing assistants will play an important role by providing feedback regarding the charting system and the
ease of being able to gather and provide information about BP readings from the patients to the APN.
Finally, the billing staff needs to provide information about the proper billing for in office versus in home BP
monitoring. The practice change team will work once per week to coordinate the change process. The
setting for the proposed practice change will be a medium size solo family practice office in a moderate size
city in the Midwest with a large or rapidly growing population of AAs.
No participants from outside agencies will be involved in the implementation of this practice
change. The monitoring of BP will be done by APNs. The practice staff will monitor all interventions.
Critical Appraisal of Evidence
Multiple sources of evidence have contributed to the development of the proposed evidence based
practice change. These sources include one Cochrane meta-analyses review and eleven randomized
controlled trials. The collection of evidence was obtained following an extensive literature review using the
following databases: Cochrane, CINAHL, PubMed, MEDLINE and PsycINFO. The literature search was
derived from the following key words: "hypertension", "blood pressure", "usual care for hypertension" "telemonitoring", "telemedicine", "nurse practitioner", "advanced practice nurse" and "African Americans".
Articles were selected for utilization based upon their applicability to the reduction of HTN in AAs. Eighty
articles were reviewed; however, a majority was eliminated because they were greater than 12 years old,
the sample size was too small, they did not completely fit the aforementioned criteria for the proposed
practice change or they were lower levels of evidence. The synthesis of evidence and strength of the
evidence tables are provided in Appendix B and C.
Jaana, Pare, and Sicotte (2007) conducted a meta-analysis to investigate the efficacy of home
blood pressure monitoring via tele-monitoring towards the reduction of HTN. Jaana, Pare and Sicottes
(2007) findings indicated that the control of BP is better achieved when measured at home as opposed to in
clinical settings. In addition to a reduction of HTN, the utilization of home BP monitoring was also shown to
be beneficial in the identification of ‘White coat syndrome’. Identification of ‘White coat syndrome’ can
prevent over treatment of patients with anti-hypertensive medications. Artinian, Washington, and Templin
(2001) performed a randomized control trial (RCT) to determine if the addition of tele-monitoring to the
'usual care' for BP management would reduce BP more than in those who just receive the 'usual care'.
Artinian (2001) concluded that patients’, who received tele-monitoring, in addition to the 'usual care',
yielded the most significant reduction in BP over the course of the clinical trial. In 2007, Artinian, Flack,
Nordstrom, Hockman, Washington, Jen, and Fathy built off the previously mentioned study, performing a
RCT on AAs with HTN. This study was comparing patients who received 'usual care' to those patients who
received tele-monitoring in addition to 'usual care' for BP management. Artinian et al. (2007) concluded that
those patients who received the 'usual care' and tele-monitoring experienced a more significant decrease in
BP than the control group.
Continuing to evaluate 'usual care', McManus, Mant, Bray, Holder, Jones, Greenfield, Kaambwa,
Bryan, Little, Williams, and Hobbs (2010) performed a RCT on 527, hypertensive adults in England. The
study was comparing the 'usual care' provided by family physicians to patient self-management via telemonitoring. The study concluded that over a monitoring period of one year, those who received the selfmanagement intervention via tele-monitoring realized a greater reduction in BP when compared to those
with 'usual care'. Parati, Omboni, Albini, Piantoni, Giuliano, Revera, Illyes, and Mancia (2009) performed a
RCT to compare patients who received 'usual care' for HTN management to those patients who utilized
tele-monitoring for HTN management. Parati et al. (2009) concluded that those individuals in which telemonitoring were the main intervention experienced an overall greater reduction in HTN than those with
'usual care'.
Brennan, Spettell, Villagra, Ofili, McMahill-Walraven, Lowy, Daniels, Quarshie and Mayberry (2010)
performed a RCT on 954, hypertensive, AA males. This study compared the management of HTN by a
telephonic nurse and in home BP monitoring against those with just in home BP monitoring. Brennan et al.
(2010) concluded that patients who received telephonic nurse intervention combined with in home BP
monitoring had a significant decrease in overall BP when compared to those that just had in home BP
monitoring. Continuing to evaluate the effects of tele-monitoring in AAs, McCant, Mckoy, Grubber, Olsen,
Oddone, Powers, and Bosworth (2009) performed a RCT to examine the feasibility of home tele-monitoring
among primary care patients with poor BP control. Of the 588 participants, 147 patients were randomized
to usual care. The remaining 441 patients were randomized to receive either (1) a nurse-administered,
tailored behavioral intervention; (2) a nurse-administered medication management according to a
hypertension decision support system; and (3) a combination of these two interventions. McCant et al.
(2009) concluded that 75% of patients were able to use tele-monitoring devices appropriately.
Bosworth, Powers, Olsen, McCant, Grubber, Smith, Gentry, Rose, Houtven, Wang, Goldstein, and
Oddone (2011) performed a RCT that examined the effects of a patient behavioral management
intervention, medication management, and a combination of the 2 interventions delivered by telephone and
activated by home BP monitoring among adults with HTN treated in primary care. Bosworth et al. (2009)
concluded that patients whose BP was poorly controlled at baseline, exhibited a significant reduction in BP
with the combination of behavioral and medication management. Hacihasanoğlu and Gözüm, (2011)
echoed similar findings when they performed a RCT on 120 hypertensive patients who residence was in
Turkey. The study concluded that targeted education from nurses resulted in a significant decrease in BP
when compared to those with usual care.
Hill, Han, Dennison, Kim, Roary, Blumenthal, Bone, Levine and Post (2003) performed a RCT on
309 hypertensive AA men. This study compared the management of HTN by a team composed of a nurse
practitioner, community health worker and physician, with that of traditional care found in the community.
After 36 months of evaluation, Hill et al. concluded that intervention delivered by the team of healthcare
providers was much more effective at lowering BP than the traditional care received. Allen, DennisonHimmelfarb, Szanton, Bone, Hill, Levine, West, Barlow, Lewis-Boyer, Donnelly-Strozzo, Curtis, and
Anderson’s (2011) RCT produced similar results. The study concluded that interventions delivered by a
community health worker and nurse practitioner were more effective at recuing cardiovascular risk factors
than 'usual care'.
Of the 12 articles critiqued and later presented in the Evidence Rubric (see Appendix D), it
can be concluded that there is strong evidence to support the utilization of advanced practice nurses and
tele-monitoring to reduce HTN amongst African American men aged 40 years and older.
Plan a Pilot Test for the Change
After review of several theoretical frameworks, Rosswurm and Larrabee’s framework was chosen
to guide the EBP proposal. The framework involves six steps: (1) assessing the need for change, (2)
locating evidence, (3) analyzing the evidence, (4) designing a practice change, (5) implementing the
practice change, and (6) maintaining the change (Melnyk & Fineout-Overholt, 2011). This model was
selected because it is simple, easy to understand, and comprise steps that suitably fit this research project.
The specific aim of the EBPCP is to implement a tailored, culturally-sensitive educational
intervention incorporating BP management via tele-monitoring by APNs employed by the private practice.
The educational intervention also includes diet management, increasing physical activity, weight control,
medication adherence, and assessment of lifestyle changes that will offer adequate control of HTN among
AA males aged 40 years and older.
The setting for the proposed EBPCP will be an inner-city medium size solo family practice office in
a moderate size city in the Midwest. The practice is run by one physician and two APNs. The practice is
surrounded by small business complexes with convenience parking accessible to main roads and interstate
highways. Nearby residential areas are within a quarter mile of the family practice office in all directions.
The nearest healthcare facilities, including a moderate hospital, dentist office and moderate nursing home
are within two miles along the main road on either direction. The practice site serves between 6,000 and
8,000 visits per year of 90% indigent AA patients ranging from minor seasonal flu complaints and allergies
to severe and life-threatening events from chronic disease complications requiring referrals to hospitals,
management of acute and minor illnesses in adults aged18 years and older.
The EBPCP has been endorsed by the owner of the practice (physician) and his associates
(APNs) because the EBPCP will augment current health care of this vulnerable population. The only
resistance may come from nursing staff because the EBPCP may add more responsibilities to the routine
activities. However, after the introduction of the benefits of the EBPCP and addressing the questions and
concerns of nursing staff, it is anticipated that the EBPCP will gain support because it will help nurses to
provide evidence based practice improvements in outcomes of AAs with HTN.
Population/Sample
Last year’s patient population at this practice was reported to be 7,058 visits; 89% (6,300) were
AAs. This estimates to about 117 AAs seen per week at this practice for health care services or about 19
AAs per day with the exception of Sunday when the practice is closed. Of the 6,300 visits, half were AA
males ages 40 years and older. Considering such a high percentage of AA patients seen in this practice on
a daily basis it will be reasonable to suggest that the EBPCP team should be able to recruit 60 AA males
with HTN into the EBPCP during the 6-months data collection period.
Sampling plan
The purposed population for the EBPCP is AA males with medical diagnosis of HTN receiving
routine and follow-up care for management of HTN at the family practice office (eligibility criteria). Their
care at the practice creates the target population from which the sample will be drawn. The sample will
include AA males ages 40 years and older who meet the following inclusion criteria: (1) have a systolic
blood pressure reading > 140 mmHg and/or diastolic blood pressure reading > 90 mmHg on two separate
occurrences and who are taking or not taking anti-hypertensive medications or (2) systolic blood pressure >
130 mm Hg systolic and/or diastolic blood pressure > 80 mm Hg for potential candidate with diabetes or
chronic kidney disease; and (3) able to read and speak English. Exclusion criteria include: (1) age less than
40 years; (2) females; (3) inability to read and speak English; (4) non- AAs; and (5) children. Purposive
sampling will target all available AA males who will meet the above inclusion criteria. The total number of
subjects in the study is 50. Over sampling will occur by 20% to account for attrition (N=60).
Recruitment procedures
A member of the EBPCP team will meet face to face at a convenient time with all six RNs who are
practicing at the family practice office and inform them of the proposed EBPCP. They will be instructed to
invite potential candidates into the study and explain eligibility and exclusion criteria and address all of their
questions and concerns before proceeding with the proposed practice change. Non- RNs will be informed
to post the EBPCP on the information board and to notify RNs of potential candidates. The RN will be
instructed to initiate the study purpose, and invite eligible patients into the study prior to or following the
initial health assessment by the physician or APNs taking into consideration the urgency of the purpose of
the visit and the present conditions of the candidate. AA males ages 40 years and older who meet inclusion
criteria will be invited to participate in the EBPCP by APNs to improve outcomes associated with HTN in AA
males ages 40 years and older.
The APN will obtain the patient’s written signature on the Informed Consent (IC) on WSU
letterhead from willing participants after explanation about benefits versus risks of EBPCP. The participants
will also be informed that there will be no penalty or coercion for refusing to participate in the EBPCP. The
APN will provide explanation regarding BP and weight assessment using anthropometric measures and
about the types of questions that the candidates will answer and how long it will take to complete the
questionnaire(s). In addition, the APN will assess for questions or concerns from the participants. The
original copy of the IC will be given to the patient and a copy will be kept in a locked files cabinet for a
member of the EBPCP to collect once a week.
Patients will be given a $15 gift card to Wal*mart’s store for participation in the questionnaire
(and or intervention) initially and a $20 bi-monthly for a total of the $75 at the end of the EBPCP.
Recruitment into the EBPCP will continue until the desired number of participants has been recruited into
the EBPCP. A member of EBPCP will have a contact number to be reached at all time for questions and
concerns by the APNs and/or the practice administration.
The EBPCP will consist of a tailored, culturally sensitive education intervention incorporating telemonitoring by APNs employed by the private practice. The educational intervention will include diet
management, physical activity, weight control, medication adherence, and assessment of lifestyle changes.
The intervention will be measured using various instruments, including BP and weight via anthropometric
measures, exercise pattern (Lorig et al., 1996), diet type and frequency (ordinal scale), medication
adherence (Morisky’s scale), and smoking and alcohol consumption (self-reported on a nominal scale), the
later scale’s content validity was 0.86 and inter-rater reliability ranged from 0.89 to 1[kappa statistics] and
0.78-0.96[Spearman Rho correlation]. Only the overall content validity and reliability of the questionnaire
was reported by the author in the literature. Individual scale validity and reliability of the exercise scale and
medication adherence scale was not reported in the literature. In addition, we plan to use a questionnaire
developed by the team incorporating three open ended questions about the participants’ satisfaction with
the educational intervention.
Resistance might come from the staff because the EBPCP may incorporate new protocol and
development of new policies regarding the management or education of AA males with HTN. The purposed
changes may create stress and provoke resistance to APNs because of additional work responsibilities in
managing patients. With the help of the physician and APNs changes can be made incrementally and
adequate education about linkage of the benefits of the EBPCP resulting in better patients’ outcomes.
Implementation of the change may require special accommodations such as extra time for
collecting data and educating patients. It is also paramount to consider additional time commitment for the
patients when participating in the proposed educational practice change. Special accommodations and
flexibility to meet their needs is crucial to acknowledge their commitment to the EBPCP.
The proposed practice change will occur incrementally during a six-month time period. Please refer
to the Gantt chart for the proposed timeline (Appendix D). During the first month, permission will be
obtained from the practice administration to conduct the EBPCP. Stakeholders will get involved with the
introduction of PICOT question. Identification of supporters and laggards will be determined. Education
about the benefits of EBPCP will be provided to the staff and their concerns will be addressed by a member
of the EBPCP. The EBPCP will also be introduced to the APNs during a scheduled team meeting to seek
their support for this practice change and to determine if they have concerns about the feasibility of carrying
out this practice change. An open-ended interview guide will be developed by the team to determine patient
satisfaction with the proposed educational intervention. (See appendix for questions).
Assessment of the practice will be conducted to develop an appropriate strategy for the change. The
budget will be determined and funds allocated (see Appendix E). Patients who have met the inclusion
criteria and who are interested in the educational intervention will be phased in to the EBPCP during the
second through fifth month. During this time period, the APNs will determine data from the patient’s chart to
be transferred to a spreadsheet corresponding to all variables to be measured in the patients for statistical
analyses. A formative evaluation will be done to determine the progress of the EBPCP and adjustments will
be made depending on the results. During the sixth month of the EBPCP, summative evaluation will be
conducted and data will be analyzed to determine the results of the EBPCP.
Successful strategies that will help persuade others to support arguments behind the EBPCP will
include providing opportunity to discuss others concerns, addressing their questions and continuously
providing accurate information about the benefit of EBP. Communicating with the FNPs periodically will be
helpful in determining any identified problems in implementing the EBPCP and if so the recommendations
they have to improve or halt any lack of success in carrying this out. Providing education to all
stakeholders about EBP and following a SWOT analysis process by identifying strengths, weaknesses,
opportunities for success and delineating the threats or barriers with strategies to overcome them will be
beneficial in making this EBPCP a success. This strategic plan will help to share the vision of the EBPCP,
to overcome barriers, to promote engagement of staff and key stakeholders, and to establish incremental
goals for all people involved.
Evaluation
The outcomes that will be measured in this EBPCP are blood pressure, self-reported exercise
pattern, weight, self-reported diet, frequency and portion control, medication adherence, self-reported
cigarette and alcohol use, and patient satisfaction. All of these outcomes will be measured at baseline, and
again at one month, three months and six months from the commencement of the educational intervention.
The outcomes will be measured using various instruments, including blood pressure and weight via
anthropometric measures, exercise pattern (Lorig et al., 1996), self-reported diet type and frequency
(ordinal scale), medication adherence (Morisky’s scale), and smoking and alcohol consumption (nominal
scale). The latter scale’s content validity was 0.86 and inter-rater reliability ranged from 0.89 to 1 [kappa
statistics] & 0.78-0.96 [Spearman Rho correlation]. Only the overall content validity and reliability of the
questionnaire was reported by the author in the literature. Individual scale validity and reliability of the
exercise scale and medication adherence scale was not reported in the literature. In addition, we plan to
use the three-item open-ended interview guide developed by the team to ascertain the participants’
satisfaction with the educational intervention.
The primary outcome of the study will be BP control measured at baseline, one month, three
months, and six months using a standardized research protocol. At each measurement point, the APN will
ask the patients to rest for 5 minutes before obtaining 2 BP measurements using a digital
sphygmomanometer. The participant will be weighed using a digital weighing scale. During the same visit,
participants will be asked to complete a structured 24-item questionnaire comprising four sectionsdemographic profile, lifestyle behavior (smoking, drinking, exercise, and dietary habits), self-health
monitoring practices and medication adherence. Demographic profile will include age, gender, educational
status, marital status, insurance, and total household income. Lifestyle behaviors- This section of the
questionnaire will include self-reported questions to determine cigarette and alcohol consumption on a
nominal scale. Exercise scale modified from Lorig et al. (1996), will be used to assess exercise pattern.
Participants will be asked to indicate the type and frequency of physical activities on an ordinal scale.
Dietary intake will be assessed by asking the type, portion size and frequency of food on an ordinal scale.
Self-health-monitoring practice- assessment will ascertain whether the participants had performed regular
self-health checking via tele-monitoring on BP and maintained records. The measurement scale will be
dichotomous.
Medication adherence will be assessed using Morisky’s (1986) scale composed of 4 dichotomous
questions about medication use patterns. The scale is quick and simple to use for subjects to indicate their
adherence to the physician’s instructions. A summative score will be calculated to reflect the level of
medication compliance. A low score indicates high medication adherence.
Data will be collected using the above mentioned questionnaire by the APNs in the out-patient solo
family practice. Eligible patients will be invited to participate in the educational intervention. Following the
invitation, eligible patients will be asked to complete the questionnaires which can be completed in 25
minutes. Privacy will be provided in a quiet area of the private practice office during the completion of the
questionnaire. All questions will be answered by the APN. The APN will also weigh the participant on a
digital weighing scale and record the weight.
Donabedien’s (1982) program evaluation framework will guide this six-month educational
intervention. The framework includes four elements: structure, process, outcome and impact. Structure
includes the social and physical resources in place to support the proposal EBPCP. Process incorporates
what will occur during the EBPCP. Outcomes include the early expectations after the practice change;
whereas impact refers to the long term effects of the practice change measured against the “gold
standards” such as clinical practice standards developed by the American Heart Association in year 2012.
For the purpose of this EBPCP, we plan to incorporate the outcome during the six-month
educational intervention. As a result of this practice change, positive outcomes will be measured and
achieved by assessment of the following: Decrease of blood pressure to within normal range <120/80
mmHg; patients will report better lifestyle choices through selection of adherence to DASH, increase in
physical activity, weight control, medication adherence, and lifestyle changes (smoking cessation and
limited alcohol consumption) and an increase in patient satisfaction. The Donabedien’s program evaluation
framework was chosen because it is simple and easy to understand and it includes the outcome element
among its evaluation strategy which is the main focus of this EBPCP.
The practice change will be monitored by ascertaining changes in blood pressure, self-reported
changes in adherence to DASH diet, increase in physical activity, weight control via anthropometric
measures, medication adherence, lifestyle changes (smoking cessation and limited alcohol consumption)
incrementally and over the six-month educational intervention. Creating small successes along the way will
help in implementing the change. For example, during the six-month time period, we will ask the patient
how they are managing behavioral lifestyles as measured by the stated measures.
The long term effects of the practice change will be monitored by quarterly audits of charts to
evaluate the variables of interest. When patients come back for regular follow up care BP readings within
normal range of 120/80 mmHg will indicate that the practice change was successful in maintaining longterm effects. Patients who are unsuccessful in maintaining the practice change can be reeducated and
empowered. Every six months the APNs will make phone calls to the patients and enquire regarding their
health status This will help nourish the new culture to make the change last.
Success of the practice change project will be determined by the team’s observation of changes in
the patient’s BP measurement and self-reported changes in adherence to the DASH diet, increase in
physical activity, weight loss, smoking cessation, decreased alcohol consumption, and an increase in
patient satisfaction.
This study will use non-parametric statistics (mean, median, mode, range, standard deviation, %,
and frequency) to measure its variables, and parametric statistics- analysis of variance (ANOVA) will be
used to measure four dependent variables including a decrease in SBP & DBP, adherence to DASH,
increase in physical activity, and a decrease in weight. Data entry and interpretation will be done by WSU
Statistical Consultant Center in consultation with the researcher.
Human Subjects
Educational interventions will be screened by Expedited IRB at WSU. However, the Review Board
or Screening Committee at the family practice office will review the EBPCP and guarantee permission prior
to implementation of the proposed educational practice change with the goal of providing adequate
management of HTN among AA males aged 40 years and older. The proposed practice change will consist
of an educational component as reported in the literature to improve health outcomes associated with HTN
among AA males aged 40 years and older by the APNs following instructions given by the EBPCP team.
The data collected will be kept in the small locked file cabinet located in the practice’s office, only
accessible to the EBPCP team members and the APNs involved for statistical analyses. Confidentiality and
anonymity will be kept as established by the practice and by the research protocol if any publication of
results will be done to disseminate information.
Budget
Funding will be received from the American Heart Association National Clinical Research Program.
This grant offers $77,000 for two years to practitioners offering clinical studies that will promote
cardiovascular health. This amount will be used for equipment and additional staffing to support the
increased level of blood pressure monitoring. The APNs salary which is approximately $92,000 per year will
be prorated for one day/week which is approximately $9,200 over a period of six months.
The budget will be split in the following manner: 50% will go to additional staffing and APNs salary,
25% to purchasing equipment and updating the practice computer system to work with the tele-monitoring
system, 15% to additional supplies needed to be able to take appropriate blood pressure measurements
and 10% for travel to patients homes for set up of the tele-monitoring system and patient education. This is
shown as a pie chart in Appendix F.
The cost of implementing this practice change will be higher in the first year due to the technology
updates that will be required. This cost will decrease with time. The cost will be justified if the intended
results of normal blood pressure for the patients of the practice and if the sequelae associated with high
blood pressure are reduced.
Conclusion
Overall the implementation of the EBPCP by APNs will be beneficial to the practice given the
strength of the evidence obtained from the various research studies on the benefits of tele-monitoring as
successful patient-management approach. Improving the rate of blood pressure control for the AA male
population aged > 40 years will help in preventing the sequelae associated with HTN and improve quality of
life. Tele-monitoring may improve the quality of decision making and provide the ongoing surveillance
required for timely interventions for BP control, although it may be more resource intensive than traditional
clinic visits.
HYPERTENSION
20
References
Allen, J.K., Dennison-Himmelfarb, C.R., Szanton, S.L., Bone, L., Hill, M.N., Levine, D.M., West, M.,
Barlow,A., Lewis-Boyer, L. Donnelly-Strozzo, M., Curtis, C., & Anderson, K. (2011). Community
Outreach and Cardiovascular Health (COACH) Trial: A Randomized, Controlled Trial of Nurse
Practitioner/Community Health Worker Cardiovascular Disease Risk Reduction in Urban
Community Health Centers. Circulation: Cardiovascular Quality & Outcomes, 4(6), 595-602.
American Heart Association. (2012). Understanding blood pressure readings. Retrieved March 5, 2012,
from
http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/AboutHighBloodPressure/Unders
tanding-Blood-Pressure-Readings_UCM_301764_Article.jsp
Artinian NT, Flack JM, Nordstrom CK, Hockman EM, Washington OGM, Jen KC, & Fathy M. (2007). Effects
of nurse-managed telemonitoring on blood pressure at 12- month follow-up among urban African
Americans. Nursing Research, 56(5), 312-322. doi:10.1097/01.NNR.0000289501.45284.6e
Artinian, N., Washington, O., and Templin, T., (2001). Effects of home tele-monitoring (TM) and communitybased monitoring on blood pressure control in urban African Americans: A pilot study. Heart and
Lung Journal, 30(3), 191-199.
Bosworth, H. B., Powers, B. J., Olsen, M. K., McCant, F., Grubber, J., Smith, V., Gentry, P. W., Rose, C.,
Houtven, C. V., Wang, V., Goldstein, M.K., & Oddone, E. Z. (2011). Home blood pressure
management and improved blood pressure control. Archives of Internal Medicine, 171(13), 11731180.
Brennan, T., Spettell, C., Villagra, V., Ofili, E., McMahill-Walraven, C., Lowy, E. … Mayberry, R. (2010).
Disease management to promote blood pressure control among African Americans. Population
Health Management Journal, 13(2), 65-72. doi: 10.1089/pop.2009.0019
Center for Disease Control and Prevention. (2011). Trends in the prevalence of high blood pressure.
Retrieved from http://www.cdc.gov/nchs/data/databriefs/db48.pdf
Centers for Disease Control and Prevention. (2012). About the National Center for Health Statistics.
Retrieved March 5, 2012 from http://www.cdc.gov/nchs/about.htm
Hacihasanoğlu, R., & Gözüm, S. (2011). The effect of patient education and home monitoring on
medication compliance, hypertension management, healthy lifestyle behaviors and BMI in a
primary health care setting. Journal of Clinical Nursing, 20(5/6), 692-705.
Hill, M. (2003). Hypertension care and control in underserved urban African American men: behavioral and
psychological outcomes at 36 months. American Journal of Hypertension 16, 906-913.
doi:10.1016/S0895-7061(03)01034-3
Institute of Medicine. (2010). A Population-Based Policy and Systems Change Approach to
Prevent and Control Hypertension. Retrieved January 25, 2012 from
http://iom.edu/Reports/2010/A-Population-Based-Policy-and-Systems-Change-Approach-toPrevent-and-Control-Hypertension.aspx
Jaana, M., Pare, G., & Sicotte, C. (2007). Hypertension home telemonitoring: Current evidence and
recommendations for future studies. Disease Management and Health Outcomes, 15 (1), 19-31.
McCant, F., Mckoy, G., Grubber, J., Olsen, M. K., Oddone, E., Powers, B., & Bosworth, H. B. (2009).
Feasibility of blood pressure telemonitoring in patients with poor blood pressure control. Journal of
Telemedicine and Telecare. 15, 282-285.
McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, Kaambwa B, Bryan S, Little P, Williams
B, & Hobbs FD. (2010). Telemonitoring and self-management in the control of hypertension
(TASMINH2): a randomized controlled trial. Lancet, 376(9736), 163-172. doi:10.1016/S01406736(10)60964-6
Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence based practice in nursing and healthcare: A guide
to best practice (2nd ed.). Philadelphia, PA: Lippincott Williams & Williams.
National Institutes of Health. (2012). Hypertension. Retrieved March 29, 2012 from
http://www.nlm.nih.gov/medlineplus/ency/article/000468.htm
Parati G, Omboni S, Albini F, Piantoni L, Giuliano A, Revera M, Illyes M, & Mancia G. (2009). Home blood
pressure telemonitoring improves hypertension control in general practice. The Tele-BP Care
study. Journal of Hypertension, 27(1), 198-203. doi:10.1097/HJH.0b013e3283163caf
Schwarz, K., Mion, L., Hudock, D., & Litman, G. (2008). Telemonitoring of heart failure patients and their
caregivers: a pilot randomized controlled trial. Progress in Cardiovascular Nursing, 23(1), 18-26.
United States Department of Health and Human Services. (2012). Healthy People 2020. Retrieved from
http://www.healthypeople.gov/2020/default.aspx
World Health Organization. (2011). Hypertension: Fact sheet. Retrieved January 19, 2012 from
http://www.searo.who.int/linkfiles/non_communicable_disases_hypertesnion-fs.pdf
HYPERTENSION
23
Appendix A
Table 1
PICOT TABLE
Problem Affecting
the
Patient/Population
Hypertension is a
medical condition that
is highly prevalent
among AfricanAmericans (AA) males,
ages 40 years and
older compared to
other minority
population groups or
Whites of similar ages
in the United States.
Intervention
Comparison
Outcome
Time
A tailored, culturally-sensitive educational
intervention incorporating blood pressure
management via tele-monitoring by Advance
Practice Nurses (APN’s) including
*Diet management (DASH)
*Increasing Physical activity
*Weight control
*Medication adherence
*Lifestyle changes.
Standard
educational
intervention of
blood pressure
measurement
by APNs.
Blood pressure
readings within
normal range of <
120/80 mmHg
(considered
normal range
according to the
most recent
guidelines from
the American
Heart
Association,
2011).
Over a six
month period
in monthly
visits.
Measurement/Instrumentation
*Blood pressure & weight via anthropometric
measures
*Exercise pattern-Lorig et al (1996)
*Diet: portion control, type & frequency- ordinal
scale
*Medication adherence- Morisky’s scale
*Cigarette & alcohol use: self-reported on a
nominal scale
Validity: Examined by three experts; overall
content validity was 0.86
Reliability: The inter-rater reliability ranged from
0.89 to 1 (kappa statistics) &
0.78-0.96 (Spearman Rho correlation).
Only the overall content validity and reliability of
the questionnaire was reported by the author in
the literature. Individual validity and reliability of
the exercise scale and medication adherence
scale was not reported in the literature.
PICOT question: In hypertensive African-American males aged > 40 years (P), what is the efficacy of a
tailored, culturally-sensitive educational intervention via tele-monitoring by APNs (I) in comparison to
standard educational intervention of blood pressure management by APNs (C) in reducing blood pressure
readings within normal range of less than 120/80 mm Hg (O), over a six month period (T) ?
HYPERTENSION
24
Appendix B
Table 1 – Evaluation Table of the Level of Evidence
Citation & study #
Design/method
i.e., meta-analyses
or meta-synthesis
from Cochrane
database
Sample/Setting
Major variables
studied
Measurement or
instruments, i.e.,
observation or
psychometric
tools or scales
Data analysis,
i.e., Confidence
interval = briefly
discuss)
Researchers or
authors’
expected or
anticipated
outcomes,
Findings or
results
Appraisal Worth to
practice
S=strengths versus
W=weaknesses or
L=limitations of the
study
1. Jaana, M., Pare,
G., & Sicotte, C.
(2007).
Hypertension home
telemonitoring:
Current evidence
and
recommendations
for future studies.
Disease
Management and
Health Outcomes,
15 (1), 19-31.
Meta-analysis from
Cochrane database
14 studies investigating
the use of home BP
telemonitoring that were
found in the scientific
literature of which only
three were randomized
trials.
The studies present
evidence on the
benefits of
telemonitoring as a
patient-management
approach and their
condition such as
significant BP control,
better medication
adherence, changes in
patients’ lifestyle as well
as their attitudes and
behaviors.
Comparing
results of all the
14 studies.
The findings of all
the 14 studies
were analyzed and
compared.
Home
telemonitoring to
support
hypertension
control by
allowing fast
interventions and
adjustments in
both treatment
and medications,
improving
patients’
compliance and
communication
with their
practitioners as
well as reduce
the ‘white coat’
effect.
(White coat
effect-is defined
as reproducible
A metaanalysis on the
monitoring of
BP indicates
that the control
of BP is better
achieved when
measured at
home as
opposed to in
clinical settings
especially in
cases of low
medication
compliance, co
morbidities,
and
uncontrolled
hypertension.
The electronic
transmission of
data from
Strengths:
Telemonitoring of
patients with HTN
appears to be an
effective patientmanagement
approach that supports
BP control, assists in
identifying patients
with the white coat
effect and as such
reduces the risk of
over-treatment. HTN
telemonitoring
supports patients’
empowerment and
reassurance by giving
them direct
responsibility for
continuous monitoring
of the BP and by
ensuring regular
hypertension in
the medical
setting and
normotension in
the non-medical
setting).
home BP
monitoring
allowed regular
communication
with healthcare
providers and
supports
reliable
readings that
are otherwise
not evident in
clinical
settings.
communication with
health care providers
and immediate
feedback, even
outside office hours
and in remote areas.
Weaknesses: The
issue of
reimbursement for the
home monitoring
devices and services
that are provided
remains critical when
introducing and
advocating
telemonitoring as a
patient-management
approach.
The problem of
decrease in
compliance represents
an important aspect
that needs further
exploration..
It is critical to
understand that home
telemonitoring does
not necessarily work
equally among all
patients.
Limitations: Based on
this review, the
heterogeneity of the
studies found in the
2. McCant, F.,
Mckoy, G.,
Grubber, J., Olsen,
M. K., Oddone, E.,
Powers, B., &
Bosworth, H. B.
(2009). Feasibility
of blood pressure
telemonitoring in
patients with poor
blood pressure
control. Journal of
Telemedicine and
Telecare. 15, 282285.
Randomized control
trial (RCT).
A total of 588 veterans
with a diagnosis of
hypertension from the
Durham VA Medical
Center.
147 patients were
randomized into the
usual care arm; 441
were randomized to
receive one of three
interventions that
included home BP
telemonitoring:
The intervention arms
were: (1) a nurseadministered, tailored
The feasibility of using
home blood
telemonitoring among
primary care patients
with poor BP control.
A research
assistant trained
patients in the
use of the
telemonitoring
equipment and
gave instructions
to take three BP
readings a week,
on different days.
The BP monitor
(A&D 767PC,
CareMatrix Inc)
was used to
transmit data via
a wireless link to
The data were
divided according
to the number of
alerts: 0-2 vs. > 2.
The percentage of
intervention
subjects with 0-2
vs. >2 technical
alerts for baseline
demographic
characteristics was
calculated. Means
and SDs were
calculated for
continuous
variables of
The researchers
expected that
patients would be
able to use BP
telemonitoring
devices
successfully and
thereby improve
BP control,
decrease
medication use
and overall cost
in comparison to
using clinic
measurements.
During the first
six months of
experience in
using the BP
monitoring
equipment 693
technical alerts
were
generated by
267 patients.
About half of
these patients
(112)
generated
more than two
technical
literature makes the
comparison and
aggregation of findings
difficult. Over all most
of the studies were
conducted over a short
period of time and
involved small
samples of patients
which limits the
generalizability of the
findings especially in
relation to the
sustainability and
effectiveness of home
telemonitoring as a
patient-monitoring
approach.
Strengths: The study
was successful in
getting 75% of the
patients to use the
devices correctly.
Weaknesses: Certain
patients will require
more support to use
the equipment
successfully. For some
patients this
technology may not be
appropriate or is
problematic; patients
may be either nonadherent or unable to
behavioral intervention;
(2) a nurseadministered
medication
management according
to a hypertension
decision support
system; (3) a
combination of 1&2 (4)
usual care.
3. Bosworth, H. B.,
Powers, B. J.,
Olsen, M. K.,
McCant, F.,
Grubber, J., Smith,
V., Gentry, P. W.,
Rose, C., Houtven,
C. V., Wang, V.,
Goldstein, M.K., &
Randomized control
trial (RCT)
591 individuals were
randomized to either
usual care or 1 of 3
telephone-based
intervention groups. (1)
nurse-administered
behavioral management
(2) nurse-and
physician-administered
Interventions that use
home BP telemonitoring
linked with patient
feedback and
medication titration may
enhance access and
improve outcomes for
adults with
hypertension.
a home telephone
line.
interest.
Differences in
baseline
characteristics
between
intervention
subjects were
calculated using a
two-tailed chisquare test for
categorical
variables and ttests for
continuous
variables. Race
and employment
status were
divided into 2 level
variables
(Caucasian vs
non-Caucasian;
retired vs. not
retired) for the chisquare tests.
The primary
outcome of the
study was BP
control measured
at baseline and at
6, 12, and 18
months using a
standardized
research protocol.
For the primary
analysis, a logistic
mixed-effects
regression model
was used to
estimate
differences in BP
control at each
post baseline time
alerts.
Resolution of
the alerts
showed that
61% were
caused by
patient nonadherence.
Patient who
generated >2
technical alerts
were younger
(61 vs. 64
years;
p=0.001) and
were more
likely to be
non-Caucasian
(64% vs. 47%,
p=0.002) than
those
generating 2 or
fewer alerts.
Home BP
telemonitoring
may improve the
quality of decision
making and
provide the
ongoing
surveillance
required for timely
Of the 591
study patients,
48% were AA,
92% were
male, and 59%
of participants
had their BP
under control
at baseline
fulfill the intervention
protocol. The study
team should be
prepared for changes
in the telephone
system and device
infrastructure, and
have alternative data
collection methods
available. The
increased time and
attention required by
the non-adherent
patients or those
unable to manage the
technology may have
significant cost
implications.
Limitations: The study
participants came from
a pool of veterans who
received their primary
health care through
the Durham VA
primary care clinics.
Strengths: Among
those individuals with
poor baseline BP
control, the combined
intervention
significantly decreased
systolic BP and
diastolic BP at 12 and
18 months.
Oddone, E. Z.
(2011). Home blood
pressure
management and
improved blood
pressure control.
Archives of Internal
Medicine, 171(13),
1173-1180.
medication
management, or (3) a
combination of both (4)
usual care. 49% were
African American. The
study was conducted at
the primary care clinics
at a Veteran Affairs
Medical Center
At each
measurement
point, a research
assistant masked
to intervention
arms asked
patients to rest for
5 minutes before
obtaining 2 BP
measurements
using a digital
sphygmomanome
ter.
point for each of
the intervention
groups relative to
usual care.
Marginalized
estimates and
corresponding
confidence
intervals for the
proportion in BP
control for the
usual care and
each intervention
group at 6, 12, and
18 months were
calculated to
estimate the
relative
improvement in
proportion of
patients with BP
control. For
secondary
analyses, the
intervention group
effects on mean
systolic and
diastolic BPs over
time were
examined.
Longitudinal data
analysis models
with an
unstructured
interventions for
poor BP control.
using
standardized
measurements.
Both the
behavioral
management
and medication
management
alone showed
significant
improvement at
12 months12.8% (95%
CI, 1.6%24.1%) and
12.5% (95%
CI, 1.3-23.6%),
respectivelybut not at 18
months. In
subgroups
analyses,
among those
with poor
baseline BP
control, systolic
BP decreased
in the
combined
intervention
group by
14.8mmHg
(95% CI, -21.8
to-7.8mmHg)
Weaknesses: The cost
of the interventions
alone was
approximately $ 1100
per patient over 18
months. Each
intervention
demonstrated
improvements in BP
control or systolic BP
at 12 months; none of
these improvements
were sustained at 18
months and did not
result in lower medical
care costs.
Limitations: The fact
that the study
participant’s blood
pressures were lower
than anticipated at
baseline may have
hampered the ability to
detect larger
improvements in the
BP control in the
overall analyses.
covariance was
utilized to account
for the correlation
of patients’
repeated
measurements
over time. Mean
differences
between each
intervention group
and the usual care
group at 6,12, and
18 months were
calculated, along
with corresponding
95% CI, using SAS
ESTIMATE
statements.
4. Artinian, N.,
Washington, O.,
and Templin, T.,
(2001). Effects of
home telemonitoring (TM)
and communitybased monitoring
on blood pressure
control in urban
African Americans:
A pilot study. Heart
and Lung Journal,
Randomized Control
Trial (RCT)
Subject were recruited
from a family
community center on
the east side of Detroit.
The sample contained
26
African Americans
with a mean age of 59
years.
This pilot study
compared 2
experimental
interventions- home TM
plus usual care or
community – based
monitoring plus usual
care-with usual care
only.
Participants had
their BP
measured and
completed an
investigatordeveloped
demographic
profile and HTN
history form.
BPs were
measured by
using an
electronic BP
monitor (model A
&D UA 767PC)
Both experimental
groups yield
positive results
with SBP and DBP
dropped
significantly during
the 3-months
intervention period
(p=.03;p=.04
respectively). In
home TM group
the decrease in
SBP/DBP was
148.8+/- 13.8mm
Hg/90.2+/- 5.79
at 12 months
and 8.0 mmHg
(95% CI, -15.5
to -0.5 mmHg)
at 18 months,
relative to
usual care.
The purpose of
this pilot study
was to test the
following
hypothesis:
Persons who
participate in
nurse-managed
home TM plus
usual care or who
participate in
nurse-managed
community-based
monitoring (CBM)
plus usual care
Both the HT
group and the
CBM group
had clinically
and statistically
significant (P
<.05) drops in
systolic blood
pressure (SBP)
and diastolic
blood pressure
(DBP) at 3
months' followup, with
participants in
Strengths: the study
determined that the
cost of TM is about
$1.50 per day, which
includes the cost of all
equipment, shipping
the monitor directly to
the person’s home,
telephone training, and
unlimited toll-free teletransmission of the
data. If BP control can
be achieved in a
person with HTN and
diabetes, the incidence
30(3), 191-9.
that has been
validated and is
accurate to within
±3 mm Hg or 5%
and falls within
the Advancement
of Medical
Instrument
standards.
mm Hg at baseline
to the 3-months’
follow up level of
124.1+/-13.82mm
Hg/75.58+/- 11.4.
In the communitybased monitoring
group SBP
dropped from
baseline level of
155.25+/17.014mm Hg to
142.3+/-12.1 and
DBP dropped from
89.42+/-10.95 to
78.25+/-6.86. In
the usual care
group, BPs were
unchanged with
Large effect sizes
were found (f=0.59
and 0.53) for SBP
and DBP
respectively.
Despite the small
sample size, the
results indicated
that participants in
the home TM and
community-based
monitoring groups
had clinically and
statistically
significant
will have greater
improvement in
blood pressure
from baseline to 3
months' follow-up
than will persons
who receive usual
care only.
the HT group
demonstrating
the greatest
improvement
(HT: baseline
SBP 148.8 +/13.8, DBP 90.2
+/- 5.79; 3
months' followup SBP 124.1
+/- 13.82, DBP
75.58 +/- 11.4;
CBM: baseline
SBP 155.25 +/17.014, DBP
89.42 +/10.95; 3
months' followup SBP 142.3
+/- 12.1, DBP
78.25 +/- 6.86).
There was little
change in SBP
or DBP at 3
months' followup in the usual
care only
group.
CONCLUSION
: These are
important pilot
results, which if
replicated in a
larger sample
of extremely costly
sequelae such as endstage renal disease
and heart failure can
be reduced. It is likely
that the reduction in
end-organ damage will
far outweigh the cost
of TM, but testing of
this assumption is
required. In addition,
TM has the ability to
identify patients with
white-coat HTN,
thereby avoiding
excess treatment.
Weaknesses: Although
we know that there
may be advantages to
home BP TM, there is
a need for more
research because we
do not know the
effects of this strategy
on long-term control of
BP. The next phase of
research needs to
monitor the effects of
the intervention for a
longer period and
allow for a gradual
reduction in the
intensity of the
intervention. It is
reductions in both
SBP and DBP
during the 3 month
monitoring period
compared to the
participants in the
usual care group.
5. Brennan , T.,
Spettell, C.,
Villagra, V., Ofili,E.,
McMahill-Walraven,
C., J. Lowy, E., …
Mayberry, R.
(2010). Disease
management to
promote blood
pressure control
among African
Americans.
Population Health
Management
Journal, 13(2), 65-
Randomized Control
Trial (RCT)
A prospective
randomized controlled
study (March 2006—
December 2007) was
conducted, with 12
months of follow-up on
each subject. A total of
5932 health plan
members were
randomly selected from
the population of
self-identified African
Americans, age 23 and
older, in health
maintenance
organization plans, with
hypertension;
954 accepted, 638
1. BP. The main
dependent variable was
the proportion of
subjects in each group
with BP<120=80, the
optimal level
recommended by JNC
7 and ISHIB
hypertension
management
guidelines.
Frequency of BP
Monitoring. The
frequency of BP
monitoring
was collected at initial
and final assessments
2. Frequency of BP
1.Two BP
measurements
were requested
from the
participant at the
start and end of
the initial
assessment
telephone call
and the final
assessment call.
The lowest
systolic and
diastolic readings
reported during a
call were used in
the analyses
consistent with
After adjusting for
differences
between the
groups at time of
initial assessment,
the intervention
group was 46%
more likely to
report monitoring
BP at least weekly
in comparison to
the control group
(odds ratio [OR]
1.46,95%
confidence Interval
[CI] 1.07-2.00,
P=0.02). The
intervention group
will significantly
improve care
for urban
African
Americans
with
hypertension.
It was
hypothesized that
a greater
proportion of
intervention
group participants
would have
BP<120=80 than
control group
participants at the
end of the 12month study.
It was also
hypothesized that
intervention group
participants
would have lower
mean systolic and
This study
demonstrated
that home BP
monitoring,
coupled
with a DM
program that
employs
nurses who
received
cultural
competence
training as well
as culturally
sensitive
materials, can
improve BP
compliance
important to determine
how much the
intervention helped
participants make BP
monitoring and lifestyle
modification a routine
part of their daily lives.
Limitations: alternative
community- based
approaches to
monitoring BP hold
promise as a means of
facilitating access to
care and obtaining
control of HTN. More
research is needed.
Strengths: The
success of the current
program likely lies in
the combination of BP
monitoring in the home
and a thoughtful,
culturally sensitive DM
program. The
improvement in BP
control should be
generalizable to
African American
members with health
insurance who will
participate or interact
with their health plan’s
DM program.
72.
completed initial
assessment, and 485
completed follow-up
assessment.
Monitoring. The
frequency of BP
monitoring was
collected at initial and
final assessments.
3. Number of antihypertension
medication classes.
4. Health care
utilization. Health care
utilization.
Healthcare
Effectiveness
Data and
Information Set
(HEDIS_)
guidelines for
multiple BP
measurements on
a single visit.
2. Using the
following
question: ‘‘About
how often do you
or your family
member or friend
take your blood
pressure?’’ The
frequency of BP
monitoring
categories were
collapsed into
‘‘weekly or more’’
and ‘‘less than
weekly’’
monitoring.
3. The proportion
of members
taking 2 or more
anti- hypertension
medication
classes was
measured in 2
ways. First,
information was
was 50% more
likely to have BP in
compliance at final
assessment than
the control group
(OR= 1.50, 95% CI
0.997-2.27,
P=0.052), and
showed
improvement in BP
readings that
approached the
level of statistical
significance
established for the
study.
diastolic
pressures,
would monitor
their BP more
frequently, and
would be more
likely to use 2 or
more
antihypertensive
medications than
control group
participants.
and reduce
systolic BP
more than a
home BP
monitoring
device alone.
While a 3.1point decrease
in systolic BP
may seem
small, the
ALLHAT
study
estimated that
a 3-point
change in
systolic BP
could explain a
10%–20%
difference in
the risk of
major
cardiovascular
events. While
mean systolic
and diastolic
BPs were
lower for both
groups
compared to
initial
assessment,
the systolic BP
adjusted
Weaknesses: With the
greater prevalence of
both hypertension and
uncontrolled HTN in
the AA community,
and with effective
hypertension
treatments available, it
is imperative that the
health care community
identify effective
methods to engage
AAs in programs to
improve their
hypertension control.
More participants were
needed.
Limitations: Limitations
of this randomized
clinical trial include the
potential for selfselection bias among
participants, as
evidenced by a low
recruitment rate
compared to the
number of invited
individuals. This
underscores a
common problem with
large- scale DM
programs and is not
unique to this study.
collected from the
participant during
the initial and
post-telephonic
assessments
using a
questionnaire.
The second
method used
pharmacy claims
for participants
who were with the
health plan’s
pharmacy plan
during the study
period.
4. Health care
utilization data
were obtained
from the health
plan’s claims
system.
6. Hill M. (2003).
Hypertension care
and control in
underserved urban
African American
men: behavioral
and psychological
outcomes at 36
months. American
Randomized Control
Trial (RCT)
The study population
included 309
hypertension AAs men
between the ages of 21
and 54 years and
residing in inner city
Baltimore.
The study evaluated the
effectiveness of a more
intensive
comprehensive
educational-behavioralpharmacologic
intervention by a nurse
practitioner-community
health worker-physician
(NP/CHW/MD) team
Trained
OPD-GCRC
personnel blinded
to group
assignment
obtained three BP
measurements at
1-min intervals
with a
Hawksley random
mean of the
intervention
group was
significantly
lower than that
of the control
group (123.6
vs. 126.7,
P¼0.03)
post
intervention
The only
confidence interval
(CI) reported was
in the change in
creatinine serum.
The relative
hazard ratio
associated with
assignment to
more intensive
This randomized
clinical trial
compared the
effect of a less
intensive
intervention to a
more intensive
intervention to
improve HTN in
AAs.
At 36 months,
the mean
SBP/DBP
change from
baseline was 7.5/-10.1 mm
Hg for less
intensive group
(p=.001 and
.005 for
Strength: the lowering
of BP to meet new
national goals for highrisk patients is a
daunting challenge,
one that will require a
redesign of the
traditional delivery of
HTN care as well as
stronger lifestyle and
Journal of
Hypertension 16,
906-913.
and a less intensive
education and referral
intervention in
controlling blood
pressure (BP) and
minimizing progression
of left ventricular
hypertrophy (LVH) and
renal insufficiency.
Changes in BP, left
ventricular mass (LVM),
and serum creatinine
from baseline to 36
months were compared
between groups.
zero
sphygmomanome
ter.
A trained
sonographer
performed
transthoracic
echocardiography
.
The twodimensional 5/6
area–length
method was used
because of its
potential for
generating
greater accuracy
and
reproducibility
than M-mode
methods.
Serum creatinine,
total cholesterol,
and HDL
cholesterol
(in milligrams per
deciliter) were
measured by
standard
procedures
through Quest
Laboratories.
Diabetes was
defined as
versus less
intensive was 0.63
(hazard ratio 95%
CI=0.36-1.11,
p=.11).
between-group
differences in
SBP and DBP,
respectively).
The proportion
of men with
controlled BP
(< 140/90 mm
Hg) was 44%
in the more
intensive group
and 31% in the
less intensive
group (p=.045).
The LVM was
significantly
lower in the
more intensive
group than in
the less
intensive group
(more
intensive, 274
g; less
intensive, 311
g; p=.004).
There was a
trend toward
slowing of the
progression of
renal
insufficiency
(incidence of
50% increase
pharmacologic
interventions. As
demonstrated in this
trial and in previous
studies, a
multidisciplinary team
approach that crosses
settings and
communicates with
patients between office
visits has been shown
to increase control
rates.
Weaknesses:
However, we suggest
that since this study
has
been conducted
successfully in the
East Baltimore
community,
one of the most
impoverished urban
environments
in the US, it could be
replicated in more
advantageous
communities, yielding
similar or even better
outcomes.
Limitations: this was a
single-site study with
relatively
small sample size, we
physician
diagnosis of
diabetes or serum
glucose _200
mg/dL.
Illicit drug use
was determined
by
urine drug
screen. The staff
interviewed
participants about
sociodemographic and
behavioral risk
factors, using
items
from the National
Health Interview
Survey and HillBone
Compliance
Scale. Health
care utilization
was assessed by
asking
participants
whether they
currently had a
health care
provider for HTN
and whether they
were on
antihypertensive
in serum
creatinine) in
more intensive
group
compared to
the less
intensive group
(more
intensive,
5.2%; less
intensive,
8.0%; p=.08).
The only
confidence
interval
reported was in
the change in
creatinine
serum. The
relative hazard
ratio
associated with
assignment to
more intensive
versus less
intensive was
0.63 (hazard
ratio 95%
CI=0.36-1.11,
p=.11).
believe that the
findings have
important
clinical implications for
improving HTN care
and
control in urban underserved African
American men.
medications.
7. Allen,
J.K.,Denniso
nHimmelfarb,
C.R.,
Szanton,
S.L., Bone,
L., Hill, M.N.,
Levine, D.M.,
West, M.,
Barlow, A.,
Lewis-Boyer,
L. DonnellyStrozzo, M.,
Curtis, C., &
Anderson, K.
(2011).
Community
Outreach and
Cardiovascul
ar Health
(COACH)
Trial: A
Randomized,
Controlled
Trial of Nurse
Practitioner/C
ommunity
Health
Randomized Control
Trial (RCT)
A total of 525 patient,
from urban community
health centers, with
documented
cardiovascular disease,
type 2 diabetes,
hypercholesterolemia,
or hypertension and
levels of LDL
cholesterol, blood
pressure, or HbA1c that
exceeded goals
established by
national guidelines were
randomly assigned to
NP/CHW (n_261) or
EUC (n_264) groups
Randomized,
controlled clinical trial
evaluating the
effectiveness of a
comprehensive
program of
cardiovascular disease
risk reduction
delivered by nurse
practitioner /community
health worker
(NP/CHW) teams
versus enhanced usual
care (EUC) to improve
lipids, blood pressure,
glycated hemoglobin
(HbA1c), and patient
perceptions of the
quality of their chronic
illness care in patients
in urban community
health centers
The primary
outcomes were
changes from
baseline to one
year in lipids, BP,
HbA1c, and
patients’
perceptions of the
quality of their
chronic illness
care. The primary
outcomes also
were
operationalized
as meeting the
goals for
secondary
prevention or
experiencing a
clinically
significant change
as follows: HbA1c
_7% or clinically
significant
decrease of
_0.5%; systolic
BP _140 mm Hg
or
_130 mm Hg if
The data analysis
for this report was
generated using
SAS version
9.2 for Windows.
Statistical tests
were used to study
differences in
baseline
demographic,
clinical, and risk
factor
characteristics,
with a
t test used for
continuous
variables and a x 2
test for categorical
variables. Similar
statistical tests
were used to
compare baseline
characteristics for
subjects
completing the
study to those lost
to follow-up for any
reason.
Generalized linear
Evaluating the
effectiveness of a
comprehensive
program of
cardiovascular
disease risk
reduction
delivered by
nurse practitioner
/community
health worker
(NP/CHW) teams
versus enhanced
usual care (EUC)
to improve lipids,
blood pressure,
glycated
hemoglobin
(HbA1c), and
patient
perceptions of the
quality of their
chronic
illness care in
patients in urban
community health
centers.
At 12 months,
patients in the
intervention
group had
significantly
greater overall
improvement in
total
cholesterol,
LDL-C,
triglycerides,
systolic and
diastolic BP,
HbA1c, and
perceptions of
the quality of
their chronic
illness care
compared
with patients
receiving EUC.
At the 12month
follow-up, a
significantly
higher
percentage of
patients in the
intervention
Strengths:
An intervention
delivered by an
NP/CHW team using
individualized
treatment regimens
based on treat-totarget algorithms can
be an effective
approach to improve
risk factor status and
perceptions of chronic
illness
care in high-risk
patients
Weaknesses:
Adoption and
sustainability of this
model of care will
require
financing mechanisms
for CHWs. Funding,
reimbursement,
and payment policies
for CHWs must be
established to ensure
that CHW models are
adopted in mainstream
health care.
Worker
Cardiovascul
ar Disease
Risk
Reduction in
Urban
Community
Health
Centers.
Circulation:
Cardiovascul
ar Quality &
Outcomes,
4(6), 595602.
patient had
diabetes or
kidney disease or
clinically
significant
decrease of _10
mm Hg; and LDLC _100 mg/dL or
_130 if no CVD or
diabetes or a
clinically
significant
decrease of
_20%. The
chemistry
laboratory at
Johns Hopkins
performed all
biochemical
measures. Total
cholesterol,
triglycerides, and
high-density
lipoprotein
cholesterol (HDLC) were
measured directly
after a 12-hour
fast. LDL-C was
estimated using
the Friedewald
equation.31 In the
event of
triglyceride levels
mixed models,
using a random
patient-level
intercept model,
were used to build
multilevel models
comparing the
effectiveness of
the NP/CHW
intervention with
EUC on each
outcome,
controlling for the
covariates of age,
sex, race, body
mass
index, and
insurance status,
which were
determined by
univariate
analyses to be
predictive of
outcomes. Mixed
models are the
optimal
statistical method
to use with preintervention and
post intervention
repeatedmeasures data, as
this modeling
approach accounts
group
compared with
the EUC group
had values
that reached
guideline goals
or showed
clinically
significant
improvements
in LDL-C (EUC
=58%; I = 75%,
P < 0.001),
systolic BP
(EUC = 74%; I
= 82%, P =
0.018), and
HbA1c
(EUC = 47%; I
= 60%, P=
0.016).
Limitations:
The limitations of the
COACH Trial include
the fact that it was
conducted in one
federally qualified
community health
system and used
highly trained NPs and
CHWs, which may
limit generalizability.
Second, the
recruitment and
screening
process resulted in the
inclusion of a sample
of predominately
black women.
However, this
represents the majority
of
patients seen in these
and other similar
community health
clinics, which
increases confidence
in the generalizability
of
findings to similar
settings. Third,
physicians had
patients in
both the intervention
and EUC groups. This
_400 mg/dL,
direct
measurement of
LDL-C through
ultracentrifugation
methods was
performed. In
participants with
diabetes, HbA1c
was measured
using
high-pressure
liquid
chromatography.
BP was
measured using
the
Omron Digital
Blood Pressure
Monitor HEM907XL automatic
BP
device according
to JNC VII
guidelines, after 5
minutes of quiet
rest,
in the right arm
with the person
seated in a chair
with arm
supported
at heart level. The
average of 3 BPs
for the
correlated data
structure.
may have
resulted in a change in
the level of care
provided to their
patients in the EUC
group as they received
laboratory reports
at baseline and tended
to become more
vigilant with the
assessment,
treatment, and followup for cardiovascular
risk factor
management. This
may explain the
improvements in
clinical measures in
the EUC group.
Nevertheless,
improvements
in clinical outcomes
and perceptions of the
quality of
care were significantly
greater among
patients in the
intervention
group compared with
the EUC group.
Finally, there was a
higher attrition rate in
the intervention group
(13%) as
was recorded.
The patient’s
ratings of care
received from
their health care
team
was measured by
the Patient
Assessment of
Chronic Illness
Care
(PACIC) Survey,
a 20-item patient
report instrument
that assesses
patient’s
perceptions of the
receipt of clinical
services and
actions
consistent with
quality care
defined by the
Chronic Care
Model.32
The 5 subscales
are Patient
Activation;
Delivery
System/Decision
Support; Goal
Setting; Problemsolving/Contextua
l Counseling; and
compared with the
EUC group (9%).
However, the study
was
powered to account for
a dropout rate of 25%.
The slightly
differential dropout
rate in the intervention
group may be due to
the increased
commitment to
participate in the
intervention
group, including more
visits to the clinic
resulting in more costs
to the participant.
Followup/Coordination.
Secondary
outcomes
included the
lifestyle behaviors
of dietary
intake measured
by the Habits and
History Food
Frequency
Questionnaire,
Block
2005.1,33,34 and
physical activity
was evaluated
with
the Stanford 7Day Physical
Activity
Recall.35,36
Quality of life was
measured by the
5-item EuroQol
questionnaire,37
and resource
utilization and
patients’ health
care utilization
data were
collected to
conduct a cost
effectiveness
analysis, which
8. Hacihasanoğlu,
R., & Gözüm, S.
(2011). The effect
of patient education
and home
monitoring on
medication
compliance,
hypertension
management,
healthy lifestyle
behaviors and bmi
in a primary health
care setting.
Journal Of Clinical
Nursing, 20(5/6),
692-705.
Randomized Control
Trial (RCT)
This study conducted in
Turkey used a study
group comprised of 120
subjects (40 Group A,
40 Group B, 40
controls),
all previously diagnosed
with hypertension and
who started medication
therapy at least one
year prior to start of
study. The study
was conducted between
February–November
2006 at public primary
health care facilities and
homes of the study
participants.
The aim of this study
was to determine the
effect of antihypertensive patientoriented education and
in-home monitoring
for medication
adherence and
management of
hypertension in a
primary care setting, by
providing education on
healthy lifestyle
behaviors and
medication adherence.
will be reported
separately.
Pretest data were
collected through
the administration
of a descriptive
questionnaire,
medication
adherence selfefficacy
scale (MASES),
health-promoting
lifestyle profile
(HPLP) to
130 hypertensive
patients in the
1st, 2nd and 3rd
primary
health care
facilities of
Erzincan province
and from
personal
data (blood
pressure, height,
weight available
in the subjects’
medical records).
Final data were
collected through
re-administration
of
the pretest
questionnaires
Data were
analyzed using
SPSS statistics
software, version
11.0 for Windows.
To treat analysis,
minimum and
maximum
values were
controlled before
the evaluation of
the
data. Chi-square
and variance
analysis (ANOVA)
were used
for the assessment
of the experimental
groups and the
control group;
paired t-test was
used for intragroup
assessment of
significance of the
difference between
the
average pretest–
posttest scores of
MASES, HPLP,
BMI and
SBP-DBP;
Our hypotheses
were as follows:
(1) Education in
medication
adherence and
healthy lifestyle
behaviors will
improve
medication
adherence in the
study groups
(Groups A and
B).
(2) Education in
medication
adherence and
healthy lifestyle
behaviors will
result in lower
average blood
pressure values
in study groups
(Groups A and
B).
(3) Medication
adherence
levels in study
Group B
(education in both
medication
adherence and
healthy lifestyle
When the
effectiveness
of interventions
in the both
control
and
intervention
groups was
compared
using the SBP,
DBP
MASES, it was
found out that
the both
interventions
were
effective, but
combined
education
(Group B)
more effective
than
medication
adherence
education
alone (Group
A) on
blood pressure
MASES scores
of intervention
groups were
significantly
Strengths:
To the authors’
knowledge, this study
is the first nursing
intervention study to
improve both
medication adherence
and
healthy lifestyle
behaviors for
hypertensive patients
in
Turkey. In this study,
we shed light on
professional educator
roles of the nurse. Our
results indicate the
importance of
receiving nursing
intervention for
controlled blood
pressure,
healthy lifestyle
behaviors and
medication adherence
self efficacy. Our
results can be
applicable to primary
care
facilities worldwide
because uncontrolled
blood pressure,
and scales, blood
pressure
measurements
and weight
measurement. All
data were
obtained
by face-to-face
interview. The
entire education
intervention
was comprised of
six interviews,
two during a
home visit
and four at the
primary care
facilities. A
sphygmomanome
ter (ERKA) was
used for the
measurement.
Systolic (SBP)
and diastolic
blood
pressures (DBP)
were recorded
based on
Korotkoff sounds.
Height
measurement
was obtained
using a tape
measure
variance analysis
was used for intergroup
assessment of
significance of the
difference between
the
average pretest–
posttest scores of
MASES, HPLP,
BMI and
SBP-DBP; Tukey
test was used for
advanced analysis;
and
McNemar test was
used for
assessment of
significance of
the difference
between the
pretest–posttest
levels of
regular and
irregular using of
medications in
experimental
groups and the
control group.
Internal
consistencies of
the
MASES and HPLP
scales were tested
behaviors) will be
higher
than that of the
patients in group
A (who receive
only medication
adherence
education).
(4) The average
blood
pressures of
patients in study
Group B who
have received
education for both
medication
adherence and
healthy lifestyle
behaviors will be
better than the
patients in study
group A
who have
received only
medication
adherence
education.
increased.
Significant
differences
were noted
when
comparing
HPLP average
scores
between the
two study
groups and
between study
groups and the
control groups
(p < 0.001).
For BMI, no
difference was
found between
the study
groups A and
B, nor between
Group
A and the
control group
(p > 0.05);
however,
significant
differences
were observed
between Group
B and the
control
group (p <
0.05). The
non-adherence
medications and
unhealthy lifestyle
behaviors
are global problems.
The present study
showed that a sixmonth education
program taught by the
investigator, who is a
nurse, along with inhome monitoring
had a significant
impact on blood
pressure control. This
finding supports the
literature and verifies
our second
hypothesis.
Weaknesses:
Individual patient
education has
positive effects on
hypertension;
however, we advise for
future studies that
group education may
be more appropriate
in some settings
because it saves time
and is more cost
effective.
Limitations:
In this study,
9
9. Schwarz, K.,
Mion, L., Hudock,
D., & Litman, G.
(2008).
Telemonitoring of
heart failure
Randomized Control
Trial (RCT)
This pilot study was
conducted at
a 537-bed tertiary
teaching hospital
in Northeastern Ohio.
Potential participants for
The
purpose of this pilot
study was to examine
whether telemonitoring
by an advanced
practice nurse reduced
with the patient
standing on a
horizontal surface
with the
head, shoulder,
hip and heel
touching a
vertical wall.
Values
were recorded in
centimetres (cm).
Weight
measurement
was
obtained using a
standard scales
with patients
wearing
lightweight
clothes. Values
were recorded in
kilograms (kg).
Body weight
(kg)/height (m)2
was calculated as
BMI according
to the WHO
standards.
Days to
readmission,
defined as the
number of days
between
the date of initial
using Cronbach’s
alpha reliability
coefficients. A
significance level
of p = 0.05
was used for all
comparisons.
Descriptive and
comparative
analyses
were performed
using SPSS for
windows, version
The research
hypotheses were
as follows:
(1): Hospital
readmissions,
ED visits, and
most significant
reduction in
systolic and
diastolic
blood pressure
was seen in
the intervention
Group B
standardization of
physical measurement
tools was not
compared by an
accredited institution.
Use of
other robust tools for
end might be
considered as an
important limitation for
this study.
There was no
difference in
hospital
readmission
between the
intervention
Strengths:
We found no
significant health care
consumption or
psychological benefit
to patients by adding
patients and their
caregivers: a pilot
randomized
controlled trial.
Progress In
Cardiovascular
Nursing, 23(1), 1826.
the study included
patient/caregiver dyads
who met the following
criteria and routinely
used the participating
hospital. The patients,
aged 65 years or older,
had a diagnosis of New
York Heart Association
(NYHA) classification II,
III, or IV HF and were
functionally impaired in
at least 1 activity of
daily
living (ADL) or one
instrumental
activity of daily living
(IADL), necessitating
assistance of a family
caregiver.
They received home
care from the
participating home care
agency if it
was ordered by their
physician, had
Medicare eligibility and
an operating telephone
line, and were able to
speak English. Classic
symptoms of clinical HF
are shortness of breath
and fatigue, and
abnormalities of systolic
subsequent hospital
readmissions,
emergency department
visits, costs, and risk of
hospital readmission for
patients with HF.
hospital
discharge and
the first
readmission to
the hospital,
was assessed
through medical
record
review after 90
days’ post
discharge.
Physiologic
health indicators,
blood
pressure, apical
pulse, weight,
and oxygen
saturation were
assessed by the
PI or research RN
at baseline and 3
months later. Co
morbidities and
prescribed
medications were
abstracted
from the medical
record before
hospital
discharge and
were confirmed at
baseline. Use of
home health care
was
13 (SPSS, Inc,
Chicago, IL).
Descriptive
statistics,
frequencies, and
measures of
central
tendency and
dispersion were
used
to describe the
sample.
Associations
between variables
were analyzed with
Pearson
correlation
coefficients for
interval variables
and the Spearman
correlation
coefficient for
ordinal
variables. Means
were substituted
for
the relatively few
areas of missing
data.
The effectiveness
of the intervention
was examined by
using an intention
to treat analysis; a
costs of care
will be
significantly lower
for HF
patients with
EHM as
compared
with usual care.
(2): Rates of
depressive
symptoms will be
lower, but days to
readmission and
measures of
quality
of life and
caregiver mastery
will be
significantly
higher in the EHM
group compared
with usual care.
(3): Caregiver
mastery,
informal social
support, and
EHM
will significantly
reduce the risk of
hospital
readmission for
patients
with HF.
(n=12) and
usual care
(n=13) groups
(c2=0.27;
P=.60).
Hospital
charges
alone did not
differ
significantly
between
intervention
and usual care
groups
($10,996.86•}$
29,230.05;
$5,462.58•}$9,
825.00,
respectively;
P=.26). In
addition, outof-pocket
costs for
medications,
physician office
visits, and
laboratory
testing were
similar
between
groups.
While
differences
existed
telemonitoring
in the health service.
Weaknesses:
The overall lack of
effect of our
intervention might be
related to several
issues, including the
experience of the
current cohort of older
adults and the
nature of their illness.
Baby boomers
are more experienced
with technology
and they may desire
more sophisticated
means of monitoring
their health as they
age.
Limitations:
Our study has several
limitations. Our
findings are limited to
patients classified
in NYHA classes II, III,
and IV. Since
31% of patients in this
study were
NYHA class IV, a
replication study
using less severely ill
patients may lead
to greater differences
and diastolic
dysfunction may
coexist.
The principal
investigator (PI)
validated the diagnosis
of systolic and/
or diastolic HF with
chart review of
the cardiologist’s
impressions related
to signs and symptoms
of HF, ejection
fraction and/or the
echocardiography
report after gaining oral
consent from
the patient before
hospital discharge.
Overall, 562 patients
were screened for
eligibility (Figure).
Of these, 152 (27%)
were eligible; 102
(67%) agreed to
participate.
documented with
a computerized
chart
review after 90
days’ post
discharge.
Severity of HF
was assessed
subjectively
by the PI or
research RN
using the
NYHA functional
class at baseline
and at 90 days’
post discharge.
Functional status
was measured
as the ability to
perform ADLs
and
IADLs at baseline
and 90 days’ post
discharge.
The ADL tool27
consists
of 6 items (eating,
dressing, bathing,
transfers,
incontinence, and
toileting)
and is scored
from 0 (totally
independent)
was set at ≥.05.
Outcomes were
examined between
the
2 groups using chisquared likelihood
ratio tests for
categorical
variables,
t tests for
approximately
normally
distributed
variables, and
Wilcoxon
rank sum tests for
skewed variables.
Subgroup
analyses were
conducted,
comparing the
intervention and
usual
care groups by risk
status. Survival
analysis with Cox
proportional
hazard modeling
was used to
assess risk for
hospital
readmission by
the number of
days between
between
groups at
baseline with
regard to
caregiver
mastery, there
were no
differences
between
groups for any
outcome at
the 90-day
follow-up visit.
Cox
proportional
hazards
regression
modeling was
used to identify
independent
predictors of
risk
for hospital
readmission in
days.
Independent
variables
included
caregiver
mastery,
informal social
support, and
telemonitoring
(yes/
between groups,
even with a short
follow-up period.
Although the majority
of intervention
patients reported that
they used the
EHM system on a
regular basis, the PI
did not have
information about
whether
teaching before
hospital discharge was
consistent between
groups.
Functional status,
number of
co morbidities, and
medication use
did not differ
significantly between
groups at baseline or
90 days’ post
discharge.
Patients subjectively
reported
their functional
abilities, however, and
severity of co
morbidities was not
studied.
In past studies of
patients with
to 2 (totally
dependent).
Depressive
symptomatology
was measured
using the Center
for
Epidemiological
Studies
Depression
Scale (CES-D) at
baseline and 90
days’ post
discharge.
Participants rated
20 items on a 4point Likert scale
from 0 (“rarely”)
to 3 (“most or all
of
the time”) with a
possible range of
0
to 60. Higher
scores indicate
more depressive
symptoms.
Quality of life,
defined as
patient’s
perceptions of the
effects of HF on
one’s life, was
measured with 18
discharge
and first
readmission. Cox
proportional
hazard modeling
accommodates for
the censoring of
information and
accounts
for the competing
risk. The pool of
potential predictors
of risk for hospital
readmission
specific to the
dyad included
caregiver mastery,
informal social
support, and EHM.
The multivariable
model was derived
using multiple
model building
techniques:
backward
elimination with
a=.05 stay criteria,
stepwise with
a=.25 enter
criteria, and
a=.05 stay criteria
to identify
independent
predictors of days
no). None of
these predicted
risk of
hospital
readmission.
HF, researchers
reported variations in
how medications were
prescribed and
issues with
compliance.39,40
Although
patients reported
taking medications
as prescribed, a
formalized monitoring
system was not used.
Information
about dosages or
changes in
medications
was not collected, and
these
variables could have
differed between
groups and affected
results.
Specific number of
visits to the
patients’
cardiologist/primary
physician
and how physicians
responded
to nursing
assessments were
also not
obtained as part of the
study. Several of
items from the
Minnesota Living
with HF
questionnaire
(MLWHF) at
baseline
and 90 days’ post
discharge. The
MLWHF
measures
individuals’
perceptions
of the ways in
which symptoms
of HF have
impacted their
lives in the past
month. Since the
majority of
patients were
older and not
employed
and depression
was assessed
with the
CES-D, questions
about working,
sexual activities,
and depression
were eliminated
from the original
scale. Eighteen
items were rated
on a 6-point Likert
to readmission.
the cardiologists
voiced concerns about
the amount of
paperwork involved
when monitoring via
an EHM system. Lack
of attention to
paperwork could
have minimized
information used in
decision making and
therefore limited
actions that could have
prevented
hospitalization
or early readmission.
Limitations of the study
may be
due to absence of
control over usual
care provided by the
home care agency.
Contrary to this study,
others used
a study nurse to
provide care, and
together the PI and
nurse reviewed
assessments of
patients.20 Finally,
there
was no group that
received EHM and
not home care in our
scale from 0
(“no”) to 5 (“very
much”), with a
possible range of
0
to 90. A higher
score indicated
more
symptomatic
impact on one’s
life.
Caregiver
mastery, defined
as a
positive view of
one’s ability to
provide care, was
measured with
the mastery
subscale from the
Philadelphia
Geriatric Center
Care giving
Appraisal
Scale (PGCCAS)
at baseline and
90
days’ post
discharge. Six
items assess the
likelihood of
caregiver
uncertainty
about how to
study. Thus, we
do not know whether
EHM would
benefit patients who
have a similar
status as a solo
resource/service.
provide care,
reassurance
that the patient is
receiving proper
care, feeling on
whether they
should
be doing more for
the patient,
feeling
that they are
doing a good job
of providing care,
perceptions about
capability of
dealing with
problems as
they arise, and
identifying the
patient’s
needs.
Caregivers rated
6 items on a
5-point Likert
scale from 1
(“never”)
to 5 (“nearly
always”), with a
possible
range of 6 to 30.
Higher scores
indicated
greater mastery.
Informal social
support,
described
as instrumental
activities
performed
by families and
friends, was
measured
with the tangible
subscale from
the Modified
Inventory of
Socially
Supportive
Behaviors Scale
(MISSB)36
at baseline. The
tangible subscale
reflects activities
such as receiving
a
monetary loan.
Caregivers rated
9
items on a 4-point
Likert scale from
1 (“never”) to 4
(“very often”),
with
a possible sum
score of 9 to 36.
Higher scores
indicated more
informal
10.
Artinian NT, Flack
JM,
Nordstrom CK,
Hockman
EM, Washington
OGM, Jen KC,
& Fathy M. (2007).
Effects of nursemanaged
telemonitoring on
blood pressure at
12-month follow-up
among urban
Randomized Control
Trial (RCT)
Subjects were recruited
from a family
community center on
the east side of Detroit.
Participants were
conveniently selected
from the community
center. The primary
goal of screening was
to identify otherwise
healthy African
American men and
women with HTN.
Criteria for inclusion
Persons who participate
in nurse-managed
home telemonitoring
(HT) plus usual care or
who participate in
nurse-man- aged
community-based
monitoring (CBM) plus
usual care will have
greater improvement in
blood pressure from
baseline to 3 months’
follow-up than will
persons who receive
social support.
Cost of care was
calculated for the
90-day period
post–initial
hospitalization.
Charges post
hospitalization
were calculated
by tracking billing
charges for
rehospitalization,
emergency
department visits,
and charges
for usual home
care from the
provider
of home health
care.
BPs were
measured by
using an
electronic BP
monitor (model
A&D UA 767PC)
that has been
validated and is
accurate to within
±3 mm Hg or 5%
and falls within
the Advancement
of Medical
Instrument
A 100%
compliance rate
meant that all BPs
(a total of 60) were
measured in the
10-week interval
between baseline
at week 1 and
follow-up at week
12. There was a
mean 67%
compliance rate
(SD, 0.233) in the
telemonitoring
Providing easy
access to BP
monitoring can
inform persons
that their BP is
elevated and will
remind them of
the need to take
action. Taking
action can mean
complying with
recommended
lifestyle changes
and, when
Both the HT
group and the
CBM group
had clinically
and statistically
significant (P <
.05) drops in
systolic blood
pressure (SBP)
and diastolic
blood pressure
(DBP) at 3
months’ followup, with
Strengths:
Randomization and
high compliance rate
Weaknesses: Small
sample size
Limitations: The
findings from this
research raise another
important question:
why did the
intervention work? We
do not know the
mechanisms by which
telemonitoring works to
African Americans.
Nursing Research,
56(5), 312-322.
doi:10.1097/01.NN
R.0000289501.452
84.6e
were an age ≥18 years
and an SBP ≥140 mm
Hg or a DBP ≥90 mm
Hg, unless the person
self-identified as having
diabetes or claimed a
history of a heart attack,
in which case an SBP
≥130 mm Hg or a DBP
≥85 mm Hg were
acceptable. Principal
exclusion criteria
included the following:
receiving hemodialysis,
having been diagnosed
with dementia or
another mental illness
defined as not being
oriented to time,
person, or place, having
compliance risk (ie, selfidentified heroin,
cocaine, or other illicit
drug user), being homeless, or having other
major health problems
such as the terminal
stages of cancer or
advanced liver disease.
The sample contained
26 African Americans
with a mean age of 59
years.
usual care only.
standards.20 BPs
were measured
after a 5-minute
rest period; 2 BPs
were measured 5
minutes apart and
the average of
the 2 was used
for analyses.
Participants wore
unrestrictive
clothing and sat
next to the
investigator’s
desk, with their
feet on the floor,
their back
supported, and
their arm
abducted, slightly
flexed, and
supported at
heart level by the
smooth, firm
surface of the
desk.
group and a mean
89% compliance
rate (SD, 0.082) in
the community
group (t10 = –2.23,
P = .06). The
significance level
was set at 0.05.
necessary,
implementing an
antihypertensive
drug regimen. By
offering
telemonitoring to
patients these
goals can be
achieved.
participants in
the HT group
demonstrating
the greatest
improvement
(HT: baseline
SBP 148.8 ±
13.8, DBP 90.2
± 5.79; 3
months’ followup SBP 124.1
± 13.82, DBP
75.58 ± 11.4;
CBM: baseline
SBP 155.25 ±
17.014, DBP
89.42 ± 10.95;
3 months’
follow-up SBP
142.3 ± 12.1,
DBP 78.25 ±
6.86). There
was little
change in SBP
or DBP at 3
months’ followup in the usual
care only
group.
lower BP and achieve
BP control.
11.
McManus RJ, Mant
J, Bray EP, Holder
R, Jones MI,
Greenfield S,
Kaambwa B, Bryan
S, Little P, Williams
B, & Hobbs FD.
(2010).
Telemonitoring and
self-management in
the control of
hypertension
(TASMINH2): a
randomized
controlled trial.
Lancet, 376(9736),
163-172.
doi:10.1016/S01406736(10)60964-6
Randomized Control
Trial (RCT)
Patients were eligible
for enrolment if they
were aged 35–85 years,
receiving treatment for
hypertension with two
or fewer
antihypertensive drugs,
had a blood pressure at
baseline of more than
140/90 mm Hg, and
were willing to monitor
their own blood
pressure and self-titrate
medication. The age
range for eligibility had
been increased from
35–75 years to 35–85
years after 3 months
when it became
apparent that older
patients were able to
undertake the trial
procedures and there
were concerns about
recruitment. Exclusion
criteria were blood
pressure more than
200/100 mm Hg,
postural hypotension
(>20 mm Hg systolic
drop), terminal disease,
dementia, score of
more than ten on the
short orientation
Control of blood
pressure is a key
component of
cardiovascular disease
prevention, but is
difficult to achieve and
until recently has been
the sole preserve of
health professionals.
This study assessed
whether selfmanagement by people
with poorly controlled
hypertension resulted in
better blood pressure
control compared with
usual care.
Patients assigned
to the intervention
group were
invited to two
training sessions
run by the
research team.
Participants were
trained to monitor
their own blood
pressure for the
first week of each
month with a
validated
automated
sphygmomanome
ter (Omron 705IT;
Omron
Healthcare
Europe,
Hoofddorp,
Netherlands) and
to transmit blood
pressure readings
to the research
team by means of
an automated
modem device (imodem;
Netmedical, De
Meern,
Netherlands),
which was
connected to the
After 12 months,
166 (71%) of 234
patients in the
intervention group
ranked selfmonitoring as their
preferred method
of blood pressure
monitoring
compared with 103
(43%) of 242 in the
control group
(p<0·0001).
Confidence
Interval was set at
95%
Self-management
of hypertension in
combination with
telemonitoring of
blood pressure
measurements
represents an
important new
addition to control
of hypertension in
primary care.
527
participants
were randomly
assigned to
selfmanagement
(n=263) or
control
(n=264), of
whom 480
(91%; selfmanagement,
n=234; control,
n=246) were
included in the
primary
analysis. Mean
systolic blood
pressure
decreased by
12·9 mm Hg
(95% CI 10·4–
15·5) from
baseline to 6
months in the
selfmanagement
group and by
9·2 mm Hg
(6·7–11·8) in
the control
group
(difference
between
Strengths:
Randomization, Large
sample size, high
compliance rate.
Weaknesses: there is
a need for more
research because we
do not know the effects
of this strategy on
long-term control of
BP. The next phase of
research needs to
monitor the effects of
the intervention for a
longer period and allow
for a gradual reduction
in the intensity of the
intervention.
memory concentration
test,14 hypertension not
managed by their family
doctor, or spouse
already randomized to
study group. This
randomized controlled
trial was undertaken in
24 general practices in
the UK.
sphygmomanome
ter and plugged
into a normal
telephone socket
like an
answerphone.17
Two selfmeasurements
were made each
morning with a 5min interval and
the second
reading acted
upon. A color
traffic light system
was used by
participants to
code these
readings as green
(below target but
above safety
limit), amber
(above target but
below safety
limits) and red
(outside of safety
limits). A month
was deemed to
be “above target”
if the readings on
4 or more days
were above
target.
groups 3·7 mm
Hg, 0·8–6·6;
p=0·013).
From baseline
to 12 months,
systolic blood
pressure
decreased by
17·6 mm Hg
(14·9–20·3) in
the selfmanagement
group and by
12·2 mm Hg
(9·5–14·9) in
the control
group
(difference
between
groups 5·4 mm
Hg, 2·4–8·5;
p=0·0004).
Frequency of
most sideeffects did not
differ between
groups, apart
from leg
swelling (selfmanagement,
74 patients
[32%]; control,
55 patients
[22%];
p=0·022).
12 Parati G,
Omboni S, Albini F,
Piantoni L, Giuliano
A, Revera M, Illyes
M, & Mancia G.
(2009). Home blood
pressure
telemonitoring
improves
hypertension
control in general
practice. The
TeleBPCare study.
Journal of
Hypertension,
27(1), 198-203.
doi:10.1097/HJH.0b
013e3283163caf
Randomized Control
Trial (RCT)
a minimum number of
288 patients were
required to guarantee a
power of 80% and a
minimum level of
significance of 0.05.
Three hundred and
ninety-one hypertensive
patients, consecutively
seen in the GPs’
offices, were screened
for inclusion in the
study. Inclusion criteria
were an age between
18 and 75 years, a
diagnosis of
uncontrolled essential
hypertension, as
defined by the
occurrence of an office
SBP of at least 140
mmHg or DBP of at
least 90 mmHg and by
an ambulatory mean
daytime SBP of at least
130 mmHg or DBP of at
least 80 mmHg
(regardless of whether
patients were or were
not treated). Exclusion
criteria were a
Self blood pressure
monitoring at home may
improve blood pressure
control and patients’
compliance with
treatment, but its
implementation in daily
practice faces
difficulties.
Teletransmission
facilities may offer a
more efficient approach
to long-term home
blood pressure
monitoring.
All patients were
subjected to at
least five office
visits: at
screening (visit
one), at
randomization
(visit two, after 1
week), and during
follow-up (visits
three to five, after
4, 12, and 24
weeks,
respectively). At
inclusion, the
patient’s history
was taken,
combined with a
physical
examination and
two BP
measurements at
a 5 min interval
using the
validated
oscillometric
device that had to
be used for
HBPM
(Tensiophone
device;
288 patients were
required to
guarantee a power
of 80% and a
minimum level of
significance of
0.05. Out of these
329 patients, 288
patients, in whom
all data were
available at the
end of the study,
were included in
the intention-totreat analysis.
Data analysis was
carried out by the
SPSS for Windows
software, version
11.5 (SPSS Inc.,
Chicago, Illinois,
USA). Quantitative
variables were
described through
the calculation of
average � SD
values for each
dataset. Discrete
variables were
described by their
absolute and
Self home blood
pressure
monitoring
(HBPM) has a
number of
potential
advantages in the
management of
hypertension [1].
These
advantages
include avoidance
of the ‘white-coat
effect’, availability
of multiple BP
readings over a
wide time
window,
evaluation of the
effects of
treatment on BP
at different times
of the day, and
improvement in
patients’
adherence to
therapy
Baseline office
blood
pressures were
149 W 12/
89W9 and
148W13/89W7
mmHg in
groups A
(nU111) and B
(n U 187)
respectively,
the
corresponding
daytime values
being 140 W
11/84 W 8 and
139 W 11/84 W
8 mmHg. The
percentage of
daytime blood
pressure
normalization
was higher in
group B (62%)
than in group A
(50%)
(P < 0.05).
There were
less frequent
treatment
Strengths: BP control
was determined by
ABP monitoring which
provides BP values
devoid of
inconveniences such
as the white-coat
effect, the advantage
of combining selfmeasurement of BP at
home with data
teletransmission is
supported by two
additional findings.
Weaknesses: the study
design prevented a
comparison with the
control group
Limitations: The
design adopted does
not allow us to
discriminate the role
played by HBPM per
se and by HBPM
combined with
teletransmission
facilities in obtaining a
greater rate of BP
control.
diagnosis of secondary
hyper- tension; major
systemic diseases;
atrial fibrillation or
frequent cardiac
arrhythmias or severe
atrioventricular block,
that is, conditions that
could make HBPM and
ABP measurements
unreliable; obesity (BMI
>30 kg/m2) or an arm
circumference of more
than 32 cm or both, to
avoid inaccuracies in
automated BP readings
due to arm– cuff
mismatch; and any
condition that might
prevent patients’
participation in the
study, for example,
technical problems due
to incompatible phone
lines at home.
Tensiomed,
Budapest,
Hungary). The
software of this
device was
validated
according to the
International
Protocol
recommended by
the European
Society of
Hypertension
Working Group
on BP monitoring
[11]. The device
is equipped with a
built-in modem
permanently
plugged to the
house phone line
and subjected to
remote
programming of
the frequency of
measurements as
well as of the time
of a telereminding
beep, which can
be sent to the
patient to
stimulate
adherence to
measurement
relative frequency
of occurrence.
Between-group
differences were
assessed by
analysis of
variance for
continuous
variables and by
the chi-squared
test of Mantzel–
Haenszel for
discrete variables.
The betweengroup comparison
of the percentage
of patients with
normalized ABP
was made by chisquared test.
Throughout the
study, the level of
statistical
significance was
set at a P value of
less than 0.05.
changes in
schedule
whenever
appropriate. Selfmonitored BP
values were
regularly
transmitted to a
referral centre
where data were
checked and
stored in a digital
database. Values
exceeding upper
and lower
predefined
arbitrary safety
thresholds
(180/110 and
100/60 mmHg,
respectively)
triggered an
alarm, on the
basis of which a
dedicated trained
nurse called the
patient at home to
check his/her
clinical status and
the possibility of
artefactual
measurements.
HYPERTENSION
58
Appendix C
Table3
Levels and Types of Evidence
Levels and Types of Evidence
Level 1
Meta-analysis or meta-syntheses from
Cochrane Review (Highest)
Level 2
RCT with randomization
Level 3
RCT without randomization
Level 4
Case control or cohort study
Level 5
Systematic review of qualitative or
descriptive study
Level 6
Single or individual qualitative or
descriptive study Clinical practice
guidelines
Level 7
Expert opinion or state of the science
report (Lowest)
1
2
3
4
5
6
7
8
9
10
11
12
X
X
X
X
X
X
X
X
X
X
X
X
HYPERTENSION
59
Appendix D
Table 4
Level of Evidence (Quality Score)
Study
Quality
1-3
1=best
1
Score
LxQ
Design
Study # 1
Level
1-6
1=best
1
1
Study # 2
2
1
2
Metaanalysis
RCT
Study # 3
2
1
2
RCT
Study # 4
2
1
2
RCT
Study # 5
2
1
2
RCT
Study # 6
2
1
2
RCT
Study # 7
2
1
2
RCT
Study # 8
2
1
2
RCT
Study # 9
2
1
2
RCT
Study # 10
2
1
2
RCT
Study # 11
2
1
2
RCT
Study # 12
2
1
2
RCT
HYPERTENSION
60
Appendix E
Table 5
GANTT chart
HYPERTENSION
61
Appendix F
Budget for EBPCP Implementation
HYPERTENSION
62
Appendix G
Interview Sample Questions for Patients’ Satisfaction Evaluation
Open-ended questions
1) How is this educational intervention via tele-monitoring helpful to you in managing your HTN,
adhering to the BP medications, BP monitoring, increasing physical activity, diet control, smoking
cessation and decreasing alcohol consumption?
2) How satisfied are you with the proposed educational intervention incorporating home telemonitoring by APNs?
3) What additional information would you want us to include in this educational intervention?