Download Avatar-based Heart Failure Application for Improvement in

Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
Avatar-based Heart Failure Application for
Improvement in Knowledge, Self-care
Management and Reduction of 30-Day Post
Discharge Hospitalization Readmission Among
Ambulatory HF Patients
Investigator: Anne-Marie Uebbing, NP, DNP
Contact information: [email protected]
Associate Professor, Mount Saint Mary College, Newburgh, NY
Mount Saint Mary College, Newburgh, NY
Background
Heart Failure (HF) is a complex disease requiring multiple interventions and extensive follow up.
Furthermore, HF contributes to great morbidity, mortality, an inferior quality of life and is a leading
cause of hospitalization and costly global healthcare budgeting .1 HF affects not only the heart’s
ventricular pumping ability but an additional cascade of events complicating pulmonary and renal
function. 1,2 Additionally, the HF patient frequently experiences anxiety, alienation and a loss of control
due to the many significant lifestyle changes required to prevent complications of HF. These challenges
are disincentives to practice self-care HF management that contribute to poor clinical outcomes. 3,4
Innovative patient-centered strategies to redirect locus of control should prompt investigation to improve
clinical outcomes.
HF has a prevalence of 5.7 million in the United States, and an exponential increase among older
adults; particularly those aged 75 years and above. 6 The 2015 recorded incidence is 10.1% and 4.2/1,000
(ages 45- 54 years), 21.4 and 8.9 %/1,000 (ages 55-64years), 34.6% and 20.0%/1,000 (ages 65-74 years);
increasing dramatically to 59.2% and 40.2%/1,000 (ages 75-84 years), and 74.4% and 65.2%/1,000 (ages
85-94 years). (Men and women respectively). 6 HF is responsible for more than one million primary and
three million secondary hospital admissions annually in the United States.6,7 Similar prevalence exists
globally which warrants different strategies to reduce cardiac complications and costly hospitalizations.
It is also important to consider the prevalence of HF-based differences related to race, ethnicity
and genetics in addition to age and gender. Research identifies higher rates of HF among African
Americans as compared to Whites and Asians but does not distinguish HF-related differences based on
genetic, and ethnicity. 8
The majority of HF readmissions occur within the first 30-day post discharge period and involves
older patients. 6 Recipients of Medicare benefits are reported to have a 20% rate of hospital readmission
between 30 to 90 days after hospital discharge. 7 The majority of these readmissions are for medicationrelated complications, largely attributed to patient non-adherence to medication regimens, therapeutic
protocols, and symptom monitoring. 9 Patient teaching strategies that are continuous, daily and engage
the patient in self-care management demonstrate improved knowledge and locus of control. 5,6 Effective
teaching strategies may help mitigate recurrent acute care interventions and hospital readmissions. 5, 7, 8
HF management places tremendous financial stressors on individuals, caretakers, hospitals and
national health care budgets-notably Medicare. Direct HF medical care costs in the United States are in
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Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
excess of 39 billion dollars and indirect costs amount to 115 million dollars. 7 Clinical staffing demands
for HF patients also present major challenges to the hospital workforce. Initiatives such as Healthy
People 2020 have thus established goals to reevaluate the high incidence, cost and management of chronic
illnesses such as HF-related readmission rates and demand better health care management.9
Research findings indicate that patient-centered care supports better quality of life outcomes. 8,9,10
These findings indicate improved knowledge and continuity of patient self-care, they do not, however,
demonstrate improvement in clinical outcomes. (op. cit.) Additional studies and interventions are
therefore needed to examine potential clinical benefits of patient-centered strategies that directly engage
the HF patient and result in measurable healthcare outcomes including reduced chronic care clinical
management and hospital readmission.
The use of innovative teaching strategies to improve a patients’ knowledge about their condition
has remained a critical focus of HF management. Self-care management closely monitored by dedicated
HF outreach and collaboration with
primary care has demonstrated inconsistent outcomes. This warrants further exploration of other potential
self-care management strategies to support clinical outcomes and patient quality of life. 7.8,9 Strategies
that incorporate mobile technology such as patient-centered HF applications with a leading objective of
improving patient self-care management have proved effective among some populations but require
randomized controlled trials (RCTs) to support evidence-based reduction on HF readmission rates 8,12
Technology Considerations Among Older Adults
The technologic learning curve and demonstrated trends in consumer Smartphone ownership
indicate that older adults (aged 65 and above) are increasingly adopting newer technologies. According to
2013 and 2014 Pew Research Center’s Internet surveys, greater than 77% of adults over 65 years of age
own cell phones (inclusive of Smartphones and Androids). 13, 14 The majority (59%) of the older adult
population, ages 65-75 years, are accessing the Internet for information and social networking and 82% at
least once daily. (op.cit). Older adults prefer Tablets or e-Book computers as compared to Smartphones
and Androids. 14 Smartphones, Androids and desktop touchscreen devices offer voice-activated and handheld options adaptable to the visual, auditory and fine-motor needs of older adults that can mitigate
adaptability concerns. These adaptions support independence among older adults which contributes to an
improved locus of control and is essential in the selection of appropriate devices for study participants.15
For the purposes of this study we will identify participant preferences for phone or tablet app installment.
Projected Benefits of Avatar-based Mobile Applications
HF patient-focused avatar-based teaching has not been tested as a discharge education strategy but
other mobile choices are available to patients. A recent
4
mobile health HF intervention identified 70% greater medication adherence rates as well as reduced
edema and pulmonary symptoms among HF participants after 6 months of receiving self-management
intervention via automated e-mails sent from the patient to their primary care providers.19
HF Mobile applications such as Atlanti Care’s WOW Me 2000mg App have been used to provide
extensive resources to HF patients and the HF community to complement clinical intervention. 19, 20 The
Atlanti Care app provides guidance to the HF patient but it is a narrative-only patient resource, that lacks
an interactive “live” teaching strategy.
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Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
Our research study intends to explore a unique patient teaching strategy. The avatar-based app is
designed to maintain a loop-interactive ability (providing a patient-centered voice-activated feedback
immediately following patient responses). Our research objectives aim to demonstrate the benefits of this
teaching strategy as a means to motivate patients to actively engage in their self-care to produce long-term
health benefits to patients.
Literature Review
A systematic review (SR) of the literature identified no clinically-supported randomized controlled
trials of avatar-based applications as a teaching strategy for HF patients. Avatars have been studied in
chronic illness management, ranging from interactive rehabilitation of stroke patients via game-based
avatar interfaces, Alzheimer’s disease animated interactive software21, 22, depression avatar interventions
to supportive psychotherapy and interventional 23,24 support for anti-viral medication management among
patients with Human Immunodeficiency Virus.25,
Carr, McDermott et al.’s 2014 SR 26 of the literature on the benefits of
computer-assisted learning as a supplement to HF patient discharge education identified only 2 studies
(one randomized control and the other a quasi-experimental design study) that considered the
effectiveness of this strategy on knowledge, quality of life and reduction in 30-day post discharge
readmission. The SR revealed minimal statistically significant evidence of better health outcomes using
computer-assisted learning (op. cit.). The authors recommended additional randomized controlled trials
to that show greater statistical rigor and participant size (op cit.).
Purpose
Research Question:
What is the efficacy of an avatar-based Smartphone application on improvement of CHF patients’
knowledge, self-management, locus of control and reduction in 30-day post-discharge
readmission?
Study Objectives:
This study aims to demonstrate the role and benefits of an avatar-based application as a teaching
strategy for recently discharged HF patients.
Additional objectives hope to demonstrate that participants receiving this intervention will develop
a better understanding of their HF condition, develop self-care management skills and have
reduced 30-day readmission rates.
o The primary hypothesis is that HF patients will develop improved knowledge of their condition,
develop enhanced skills self-management, and a locus of control.
o
The secondary hypothesis suggests that a correlation can be made between a patient’s
enhanced HF knowledge and self-care management and reduction in acute illness leading to rehospitalization within 30 days of discharge.
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Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
In this RCT of 200 recently-discharged HF patients 100 control participants will receive
traditional nurse-led discharge education and phone follow up, and 100 participants will receive the
intervention-based strategy -- an avatar-based application uploaded to their mobile device with designated
prompts for daily blood pressure, weight, heart failure knowledge and self-management diary (focusing
on heart-healthy regimens including medication adherence, dietary choices and exercises and selfbehavior evaluation in addition to traditional discharge education.
Methods
Method design
Intervention clinical trial – We plan a prospective randomized controlled trial of avatar-based smartphone
application as a teaching strategy vs. standardized heart failure discharge education and transitional care
follow-up.
Methods – Sample
Convenience Sampling
Participants will be recruited by a convenience sample method. A dedicated HF nurse and research study
assistant will administer flyers to patients in the HF/observational units. Each participant will also receive
a daily 20-minute bedside
discussion in the presence of a dedicated HF nurse or research assistant with an opportunity for questions
and answers following the discussion. This should result
in 4 sessions of HF avatar-based app teaching. Power points and will be used to support the discussion
and shared with prospective participants via an IPAD or Laptop computer. An accompanying PP handout
will be given to the patient.
Electronic Records
Prospective participants will be identified only by electronic health record coding to preserve the identity
of the patient. Diagnostic coding will also be retrieved from the patient census and or the patient
database. The participant’s clinical history and medication regimen, allergies and pertinent clinical
discharge information will also be noted under a coded, nameless account for those who meet inclusion
criteria.
Sample Size
A total sample size of n=200 participants (100 control/100 intervention) will be selected.
Power analysis
Based on the study’s proposed sample size of 200, a reliable estimation of a reasonable minimal effect to
detect the effect of the intervention, a power analysis of 0.10 (Null hypothesis p = 0.55) is required.
Participant Assignment
Participants will be recruited from a community hospital heart failure or observational unit.
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Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
Intervention group
A group of randomly assigned participants who will receive standard discharge education during their
hospital stay in addition to repeat-demonstration avatar-based HF application navigation, questionnaire
responses and bedside demonstration on directions for wireless bedside weights and blood pressure cuff
recording and review of checklist for biometric data and diary completion.
Control group
A group of randomly assigned participants of will receive traditional nurse-led HF discharge bedside
education and follow up phone calls as per the current transitional care protocol on the HF or
Observational unit.
Setting
(Primarily ambulatory home-based)
Participants will initially be inpatients in a HF or Observational unit. On day 1 of hospital admission
upon meeting the study inclusion criteria and agreeing to Informed Patient Consent patients will be
assigned to study groups (control and intervention). On day 2-through day of discharge participants will
receive participant study task instructions. Upon discharge to home, participants will actively engage in
data submission from their homes via their assigned devices. Participants must be capable of ambulation
and provide routine self-care (e.g., obtaining daily weights and blood pressure measurements, selfadministration of medications, provision of heart-healthy nutrition and exercise.)
Design:
This is a randomized controlled educational teaching strategy intervention-based clinical trial.
Questionnaires
Participants will receive a daily questionnaire derived from the Minnesota Living with Heart Failure
Toolkit (MLWHFQ. Including a 6 question survey assessment. (MLWHFQ) 27 Questions will focus on
routine daily activities (inclusive of
biometric data, medication use and lifestyle practices). This questionnaire will have additional prompts to
encourage participant responses and provide positively reinforced messages (e.g., “Great. You are right
on target.”) or re-direct the patient to assess their knowledge, health behaviors and regimen. (e.g., “You
can benefit from some guidance on this. Let’s review your medication regimen.”)
Preliminary questionnaire
A Likert-9 question survey derived from the Dutch Heart Failure Knowledge Assessment questionnaire 28
will be administered prior to the initiation of the study to assess prospective participants preferences with
the use of avatar versus a narrative interventional design. (Participants will be administered either a
voice-activated avatar-based questionnaire or a narrative questionnaire at the point of discharge prior to
the initiation of the larger study.) This will be used as a validation method to determine the reliability of
the avatar vs. narrative preference and impact on participants’ behavioral and self-management outcomes.
It will be included in the post-study analysis.
(An example of this preliminary questionnaire is attached in Appendix A)
Pre-and Post Participant Satisfaction Survey
It is essential that an assessment of participants’ feedback of the study design, and implementation be
considered. A brief 6 question focused Likert-based questionnaire covering various aspects of the study
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Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
will be given to participants upon enrollment and post-completion. (e.g., “Do you believe you have a
good understanding of your heart condition?”)
Inclusion Criteria
o Adult men and women inpatients and recently discharged patients with a diagnose of heart
failure
o Age over 18 years.
o Participants who demonstrate an ability to navigate a Smartphone or android phone, or
have a comparable device.
o Participants who have a command of English, Spanish, French, Creole, Chinese, and
Filipino
o Participants who have a 4th grade reading level based on CASCAS testing*
Exclusion Criteria:
o Participants younger than 18 years of age.
o Participants without a diagnosis of HF.
o Participants who are incapable of navigating a smartphone or android phone, or
comparable device.
o Participants with cognitive impairment (e.g. delirium, dementia, Alzheimer’s disease).
o Participants who do not have a command of English, Spanish, French, Creole, Chinese,
and Filipino are excluded. Participants who do not have a 4th grade reading level based on
CASAS testing*.
* Subject to change
Safety Considerations
Participants’ safety is of utmost consideration and will be protected at all costs. If a participant is
determined to be potentially at risk for any health complication during the actual study based on electronic
or verbal data received by the dedicated heart failure nurse, or study investigator, the participant will be
advised to seek clinical evaluation immediately according to the hospital protocol for HF patients already
in place within the hospital. The study’s goal is to supplement the current HF hospital protocol following
the chain of command. The HF coordinator or designated clinician on call will be contacted. Primary
care providers, cardiologists or any individual identified as the participants chief health provider will be
contacted with electronic and/ or verbal data as per the hospital protocol.
Participants will be reminded to activate an emergency response contact/”911” if they experience
emergent symptoms that involve airway, breathing or circulation symptoms as per the discharge protocol
for HF patients.
As research investigators we will be aware of daily variations in the participant’s biometrics
(weights, blood pressure, medication adherence, activity level, and behavioral diary). This data can
indicate early participant health complications. These findings will be shared with the dedicated HF nurse
team as well as other health care providers as per the hospital HF protocol.
Timeline
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Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
Optimal recruitment of participants will occur during the inpatient period, preferably on day 1 of
admission to the HF, or observational unit. Participants who meet the study criteria and agree to the
Participant’s Informed Consent will be enrolled in the study for a period of 30 days, or, until the
endpoint/ re-admission occurs.
During the 30-day enrollment period should a participant be readmitted to the hospital for HFrelated symptoms, the participant will remain enrolled in the study. At the end of the study the participant
will be stratified according to their unique characteristics (e.g., readmission).
Benchmarks
This study aims to recruit and enroll 200 CHF participants over a period of 90 days beginning
September 1, 2015 and concluding November 30, 2015 for the purposes of administering a preliminary
10-question Likert questionnaire.
If more than 90 days are required to recruit participants it is
foreseeable that 120 days will be requested, or, until 200 participants have been enrolled.
Post-study analysis will occur 2-6 months subsequent to achieving the 200 participant enrollment
completion of questionnaires and any additional surveys.
Following the data outcome analysis of the preliminary questionnaire a full study will be initiated
to determine the effectiveness of an avatar-based HF Smartphone application (HeartLove * 29) to improve
HF knowledge, locus of control, self management and a reduction in 30-day post discharge hospital
readmission. The timeframe of the full study is expected to entail 6-12 months including randomization,
collection of data, data analysis and documentation of findings, however, this is subject to change
depending on the amount of time required for recruitment and enrolment of study participants.
* Copyright pending
Benchmark Dates:
Months 1-3: Prepare study tools (in-progress)
Months 4-7: Administer preliminary study questionnaire (Heart Failure Knowledge and
Assessment of Avatar vs. Narrative Preference) Nov, 2015-March, 2016
Months 8-9: Collect Data (April - May, 2016)
Months 10-13: Analyze data (June –Sept, 2016)
Months 14- 18: Initiate study (Oct, 2016– Feb, 2017)
Data Analysis
Univariable analysis – Items including incidence and duration of hospital readmission, biometric
collection (daily variance of desirable weight and blood pressure parameters), medication adherence, HF
knowledge assessment and self-perception of illness data will be collected, collated and analyzed for
range, mean and mode and frequency distribution and provided in a post-study report.
Bivariable analysis – participant demographic variables will be collected (e.g., language, spatial
image comprehension), collated, analyzed for range, mean and mode of frequency distribution and
presented in a post-study report. An example is provided below.
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Anne-Marie Uebbing / International Journal of New Technologies in Science and Engineering
Vol. 3, Issue. 1,January 2016, ISSN 2349-0780
Sex
Control Group (n= 100)
Age (18- Age (26- Age (36- Age (46- Age (56- Age (66- Age (7525)
35)
45)
55)
65)
75)
86)
Male
Female
14
Intervention Group (n=100)
Sex
Age (18- Age (26- Age (36- Age (46- Age (56- Age (66- Age (7525)
35)
45)
55)
65)
75)
86)
Male
Female
Statistical testing
SPSS software will be used for quantitative statistical analysis
Anova testing will be used for qualitative analysis
Calculation of confidence intervals
A sample distribution using a standard deviation and 95% of the distribution will be use to calculate
confidence (normal distribution). If less than the optimal participant sample size is achieved a tdistribution will be used to determine the confidence interval.
15
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