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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 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 Available online @ www.ijntse.com 49 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. Available online @ www.ijntse.com 50 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. Available online @ www.ijntse.com 51 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. Available online @ www.ijntse.com 52 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 Available online @ www.ijntse.com 53 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 Available online @ www.ijntse.com 54 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. Available online @ www.ijntse.com 55 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 References 1 Friedmann, E., Thomas, S., Liu, F., Morton, P., Chapa, D., Gottlieb, S., Relationship of depression, anxiety, and social isolation to chronic heart failure outpatient mortality (2006) American Heart Journal 15(2(5):940.e1-940.e8. retrieved from: ahjonlin.com doi: 10.1161/CIR.0b013e31828124ad-e24ad 2 Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravatta DM, Dai S, et al. Heart disease and stroke statistics –2013 update: A report from the American heart association. Circulation 2013;127(1 :e6e245.doi: 10.1161/CIR.0b013e31828124ad. (2013) 3 American Heart Association, Inc. Factsheet (2015). Retrieved from: heart.org 4 Jeon Y-H, Krauss S, Jowsey, T., Glasgow N. The experience of living with chronic heart failure: a narrative review of qualitative studies. 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Retrieved from: license.umn.edu 19 van der Wal, M H L, Jaarsma, T, Moser, D, and van Veldhuisen, D J (2005) Development and Testing of the Dutch Heart Failure Knowledge Scale. Eur J Cardiovasc Nurs December 2005 4(4) 273-277. doi: 10.1016/j.ejcnurse.2005.07.003 28 29 HeartLove app (Pending copyright) Uebbing, A. (2015). Available online @ www.ijntse.com 58