Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial

Ubolrat Piamjariyakul, Trisha Petitte, Angel Smothers, Sijin Wen, Elizabeth Morrissey, Stephanie Young, George Sokos, Alvin H Moss, Carol E Smith, Ubolrat Piamjariyakul, Trisha Petitte, Angel Smothers, Sijin Wen, Elizabeth Morrissey, Stephanie Young, George Sokos, Alvin H Moss, Carol E Smith

Abstract

Background: Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home.

Methods: This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients' preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state.

Discussion: The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process.

Trial registration: ClinicalTrials.gov NCT04153890, Registered on 4 November 2019.

Keywords: Appalachia; End-of-life; Heart failure; Palliative care; Randomized controlled trial; Study protocol.

Conflict of interest statement

All authors declare that they have no competing interests.

References

    1. Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, et al. Heart disease and stroke statistics – 2019 update: a report from the American Heart Association. Circulation. 2019;139:e56–e528. doi: 10.1161/CIR.0000000000000659.
    1. Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, et al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013;6:606–619. doi: 10.1161/HHF.0b013e318291329a.
    1. Fang JC, Ewald GA, Allen LA, Butler J, Westlake Canary CA, Colvin-Adams M, Dickinson MG, Levy P, et al. Advanced (stage D) heart failure: a statement from the Heart Failure Society of America guidelines committee. J Card Fail. 2015;21:519–534. doi: 10.1016/j.cardfail.2015.04.013.
    1. Munro CL, Savel RH. Aggressive care and palliative care. Am J Crit Care. 2018;27:84–86. doi: 10.4037/ajcc2018757.
    1. WV Health Statistics Center, Department of Health and Human Resources, Bureau for Public Health . West Virginia behavioral risk factor surveillance system report. 2013.
    1. Center for Medicare and Medicaid Services. Conditions prevalence trends: 2007–2014. . Accessed 11 Aug 2019.
    1. Crouch E, Bennett KJ, Probst JC. Rural-urban differences in Medicare service use in the last six months of life. 2017.
    1. National Institute of Nursing Research (NINR). Palliative Care: The relief you need when you have a serious illness. . Accessed 26 Oct 2019.
    1. World Health Organization (WHO). Palliative care: Key facts. . Accessed 26 Oct 2019.
    1. West Virginia Center for End-of-Life Care. Palliative Care: comfort and support for persons with serious illness and their families. . Accessed 1 Oct 2019.
    1. American Association of Heart Failure Nurses (AAHFN). AAHFN releases position statement on patient access. Nurses are in a key position and must advocate for patients and their families across the continuum of care. Accessed 11 Aug 2019.
    1. Braun LT, Grady KL, Kutner JS, Adler E, Berlinger N, Boss R, Butler J, Enguidanos S, et al. Palliative care and cardiovascular disease and stroke: a policy statement from the American Heart Association/American Stroke Association. Circulation. 2016;134:e198–e225. doi: 10.1161/CIR.0000000000000438.
    1. Moser DK, Robinson S, Biddle MJ, Pelter MM, Nesbitt TS, Southard J, Cooper L, Dracup K. Health literacy predicts morbidity and mortality in rural patients with heart failure. J Card Fail. 2015;21:612–618. doi: 10.1016/j.cardfail.2015.04.004.
    1. Buck HG, Harkness K, Wion R, Carroll SL, Cosman T, Kaasalainen S, Kryworuchko J, McGillion M, et al. Caregivers’ contributions to heart failure self-care: a systematic review. Eur J Cardiovasc Nurs. 2015;14:79–89. doi: 10.1177/1474515113518434.
    1. Piamjariyakul U, Smith CE, Russell C, Werkowitch M, Elyachar A. The feasibility of a telephone coaching program on heart failure home management for family caregivers. Heart Lung. 2013;42:32–39. doi: 10.1016/j.hrtlng.2012.08.004.
    1. Piamjariyakul U, Werkowitch M, Wick J, Russell C, Vacek JL, Smith CE. Caregiver coaching program effect: reducing heart failure patient rehospitalizations and improving caregiver outcomes among African Americans. Heart Lung. 2015;44:466–473. doi: 10.1016/j.hrtlng.2015.07.007.
    1. Meyers DE, Goodlin SJ. End-of-life decisions and palliative care in advanced heart failure. Can J Cardiol. 2016;32:1148–1156. doi: 10.1016/j.cjca.2016.04.015.
    1. Wongpiriyayothar A, Piamjariyakul U, Williams PD. Effects of coaching using telephone on dyspnea and physical functioning among persons with chronic heart failure. Appl Nurs Res. 2011;24:e59–e66. doi: 10.1016/j.apnr.2010.02.007.
    1. Piamjariyakul U, Yadrich DM, Russell C, Myer J, Prinyarux C, Vacek JL, Ellerbeck EF, Smith CE. Patients’ annual income adequacy, insurance premiums and out-of-pocket expenses related to heart failure care. Heart Lung. 2014;43:469–475. doi: 10.1016/j.hrtlng.2014.05.013.
    1. Piamjariyakul U, Smith CE, Werkowitch M, Thompson N, Fox M, Williamson KP, Olson L. Designing and testing an end-of-life discussion intervention for African American patients with heart failure and their families. J Hosp Palliat Nurs. 2016;18:528–535. doi: 10.1097/NJH.0000000000000290.
    1. Piamjariyakul U, Smith CE, Smothers A, Young S, Krupp JE, Parker J. Empirical Verification of a Coaching Model for Home Care of Rare and Advanced Lung Diseases. Int J Pul & Res Sci. 2018;3(2):555607. doi: 10.19080/IJOPRS.2018.03.555607.
    1. Khariton Y, Nassif ME, Thomas L, Fonarow GC, Mi X, DeVore AD, Duffy C, Sharma PP, et al. Health status disparities by sex, race/ethnicity, and socioeconomic status in outpatients with heart failure. JACC Heart Fail. 2018;6:465–473. doi: 10.1016/j.jchf.2018.02.002.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687.
    1. Badr H, Smith CB, Goldstein NE, Gomez JE, Redd WH. Dyadic psychosocial intervention for advanced lung cancer patients and their family caregivers: results of a randomized pilot trial. Cancer. 2015;121(1):150–158. doi: 10.1002/cncr.29009.
    1. Buck HG, Mogle J, Riegel B, McMillan S, Bakitas M. Exploring the relationship of patient and informal caregiver characteristics with heart failure self-care using the actor-partner interdependence model: implications for outpatient palliative care. J Palliat Med. 2015;18(12):1026–1032. doi: 10.1089/jpm.2015.0086.
    1. McCambridge J, Kypri K, Elbourne D. In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials. J Clin Epidemiol. 2014;67:247–253. doi: 10.1016/j.jclinepi.2013.09.004.
    1. Campbell ML, Kiernan JM, Strandmark J, Yarandi HN. Trajectory of dyspnea and respiratory distress among patients in the last month of life. J Palliat Med. 2018;21:194–199. doi: 10.1089/jpm.2017.0265.
    1. Williams BA, Doddamani S, Troup MA, Mowery AL, Kline CM, Gerringer JA, Faillace RT. Agreement between heart failure patients and providers in assessing New York heart Association functional class. Heart Lung. 2017;46:293–299. doi: 10.1016/j.hrtlng.2017.05.001.
    1. Pang PS, Lane KA, Tavares M, Storrow AB, Shen C, Peacock WF, Nowak R, Mebazaa A, et al. (2017). Is there a clinically meaningful difference in patient reported dyspnea in acute heart failure? An analysis from URGENT dyspnea. Heart Lung. 2017;46:300–307. doi: 10.1016/j.hrtlng.2017.03.003.
    1. Carpenter R, Theeke LA. Strategies for recruiting a sample of adults with type 2 diabetes from primary care clinics in rural Appalachia: incorporating cultural competence. Int J Nurs Sci. 2018;19(5):230–237.
    1. Motzer S, Moseley JR, Lewis FM. Recruitment and retention of families in clinical trials longitudinal designs. West J Nurs Res. 1997;19:314–333. doi: 10.1177/019394599701900304.
    1. Institute for Healthcare Improvement Initiatives: Conversation Ready. . Accessed 1 Aug 2019.
    1. American Association of Heart Failure Nurses. Care for the Caregiver. . Accessed 1 Aug 2019.
    1. Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, et al. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH behavior change consortium. Health Psychol. 2004;23:443–451. doi: 10.1037/0278-6133.23.5.443.
    1. Keppel G, Wickens TD. Design & Analysis: a Researcher’s handbook. 4. New Jersey: Prentice Hall; 2004.
    1. Lewis WF, Claggett BL, McMurray JCV, Packer M, Lefkowitz MP, Rouleau JL, Liu J, Shi VC, et al. Health-related quality of life outcomes in PARADIGM-HF. Circ Heart Fail. 2017;10:e003430. doi: 10.1161/CIRCHEARTFAILURE:116.003430.
    1. Spertus JA, Jones PG. Development and validation of a short version of the Kansas City cardiomyopathy questionnaire. Circ Cardiovasc Qual Outcomes. 2015;8:469–476. doi: 10.1161/CIRCOUTCOMES.115.001958.
    1. Kroenke K, Spitzer RL, Williams JB, Löwe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009;50:613–621.
    1. Bowden K, Fitzgerald SA, Piamjariyakul U, Werkowitch M, Thompson NC, Keighley J, Smith CE. Comparing patient and nurse specialist reports of causative factors of depression related to heart failure. Perspect Psychiatr Care. 2011;47:98–104. doi: 10.1111/j.1744-6163.2010.00279.x.
    1. Jaarsma T, Arestedt KF, Martensson J, Dracup K, Strömberg A. The European heart failure self-care behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009;11:99–105. doi: 10.1093/eurjhf/hfn007.
    1. Riegel B, Carlson B, Moser DK, Sebern M, Hicks FD, Roland V. Psychometric testing of the self-care of heart failure index. J Card Fail. 2004;10:350–360. doi: 10.1016/j.cardfail.2003.12.001.
    1. Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990;13:375–384. doi: 10.1002/nur.4770130605.
    1. Ware JE, Jr, Kosinski M, Turner-Bowker DM, Gandek B. How to score version 2 of the SF-12® health survey (with a supplement documenting version 1) Lincoln, RI: QualityMetric Incorporated; 2002.
    1. Al-Rawashdeh SY, Lennie TA, Chung ML. Psychometrics of the Zarit Burden Interview in caregivers of patients with heart failure. J Cardiovasc Nurs. 2016;31:E21–E28. doi: 10.1097/JCN.0000000000000348.
    1. Higginson IJ, Gao W, Jackson D, Murray J, Harding R. Short-form Zarit caregiver burden interviews were valid in advanced conditions. J Clin Epidemiol. 2010;63:535–542. doi: 10.1016/j.jclinepi.2009.06.014.
    1. Verbeke G, Molenberghs G. Linear mixed models for longitudinal data. New York: Springer; 2001.
    1. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457–481. doi: 10.1080/01621459.1958.10501452.
    1. Fitrianto A, Jiin RLT. Several types of residuals in cox regression model: an empirical study. Int J Math Anal. 2013;7:2645. doi: 10.12988/ijma.2013.38193.
    1. Duenas A. Cost-Minimization Analysis. In: Gillman MD, Turner JR, editors. Encyclopedia of Behavioral Medicine. 2013. p. 516.
    1. Bengtsson Mariette. How to plan and perform a qualitative study using content analysis. NursingPlus Open. 2016;2:8–14. doi: 10.1016/j.npls.2016.01.001.
    1. Nicholas Dionne-Odom J, Hooker SA, Bekelman D, Ejem D, McGhan G, Kitko L, Strömberg A, Wells R, et al. IMPACT-HF National Workgroup. Family caregiving for persons with heart failure at the intersection of heart failure and palliative care: a state-of-the-science review. Heart Fail Rev. 2017;22:543–557. doi: 10.1007/s10741-017-9597-4.
    1. Smith CE, Piamjariyakul U, Wick J, Spertus JA, Russell C, Dalton KM, Elyachar A, Vacek JL, et al. Multidisciplinary group clinic appointments: the self-management and Care of Heart Failure (SMAC-HF) trial. Circ Heart Fail. 2014;7:888–894. doi: 10.1161/CIRCHEARTFAILURE.113.001246.

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