A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial

Jeanne T Black, Patrick S Romano, Banafsheh Sadeghi, Andrew D Auerbach, Theodore G Ganiats, Sheldon Greenfield, Sherrie H Kaplan, Michael K Ong, BEAT-HF Research Group, Arjang Ahmadpour, Wendy Davila, Susanne Engel, Ronald Jacolbia, Herman Lee, Laura Linares, Elizabeth Michel, Meghan Soulsby, Elizabeth Zellmer, Lida Esbati-Mashayekhi, Elisabeth Haddad, Marian Haskins, Tianne Larson, Kathryn Pratt, Hendry Ansorie, Kymberly Aoki, Ruth Baron, Eileen Brinker, Maureen Carroll, Annette Contasti, Anne Fekete, Vivian Guzman, Linda Larsen, Lisa Martinez, Sharon Myers, Amanda Schnell-Heringer, Arlene Taylor, Tracy Tooley, Melanee Schimmel, Geoffrey van den Brande, Evanthia Zaharias, John Billimek, Rocio Castaneda, Ma Elloi Delos Reyes, Dana Fine, Hassan Tammy Lo, Xoan Luu, Socorro Ochoa, Mayra Perez, David Rincon, Fidelia Sillas, Esther Wang, Visith Uy, Haiyong Xu, Stella Yala, Tingjian Yan, Jeanne T Black, Patrick S Romano, Banafsheh Sadeghi, Andrew D Auerbach, Theodore G Ganiats, Sheldon Greenfield, Sherrie H Kaplan, Michael K Ong, BEAT-HF Research Group, Arjang Ahmadpour, Wendy Davila, Susanne Engel, Ronald Jacolbia, Herman Lee, Laura Linares, Elizabeth Michel, Meghan Soulsby, Elizabeth Zellmer, Lida Esbati-Mashayekhi, Elisabeth Haddad, Marian Haskins, Tianne Larson, Kathryn Pratt, Hendry Ansorie, Kymberly Aoki, Ruth Baron, Eileen Brinker, Maureen Carroll, Annette Contasti, Anne Fekete, Vivian Guzman, Linda Larsen, Lisa Martinez, Sharon Myers, Amanda Schnell-Heringer, Arlene Taylor, Tracy Tooley, Melanee Schimmel, Geoffrey van den Brande, Evanthia Zaharias, John Billimek, Rocio Castaneda, Ma Elloi Delos Reyes, Dana Fine, Hassan Tammy Lo, Xoan Luu, Socorro Ochoa, Mayra Perez, David Rincon, Fidelia Sillas, Esther Wang, Visith Uy, Haiyong Xu, Stella Yala, Tingjian Yan

Abstract

Background: Heart failure is a prevalent health problem associated with costly hospital readmissions. Transitional care programs have been shown to reduce readmissions but are costly to implement. Evidence regarding the effectiveness of telemonitoring in managing the care of this chronic condition is mixed. The objective of this randomized controlled comparative effectiveness study is to evaluate the effectiveness of a care transition intervention that includes pre-discharge education about heart failure and post-discharge telephone nurse coaching combined with home telemonitoring of weight, blood pressure, heart rate, and symptoms in reducing all-cause 180-day hospital readmissions for older adults hospitalized with heart failure.

Methods/design: A multi-center, randomized controlled trial is being conducted at six academic health systems in California. A total of 1,500 patients aged 50 years and older will be enrolled during a hospitalization for treatment of heart failure. Patients in the intervention group will receive intensive patient education using the 'teach-back' method and receive instruction in using the telemonitoring equipment. Following hospital discharge, they will receive a series of nine scheduled health coaching telephone calls over 6 months from nurses located in a centralized call center. The nurses also will call patients and patients' physicians in response to alerts generated by the telemonitoring system, based on predetermined parameters. The primary outcome is readmission for any cause within 180 days. Secondary outcomes include 30-day readmission, mortality, hospital days, emergency department (ED) visits, hospital cost, and health-related quality of life.

Discussion: BEAT-HF is one of the largest randomized controlled trials of telemonitoring in patients with heart failure, and the first explicitly to adapt the care transition approach and combine it with remote telemonitoring. The study population also includes patients with a wide range of demographic and socioeconomic characteristics. Once completed, the study will be a rich resource of information on how best to use remote technology in the care management of patients with chronic heart failure.

Trial registration: ClinicalTrials.gov # NCT01360203.

Figures

Figure 1
Figure 1
Diagram of BEAT-HF patient enrollment, randomization, intervention, and time line.

References

    1. Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013;61:391–403. doi: 10.1016/j.jacc.2012.09.038.
    1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME. et al.Heart disease and stroke statistics - 2013 update: a report from the American Heart Association. Circulation. 2013;127:e6–e245. doi: 10.1161/CIR.0b013e31828124ad.
    1. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360:1418–1428. doi: 10.1056/NEJMsa0803563.
    1. Yale New Haven Health Services Corporation/Center for Outcomes Research & Evaluation. 2013 measures updates and specifications report: hospital-level 30-day risk-standardized readmission measures for acute myocardial infarction, heart failure, and pneumonia (version 6.0) New Haven, CT: YNHHSC/CORE; 2013.
    1. Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Norman S-L, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009;2:407–413.
    1. Ong MK, Mangione CM, Romano PS, Zhou Q, Auerbach AD, Chun A, Davidson B, Ganiats TG, Greenfield S, Gropper MA, Malik S, Rosenthal JT, Escarce JJ. Looking forward, looking back: assessing variations in hospital resource use and outcomes for elderly patients with heart failure. Circ Cardiovasc Qual Outcomes. 2009;2:548–557.
    1. Department of Health and Human Services, Centers for Medicare & Medicaid Services. Provisions for the Hospital Readmissions Reduction Program. Final rule. Fed Regist. 2011;76(160):51559.
    1. Van Walraven C, Jennings A, Forster AJ. A meta-analysis of hospital 30-day avoidable readmission rates. J Eval Clin Pract. 2012;18:1211–1218. doi: 10.1111/j.1365-2753.2011.01773.x.
    1. Naylor MD, Brooten D, Campbell R, Jacobsen BS, Mezey MD, Pauly MV, Schwartz JS. Comprehensive discharge planning and home follow-up of hospitalized elders: a randomized clinical trial. JAMA. 1999;281:613–620. doi: 10.1001/jama.281.7.613.
    1. Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004;52:675–684. doi: 10.1111/j.1532-5415.2004.52202.x.
    1. Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006;166:1822–1828. doi: 10.1001/archinte.166.17.1822.
    1. Stauffer BD, Fullerton C, Fleming N, Ogola G, Herrin J, Martin Stafford P, Ballard DJ. Effectiveness and cost of a transitional care program for heart failure: a prospective study with concurrent controls. Arch Intern Med. 2011;171:1238–1243. doi: 10.1001/archinternmed.2011.274.
    1. Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JGF. Structured telephone support or telemonitoring programmes for patients with chronic heart failure (Review) Cochrane Database Syst Rev. 2010;8 CD007228.
    1. Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JGF. Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: abridged Cochrane review. Eur J Heart Fail. 2011;13:1028–1040. doi: 10.1093/eurjhf/hfr039.
    1. Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010;363:2301–2309. doi: 10.1056/NEJMoa1010029.
    1. Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Boehm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan B-A, Anker SD. on behalf of the Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure. Circulation. 2011;123:1873–1880. doi: 10.1161/CIRCULATIONAHA.111.018473.
    1. Krumholz HM, Amatruda J, Smith GL, Mattera JA, Roumanis SA, Radford MJ, Crombie P, Vaccarino V. Randomized trial of an education and support intervention to prevent readmission of patients with heart failure. J Am Coll Cardiol. 2002;39:83–89.
    1. Desai AS, Stevenson LW. Connecting the circle from home to heart-failure disease management. New Engl J Med. 2010;363:2364–2367. doi: 10.1056/NEJMe1011769.
    1. Ryan C. Language use in the United States, 2011. American community survey reports 2013, ACS-22. .
    1. Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002;40:771–781. doi: 10.1097/00005650-200209000-00007.
    1. DeWalt DA, Malone RM, Bryant ME, Kosnar MC, Corr KE, Rothman RL, Sueta CA, Pignone MP. A heart failure self-management program for patients of all literacy levels: a randomized, controlled trial [ISRCTN11535170] BMC Health Serv Res. 2006;6:30. doi: 10.1186/1472-6963-6-30.
    1. Cleland JGF, Louis AA, Rigby AS, Janssens U, Balk AHMM. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the Trans-European Network-Home-Care Management System (TEN-HMS) study. J Am Coll Cardiol. 2005;45:1654–1664. doi: 10.1016/j.jacc.2005.01.050.
    1. Rector T, Kubo S, Cohn J. Patient’s self-assessment of their congestive heart failure. Part 2: content, reliability and validity of a new measure, the Minnesota Living with Heart Failure Questionnaire. Heart Failure. 1987;3:198–209.
    1. Litwin MS, Greenfield S, Elkin EP, Lubeck DP, Broering JM, Kaplan SH. Assessment of prognosis with the Total Illness Burden Index for prostate cancer: aiding clinicians in treatment choice. Cancer. 2007;109:1777–1783. doi: 10.1002/cncr.22615.
    1. Kessler RC, Ames M, Hymel PA, Loeppke R, McKenas DK, Richling D, Stang PE, Ustun TB. Using the World Health Organization Health and Work Performance Questionnaire (HPQ) to evaluate the indirect workplace costs of illness. J Occup Environ Med. 2004. pp. S23–S37.
    1. Parry C, Mahoney E, Chalmers SA, Coleman EA. Assessing the quality of transitional care: further applications of the Care Transitions Measure. Med Care. 2008;46:317–322. doi: 10.1097/MLR.0b013e3181589bdc.
    1. Bass PF 3rd, Wilson JF, Griffith CH. A shortened instrument for literacy screening. J Gen Intern Med. 2003;18:1036–1038. doi: 10.1111/j.1525-1497.2003.10651.x.
    1. Sheikh JI, Yesavage JA. In: Clinical Gerontology: A Guide to Assessment and Intervention. Brink TL, editor. New York: The Hayworth Press; 1986. Geriatric Depression Scale (GDS): recent evidence and development of a shorter version; pp. 165–174.
    1. Riegel B, Lee CS, Dickson VV, Carlson B. An update on the Self-Care of Heart Failure Index. J Cardiovasc Nurs. 2009;24:485–497. doi: 10.1097/JCN.0b013e3181b4baa0.
    1. Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006;46:503–513. doi: 10.1093/geront/46.4.503.
    1. Sayers SL, White T, Zubritsky C, Oslin DW. Family involvement in the care of healthy medical outpatients. Fam Pract. 2006;23:317–324. doi: 10.1093/fampra/cmi114.
    1. Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens. 2008;10:348–354. doi: 10.1111/j.1751-7176.2008.07572.x.
    1. Stewart S, Carrington MJ, Marwick TH, Davidson PM, Macdonald P, Horowitz JD, Krum H, Newton PJ, Reid C, Chan YK, Scuffham PA. Impact of home versus clinic-based management of chronic heart failure: the WHICH? (Which heart failure intervention is most cost-effective & consumer friendly in reducing hospital care) multicenter, randomized trial. J Am Coll Cardiol. 2012;60:1239–1248. doi: 10.1016/j.jacc.2012.06.025.
    1. Scalvini S, Giordano A. Optimal postdischarge management of chronic HF. Nat Rev Cardiol. 2012;10:9–10. doi: 10.1038/nrcardio.2012.161.
    1. American College of Healthcare Executives announces top issues confronting hospitals. 2012. .
    1. Roccaforte R, Demers C, Baldassare F, Teo KK, Yusuf S. Effectiveness of comprehensive disease management programmes in improving clinical outcomes in heart failure patients. A meta analysis. Eur J Heart Failure. 2005;7:1133–1144. doi: 10.1016/j.ejheart.2005.08.005.

Source: PubMed

3
S'abonner