Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial

BMC Cardiovascular Disorders

John S Rumsfeld⁴  Paul Heidenreich³  Jonathan Potfay⁷  Kenneth G Lehmann²  Connor McBryde⁵  Brack Hattler⁴  Karin Nelson⁸  Mark D Sullivan⁶  Mary E Plomondon⁴  David B Bekelman¹ 

[1] Department of Medicine, University of Colorado School of Medicine at the Anschutz Medical Campus, Aurora, CO, USA;VA Puget Sound Health Care System, 1660 South Columbian Way, 98108 Seattle, WA, USA;VA Palo Alto Health Care System Cardiology (111C), 3801 Miranda Avenue, 94304 Palo Alto, CA, USA;Department of Veterans Affairs, Eastern Colorado Health Care System Cardiology (111B), 1055 Clermont Street, Research (151), 80220 Denver, CO, USA;Department of Veterans Affairs, Eastern Colorado Health Care System, Ambulatory Care 11-B, 1055 Clermont Street, 80220 Denver, CO, USA;Department of Psychiatry and Behavioral Sciences, University of Washington, Box 356560, 98195 Seattle, WA, USA;Richmond VA Medical Center, 1201 Broad Rock Blvd, 23249 Richmond, VA, USA;Department of Medicine, University of Washington, Seattle, WA, USA

关键词: Health status;    Quality of life;    Patient reported outcomes;    Clinical trial;    Heart failure;   

Others  :  857607
DOI  :  10.1186/1471-2261-13-49

 received in 2013-04-30, accepted in 2013-06-18,  发布年份 2013

【 摘 要 】

Background

Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status.

Methods/design

Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality.

Discussion

The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an ‘effectiveness trial’ to support broader implementation in the healthcare system if it is successful.

Trial registration

Unique identifier: NCT00461513

【 授权许可】

   
2013 Bekelman et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Chen J, Normand SL, Wang Y, Krumholz HM: National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries, 1998–2008. JAMA 2011, 306:1669-1678.
• [2]Heidenreich PA, Spertus JA, Jones PG, Weintraub WS, Rumsfeld JS, Rathore SS, Peterson ED, Masoudi FA, Krumholz HM, Havranek EP, et al.: Health status identifies heart failure outpatients at risk for hospitalization or death. J Am Coll Cardiol 2006, 47:752-756.
• [3]DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, West JA, Fowler MB, Greenwald G: Care management for low-risk patients with heart failure: a randomized, controlled trial. Ann Intern Med 2004, 141:606-613.
• [4]Galbreath AD, Krasuski RA, Smith B, Stajduhar KC, Kwan MD, Ellis R, Freeman GL: Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart failure. Circulation 2004, 110:3518-3526.
• [5]Laramee AS, Levinsky SK, Sargent J, Ross R, Callas P: Case management in a heterogeneous congestive heart failure population: a randomized controlled trial. Arch Intern Med 2003, 163:809-817.
• [6]Smith B, Forkner E, Zaslow B, Krasuski RA, Stajduhar K, Kwan M, Ellis R, Galbreath AD, Freeman GL: Disease management produces limited quality-of-life improvements in patients with congestive heart failure: evidence from a randomized trial in community-dwelling patients. Am J Manag Care 2005, 11:701-713.
• [7]Rumsfeld JS, Havranek E, Masoudi FA, Peterson ED, Jones P, Tooley JF, Krumholz HM, Spertus JA: Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol 2003, 42:1811-1817.
• [8]Bodenheimer T, Wagner EH, Grumbach K: Improving primary care for patients with chronic illness. JAMA 2002, 288:1775-1779.
• [9]Von KM, Gruman J, Schaefer J, Curry SJ, Wagner EH: Collaborative management of chronic illness. Ann Intern Med 1997, 127:1097-1102.
• [10]Piette JD, Richardson C, Valenstein M: Addressing the needs of patients with multiple chronic illnesses: the case of diabetes and depression. Am J Manag Care 2004, 10:152-162.
• [11]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.
• [12]Go AS, Yang J, Ackerson LM, Lepper K, Robbins S, Massie BM, Shlipak MG: Hemoglobin level, chronic kidney disease, and the risks of death and hospitalization in adults with chronic heart failure: the Anemia in Chronic Heart Failure: Outcomes and Resource Utilization (ANCHOR) Study. Circulation 2006, 113:2713-2723.
• [13]Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA: The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med 1998, 158:1789-1795.
• [14]Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, et al.: 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation 2009, 119:391-479.
• [15]Fihn SD, Bucher JB, McDonell M, Diehr P, Rumsfeld JS, Doak M, Dougherty C, Gerrity M, Heidenreich P, Larsen G, et al.: Collaborative care intervention for stable ischemic heart disease. Arch Intern Med 2011, 171:1471-1479.
• [16]Unutzer J, Katon W, Callahan CM, Williams JW Jr, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noel PH, Lin EH, et al.: Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA 2002, 288:2836-2845.
• [17]Green CP, Porter CB, Bresnahan DR, Spertus JA: Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol 2000, 35:1245-1255.
• [18]Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA, Pina I, Tooley J, Weintraub WS, et al.: Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J 2005, 150:707-715.
• [19]Kroenke K, Spitzer RL, Williams JB: The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001, 16:606-613.
• [20]Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L: The Hopkins Symptom Checklist (HSCL). A measure of primary symptom dimensions. Mod Probl Pharmacopsychiatry 1974, 7:79-110.
• [21]Steiner JF, Koepsell TD, Fihn SD, Inui TS: A general method of compliance assessment using centralized pharmacy records. Description and validation. Med Care 1988, 26:814-823.
• [22]Greenfield S, Nadler MA, Morgan MT, Shine KI: The clinical investigation and management of chest pain in an emergency department: quality assessment by criteria mapping. Med Care 1977, 15:898-905.
• [23]Sohn MW, Arnold N, Maynard C, Hynes DM: Accuracy and completeness of mortality data in the Department of Veterans Affairs. Popul Health Metr 2006, 4:2. BioMed Central Full Text
• [24]Laird NM, Ware JH: Random-effects models for longitudinal data. Biometrics 1982, 38:963-974.
• [25]Katon W, Cantrell CR, Sokol MC, Chiao E, Gdovin JM: Impact of antidepressant drug adherence on comorbid medication use and resource utilization. Arch Intern Med 2005, 165:2497-2503.
• [26]Grol R, Grimshaw J: From best evidence to best practice: effective implementation of change in patients’ care. Lancet 2003, 362:1225-1230.
• [27]Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM: Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med 2006, 355:251-259.