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- Ensayo clínico NCT00461513
Patient-Centered Heart Failure Trial (PCDM)
Patient-Centered Disease Management for Heart Failure Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background/Rationale: Chronic heart failure (CHF) is a leading cause of morbidity and mortality in the VA. Disease management is a promising strategy to improve care and outcomes, but evidence supporting CHF disease management is inconsistent and open questions remain. Prior studies have not evaluated a multi-modal intervention combining multidisciplinary collaborative care, telemonitoring, promotion of patient self-care, and an explicit intervention for comorbid depression, which is a barrier to optimal CHF care and outcomes. Moreover, the effectiveness of CHF disease management has not been evaluated in the VA.
Objective(s): We propose to evaluate a Patient-Centered Disease Management (PCDM) intervention that includes case finding, collaborative care management for both CHF and comorbid depression, and home telemonitoring. The primary aim will be to ascertain whether the PCDM intervention results in better patient health status (i.e. symptom burden, functional status, and quality of life) than usual care. Secondary aims will include assessment of whether the intervention will reduce hospitalizations or mortality, result in more guideline-concordant care, and reduce depression while increasing patient medication adherence, self-efficacy and satisfaction with treatment.
Methods: We propose a 3-year, multi-site randomized study. VA patients with CHF from 4 VA Medical Centers (Denver, Palo Alto, Richmond, and Seattle) and their affiliated clinics who have diminished CHF-specific health status (Kansas City Cardiomyopathy Questionnaire scores<50) will be eligible. We will randomize enrolled patients to a 12-month PCDM intervention versus usual care (target 300 patients in each arm). The PCDM intervention will include collaborative care management for CHF and comorbid depression and daily telemonitoring. Patient self-care will be promoted through the telemonitoring intervention and the depression intervention. The primary analysis will be a comparison of change in health status (KCCQ scores) between enrollment and 12 months for the intervention versus usual care groups. Secondary analyses will include comparison of rates of hospitalization and death, depressive symptoms, the proportion of patients with guideline concordant CHF care, medication adherence, 6-minute walk test, self-efficacy, and patient satisfaction. In addition, cost-effectiveness analysis will be performed. All analyses will be intention to treat.
Impact: If successful, the proposed intervention will improve the quality of care and outcomes of veterans with CHF and be cost effective. The intervention has the potential to serve as model for other disease management interventions in the VA, and is designed as an 'effectiveness' trial to enhance implementation. This study will be a joint effort of the CHF and IHD QUERI groups, Patient Care Services, and Office of Care Coordination. The study directly addresses several aims of the recently published 'QUERI: A New Direction' position statement, including: a) partnership between QUERI groups; b) explicit collaborative ties between QUERI and 'operational' components of the VA (i.e. Patient Care Services and Office of Care Coordination); c) focus beyond a single disease entity (i.e. CHF and depression); and d) clinical studies of interventions that might be candidates for national VA implementation. Moreover, this study specifically engages patients in their care and emphasizes quality of life outcomes, both of central import to the VA health care mission.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Palo Alto, California, Estados Unidos, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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Colorado
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Denver, Colorado, Estados Unidos, 80220
- VA Eastern Colorado Health Care System, Denver, CO
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Virginia
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Richmond, Virginia, Estados Unidos, 23249
- Hunter Holmes McGuire VA Medical Center, Richmond, VA
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Washington
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Seattle, Washington, Estados Unidos, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Diagnosis of Chronic Heart Failure;
- low health status.
Exclusion Criteria:
- Cognitive/psychiatric impairment (inability to complete questionnaires);
- nursing home resident;
- irreversible non-cardiac medical condition likely to affect 6-month survival or ability to execute study protocol;
- prior heart transplantation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Intervention
The PCDM intervention will include evaluation of CHF care by the collaborative care team, with diagnostic and therapeutic treatment recommendations based on current ACC/AHA national clinical practice guidelines, daily telemonitoring and patient self-care support utilizing the VA telemonitoring system, and screening and treatment for comorbid depression.
The Collaborative Care (CC) team at each site will consist of a primary care provider, cardiologist, and psychiatrist, who are local opinion leaders, as well as a nurse site coordinator and pharmacist.
For a given intervention patient, there will be an initial assessment of care by the CC team following the enrollment visit.
Each intervention patient will be re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months).
In addition, patients will have daily telemonitoring, and their care will be reviewed by the CC team if the telemonitoring data suggests clinical deterioration.
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Disease management has emerged as a promising strategy to improve the outcomes of patients with CHF.
Disease management in this study will use a multidisciplinary collaborative care, leveraging health information technology, and focusing on patient self-care.Collaborative care is the use of multidisciplinary teams to deliver evidence-based treatment to a defined population of patients with chronic illness.
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Usual Care
Patients randomized to the usual care arm will continue to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment.
Patients in the usual care group will also be given information sheets that outline self-care for CHF, and will be provided with a scale, if needed, at the enrollment visit.
Patients in the usual care group will have the same amount of interaction with the study team as the intervention patients (i.e.
complete questionnaires at the same frequency; have the same study visits).
PCPs of usual care patients will be notified of the results of all screening studies (patient survey results, lab tests) as we have done in previous studies.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.
Periodo de tiempo: 12 months
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The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score.
This is reported for each group (Intervention and Usual Care).
The average for each group and standard deviation are reported.
A positive score change represents an improvement in overall patient health status for the group of patients with congestive heart failure.
A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mortality at 1 Year
Periodo de tiempo: 12 months
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Mortality at 1 year
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12 months
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Hospitalization at 1 Year
Periodo de tiempo: 12 months
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Hospitalization at 1 year
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John Spalding Rumsfeld, MD PhD, VA Eastern Colorado Health Care System, Denver, CO
Publicaciones y enlaces útiles
Publicaciones Generales
- Bekelman DB, Plomondon ME, Sullivan MD, Nelson K, Hattler B, McBryde C, Lehmann KG, Potfay J, Heidenreich P, Rumsfeld JS. Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial. BMC Cardiovasc Disord. 2013 Jul 9;13:49. doi: 10.1186/1471-2261-13-49.
- Lum HD, Carey EP, Fairclough D, Plomondon ME, Hutt E, Rumsfeld JS, Bekelman DB. Burdensome Physical and Depressive Symptoms Predict Heart Failure-Specific Health Status Over One Year. J Pain Symptom Manage. 2016 Jun;51(6):963-70. doi: 10.1016/j.jpainsymman.2015.12.328. Epub 2016 Feb 26.
- Bekelman DB, Plomondon ME, Carey EP, Sullivan MD, Nelson KM, Hattler B, McBryde CF, Lehmann KG, Gianola K, Heidenreich PA, Rumsfeld JS. Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial. JAMA Intern Med. 2015 May;175(5):725-32. doi: 10.1001/jamainternmed.2015.0315.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIR 06-068
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Insuficiencia Cardíaca Congestiva
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Region SkaneInscripción por invitaciónInsuficiencia cardíaca New York Heart Association (NYHA) Clase II | Insuficiencia cardíaca New York Heart Association (NYHA) Clase IIISuecia
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... y otros colaboradoresAún no reclutandoInsuficiencia Cardíaca Sistólica | Insuficiencia cardíaca con fracción de eyección reducida | Insuficiencia cardíaca Clase IV de la New York Heart Association | Insuficiencia cardíaca Clase III de la New York Heart AssociationPolonia
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Novartis PharmaceuticalsTerminadoPacientes que completaron con éxito el período de tratamiento de 12 meses del estudio principal (receptores de Novo Heart) que estaban interesados en recibir tratamiento con EC-MPS
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University of WashingtonAmerican Heart AssociationTerminadoInsuficiencia cardíaca, congestiva | Alteración mitocondrial | Insuficiencia cardíaca Clase IV de la New York Heart AssociationEstados Unidos
Ensayos clínicos sobre Intervention
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University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
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Shiraz University of Medical SciencesTerminado
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Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
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Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
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IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
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The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
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VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
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IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
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Sahlgrenska University Hospital, SwedenKarolinska University Hospital; Skane University Hospital; Karlstad Central Hospital y otros colaboradoresActivo, no reclutandoClaudicación intermitenteSuecia