- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00461513
Patient-Centered Heart Failure Trial (PCDM)
Patient-Centered Disease Management for Heart Failure Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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California
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Palo Alto, California, Stati Uniti, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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Colorado
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Denver, Colorado, Stati Uniti, 80220
- VA Eastern Colorado Health Care System, Denver, CO
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Virginia
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Richmond, Virginia, Stati Uniti, 23249
- Hunter Holmes McGuire VA Medical Center, Richmond, VA
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Washington
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Seattle, Washington, Stati Uniti, 98108
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mortality at 1 Year
Lasso di tempo: 12 months
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Mortality at 1 year
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12 months
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Hospitalization at 1 Year
Lasso di tempo: 12 months
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Hospitalization at 1 year
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12 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: John Spalding Rumsfeld, MD PhD, VA Eastern Colorado Health Care System, Denver, CO
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IIR 06-068
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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