Blended Collaborative Care for Heart Failure and Co-Morbid Depression

Phase 2

Completed

• Conditions: Heart Failure, Systolic; Depression; Cardiovascular Disease
• Interventions: Behavioral: Collaborative Care for Heart Failure; Behavioral: Collaborative Care for Depression

• Registration Number: NCT02044211
• Lead Sponsor: University of Pittsburgh

Brief Summary

Depression is highly prevalent among patients with heart failure (HF) and associated with lower levels of health-related quality of life and physical functioning, and higher risk of rehospitalization and mortality, and higher health costs. This Project will compare the effectiveness of a "blended" telephone-delivered collaborative care intervention for treating both HF and depression to: (1) collaborative care for HF-alone ("enhanced usual care"; eUC); and (2) doctors' "usual care" for depression (UC). If proven effective and cost-effective, the potentially more powerful, scalable, efficient "blended" care approach for treating HF and co-morbid depression could have profound implications for improving chronic illness care and stimulate development of "blended" interventions for treating other clusters of related medical conditions.

Detailed Description

Heart failure (HF) is an important public health problem that affects approximately 6.6 million Americans. Despite improvements in cardiac care, it remains the leading cause for hospitalization among Medicare patients and the only major cardiovascular disease whose mortality rate has remained essentially unchanged over the past decade. This failure to improve HF outcomes may be due, in part, to unrecognized and/or inadequately treated depression that is highly prevalent in HF patients. Yet while new HF treatment guidelines advocate routine screening for depression, this recommendation is unlikely to be widely adopted without trial evidence that depression care improves outcomes and efficient methods to provide it.

"Collaborative care" strategies are being increasingly utilized to improve care for HF and other chronic medical conditions, and we recently demonstrated its clinical and cost-effectiveness at treating depression following coronary artery bypass graft surgery. Yet it may be impractical for health care delivery systems to support separate treatment programs for HF and depression. Thus we are encouraged by emerging evidence indicating "blended" collaborative care strategies that target both psychiatric and physical conditions produce greater improvements in mood symptoms and control of cardiovascular risk factors than programs focused solely on depression to propose testing a novel adaptation that could be provided in routine care.

The Specific Aims of this Project are to: (1) evaluate the effectiveness of a telephone-delivered "blended" collaborative care intervention for treating HF and depression that could be adopted into routine clinical practice if proven effective; and (2) advance our understanding of the moderators and mediators of depression treatment on clinical outcomes. We will screen hospitalized patients with systolic HF for depression, and then randomize 625 who screen positive and have at least a moderately elevated level of depressive symptoms at two-weeks following hospital discharge to either: (1) collaborative care for treating both HF and depression ("blended"); (2) collaborative care for treating HF alone (enhanced usual care (eUC)); or (3) their doctors' "usual care" (UC). Additionally, we will enroll 125 non-depressed HF patients to better evaluate the benefits derived from treating depression (total N=750). Our co-primary hypotheses will test whether "blended" collaborative care can produce at 12-months follow-up a: (A) 0.50 effect size (ES) or greater improvement in health-related quality of life (HRQoL) vs. UC; and (B) 0.30 ES or greater improvement in HRQoL vs. eUC. Secondary hypotheses will evaluate the effects of our "blended" intervention on mood, functional status, adherence with guideline-consistent care, incidence of cardiovascular events, health care utilization, and costs.

Improving chronic illness care for medically complex patients is one of the major challenges facing medicine today. We propose to test the effectiveness of an innovative, efficient, scalable, and sustainable intervention that could transform the way HF and other cardiovascular disorders are treated in routine practice.

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-02
• Primary Completion: 2018-10
• Study Completion: 2020-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

1. Systolic heart failure (documented ejection fraction ≤ 40%).
2. HF symptoms meeting criteria for New York Heart Association (NYHA) classes II, III or IV.
3. Inpatient two-item Patient Health Questionnaire (PHQ-2) screen-positive for depression; or PHQ-2 screen negative for depression and PHQ-9 <5 if non-depressed control.
4. PHQ-9 ≥ 10 when reassessed two-weeks following hospital discharge, or PHQ-9 <5 if non-depressed control.
5. No cognitive impairment (as documented in the record, use of donepezil or similar medications for treating cognitive impairment, or the Montreal Cognitive Assessment).
6. Able to be evaluated and treated for depression as an outpatient.
7. English speaking, not illiterate, or possessing any other communication barrier.
8. Have a household telephone.

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Exclusion Criteria

1. Receiving active treatment for a mood or anxiety disorder from a mental health specialist.
2. Unstable medical condition as indicated by history, physical, and/or laboratory findings.
3. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer).
4. Organic mood syndromes, including those secondary to medical illness or drugs.
5. Active suicidal ideation.
6. Current or history of psychotic illness.
7. Current or history of bipolar illness according to patient self-report, past medical history, and diagnostic criteria.
8. Current alcohol or other substance abuse as evidenced by chart review and the AUDIT-C questionnaire.
9. Age ≤ 21 years.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collaborative Care for Heart Failure + Depression	Collaborative Care for Depression	Collaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Counseling for depression Drug: Pharmacotherapy for heart failure Pharmacotherapy for depression
Collaborative Care for Heart Failure Only	Collaborative Care for Heart Failure	Collaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Usual care for depression Drug: Pharmacotherapy for heart failure Usual Care for depression
Collaborative Care for Heart Failure + Depression	Collaborative Care for Heart Failure	Collaborative care program for heart failure and depression involving a nurse care manager providing counseling and treatment advice via telephone Interventions: Behavioral: Counseling for heart failure self-care Counseling for depression Drug: Pharmacotherapy for heart failure Pharmacotherapy for depression

Primary Outcome Measures

Name	Time	Method
Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)	12-Months Follow-Up	Mental Health-Related Quality of Life

Secondary Outcome Measures

Name	Time	Method
Mortality	12-Month Follow-Up	All-Cause and Cardiovascular Mortality
Employment	12-Months Follow-Up
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	12-Month Follow-Up	Disease-Specific Health-Related Quality of Life
Hamilton Rating Scale for Depression (17-Item)	12-Months Follow-Up	Mood symptoms
Incidence of Rehospitalization	12-Month Follow-Up
Health Care Costs	12-Month Follow-Up	Claims data

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States