Blended Collaborative Care for Heart Failure and Co-Morbid Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bruce Rollman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02044211
First received: January 21, 2014
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure, Systolic
Depression
Cardiovascular Disease
Behavioral: Collaborative Care for Heart Failure
Behavioral: Collaborative Care for Depression
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Blended Collaborative Care for Heart Failure and Co-Morbid Depression

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS) [ Time Frame: 12-Months Follow-Up ] [ Designated as safety issue: No ]
    Mental Health-Related Quality of Life


Secondary Outcome Measures:
  • Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: 12-Month Follow-Up ] [ Designated as safety issue: No ]
    Disease-Specific Health-Related Quality of Life

  • Hamilton Rating Scale for Depression (17-Item) [ Time Frame: 12-Months Follow-Up ] [ Designated as safety issue: Yes ]
    Mood symptoms

  • Incidence of Rehospitalization [ Time Frame: 12-Month Follow-Up ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 12-Month Follow-Up ] [ Designated as safety issue: Yes ]
    All-Cause and Cardiovascular Mortality

  • Health Care Costs [ Time Frame: 12-Month Follow-Up ] [ Designated as safety issue: No ]
    Claims data

  • Employment [ Time Frame: 12-Months Follow-Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: February 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Collaborative Care for Heart Failure + 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

Behavioral: Collaborative Care for Heart Failure

Nurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments.

After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist.

Behavioral: Collaborative Care for Depression
The care manager will telephone patients randomized to "blended" care patient to review their psychiatric history including use of antidepressant pharmacotherapy, herbal supplements, and alcohol possibly used to self-medicate depressive symptoms; provide basic psychoeducation about depression and its impact on cardiac disease; recommend various self-management strategies (e.g., sufficient rest and exercise); and describe treatment options. They will include: (1) use of a workbook or computer program to enhance patients' understanding and ability to self-care; (2) initiation or adjustment of antidepressant pharmacotherapy prescribed under their primary care physicians' direction; or (3) referral to a local mental health specialist. The nurse will then telephone the patient to monitor symptoms and pharmacotherapy use, practice skills imparted through workbook assignments, promote adherence with recommended care, and suggest adjustments in treatment as applicable.
Active Comparator: Collaborative Care for Heart Failure Only

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

Behavioral: Collaborative Care for Heart Failure

Nurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments.

After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist.

No Intervention: Usual Care for Heart Failure and Depression
Control group will receive their doctors' usual care for heart failure and depression
No Intervention: Non-Depressed Comparison Cohort
Control group will receive their doctors' usual care for heart failure

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044211

Contacts
Contact: Bruce L. Rollman, MD, MPH (412) 692-2659 rollmanbl@upmc.edu
Contact: Bea Herbeck Belnap, Dr. Biol Hum 412-692-2666 belnapbh@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Bruce L. Rollman, MD,MPH         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Bruce L. Rollman, MD, MPH University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Bruce Rollman, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02044211     History of Changes
Other Study ID Numbers: R01 HL114016
Study First Received: January 21, 2014
Last Updated: September 18, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Heart Failure, Systolic
Depressive Disorder
Depressive Disorder, Major
Mood Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Failure
Cardiovascular Diseases
Heart Failure, Systolic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases

ClinicalTrials.gov processed this record on September 30, 2014