Clinical trial NCT02044211: Blended Collaborative Care for Heart Failure and Co-Morbid Depression
Official title: Blended Collaborative Care for Heart Failure and Co-Morbid Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure, Systolic
Depression
Cardiovascular Disease
Keywords: Heart Failure, Systolic
Depressive Disorder
Depressive Disorder, Major
Mood Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-01-23
Enrollment: 756
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "Blended" intervention: Blended, centralized, nurse-provided, telephone-delivered collaborative care for both heart failure and depression;

Collaborative care for heart failure: Blended, centralized, nurse-provided, telephone-delivered collaborative care for heart failure alone

Usual Care: PCPs usual care for heart failure and depression; and

Non-Depressed comparison cohort (randomly sampled, not randomized).
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Medical Outcomes Study (MOS) 12-Item Short Form Health Survey Mental Component Summary (SF-12 MCS)
timeFrame: 12-Months Follow-Up
Secondary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 12-Month Follow-Up
measure: Hamilton Rating Scale for Depression (17-Item)
timeFrame: 12-Months Follow-Up
measure: Incidence of Rehospitalization
timeFrame: 12-Month Follow-Up
measure: Mortality
timeFrame: 12-Month Follow-Up
measure: Health Care Costs
timeFrame: 12-Month Follow-Up
measure: Employment
timeFrame: 12-Months Follow-Up
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Bruce L. Rollman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deveney TK, Belnap BH, Mazumdar S, Rollman BL. The prognostic impact and optimal timing of the Patient Health Questionnaire depression screen on 4-year mortality among hospitalized patients with systolic heart failure. Gen Hosp Psychiatry. 2016 Sep-Oct;42:9-14. doi: 10.1016/j.genhosppsych.2016.06.005. Epub 2016 Jun 30.
citation: Schuster JM, Belnap BH, Roth LH, Rollman BL. The Checklist Manifesto in action: integrating depression treatment into routine cardiac care. Gen Hosp Psychiatry. 2016 May-Jun;40:1-3. doi: 10.1016/j.genhosppsych.2016.01.005. Epub 2016 Jan 22. No abstract available.
citation: Herbeck Belnap B, Anderson A, Abebe KZ, Ramani R, Muldoon MF, Karp JF, Rollman BL. Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial. Psychosom Med. 2019 Jul/Aug;81(6):495-505. doi: 10.1097/PSY.0000000000000706.
citation: Rollman BL. Exercise and Cognitive Training to Improve Neurocognitive Outcomes in Patients With Heart Failure: Can Cardiac Rehabilitation Deliver? Am J Geriatr Psychiatry. 2019 Aug;27(8):820-822. doi: 10.1016/j.jagp.2019.05.001. Epub 2019 May 6. No abstract available.
citation: Holber JP, Abebe KZ, Huang Y, Jakicic JM, Anderson AM, Belnap BH, Rollman BL. The Relationship Between Objectively Measured Step Count, Clinical Characteristics, and Quality of Life Among Depressed Patients Recently Hospitalized With Systolic Heart Failure. Psychosom Med. 2022 Feb-Mar 01;84(2):231-236. doi: 10.1097/PSY.0000000000001034.
citation: Rollman BL, Anderson AM, Rothenberger SD, Abebe KZ, Ramani R, Muldoon MF, Jakicic JM, Herbeck Belnap B, Karp JF. Efficacy of Blended Collaborative Care for Patients With Heart Failure and Comorbid Depression: A Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1369-1380. doi: 10.1001/jamainternmed.2021.4978.