Blended Collaborative Care for Heart Failure and Co-Morbid Depression

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.

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.