Abstract

Depression is often comorbid in patients with heart failure (HF) and is associated with worse clinical outcomes. However, depression generally goes unrecognized and untreated in this population. To determine whether a blended collaborative care program for treating both HF and depression can improve clinical outcomes more than collaborative care for HF only and physicians' usual care (UC). This 3-arm, single-blind, randomized effectiveness trial recruited 756 participants with HF with reduced left ventricular ejection fraction (<45%) from 8 university-based and community hospitals in southwestern Pennsylvania between March 2014 and October 2017 and observed them until November 2018. Participants included 629 who screened positive for depression during hospitalization and 2 weeks postdischarge and 127 randomly sampled participants without depression to facilitate further comparisons. Key analyses were performed November 2018 to March 2019. Separate physician-supervised nurse teams provided either 12 months of collaborative care for HF and depression ("blended" care) or collaborative care for HF only (enhanced UC [eUC]). The primary outcome was mental health-related quality of life (mHRQOL) as measured by the Mental Component Summary of the 12-item Short Form Health Survey (MCS-12). Secondary outcomes included mood, physical function, HF pharmacotherapy use, rehospitalizations, and mortality. Of the 756 participants (mean [SD] age, 64.0 [13.0] years; 425 [56%] male), those with depression reported worse mHRQOL, mood, and physical function but were otherwise similar to those without depression (eg, mean left ventricular ejection fraction, 28%). At 12 months, blended care participants reported a 4.47-point improvement on the MCS-12 vs UC (95% CI, 1.65 to 7.28; P = .002), but similar scores as the eUC arm (1.12; 95% CI, -1.15 to 3.40; P = .33). Blended care participants also reported better mood than UC participants (Patient-Reported Outcomes Measurement Information System-Depression effect size, 0.47; 95% CI, 0.28 to 0.67) and eUC participants (0.24; 95% CI, 0.07 to 0.41), but physical function, HF pharmacotherapy use, rehospitalizations, and mortality were similar by both baseline depression and randomization status. In this randomized clinical trial of patients with HF and depression, telephone-delivered blended collaborative care produced modest improvements in mHRQOL, the primary outcome, on the MCS-12 vs UC but not eUC. Although blended care did not differentially affect rehospitalization and mortality, it improved mood better than eUC and UC and thus may enable organized health care systems to provide effective first-line depression care to medically complex patients. ClinicalTrials.gov Identifier: NCT02044211.

Highlights

  • After our study nurses obtained patients’ oral consent through a nurse or physician involved with their care, they confirmed the presence of New York Heart Association class II to IV symptoms and administered the Patient Health Questionnaire (PHQ-2) depression screen.[38]

  • Rates of follow-up assessments were similar by baseline depression status and treatment assignment

  • Primary Outcome Measure At 12-month follow-up, patients with Heart failure (HF) and depression randomized to blended care reported a 4.47-point improved MCS-12 score vs usual care (UC) (Figure 2) (0.34 effect size (ES) improvement; 95% CI, 0.13 to 0.56; P = .002)

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Summary

Methods

Participants Our full study protocol (Supplement 1; the statistical analysis plan is in Supplement 2) has been published[37] and was approved by the University of Pittsburgh’s Institutional Review Board prior to the start of recruitment. Nurse-recruiters identified medically stable hospitalized patients aged 21 years and older with a left ventricular ejection fraction (LVEF) of 45% or less at 2 university-affiliated and 6 community Pittsburgh, Pennsylvania, area hospitals. After our study nurses obtained patients’ oral consent through a nurse or physician involved with their care, they confirmed the presence of New York Heart Association class II to IV symptoms and administered the Patient Health Questionnaire (PHQ-2) depression screen.[38]. We classified the PHQ-2 screen as positive when a patient replied “yes” to at least 1 PHQ item and required that patients be medically stable and discharged home; have no current alcohol abuse, substance abuse, or bipolar disorder; not be in treatment with a mental health specialist or report active suicidality; have no communication barrier; and be mentally competent to provide consent.[39] Upon verification, the nurserecruiters obtained patients’ signed consent. Two weeks after hospital discharge, we telephoned patients to administer the PHQ-940 and required they score 10 or higher to remain protocol eligible

Results
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