TY - JOUR
T1 - Efficacy of Blended Collaborative Care for Patients with Heart Failure and Comorbid Depression
T2 - A Randomized Clinical Trial
AU - Rollman, Bruce L.
AU - Anderson, Amy M.
AU - Rothenberger, Scott D.
AU - Abebe, Kaleab Z.
AU - Ramani, Ravi
AU - Muldoon, Matthew F.
AU - Jakicic, John M.
AU - Herbeck Belnap, Bea
AU - Karp, Jordan F.
N1 - Funding Information:
Anderson, and Muldoon reported receiving grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Jakicic reported receiving grants from the National Institutes of Health during the conduct of the study; and personal fees from WW International, Inc (scientific advisory board) and Naturally Slim (advisory board) outside the submitted work. Dr Karp reported serving as an adviser for Aifred Health and NightWare; receiving medication supplies for investigator-initiated studies from Pfizer and Indivior; receiving compensation for work on the editorial boards of the Journal of Clinical Psychiatry and American Journal of Geriatric Psychiatry; and preparing and delivering a webinar for Otsuka. No other disclosures were reported.
Funding Information:
Funding/Support: This study was funded by a grant from the National Heart, Lung, and Blood Institute to Dr Rollman (R01 HL114016). The statements in the article are solely the responsibility of the authors and do not necessarily represent the views of the sponsor.
Publisher Copyright:
© 2021 American Medical Association. All rights reserved.
PY - 2021/10
Y1 - 2021/10
N2 - Importance: 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. Objective: 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). Design, Setting, and Participants: 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. Interventions: 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]). Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02044211.
AB - Importance: 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. Objective: 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). Design, Setting, and Participants: 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. Interventions: 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]). Main Outcomes and Measures: 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. Results: 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. Conclusions and Relevance: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT02044211.
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U2 - 10.1001/jamainternmed.2021.4978
DO - 10.1001/jamainternmed.2021.4978
M3 - Article
C2 - 34459842
AN - SCOPUS:85114107566
VL - 181
SP - 1369
EP - 1380
JO - Archives of internal medicine (Chicago, Ill. : 1908)
JF - Archives of internal medicine (Chicago, Ill. : 1908)
SN - 2168-6106
IS - 10
ER -