A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00847132
First received: February 17, 2009
Last updated: November 29, 2010
Last verified: November 2010
  Purpose

Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.

The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.

The following specific aims capture the stepwise goals of this program:

  1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).
  2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 6 weeks, 12 weeks, and 6 months, compared to usual care.

Condition Intervention
Coronary Artery Disease
Congestive Heart Failure
Arrhythmia
Depression
Behavioral: Collaborative care vs. usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Rates of adequate depression treatment at discharge [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depressive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: July 2007
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Collaborative care
A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
Behavioral: Collaborative care vs. usual care
depression education, treatment recommendations, coordination of care
Active Comparator: Usual care
Primary medical providers are informed that the patient has depression and that treatment is recommended.
Behavioral: Collaborative care vs. usual care
depression education, treatment recommendations, coordination of care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inpatient admission for cardiac diagnosis
  • Positive depression evaluation (PHQ-2>2, PHQ-9>9)
  • Ability to provide informed consent

Exclusion Criteria:

  • Active suicidal ideation
  • Bipolar disorder, psychotic disorder, active substance use disorder
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00847132

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff C Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00847132     History of Changes
Other Study ID Numbers: 2007P-001152
Study First Received: February 17, 2009
Last Updated: November 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Collaborative Care

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Depression
Depressive Disorder
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014