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A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00847132
First received: February 17, 2009
Last updated: March 21, 2017
Last verified: March 2017
  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 Treatment Behavioral: Usual Care Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Jeff C. Huffman, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Rates of Adequate Depression Treatment at Discharge [ Time Frame: 5 days after enrollment ]

    Adequate treatment was defined a priori as either: (1) discharge prescription of an antidepressant at a clinically effective dose based on manufacturers' package labeling and treatment guidelines for the treatment of depression or (2) referral to a mental health treatment provider for psychotherapy (unless pre-planned as less than six sessions).

    Timeframe of "5 days after enrollment" was determined by calculating the median length of hospitalization for all subjects.



Secondary Outcome Measures:
  • Change in Depression Symptoms From Baseline to 6 Months [ Time Frame: Baseline, 6 weeks, 12 weeks, 6 months ]
    Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.


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
Collaborative Care Treatment: 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 Treatment
Depression education, treatment recommendations, coordination of care
Active Comparator: Usual Care
Usual Care Treatment: Primary medical providers are informed that the patient has depression and that treatment is recommended.
Behavioral: Usual Care Treatment
Treatment as usual, providers are notified of diagnoses

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff C. Huffman, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00847132     History of Changes
Other Study ID Numbers: 2007P-001152
Study First Received: February 17, 2009
Results First Received: August 14, 2014
Last Updated: March 21, 2017

Keywords provided by Jeff C. Huffman, MD, Massachusetts General Hospital:
Collaborative Care

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

ClinicalTrials.gov processed this record on August 23, 2017