A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00847132|
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
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:
- 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).
- 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 or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Congestive Heart Failure Arrhythmia Depression||Behavioral: Collaborative Care Treatment Behavioral: Usual Care Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|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|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||June 2010|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847132
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jeff C Huffman, MD||Massachusetts General Hospital|