A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Conditions
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Coronary Artery Disease, Congestive Heart Failure, Arrhythmia, Depression

Intervention / Treatment
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* Behavioral: Collaborative Care Treatment
* Behavioral: Usual Care Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care<br>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<br>* Depression education, treatment recommendations, coordination of care<br>|
| Active Comparator: Usual Care<br>Usual Care Treatment: Primary medical providers are informed that the patient has depression and that treatment is recommended. | Behavioral: Usual Care Treatment<br>* Treatment as usual, providers are notified of diagnoses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Adequate Depression Treatment at Discharge | 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. | 5 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Symptoms From Baseline to 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. | Baseline, 6 weeks, 12 weeks, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collaborative Care