Coronary Artery Disease, Congestive Heart Failure, Arrhythmia, Depression
Conditions
Keywords
Collaborative Care
Brief summary
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.
Interventions
BEHAVIORALCollaborative Care Treatment
Depression education, treatment recommendations, coordination of care
BEHAVIORALUsual Care Treatment
Treatment as usual, providers are notified of diagnoses
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Adequate Depression Treatment at Discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Symptoms From Baseline to 6 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Collaborative Care Treatment: depression education, treatment recommendations, coordination of care | 90 |
| Usual Care Primary medical providers are informed that the patient has depression and that treatment is recommended.
Usual Care Treatment: treatment as usual, providers are notified of diagnoses | 85 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Collaborative Care | Total |
|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 12.2 | 62.1 years STANDARD_DEVIATION 12.8 | 62.35 years STANDARD_DEVIATION 12.5 |
| Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) | 9.7 units on a scale STANDARD_DEVIATION 4 | 10.8 units on a scale STANDARD_DEVIATION 4.5 | 10.3 units on a scale STANDARD_DEVIATION 4.3 |
| Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) | 25.4 units on a scale STANDARD_DEVIATION 4.4 | 26.1 units on a scale STANDARD_DEVIATION 5.2 | 25.7 units on a scale STANDARD_DEVIATION 4.8 |
| Medical Outcomes Study Short Form-12 Mental Component Score (SF-12 MCS) | 32.5 units on a scale STANDARD_DEVIATION 7.8 | 30.9 units on a scale STANDARD_DEVIATION 8 | 31.7 units on a scale STANDARD_DEVIATION 7.9 |
| Medical Outcomes Study Short Form-12 Physical Component Score (SF-12 PCS) | 31.3 units on a scale STANDARD_DEVIATION 9.4 | 32.2 units on a scale STANDARD_DEVIATION 10.4 | 31.8 units on a scale STANDARD_DEVIATION 9.9 |
| Patient Health Questionnaire-9 (PHQ-9) | 17.3 units on a scale STANDARD_DEVIATION 3.1 | 17.9 units on a scale STANDARD_DEVIATION 3.8 | 17.6 units on a scale STANDARD_DEVIATION 3.5 |
| Race/Ethnicity, Customized Not White | 8 participants | 7 participants | 15 participants |
| Race/Ethnicity, Customized White | 77 participants | 83 participants | 160 participants |
| Region of Enrollment United States | 85 participants | 90 participants | 175 participants |
| Sex: Female, Male Female | 47 Participants | 38 Participants | 85 Participants |
| Sex: Female, Male Male | 38 Participants | 52 Participants | 90 Participants |
| Women and Ischemia Syndrome Evaluation-Number (WISE) | 6.1 units on a scale STANDARD_DEVIATION 2 | 6.0 units on a scale STANDARD_DEVIATION 2.2 | 6.0 units on a scale STANDARD_DEVIATION 2.1 |
| Women and Ischemia Syndrome Evaluation-Severity (WISE) | 11.7 units on a scale STANDARD_DEVIATION 4.6 | 12.1 units on a scale STANDARD_DEVIATION 5.5 | 11.9 units on a scale STANDARD_DEVIATION 5.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 85 |
| serious Total, serious adverse events | 0 / 90 | 0 / 85 |
Outcome results
Primary
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.
Time frame: 5 days after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Care | Rates of Adequate Depression Treatment at Discharge | 71.9 percentage of participants |
| Usual Care | Rates of Adequate Depression Treatment at Discharge | 9.5 percentage of participants |
Secondary
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.
Time frame: Baseline, 6 weeks, 12 weeks, 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Collaborative Care | Change in Depression Symptoms From Baseline to 6 Months | Baseline to 6 weeks | -8.98 units on a scale |
| Collaborative Care | Change in Depression Symptoms From Baseline to 6 Months | 6 weeks to 12 weeks | -8.73 units on a scale |
| Collaborative Care | Change in Depression Symptoms From Baseline to 6 Months | 12 weeks to 6 months | -8.67 units on a scale |
| Usual Care | Change in Depression Symptoms From Baseline to 6 Months | Baseline to 6 weeks | -5.95 units on a scale |
| Usual Care | Change in Depression Symptoms From Baseline to 6 Months | 6 weeks to 12 weeks | -5.30 units on a scale |
| Usual Care | Change in Depression Symptoms From Baseline to 6 Months | 12 weeks to 6 months | -6.90 units on a scale |