Trial Outcomes & Findings for A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients (NCT NCT00847132)

Last Updated: 2017-03-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

175 participants

Primary outcome timeframe

5 days after enrollment

Results posted on

2017-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	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 vs. usual care: depression education, treatment recommendations, coordination of care	Usual Care Primary medical providers are informed that the patient has depression and that treatment is recommended. Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care
Overall Study STARTED	90	85
Overall Study COMPLETED	89	84
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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 vs. usual care: depression education, treatment recommendations, coordination of care	Usual Care Primary medical providers are informed that the patient has depression and that treatment is recommended. Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care
Overall Study Death	1	1

Baseline Characteristics

A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Collaborative Care n=90 Participants 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	Usual Care n=85 Participants 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	Total n=175 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 12.8 • n=5 Participants	62.6 years STANDARD_DEVIATION 12.2 • n=7 Participants	62.35 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	47 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	38 Participants n=7 Participants	90 Participants n=5 Participants
Race/Ethnicity, Customized White	83 participants n=5 Participants	77 participants n=7 Participants	160 participants n=5 Participants
Race/Ethnicity, Customized Not White	7 participants n=5 Participants	8 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants	85 participants n=7 Participants	175 participants n=5 Participants
Patient Health Questionnaire-9 (PHQ-9)	17.9 units on a scale STANDARD_DEVIATION 3.8 • n=5 Participants	17.3 units on a scale STANDARD_DEVIATION 3.1 • n=7 Participants	17.6 units on a scale STANDARD_DEVIATION 3.5 • n=5 Participants
Medical Outcomes Study Short Form-12 Mental Component Score (SF-12 MCS)	30.9 units on a scale STANDARD_DEVIATION 8 • n=5 Participants	32.5 units on a scale STANDARD_DEVIATION 7.8 • n=7 Participants	31.7 units on a scale STANDARD_DEVIATION 7.9 • n=5 Participants
Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)	10.8 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants	9.7 units on a scale STANDARD_DEVIATION 4 • n=7 Participants	10.3 units on a scale STANDARD_DEVIATION 4.3 • n=5 Participants
Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)	26.1 units on a scale STANDARD_DEVIATION 5.2 • n=5 Participants	25.4 units on a scale STANDARD_DEVIATION 4.4 • n=7 Participants	25.7 units on a scale STANDARD_DEVIATION 4.8 • n=5 Participants
Women and Ischemia Syndrome Evaluation-Severity (WISE)	12.1 units on a scale STANDARD_DEVIATION 5.5 • n=5 Participants	11.7 units on a scale STANDARD_DEVIATION 4.6 • n=7 Participants	11.9 units on a scale STANDARD_DEVIATION 5.1 • n=5 Participants
Medical Outcomes Study Short Form-12 Physical Component Score (SF-12 PCS)	32.2 units on a scale STANDARD_DEVIATION 10.4 • n=5 Participants	31.3 units on a scale STANDARD_DEVIATION 9.4 • n=7 Participants	31.8 units on a scale STANDARD_DEVIATION 9.9 • n=5 Participants
Women and Ischemia Syndrome Evaluation-Number (WISE)	6.0 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	6.1 units on a scale STANDARD_DEVIATION 2.0 • n=7 Participants	6.0 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants

PRIMARY outcome

Timeframe: 5 days after enrollment

Outcome measures

Outcome measures
Measure	Collaborative Care n=89 Participants 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	Usual Care n=84 Participants 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
Rates of Adequate Depression Treatment at Discharge	71.9 percentage of participants	9.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=89 Participants 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	Usual Care n=84 Participants 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
Change in Depression Symptoms From Baseline to 6 Months Baseline to 6 weeks	-8.98 units on a scale Interval -10.26 to -7.7	-5.95 units on a scale Interval -7.4 to -4.5
Change in Depression Symptoms From Baseline to 6 Months 6 weeks to 12 weeks	-8.73 units on a scale Interval -10.06 to -7.38	-5.30 units on a scale Interval -6.75 to -3.85
Change in Depression Symptoms From Baseline to 6 Months 12 weeks to 6 months	-8.67 units on a scale Interval -10.17 to -7.16	-6.90 units on a scale Interval -8.2 to -5.59

Adverse Events

Collaborative Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeff Huffman

Massachusetts General Hospital

Phone: 617-724-2910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place