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A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Primary Purpose

Coronary Artery Disease, Congestive Heart Failure, Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Care Treatment
Usual Care Treatment
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Collaborative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Collaborative Care

Usual Care

Arm Description

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

Usual Care Treatment: Primary medical providers are informed that the patient has depression and that treatment is recommended.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 17, 2009
Last Updated
March 21, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00847132
Brief Title
A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
Official Title
A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Congestive Heart Failure, Arrhythmia, Depression
Keywords
Collaborative Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Care
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care Treatment: Primary medical providers are informed that the patient has depression and that treatment is recommended.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care Treatment
Intervention Description
Depression education, treatment recommendations, coordination of care
Intervention Type
Behavioral
Intervention Name(s)
Usual Care Treatment
Intervention Description
Treatment as usual, providers are notified of diagnoses
Primary Outcome Measure Information:
Title
Rates of Adequate Depression Treatment at Discharge
Description
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
Secondary Outcome Measure Information:
Title
Change in Depression Symptoms From Baseline to 6 Months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff C Huffman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23747159
Citation
Sowden GL, Mastromauro CA, Seabrook RC, Celano CM, Rollman BL, Huffman JC. Baseline physical health-related quality of life and subsequent depression outcomes in cardiac patients. Psychiatry Res. 2013 Aug 15;208(3):288-90. doi: 10.1016/j.psychres.2013.05.019. Epub 2013 Jun 5.
Results Reference
derived
PubMed Identifier
22325974
Citation
Bauer LK, Caro MA, Beach SR, Mastromauro CA, Lenihan E, Januzzi JL, Huffman JC. Effects of depression and anxiety improvement on adherence to medication and health behaviors in recently hospitalized cardiac patients. Am J Cardiol. 2012 May 1;109(9):1266-71. doi: 10.1016/j.amjcard.2011.12.017. Epub 2012 Feb 9.
Results Reference
derived
PubMed Identifier
22210240
Citation
Celano CM, Mastromauro CA, Lenihan EC, Januzzi JL, Rollman BL, Huffman JC. Association of baseline anxiety with depression persistence at 6 months in patients with acute cardiac illness. Psychosom Med. 2012 Jan;74(1):93-9. doi: 10.1097/PSY.0b013e31823d38bc. Epub 2011 Dec 30.
Results Reference
derived
PubMed Identifier
21386067
Citation
Huffman JC, Mastromauro CA, Sowden G, Fricchione GL, Healy BC, Januzzi JL. Impact of a depression care management program for hospitalized cardiac patients. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):198-205. doi: 10.1161/CIRCOUTCOMES.110.959379. Epub 2011 Mar 8.
Results Reference
derived

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A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

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