A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

NCT ID: NCT00847132

Last Updated: 2017-03-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

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:

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.

Detailed Description

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Conditions

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Coronary Artery Disease Congestive Heart Failure Arrhythmia Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Collaborative Care Treatment

Intervention Type BEHAVIORAL

Depression education, treatment recommendations, coordination of care

Usual Care

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

Group Type ACTIVE_COMPARATOR

Usual Care Treatment

Intervention Type BEHAVIORAL

Treatment as usual, providers are notified of diagnoses

Interventions

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Collaborative Care Treatment

Depression education, treatment recommendations, coordination of care

Intervention Type BEHAVIORAL

Usual Care Treatment

Treatment as usual, providers are notified of diagnoses

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeff C. Huffman, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeff C Huffman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23747159 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22325974 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22210240 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21386067 (View on PubMed)

Other Identifiers

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2007P-001152

Identifier Type: -

Identifier Source: org_study_id

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