A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

NCT00847132 | Completed Results

• 1 other identifier: 2007P-001152
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Coronary Artery Disease; Congestive Heart Failure; Arrhythmia; Depression

Keywords

Collaborative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Depression Symptoms From Baseline to 6 Months

  Baseline, 6 weeks, 12 weeks, 6 months

Study Arms (2)

Collaborative Care

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care Treatment

Interventions

Collaborative Care Treatment BEHAVIORAL

Depression education, treatment recommendations, coordination of care

Collaborative Care

Usual Care Treatment BEHAVIORAL

Treatment as usual, providers are notified of diagnoses

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient admission for cardiac diagnosis
• Positive depression evaluation (PHQ-2\>2, PHQ-9\>9)
• Ability to provide informed consent

You may not qualify if:

• Active suicidal ideation
• Bipolar disorder, psychotic disorder, active substance use disorder

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• 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.

  PMID: 23747159 DERIVED

• 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.

  PMID: 22325974 DERIVED

• 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.

  PMID: 22210240 DERIVED

• 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.

  PMID: 21386067 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure; Arrhythmias, Cardiac; Depression

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Jeff Huffman
• Organization: Massachusetts General Hospital

jhuffman@partners.org

617-724-2910

Study Officials

• Jeff C Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: July 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 31, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-03

Locations

US (1)