An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)
Study Details
Study Description
Brief Summary
The purpose of this study is to examine the effect of a brief electronic shared decision making (eSDM) intervention on depressive symptoms in coronary heart disease patients with elevated depressive symptoms.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Depression is common in patients with coronary heart disease and associated with increased cardiac morbidity and mortality. Treating depressive symptoms appears to improve depressive symptoms and quality of life. Despite expert recommendations to screen and treat depressive symptoms fewer coronary heart disease patients engage in depression treatment than the general population, perhaps due to 1) sub-optimal provider awareness and referral rates and 2) low self-efficacy, stigma and misattribution of depressive symptoms among coronary heart disease patients. In addition, few real world theory-informed implementation trials exist for improving screening and treatment in outpatient settings.
The specific aim is to determine whether an electronic shared decision making (eSDM) and behavioral activation tool improves depressive symptoms and treatment initiation in coronary heart disease patients with elevated depressive symptoms. To accomplish these aims, a hybrid effectiveness-implementation trial will be conducted using a stepped wedge design across socioeconomically diverse cardiology and primary care clinics.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Electronic shared decision making (eSDM) Tool When a clinic's randomly allotted intervention period arrives, coronary heart disease patients in a given cluster of clinics will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive a patient preference report generated from the application. |
Behavioral: Electronic shared decision making (eSDM) tool
The web application includes depression screening, behavioral activation, and a patient preference driven treatment selection decision aid. Treatment options will include medications, cardiac rehab/exercise program, and therapy. Providers will receive a patient preference report in real time with options for coordination of care.
Other Names:
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No Intervention: Usual Care In the year prior to the allocated intervention period, coronary heart disease patients will receive usual care from their providers. |
Outcome Measures
Primary Outcome Measures
- Beck Depression Index (BDI-II) [Baseline, Follow-up visit (approximately 6 months)]
Change in total BDI (21-item measure of depressive symptoms [0-63]; higher score constitutes worse burden of symptoms) from baseline to follow visit during the pre-intervention period compared to post-intervention period
Secondary Outcome Measures
- Proportion of patients who initiate treatment [Baseline, Follow-up visit (approximately 6 months)]
Proportion of enrolled patients who initiate any depression treatment (medications, cardiac rehab/exercise program, therapy) from baseline to follow up visit in the pre-intervention compared to post-intervention period
- Mean change in quality of life years (QALYs) [Baseline, Follow-up visit (approximately 6 months)]
Change in QALYs from from baseline to follow up visit in the pre-intervention compared to post-intervention period
- Mean Patient Activation [Baseline]
Mean baseline patient activation measure [PAM] (13-items, range 0-100, higher score indicates greater activation] in the pre-intervention compared to post-intervention period
Eligibility Criteria
Criteria
Inclusion Criteria:
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History of coronary heart disease
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English or Spanish Speaking
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Elevated Depressive symptoms (PHQ9 ≥10)
Exclusion Criteria:
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Under the care of a psychiatrist (e.g., for schizophrenia)
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Diagnosis/history of psychosis or schizophrenia
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Diagnosis/history of bipolar disorder
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Attempted suicide
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Non-English or Spanish speaking
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Dementia or severe cognitive impairment
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Non-elevated depressive symptoms
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Alcohol or substance abuse
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Pregnancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Columbia University Irving Medical Center/New York Presbyterian Hospital | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Nathalie Moise, MD, MS, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAR9175 - III
- 1R01HL141609-01