An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)

Columbia University

Status: Completed

Conditions: Depressive Symptoms; Coronary Heart Disease

Treatments: Behavioral: Electronic shared decision making (eSDM) tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03882411

1R01HL141609-01 (U.S. NIH Grant/Contract)

AAAR9175 - III

Details and patient eligibility

About

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.

Full 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 pre-post design across socioeconomically diverse cardiology and primary care clinics.

Enrollment: 361 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of coronary heart disease
• English or Spanish Speaking
• Elevated Depressive symptoms (PHQ9 ≥10)
• Appointment at participating cardiology or primary care clinics

Exclusion criteria

• Under the care of a psychiatrist [**On 6/22/2022, this exclusion criteria was removed for those clusters of clinics not already in the post-implementation period**]
• Diagnosis/history of psychosis or schizophrenia
• Diagnosis/history of bipolar disorder
• Attempted suicide
• Non-English or Spanish speaking
• Dementia or severe cognitive impairment
• Non-elevated depressive symptoms
• Alcohol or substance abuse
• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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361 participants in 1 patient group

Electronic shared decision making (eSDM) Tool

Experimental group

Description:

In the pre-intervention period, patients in clinic clusters will receive usual care. When a clinic cluster's randomly allotted intervention period arrives, coronary heart disease patients in that given clinic cluster will complete a web application, which delivers screening, behavioral activation and shared decision making (eSDM), and providers will receive education and a patient preference report generated from the application. During both the pre and post intervention periods, patients will be assessed at baseline and 6 month follow up.

Treatment:

Behavioral: Electronic shared decision making (eSDM) tool