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

NCT ID: NCT03882411

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 361 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-23
• Study Completion Date: 2025-04-10

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.

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

Conditions

Depressive Symptoms; Coronary Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Electronic shared decision making (eSDM) Tool

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.

Group Type: EXPERIMENTAL

Electronic shared decision making (eSDM) tool

Intervention Type: BEHAVIORAL

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. In addition to education, providers will receive a patient preference report in real time with options for coordination of care

Interventions

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. In addition to education, providers will receive a patient preference report in real time with options for coordination of care

Intervention Type: BEHAVIORAL

Other Intervention Names

eSDM intervention

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Nathalie Moise

Assistant Professor of Medicine, Dept of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathalie Moise, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States

Countries

United States

Other Identifiers

1R01HL141609-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR9175 - III

Identifier Type: -

Identifier Source: org_study_id