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

• ClinicalTrials.gov Identifier: NCT03882411
• Recruitment Status: Recruiting
• First Posted: March 20, 2019
• Last Update Posted: November 1, 2022
• Sponsor: Columbia University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Nathalie Moise, Columbia University

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
Depressive Symptoms; Coronary Heart Disease	Behavioral: Electronic shared decision making (eSDM) tool	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 368 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pre-post single group design with 8 clinic clusters randomized to timing of receipt of intervention with patients nested within providers nested within clinic clusters.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]
• Actual Study Start Date: April 23, 2019
• Estimated Primary Completion Date: June 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

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. In addition to education, providers will receive a patient preference report in real time with options for coordination of care; Other Name: eSDM intervention

Outcome Measures

Primary Outcome Measures :

1. Beck Depression Index (BDI-II) [ Time Frame: 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 :

1. Proportion of patients who initiate treatment [ Time Frame: 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
2. Mean change in quality of life years (QALYs) [ Time Frame: 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
3. Mean Patient Activation [ Time Frame: 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
4. Mean Decisional Conflict Scale [ Time Frame: Baseline ]
   Mean decisional conflict (measures personal perceptions of uncertainty around choosing among treatment option, 10 items, range 0-100, higher score indicates greater conflict) of patients.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• History of coronary heart disease
• English or Spanish Speaking
• Elevated Depressive symptoms (PHQ9 ≥10)

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

Contacts and Locations

Contacts

Contact: Nathalie Moise, MD, MS; 2123422889; nm2562@cumc.columbia.edu

Locations

United States, New York

Columbia University Irving Medical Center/New York Presbyterian Hospital; Recruiting

New York, New York, United States, 10032

Contact: Nathalie Moise, MD, MS 212-342-2889 nm2562@cumc.columbia.edu

Principal Investigator: Nathalie Moise, MD, MS

Sponsors and Collaborators

Columbia University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Nathalie Moise, MD, MS; Columbia University

More Information

• Responsible Party: Nathalie Moise, Assistant Professor of Medicine, Dept of Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT03882411
• Other Study ID Numbers: AAAR9175 - III; 1R01HL141609-01 ( U.S. NIH Grant/Contract )
• First Posted: March 20, 2019
• Last Update Posted: November 1, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nathalie Moise, Columbia University:

Implementation science

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Depression; Behavioral Symptoms; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases