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

Study Overview
=================
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.

Official Title
-----------------
An Information tecHnology Approach to implEmenting Depression treAtment in caRdiac patienTs: [iHeartDepCare Trial]

Conditions
-----------------
Depressive Symptoms, Coronary Heart Disease

Intervention / Treatment
-----------------
* Behavioral: Electronic shared decision making (eSDM) tool


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic shared decision making (eSDM) Tool<br>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<br>* 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<br>* Other names: eSDM intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Index (BDI-II) | 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 | Baseline, Follow-up visit (approximately 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who initiate treatment | 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 | Baseline, Follow-up visit (approximately 6 months) | 
| Mean change in quality of life years (QALYs) | Change in QALYs from from baseline to follow up visit in the pre-intervention compared to post-intervention period | Baseline, Follow-up visit (approximately 6 months) | 
| Mean Patient Activation | 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 | Baseline | 
| Mean Decisional Conflict Scale | 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. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implementation science