An IT Approach to Implementing Depression Treatment in Cardiac Patients (iHeart DepCare)
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|ClinicalTrials.gov Identifier: NCT03882411|
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Coronary Heart Disease||Behavioral: Electronic shared decision making (eSDM) tool||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||368 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Stepped Wedge Design with 8 clinics randomized to timing of receipt of intervention. More clinics may be enlisted in the event that a sufficient number of participants from the initial 8 clinics is not achieved.|
|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 2023|
|Estimated Study Completion Date :||June 2023|
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 Name: eSDM intervention
No Intervention: Usual Care
In the year prior to the allocated intervention period, coronary heart disease patients will receive usual care from their providers.
- 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
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882411
|Contact: Nathalie Moise, MD, MSfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Nathalie Moise, MD, MS|
|Principal Investigator:||Nathalie Moise, MD, MS||Columbia University|