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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882411
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Nathalie Moise, Columbia University

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 stepped wedge design across socioeconomically diverse cardiology and primary care clinics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
Allocation: Randomized
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 : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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.



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



Information from the National Library of Medicine

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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 (e.g., for schizophrenia)
  • 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

Information from the National Library of Medicine

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


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

Locations
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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
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Principal Investigator: Nathalie Moise, MD, MS Columbia University

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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    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Stepped wedge design
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Depression
Behavioral Symptoms
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases