eSDM Tool for Depression in Heart Disease
Recruiting in Palo Alto (17 mi)
Overseen byNathalie Moise, MD, MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Psychosis, Schizophrenia, Bipolar, Dementia, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests a digital tool that helps heart disease patients with depression work with their doctors to choose the best treatment. The tool also encourages patients to engage in activities that can improve their mood. The goal is to see if this approach reduces depressive symptoms and helps more patients start treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the eSDM Tool for Depression in Heart Disease treatment?
Research shows that shared decision making (SDM) tools, like the eSDM Tool, help patients make informed choices and feel more involved in their treatment, which can improve outcomes in both mental health and heart disease care.
12345Is the eSDM Tool for Depression in Heart Disease safe for humans?
The research articles do not provide specific safety data for the eSDM Tool for Depression in Heart Disease, but shared decision-making tools in general have been used in various medical fields without reported safety concerns.
15678How is the eSDM Tool for Depression in Heart Disease different from other treatments?
The eSDM Tool for Depression in Heart Disease is unique because it uses an electronic shared decision-making approach to help patients actively participate in their treatment choices, which is not commonly emphasized in traditional treatments for depression in heart disease patients.
237910Eligibility Criteria
This trial is for heart disease patients who also have significant depression symptoms (PHQ9 score ≥10) and speak English or Spanish. It's not for those with psychosis, schizophrenia, bipolar disorder, recent suicide attempts, severe cognitive issues, non-elevated depression symptoms, current pregnancy, or substance abuse problems.Inclusion Criteria
You have high levels of depressive symptoms, as indicated by a score of 10 or more on the PHQ9 questionnaire.
I have a history of heart disease.
I speak English or Spanish.
Exclusion Criteria
I have dementia or severe problems with my memory and thinking.
I do not have severe depression.
I do not speak English or Spanish.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-intervention
Patients receive usual care and are assessed at baseline
Baseline period
1 visit (in-person)
Intervention
Patients complete a web application delivering screening, behavioral activation, and shared decision making (eSDM)
6 months
Ongoing virtual engagement
Follow-up
Participants are monitored for changes in depressive symptoms and quality of life
6 months
1 visit (in-person)
Participant Groups
The study is testing an electronic shared decision making tool (eSDM) designed to help coronary heart disease patients manage elevated depressive symptoms more effectively through technology-assisted care.
1Treatment groups
Experimental Treatment
Group I: Electronic shared decision making (eSDM) ToolExperimental Treatment1 Intervention
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.
Electronic shared decision making (eSDM) tool is already approved in United States for the following indications:
🇺🇸 Approved in United States as Electronic Shared Decision Making Tool for:
- Depression in coronary heart disease patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical Center/New York Presbyterian HospitalNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Shared decision making: using health information technology to integrate patient choice into primary care. [2022]Advances in shared decision making (SDM) have not successfully translated to practice. We describe our experience and lessons learned in translating an SDM process for primary care cardiovascular disease management. The SDM process operationalized recognized SDM elements using workflow modifications, a computerized patient questionnaire, an automated risk calculator to identify at-risk patients, a web-based tool for patients to choose interventions, automated feedback on the personalized benefits of choices, and a web-based tool for providers to view patient risk, patient choice, and expert advice. Although medication was typically the intervention resulting in the greatest risk reduction, the majority of patients preferred dietary and other lifestyle changes. Patients generally favored the opportunity to make and communicate choices. However, providers only viewed patient choice data in 20% of the encounters. Translation of the SDM process was successful for patients and the difference between patient choice and optimal risk reduction points to the importance of engaging in an SDM process. Lack of engagement by providers may be due to "alert fatigue" or to the failure of the SDM process to improve efficiency in the office visit.
Effectiveness of a decision aid for patients with depression: A randomized controlled trial. [2022]Shared decision making is an important component of patient-centred care and decision aids are tools designed to support patients' decision making and help patients with depression to make informed choices.
Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial. [2023]Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians' experience implementing and using the DAs.
Sharing vs. caring--the relative impact of sharing decisions versus managing emotions on patient outcomes. [2022]To assess the relative impact of cognitive and emotional aspects of shared decision making (SDM) on patient outcomes.
The Momentum trial: the efficacy of using a smartphone application to promote patient activation and support shared decision making in people with a diagnosis of schizophrenia in outpatient treatment settings: a randomized controlled single-blind trial. [2020]Shared decision making (SDM) is often defined as an interactive process that ensures that both patient and practitioner are actively involved in the treatment and that they share all relevant information to arrive at a mental health decision. Previous SDM interventions have found improvements in outcomes such as personal recovery, higher perceived involvement in treatment decisions and knowledge about one's disease. Still, SDM occurs less frequently in mental health care than in primary care. Electronic aids developed to support patient activation and SDM could be a promising mean to engage patients in their mental healthcare. The aim of this trial is to investigate the effects of using a smartphone app to promote patient activation and support SDM for people with schizophrenia-spectrum disorders in an outpatient treatment setting.
Towards More Shared Decision Making in Dermatology: Develop-ment of Evidence-based Decision Cards for Psoriasis and Atopic Eczema Treatments. [2022]In shared decision making (SDM) patients and physi-cians make treatment decisions together based on the best available evidence and the values and preferences of patients. SDM is very suitable for use in dermatological practice, but is infrequently applied by dermatologists. To support the application of SDM in dermatology we developed Decision Cards: 1-page overviews of possible treatment options, for use during a patient-physician consultation. Decision Cards provide answers to patients' most frequently asked questions, based on (inter)national guidelines, Summary of Product Characteristics, relevant literature, and clinical expertise. Three evidence-based Decision Cards were developed: 1 for biologicals or apremilast in psoriasis, and 2 for atopic eczema (1 for topical, photo- or systemic therapy, and 1 for systemic therapy only). More cards for psoriasis are currently in development. Patients, dermatologists and researchers collaborated in the development of the Decision Cards. This paper shares the framework used for the development of the Decision Cards, in order to support others in the development process.
Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease. [2022]To determine the effect of the Ischemic Heart Disease Shared Decision-Making Program (IHD SDP) an interactive videodisc designed to assist patients in the decision-making process involving treatment choices for ischemic heart disease, on patient decision-making.
Shared Decision-making in Dermatology: A Scoping Review. [2021]Shared decision-making (SDM) can improve the quality of care for patients. The extent to which this tool has been used and the evidence supporting its use in dermatology have not been systematically examined.
Implementation of a shared decision-making training program for clinicians based on the major depressive disorder guidelines in Japan: A multi-center cluster randomized trial. [2023]Although shared treatment decision-making with patients requires attention, it is not widely implemented, particularly in the field of psychiatry. The aim of this study was to assess whether a shared decision-making (SDM) training program for clinicians based on the major depressive disorder (MDD) guidelines improved the perceived involvement of the decision process for patients with MDD.
Development of a measure of decision quality for implantable defibrillators. [2022]CMS reimbursement guidelines for implantable cardioverter-defibrillators (ICDs) include mandated shared decision making (SDM), but without any manner of assessing the quality of decisions made. We developed and tested a scale meant to assess patients' knowledge of and preferences specific to ICDs. Such a tool would assess these constructs in the clinical environment, targeting resources and support for patients considering a primary prevention ICD.