eSDM Tool for Depression in Heart Disease

Overseen By Nathalie Moise, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Psychosis, Schizophrenia, Bipolar, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

361 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 5 6 7 8}

How 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. ^{2 3 7 9 10}

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.

Research Team

Nathalie Moise, MD, MS

Principal Investigator

Columbia University

Eligibility 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.

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.

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)

Treatment Details

Interventions

• Electronic shared decision making (eSDM) tool

Trial Overview 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.

Participant Groups

Group I: Electronic shared decision making (eSDM) Tool Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

The implementation of a shared decision-making (SDM) process in primary care for cardiovascular disease management showed that while patients preferred lifestyle changes over medication, the SDM approach successfully engaged them in making informed choices about their health.

Despite the positive patient response, providers rarely utilized the patient choice data, indicating a gap in engagement that may stem from provider fatigue or inefficiencies in the SDM workflow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision making: using health information technology to integrate patient choice into primary care. Jones, JB., Bruce, CA., Shah, NR., et al.[2022]

The web-based decision aid significantly improved patients' knowledge about treatment options and reduced decisional conflict among adults with unipolar depression, as shown in a randomized controlled trial with 147 participants.

However, the decision aid did not affect treatment intention or preferences for participation in decision making, indicating that while it enhances understanding, it may not change how patients choose to engage in their treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a decision aid for patients with depression: A randomized controlled trial. Perestelo-Perez, L., Rivero-Santana, A., Sanchez-Afonso, JA., et al.[2022]

Electrophysiology clinicians generally support shared decision making (SDM) and the use of decision aids (DAs) for patients considering implantable cardioverter defibrillators, but they identified challenges in consistently delivering these aids to patients.

Key barriers to effective DA implementation included logistical issues, concerns about the effectiveness of DAs in enhancing patient decision-making, and the need for DA content to better align with the specific patient populations being treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial. Knoepke, CE., Wallace, BC., Allen, LA., et al.[2023]

In a study involving 20 oncologists and 55 early breast cancer patients, cognitive aspects of shared decision making (SDM) were found to significantly predict patient satisfaction with the doctor's SDM skills and treatment decisions at 2 weeks and 4 months post-consultation, respectively.

Emotional aspects, such as the ability to respond to emotional cues and provide empathy, were linked to lower anxiety levels and decisional conflict, highlighting the importance of addressing both cognitive and emotional factors in patient consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sharing vs. caring--the relative impact of sharing decisions versus managing emotions on patient outcomes. Smith, A., Juraskova, I., Butow, P., et al.[2022]

This randomized controlled trial will assess the effectiveness of a smartphone app designed to enhance patient activation and support shared decision making (SDM) among 260 individuals with schizophrenia-spectrum disorders over a 6-month period.

The study aims to determine if the app can improve self-perceived patient activation and other outcomes related to treatment satisfaction and engagement in mental healthcare, potentially demonstrating the benefits of digital tools in facilitating SDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Vitger, T., Austin, SF., Petersen, L., et al.[2020]

Shared decision making (SDM) in dermatology can enhance treatment decisions by incorporating patient preferences, but it is not commonly practiced by dermatologists.

To facilitate SDM, researchers developed evidence-based Decision Cards that summarize treatment options for conditions like psoriasis and atopic eczema, which are designed to answer common patient questions and support informed discussions during consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards More Shared Decision Making in Dermatology: Develop-ment of Evidence-based Decision Cards for Psoriasis and Atopic Eczema Treatments. Vermeulen, FM., van der Kraaij, GE., Tupker, RA., et al.[2022]

The Ischemic Heart Disease Shared Decision-Making Program (IHD SDP) improved patient knowledge about treatment options, with scores rising from 62% in the control group to 75% in the intervention group, indicating better-informed decision-making.

Patients using the IHD SDP opted for revascularization less frequently (58% vs. 75% in controls), suggesting that the program may promote greater patient autonomy in treatment choices without negatively affecting their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease. Morgan, MW., Deber, RB., Llewellyn-Thomas, HA., et al.[2022]

Shared decision-making (SDM) is recognized as a valuable approach in dermatology, enhancing patient-centered care, with 29 studies highlighting its importance and strategies for implementation.

Despite the limited number of validated SDM tools specifically for dermatologic conditions, barriers such as time constraints and lack of clinician training were identified, along with potential solutions to improve SDM practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision-making in Dermatology: A Scoping Review. Morrison, T., Johnson, J., Baghoomian, W., et al.[2021]

A shared decision-making (SDM) training program for clinicians significantly improved patients' perceived involvement in their treatment decisions for major depressive disorder (MDD), as indicated by higher scores on the Shared Decision Making-Questionnaire-9 (SDM-Q-9) compared to usual care.

Despite the improvement in perceived involvement, the training did not lead to significant changes in decision conflict or secondary outcomes such as patient satisfaction, quality of life, or depressive symptoms, suggesting that while SDM can be implemented, its impact on overall treatment outcomes needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Takaesu, Y., Aoki, Y., Tomo, Y., et al.[2023]

The ICD decision quality (ICD-DQ) scale was developed to assess patients' knowledge and preferences regarding implantable cardioverter-defibrillators (ICDs), validated through surveys involving 295 patients and 54 clinicians, ensuring its relevance in clinical settings.

The scale demonstrated strong reliability and validity, indicating it can effectively measure the quality of shared decision-making in ICD implantation, which is crucial for improving patient outcomes and ensuring informed choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a measure of decision quality for implantable defibrillators. Knoepke, CE., Allen, LA., Sepucha, K., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Shared decision making: using health information technology to integrate patient choice into primary care. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a decision aid for patients with depression: A randomized controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Sharing vs. caring--the relative impact of sharing decisions versus managing emotions on patient outcomes. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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]

6. Sweden pubmed.ncbi.nlm.nih.gov

Towards More Shared Decision Making in Dermatology: Develop-ment of Evidence-based Decision Cards for Psoriasis and Atopic Eczema Treatments. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized, controlled trial of an interactive videodisc decision aid for patients with ischemic heart disease. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Shared Decision-making in Dermatology: A Scoping Review. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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]

10. United States pubmed.ncbi.nlm.nih.gov

Development of a measure of decision quality for implantable defibrillators. [2022]