Shared Decision Making for Aortic Stenosis

(IMPACT SDM Trial)

Recruiting at 9 trial locations

Overseen By KD Valentine, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Prior valve replacement, CABG, dialysis, COPD, others

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

Compensation: Varies

Number of Visits: 2

1300 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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Decision Aid, PrEP Decision Aid, eHealth for Integrated PrEP and MOUD, Shared Decision Making Skills Training for Aortic Stenosis?

Research shows that shared decision-making (a process where doctors and patients make decisions together) can help align treatment with patient goals, especially in severe aortic stenosis where quality of life is a priority. However, shared decision-making is not yet common practice, and more knowledge is needed to effectively implement it in treatment decisions for older patients with this condition. ^{1 2 3 4 5}

Is shared decision making safe for patients?

The research does not provide specific safety data for shared decision making, but it is generally considered a safe process as it involves discussions between patients and healthcare providers to make informed choices together. ^{1 4 6 7 8}

How does shared decision making differ from other treatments for aortic stenosis?

Shared decision making (SDM) is unique because it involves patients actively in the decision process about their treatment options, ensuring that their personal goals and preferences are considered. Unlike traditional approaches where decisions are often made solely by healthcare professionals, SDM encourages collaboration and the use of decision aids to align treatment with what matters most to the patient. ^{1 2 3 5 9}

What is the purpose of this trial?

The goal of this study is to increase shared decision making for patients considering treatment for severe aortic stenosis. The main questions it aims to answer are: * Do patient decision aids and clinician skills training course improve the quality of decisions, and do they work well for different patient populations? * Are heart clinics able to reach the majority of patients with decision aids before their specialist visit and do the majority of clinicians complete the training course? All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. Participants will complete surveys before and after their specialist visit. Researchers will compare data from patients seen during usual care with data from those seen after the interventions are implemented to see if there are improvements in the quality of decisions.

Research Team

Sammy Elmariah, MD

Principal Investigator

University of California, San Francisco

Karen Sepucha, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for patients with severe aortic stenosis who are considering treatment options. To participate, individuals must be at a stage where they're discussing potential treatments. The study excludes those who have already made their treatment decision or cannot give informed consent.

Inclusion Criteria

My heart valve is severely narrowed.

I am between 65 and 85 years old.

Language is English or Spanish

Exclusion Criteria

I have had coronary artery bypass surgery.

My condition is advanced cirrhosis.

I am able to make my own medical decisions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care

Participants receive usual care without decision aids or clinician training

Varies

1 visit (in-person)

Intervention

Participants receive decision aids and clinicians undergo shared decision making training

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for shared decision making outcomes and other secondary measures

1 week

Treatment Details

Interventions

• Decision Aid
• Shared Decision Making Skills Training

Trial Overview The study tests whether tools like patient decision aids and training courses for clinicians can improve the quality of treatment decisions in severe aortic stenosis care. It compares usual care with these new approaches by switching clinics from one to the other randomly over time.

Participant Groups

Group I: Control (usual care) Active Control 1 Intervention

This group will receive usual care without any support for using the decision aid and without any access to the clinician training.

Group II: Intervention Active Control 2 Interventions

The patients in this group will receive a decision aid that covers the main treatment options for aortic stenosis. The clinicians in this group will receive a 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Providence Health & Services

Collaborator

Trials

131

Recruited

827,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Piedmont Healthcare

Collaborator

Trials

23

Recruited

5,700+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Findings from Research

The DECIDE-LVAD study is a multicenter, randomized trial involving 168 patient-caregiver dyads aimed at evaluating the effectiveness of decision aids (pamphlets and videos) for patients considering destination therapy left ventricular assist devices (DT LVAD) in end-stage heart failure.

The study will assess primary outcomes such as patient knowledge and alignment of treatment options with their values, which is crucial for ensuring that patients make informed decisions about invasive therapies that significantly impact their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data. McIlvennan, CK., Thompson, JS., Matlock, DD., et al.[2018]

A new decision aid (DA) tool for patients with atrial fibrillation (AF) has been developed to help them understand their specific risks for stroke and bleeding when considering oral anticoagulant (OAC) treatments, based on a comprehensive review of literature and patient feedback.

The tool integrates risk assessment modules and preference assessments to facilitate shared decision-making, aiming to empower patients to make informed choices about their treatment options, although further research is needed to test its effectiveness in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. Kaiser, K., Cheng, WY., Jensen, S., et al.[2018]

References

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

Professionals' views on shared decision-making in severe aortic stenosis. [2022]

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

Patient-defined goals for the treatment of severe aortic stenosis: a qualitative analysis. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Shared decision making in older patients with symptomatic severe aortic stenosis: a systematic review. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Quality of life and prosthetic aortic valve selection in non-elderly adult patients. [2018]

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

What helps the successful implementation of digital decision aids supporting shared decision-making in cardiovascular diseases? A systematic review. [2023]

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

A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? [2022]

8. England pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. [2018]

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

The Learning Curve for Shared Decision-making in Symptomatic Aortic Stenosis. [2021]