Shared Decision Making for Aortic Stenosis

(IMPACT SDM Trial)

Enrolling by invitation at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve decision-making for patients with severe aortic stenosis, a condition where the heart's aortic valve narrows, affecting blood flow. It tests whether a decision aid (a tool to help patients understand their options) and a clinician training course can help patients make better treatment choices. The study compares usual care with an approach that includes these resources to see if they improve decision quality. Suitable participants have severe aortic stenosis and are seeing a heart specialist at a participating clinic. Participants will complete surveys before and after their specialist visit to help researchers measure the effects.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance decision-making tools for future patients.

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 prior data suggests that these decision aids and clinician training are safe and effective?

Research has shown that patients with severe aortic stenosis respond positively to decision aids. These tools enhance patients' understanding of their treatment options and improve decision quality. Patients strongly support these aids, and no major safety concerns have been reported, as they provide information rather than involve medications or medical procedures.

Research also suggests that training in shared decision-making skills is recommended for improving treatment decisions. This training enhances doctors' communication with patients about their treatment choices. No known safety issues exist with this training because it focuses on improving communication skills.

Both the decision aid and the skills training are safe and helpful for improving how patients and doctors make treatment choices together. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing aortic stenosis by enhancing patient-clinician communication. Unlike traditional treatments that focus solely on medical interventions like valve replacement or medications, this trial emphasizes shared decision making. The intervention includes a decision aid for patients, helping them understand their options better, and a training program for clinicians to improve their conversation skills. This approach has the potential to empower patients, ensuring they are more informed and involved in their treatment choices, which could lead to better health outcomes and higher satisfaction.

What evidence suggests that this trial's interventions could improve decision making for aortic stenosis?

This trial will compare usual care with an intervention that includes a decision aid and shared decision-making skills training for clinicians. Research has shown that decision aids can significantly improve how patients with severe aortic stenosis make decisions with their doctors. These tools help patients understand their treatment options and feel more confident in making informed choices. For instance, patients have found an online decision aid very helpful during medical visits. Additionally, when doctors receive training in shared decision-making skills, they communicate more effectively with patients during appointments. Evidence indicates that this training enhances the quality of interactions and supports better treatment decisions. Together, these methods can lead to more personalized and satisfying healthcare experiences for patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Sammy Elmariah, MD

Principal Investigator

University of California, San Francisco

Karen Sepucha, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. acc.org acc.org/Latest-in-Cardiology/Articles/2024/06/07/14/20/Interactive-Online-Decision-Aid-Improves-Shared-Decision-Making

Interactive Online Decision Aid Improves Shared ... A novel interactive, online decision aid used at the point of care among patients with severe aortic stenosis (AS) was strongly endorsed by patients and ...

2. tctmd.com tctmd.com/news/patient-decision-aid-improves-shared-decision-making-aortic-stenosis

Patient Decision Aid Improves Shared Decision-making in ... A novel point-of-care decision aid for patients with severe aortic stenosis not only can improve their knowledge and empower them in making choices about their ...

3. patientdecisionaid.org patientdecisionaid.org/aortic-stenosis/

Treatment Options for Severe Aortic Stenosis We partnered with the American College of Cardiology to develop a decision aid for patients considering treatment options for aortic valve replacement.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11108138/

An interactive, online decision aid assessing patient goals ... We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. Methods. This prospective multi ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38771808/

An interactive, online decision aid assessing patient goals ... An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared ...

6. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00534-x

Rationale and design of a randomized clinical trial of ... In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet ...