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Shared Decision Making for Aortic Stenosis (IMPACT SDM Trial)

N/A

Waitlist Available

Led By Karen Sepucha, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with severe aortic stenosis (aortic valve area <1cm2)

Between 65-85 years of age

Must not have

Prior coronary artery bypass surgery (CABG)

Advanced Cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks from the start of intervention period for each site

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess if decision aids and clinician training can improve decision-making for patients considering treatment for severe aortic stenosis. Surveys will measure impact of interventions.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on decision-making rather than medical interventions, there are no direct side effects from drugs or procedures. However, participants may experience stress or anxiety when engaging in shared decision making.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart valve is severely narrowed.

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I am between 65 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had coronary artery bypass surgery.

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My condition is advanced cirrhosis.

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I am able to make my own medical decisions.

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My doctor considers me at high risk for surgery.

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I need home oxygen for my severe lung disease.

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I am on dialysis for end-stage kidney disease.

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I have had surgery to replace my aortic valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks from the start of intervention period for each site

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks from the start of intervention period for each site

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks from the start of intervention period for each site for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Shared Decision Making

Secondary study objectives

Adoption

Clinician satisfaction

Patient Knowledge

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Control (usual care)Active Control1 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: InterventionActive Control2 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

0 / 9Eligibility criteria met