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Intervention for Aortic Stenosis (IMPACT SDM Trial)

Q: Is recruitment ongoing for this experiment?

The data on clinicaltrials.gov indicates that the recruitment period for this trial has been concluded; it was first posted in March 2024 and edited last December 2023. Despite its closure, there are still 320 other studies available to join at this moment.

Q: Am I eligible to take part in this research endeavor?

Eligible candidates for this medical trial must have aortic stenosis and be aged between 65 to 85. 1400 participants are needed in total.

Q: Is the minimum age requirement for this research study below 50 years old?

Participants must be no younger than 65 years of age and not exceed 85 to qualify for this trial.

Q: How many medical facilities have incorporated this clinical trial into their research in the city?

At the current moment, this clinical trial is being hosted in 8 different sites located across Boston, San Francisco and Aurora as well as other cities. For those interested in participating, it is suggested to pick a location that is nearby to lessen travel-related worries.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

IMPACT SDM Trial 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.Check my eligibility

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.See study design

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.

IMPACT SDM Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My heart valve is severely narrowed.

Select...

I am between 65 and 85 years old.

IMPACT SDM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Shared Decision Making

Secondary outcome measures

Adoption

Clinician satisfaction

Patient Knowledge

+5 more

IMPACT SDM 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,936 Previous Clinical Trials

13,197,321 Total Patients Enrolled

University of TexasOTHER

187 Previous Clinical Trials

141,053 Total Patients Enrolled

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,189,425 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment ongoing for this experiment?

"The data on clinicaltrials.gov indicates that the recruitment period for this trial has been concluded; it was first posted in March 2024 and edited last December 2023. Despite its closure, there are still 320 other studies available to join at this moment."

Answered by AI

Am I eligible to take part in this research endeavor?

"Eligible candidates for this medical trial must have aortic stenosis and be aged between 65 to 85. 1400 participants are needed in total."

Answered by AI

Is the minimum age requirement for this research study below 50 years old?

"Participants must be no younger than 65 years of age and not exceed 85 to qualify for this trial."

Answered by AI

How many medical facilities have incorporated this clinical trial into their research in the city?

"At the current moment, this clinical trial is being hosted in 8 different sites located across Boston, San Francisco and Aurora as well as other cities. For those interested in participating, it is suggested to pick a location that is nearby to lessen travel-related worries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Promoting Shared Decision Making for Severe Aortic Stenosis

Karen Sepucha 2024. "Promoting Shared Decision Making for Severe Aortic Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06171737.

All > Aortic Stenosis > Cardiology