NCT06171737

Promoting Shared Decision Making for Severe Aortic Stenosis

PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis (IMPACT SDM Study)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The goal of this study is to promote 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? This study is a batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1300 patients. All participating sites will start in the usual care group and then will be randomly assigned a time to switch to the intervention group. The interventions include a patient decision aid that was created by the American College of Cardiology CardioSmart program and a online shared decision making skills training course for clinicians. The coordinating center will provide implementation support to sites when they transition to the intervention arm. Data collection is similar across usual care and intervention groups. Patient participants will complete surveys before and after their specialist visit. Clinician participants will be randomly selected to complete a survey after the patient visit. Limited clinical data will be collected from the medical record. 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. Researchers will also calculate percentage of patients reached with decision aids and percentage of clinicians who complete training at each site to measure the success of the implementation.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
BEHAVIORAL	Decision Aid	The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
BEHAVIORAL	Shared Decision Making Skills Training	60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies

Timeline

• Start date: 2024-03-27
• Primary completion: 2027-05-31
• Completion: 2027-10-31
• First posted: 2023-12-15
• Last updated: 2025-06-08

Locations

8 sites across 1 country: United States