Summary

Eligibility
for people ages 65-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Sammy Elmariah, MD
Headshot of Sammy Elmariah
Sammy Elmariah

Description

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.

Official Title

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

Details

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 stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1400 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.

Keywords

Aortic Stenosis, aortic valve stenosis, Decision Making, Shared, decision aid, continuing medical education, cardiology, Transcatheter Aortic Valve Replacement, Pathologic Constriction, Shared Decision Making Skills Training

Eligibility

You can join if…

Open to people ages 65-85

  • Between 65-85 years of age
  • Language is English or Spanish
  • Diagnosed with severe aortic stenosis (aortic valve area <1cm2)
  • Attend Visit with Heart Valve Team physician(s)

You CAN'T join if...

  • Prior aortic valve replacement surgery
  • High surgical risk (determined by clinician or defined as Society of Thoracic Surgery score >8%)
  • Prior coronary artery bypass surgery (CABG)
  • End stage renal disease on dialysis
  • Severe lung disease (chronic obstructive pulmonary disease; COPD) requiring home oxygen
  • Advanced Cirrhosis
  • Unable to consent for self (proxy respondents are not allowed)

Locations

  • The Regents of the UCSF
    San Francisco California 94117 United States
  • Providence Health & Services - Oregon
    Portland Oregon 97225 United States

Lead Scientist at UCSF

  • Sammy Elmariah, MD
    Dr. Sammy Elmariah is an interventional cardiologist who specializes in caring for patients with heart valve disease, coronary artery disease, and adult congenital heart disease.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts General Hospital
ID
NCT06171737
Study Type
Interventional
Participants
Expecting 1400 study participants
Last Updated