Clinical trial NCT06171737: Promoting Shared Decision Making for Severe Aortic Stenosis
Official title: PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis (IMPACT SDM Study)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Aortic Stenosis
Keywords: aortic valve stenosis
Decision Making, Shared
decision aid
continuing medical education
cardiology
Transcatheter Aortic Valve Replacement
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of Colorado, Denver
name: University of North Carolina, Chapel Hill
name: Emory University
name: University of Pennsylvania
name: University of Texas Southwestern Medical Center
name: University of Washington
name: Patient-Centered Outcomes Research Institute
First posted: 2023-12-15
Enrollment: 1300
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Between 65-85 years of age
* Language is English or Spanish
* Diagnosed with severe aortic stenosis defined as (e.g. an aortic valve area \< 1 cm2 or as determined by clinician)
* Attend a scheduled visit with an Interventional Cardiologist and/or Cardiac Surgeon from the Heart Valve Team at a participating site

Exclusion Criteria:

* Prior aortic valve replacement surgery
* High risk for either SAVR or TAVI (e.g., Society of Thoracic Surgery score \>8% or clinician determined)
* 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)

Primary outcomes:
measure: Shared Decision Making
timeFrame: About 1 week post visit
Secondary outcomes:
measure: Reach
timeFrame: About 1 week post visit
measure: Patient Knowledge
timeFrame: About 1 week post visit
measure: Preference-treatment concordance
timeFrame: About 1 week post visit
measure: Patient experience
timeFrame: About 1 week post visit
measure: Clinician satisfaction
timeFrame: About 1 week post visit
measure: Adoption
timeFrame: 4 weeks from the start of intervention period for each site
measure: Timeliness (time to decision)
timeFrame: About 1 week post visit
measure: Timeliness (burden)
timeFrame: About 1 week post visit
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: The Regents of the University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sammy Elmariah, MD
role: PRINCIPAL_INVESTIGATOR
References: