Promoting Shared Decision Making for Severe Aortic Stenosis

Aortic Stenosis Clinical Trial

— IMPACT SDM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06171737
• Other study ID #: 2023P001413
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: October 31, 2027

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Karen Sepucha, PhD
• Phone: 617-724-3350
• Email: ksepucha[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: October 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Behavioral:
• Decision Aid
The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery
• 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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Providence Health & Services - Oregon	Portland	Oregon
United States	The Regents of the University of California, San Francisco	San Francisco	California

Sponsors (9)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Emory University, Patient-Centered Outcomes Research Institute, Piedmont Healthcare, Providence Health & Services, University of California, San Francisco, University of Colorado, Denver, University of North Carolina, Chapel Hill, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shared Decision Making	Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred.	About 1 week post visit
Secondary	Reach	% of eligible patients who receive decision aid	About 1 week post visit
Secondary	Patient Knowledge	Multiple choice knowledge score ranging from 0-100; higher scores indicate higher knowledge	About 1 week post visit
Secondary	Preference-treatment concordance	% of patients who received preferred treatment within 6 months of visit	About 1 week post visit
Secondary	Patient experience	CAHPS MD-patient communication subscale and visit rating score	About 1 week post visit
Secondary	Clinician satisfaction	% of clinicians who mark "very" or "extremely" satisfied with visit	About 1 week post visit
Secondary	Adoption	% of eligible clinicians who complete the shared decision making skills training	4 weeks from the start of intervention period for each site
Secondary	Timeliness (time to decision)	% of patients who report stage of decision making is "made a decision"	About 1 week post visit
Secondary	Timeliness (burden)	% of visits where clinicians report visit length is "longer than normal"	About 1 week post visit