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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06171737
Other study ID # 2023P001413
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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