Promoting Shared Decision Making for Severe Aortic Stenosis
Launched by MASSACHUSETTS GENERAL HOSPITAL · Dec 14, 2023
Trial Information
Current as of July 23, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 inte...
Gender
ALL
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)
About Massachusetts General Hospital
Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
St. Louis, Missouri, United States
Chapel Hill, North Carolina, United States
Dallas, Texas, United States
San Francisco, California, United States
Aurora, Colorado, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Portland, Oregon, United States
Patients applied
Trial Officials
Karen Sepucha, PhD
Principal Investigator
Massachusetts General Hospital
Sammy Elmariah, MD
Principal Investigator
University of California, San Francisco
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported