Promoting Shared Decision Making for Severe Aortic Stenosis

NCT06171737 | Enrolling By Invitation

• 1 other identifier: 2023P001413
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 8

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.

Conditions

Aortic Stenosis

Keywords

aortic valve stenosis; Decision Making, Shared; decision aid; continuing medical education; cardiology; Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Reach

  About 1 week post visit

• Patient Knowledge

  About 1 week post visit

• Preference-treatment concordance

  About 1 week post visit

• Patient experience

  About 1 week post visit

• Clinician satisfaction

  About 1 week post visit

Study Arms (2)

Control (usual care)

NO INTERVENTION

This group will receive usual care without any support for using the decision aid and without any access to the clinician training.

Intervention

ACTIVE COMPARATOR

The patients in this group will receive a decision aid that covers the main treatment options for aortic stenosis. The clinicians in this group will receive a 60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies

Behavioral: Decision Aid; Behavioral: Shared Decision Making Skills Training

Interventions

Decision Aid BEHAVIORAL

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

Intervention

Shared Decision Making Skills Training BEHAVIORAL

60-minute online training session that will provide practical tips, interactive case studies and tools for conducting shared decision making conversations covering core competencies

Intervention

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of California, San Francisco: collaborator
• University of Colorado, Denver: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Emory University: collaborator
• University of Pennsylvania: collaborator
• University of Texas Southwestern Medical Center: collaborator
• University of Washington: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (8)

The Regents of the University of California, San Francisco

San Francisco, California, 94117, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045-7202, United States

Location

Emory University

Atlanta, Georgia, 30308-0000, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-1350, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9020, United States

Location

Related Publications (1)

• Sepucha K, Elmariah S, Valentine KD, Cavender MA, Chang Y, Devireddy CM, Dickert NW, Gama KD, Knoepke CE, Korngold E, Kumbhani DJ, Matlock DD, Messenger JC, Strong S, Thourani VH, Nathan A, Quader N, Brescia AA. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) Study: study protocol for a cluster randomized stepped wedge trial. Trials. 2024 Dec 18;25(1):820. doi: 10.1186/s13063-024-08640-6.

  PMID: 39696639 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Karen Sepucha, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Sammy Elmariah, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: There is limited blinding in the trial due to the pragmatic focus and batched stepped wedge design. Patients will be told that the study is testing different types of decision support and while they will not be blinded to the materials they receive, they will not know what materials other patients receive. Clinicians and staff will be involved in delivery of the decision aids and will not be blinded to the study arm. Research staff entering survey data and conducting chart review will not be given any explicit information about study assignment; however, it is likely that they will have a sense for the arm due to the timing. The statistician conducting analyses will be blinded to group assignment at each step. For the clinician survey, we will use computer generated random assignment to select one specialist (either interventional cardiologist or cardiac surgeon) to receive the post-visit survey for each patient participant.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 15, 2023
• Study Start: March 27, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available, or at the time of publication the primary results, whichever comes first.
• Access Criteria: Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.

Locations

US (8)