Promoting Shared Decision Making for Severe Aortic Stenosis (IMPACT SDM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Behavioral: Decision Aid; Behavioral: Shared Decision Making Skills Training

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Sepucha, PhD; Phone Number: 617-724-3350; Email: ksepucha@partners.org
• Study Contact Backup: Name: KD Valentine, PhD; Phone Number: 617-724-1621; Email: kvalentine2@mgh.harvard.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94117
      • The Regents of the University of California, San Francisco
      • Contact: Sammy Elmariah; Email: Sammy.Elmariah@ucsf.edu
  • Colorado
    • Aurora, Colorado, United States, 80045-7202
      • University of Colorado Denver
      • Contact: Christopher Knoepke; Phone Number: 303-724-9938; Email: christopher.knoepke@cuanschutz.edu
      • Contact: Daniel Matlock; Phone Number: 303.724.9941; Email: daniel.matlock@cuanschutz.edu
  • Georgia
    • Atlanta, Georgia, United States, 30308-0000
      • Emory University
      • Contact: Chandan Devireddy; Phone Number: 404-686-2513; Email: cdevire@emory.edu
      • Contact: Neal Dickert; Phone Number: 404-712-6834; Email: njr@emory.edu
    • Atlanta, Georgia, United States, 30309-1285
      • Piedmont Healthcare
      • Contact: Vinod Thourani; Email: Vinod.Thourani@piedmont.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-1350
      • The University of North Carolina at Chapel Hill
      • Contact: Matthew Cavender; Phone Number: 919-843-1507; Email: matt.cavender@unc.edu
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Health & Services - Oregon
      • Contact: Ethan Korngold; Phone Number: 503-216-0790; Email: Ethan.korngold@providence.org
  • Texas
    • Dallas, Texas, United States, 75390-9020
      • UT Southwestern Medical Center
      • Contact: Dharam Kumbhani; Email: dharam.kumbhani@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (usual care); This group will receive usual care without any support for using the decision aid and without any access to the clinician training.
Active Comparator: Intervention; 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; The American College of Cardiology decision aid: Treatment Options for Severe Aortic Stenosis for patients deciding between Tavi and Surgery; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; University of Colorado, Denver; Emory University; University of California, San Francisco; University of North Carolina, Chapel Hill; University of Texas; Piedmont Healthcare; Providence Health & Services
• Investigators: Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital; Principal Investigator: Sammy Elmariah, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Decision Making, Shared; Transcatheter Aortic Valve Replacement; cardiology; aortic valve stenosis; decision aid; continuing medical education
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2023P001413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To promote research replicability, transparency and future use of the data, de-identified data sets will be created and will be available, by request, to outside researchers. The Data Package (comprised of the de-identified Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan, and analytic code from the project) will be deposited in the Patient-Centered Outcomes Research Institute's Data Repository at the ICPSR. Participant information sheets for the study will indicate that de-identified information will be deposited in an open access service to promote use of the data by other researchers. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set. No data will be provided from qualitative transcripts as this may lead to identifying information about participants. However, codes abstracted from qualitative transcripts may be made available.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Researchers may access the data through the PCORI-designated repository (ICPSR's website) once it is made available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No