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

Mass General Brigham

Status: Invitation-only

Conditions: Aortic Stenosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06171737

2023P001413

Details and patient eligibility

About

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.

Full 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 batched stepped wedge cluster randomized trial with 8 sites, about 56 surgeons and interventional cardiologists, and will enroll about 1300 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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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1,300 participants in 2 patient groups

Control (usual care)

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: Decision Aid

Behavioral: Shared Decision Making Skills Training