TY - JOUR
T1 - The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) Study
T2 - study protocol for a cluster randomized stepped wedge trial
AU - Sepucha, Karen
AU - Elmariah, Sammy
AU - Valentine, K. D.
AU - Cavender, Matthew A.
AU - Chang, Yuchiao
AU - Devireddy, Chandan M.
AU - Dickert, Neal W.
AU - Gama, Kristy D.
AU - Knoepke, Christopher E.
AU - Korngold, Ethan
AU - Kumbhani, Dharam J.
AU - Matlock, Daniel D.
AU - Messenger, John C.
AU - Strong, Susan
AU - Thourani, Vinod H.
AU - Nathan, Ashwin
AU - Quader, Nishath
AU - Brescia, Alexander A.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/12
Y1 - 2024/12
N2 - Background: The American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level. Methods: The study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation. Discussion: The IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts. Trial registration: ClinicalTrials.gov NCT06171737. Registered on December 15, 2023.
AB - Background: The American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level. Methods: The study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation. Discussion: The IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts. Trial registration: ClinicalTrials.gov NCT06171737. Registered on December 15, 2023.
KW - Aortic valve stenosis
KW - Cardiology
KW - Continuing medical education
KW - Decision aid
KW - Decision-making
KW - Shared
KW - Transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85212254946&partnerID=8YFLogxK
U2 - 10.1186/s13063-024-08640-6
DO - 10.1186/s13063-024-08640-6
M3 - Article
C2 - 39696639
AN - SCOPUS:85212254946
SN - 1745-6215
VL - 25
JO - Trials
JF - Trials
IS - 1
M1 - 820
ER -