Sepucha Karen, Elmariah Sammy, Valentine K D, Cavender Matthew A, Chang Yuchiao, Devireddy Chandan M, Dickert Neal W, Gama Kristy D, Knoepke Christopher E, Korngold Ethan, Kumbhani Dharam J, Matlock Daniel D, Messenger John C, Strong Susan, Thourani Vinod H, Nathan Ashwin, Quader Nishath, Brescia Alexander A
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
Trials. 2024 Dec 18;25(1):820. doi: 10.1186/s13063-024-08640-6.
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.
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.
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.
ClinicalTrials.gov NCT06171737. Registered on December 15, 2023.
美国心脏病学会、美国心脏协会以及医疗保险和医疗补助服务中心建议，对于患有严重主动脉瓣狭窄的患者，在经导管主动脉瓣置换术（TAVR）和外科主动脉瓣置换术（SAVR）之间进行选择时应采用共同决策（SDM）。尽管患者决策辅助工具（DAs）等工具以及共同决策培训已被证明可改善共同决策，但共同决策和决策辅助工具的实施仍然有限。通过共同决策改善主动脉瓣狭窄患者的治疗决策（IMPACT SDM）研究旨在：（1）确定干预措施（一种决策辅助工具和临床医生共同决策培训）在实现共同决策（主要结局）以及提高主动脉瓣置换决策质量方面的有效性；（2）确定决策辅助工具的普及程度和培训的采用情况；（3）探索在患者、临床医生和诊所层面有效性和实施的潜在机制。
该研究是一项II型混合有效性 - 实施研究，采用整群随机分批阶梯楔形试验，在美国各地有8个研究点。符合条件的患者在与心脏瓣膜团队就诊前后将接受调查；临床医生在就诊后将接受调查。将跟踪决策辅助工具的普及程度和培训的采用情况。将就实施的障碍和促进因素对临床医生进行访谈。
IMPACT SDM研究旨在提供证据，证明干预措施改善共同决策和决策质量的能力，并阐明共同决策实施的障碍和促进因素，以推动未来的实施工作。
ClinicalTrials.gov NCT06171737。于2023年12月15日注册。
