Promoting Shared Decision Making for Severe Aortic Stenosis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Shared Decision Making [Срок оценки: About 1 week post visit]

Вторичные конечные точки (8)

• Reach [Срок оценки: About 1 week post visit]
• Patient Knowledge [Срок оценки: About 1 week post visit]
• Preference-treatment concordance [Срок оценки: About 1 week post visit]
• Patient experience [Срок оценки: About 1 week post visit]
• Clinician satisfaction [Срок оценки: About 1 week post visit]
• Adoption [Срок оценки: 4 weeks from the start of intervention period for each site]
• Timeliness (time to decision) [Срок оценки: About 1 week post visit]
• Timeliness (burden) [Срок оценки: About 1 week post visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 8 центров

• The Regents of the University of California, San Francisco — San Francisco
• University of Colorado Denver — Aurora
• Emory University — Atlanta
• Massachusetts General Hospital — Boston
• Washington University School of Medicine — St Louis
• The University of North Carolina at Chapel Hill — Chapel Hill
• University of Pennsylvania — Philadelphia
• UT Southwestern Medical Center — Dallas

Публикации

• 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. PMID 39696639

Идентификаторы

NCT: NCT06171737 · 2023P001413

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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