PCORI-CDR-2022C1-26333 Promoting Shared Decision Making for Decisions About Treatment of Severe Aortic Stenosis (IMPACT SDM Study)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,300
- 试验地点
- 16
- 主要终点
- Shared Decision Making
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
There is limited blinding in the trial due to the pragmatic focus and batched stepped wedge design. Patients will be told that the study is testing different types of decision support and while they will not be blinded to the materials they receive, they will not know what materials other patients receive. Clinicians and staff will be involved in delivery of the decision aids and will not be blinded to the study arm. Research staff entering survey data and conducting chart review will not be given any explicit information about study assignment; however, it is likely that they will have a sense for the arm due to the timing. The statistician conducting analyses will be blinded to group assignment at each step. For the clinician survey, we will use computer generated random assignment to select one specialist (either interventional cardiologist or cardiac surgeon) to receive the post-visit survey for each patient participant.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Shared Decision Making
时间窗: About 1 week post visit
Shared Decision Making Process scale; Scores range 0-4 with higher scores indicating greater shared decision making occurred.
次要结局
- Reach(About 1 week post visit)
- Patient Knowledge(About 1 week post visit)
- Preference-treatment concordance(About 1 week post visit)
- Patient experience(About 1 week post visit)
- Clinician satisfaction(About 1 week post visit)
- Adoption(4 weeks from the start of intervention period for each site)
- Timeliness (time to decision)(About 1 week post visit)
- Timeliness (burden)(About 1 week post visit)
研究者
Karen Sepucha
Associate Professor
Massachusetts General Hospital