A Pilot Proof of Concept, Randomized Controlled, Single-Center Study of a Decision Aid Tool for Older Patients (Age ≥75) Considering Left Heart Catheterization as Treatment for Non-St Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Percent change in mean decisional conflict score between the control and interventional group
研究概览
简要总结
This study will be a single-center, prospective, un-blinded, randomized controlled trial evaluating a decision aid tool for older patients considering left heart catheterization (LHC) as treatment for non-ST elevation myocardial infarction (NSTEMI). The study population is 50 total inpatients (25 per study arm) with NSTEMI eligible for elective LHC. The first arm is the control group that will receive standard of care, while the second arm will have access to the decision aid and shared-decision making conversation with one of the co-investigators. Baseline characteristics and surveys/questionnaire data will be collected after study intervention (as applicable), and prior to final decision regarding LHC. Statistical analyses will be conducted on the primary endpoint, decisional conflict score, as well as on various secondary endpoints.
详细描述
A single-center, prospective, un-blinded, randomized controlled trial. Primary objective: To pilot a coronary revascularization decision aid in older adults with NSTEMI who are candidates for elective LHC in order to determine its effectiveness in lowering decisional conflict by the decisional conflict scale (DCS).
Secondary objectives: To determine decision aid feasibility by measuring time of administration and percentage of patients agreeing to use. Also, to assess efficacy of the decision aid in decreasing patient feelings of anxiety and depression (by the Hospital Anxiety and Depression Scale), increasing decision self-efficacy (by the Ottawa Decision Self-Efficacy Scale), and increasing medical knowledge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be admitted to the hospital, and there must be clinical suspicion for type I NSTEMI
- •Must be eligible for non-urgent revascularization
- •Must have capacity to consent for the study based on the judgment of the study investigators
- •Must speak English
排除标准
- •Does not meet all of the inclusion criteria listed above
- •Has significant vision or hearing impairment that prohibits use of the decision aid
- •Unable to read
- •Has a clinical diagnosis of dementia and/or severe cognitive impairment documented in the electronic medical record
结局指标
主要结局
Percent change in mean decisional conflict score between the control and interventional group
时间窗: Visit 1 (Day 0)
A reduction in decisional conflict score will be measured with the DCS tool to reflect an increase in the quality of the decision.
次要结局
- Descriptive Statistics in the use of the Patient Decision Aid(Visit 1 (Day 0))