Development of a Tailored Life-Sustaining Treatment Decision Support Intervention for Stroke Surrogate Decision Makers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Acceptability of the decision tool intervention
研究概览
简要总结
The trial is testing an investigator-developed decision support tool for surrogate decision makers for stroke patients that are unable to make medical decisions for themselves.
A historical usual care control group will be enrolled during tool development. The tool will then be tested in surrogates of hospitalized stroke patients.
详细描述
Decision support tools, specifically recommended in the 2010 Affordable Care Act, have been shown to improve the quality of decisions and reduce burden on the decision maker in multiple clinical settings, yet almost none have focused on life-sustaining treatments in acute critical illness such as stroke. This study proposes a comprehensive frame shift in how the health care team and surrogates collaborate on decisions regarding life-sustaining treatments for acute illness, by developing a tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.
The two project phases are: 1) Decision support intervention development; and 2) Pilot testing in surrogates of hospitalized stroke patients. A novel ordinal prognostic model will be developed and incorporated into the tool.
The project expects 25 surrogate-patient pairs in the control group, and 25 surrogate-patient pairs in the intervention group, which equals a total of 100 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identify as the surrogate decision maker for eligible patient
- •Able to read and communicate in English without an interpreter
- •Limited to one surrogate per patient
排除标准
- •No prior relationship with patient
- •Dementia or other cognitive or health condition that would impair their ability to participate
- •Inclusion Criteria:
- •Ischemic stroke or spontaneous intracerebral hemorrhage
- •Impaired decisional capacity (per treating team)
- •Enrolled on or before full hospital day 5
- •Minimum illness severity (either):
- •National Institutes of Health Stroke Scale ≥ 10
- •Glasgow coma scale ≤12
- •Exclusion Criteria:
- •No surrogate available for study procedures
- •Already on comfort measures only
- •Physician refuses to allow approach for consent
- •Pregnancy
结局指标
主要结局
Acceptability of the decision tool intervention
时间窗: Immediately post-intervention
The proportion of cases where the surrogate completes use of the tool with high acceptability using the Acceptability E-Scale. The Acceptability E-Scale is a 6-item scale. A score of 1 indicates a negative evaluation and 5 indicates a positive evaluation. A score of 3 indicates a neutral evaluation. An individual will be considered to have high acceptability if the average response across the 6 items is 4 or higher)
次要结局
- Decisional Self Efficacy scale(Within approximately 5 days of admission)
- Accuracy of the surrogate's prognostic estimate for functional recovery(Within approximately 5 days of admission)
研究者
Darin Zahuranec
Associate Professor of Neurology
University of Michigan