A Multifaceted Tool to Improve Decision Making About Cardio-Pulmonary Resuscitation (CPR) for Hospitalized Patients Who Are Seriously Ill
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- CPR Orders
研究概览
简要总结
Objective
The primary objective is to evaluate the efficacy of a multi-faceted, clinical decision support intervention aimed at improving the quality of decisions about Cardio Pulmonary Resuscitation (CPR) for seriously ill, elderly patients in hospital.
The hypothesis is that fewer patients in the intervention group will have a documented order for CPR and they will have greater satisfaction with decision making about CPR than patients in the control group.
详细描述
Methodological Approach
The study will be a randomized controlled trial comparing a multi-faceted decision support intervention to usual care for hospitalized patients. The primary objective of this study is to determine if our multifaceted intervention changes decisions about CPR. The components of the multifaceted intervention have already been evaluated for feasibility and acceptability in the hospital setting. The intervention has two parts: the first is a values clarification exercise, and the second part is a CPR video decision aid that explains the risks and benefits of CPR as well as the reasons a patient may choose to receive CPR or not. From previous research it is known that many hospitalized patients have prescribed orders for CPR despite expressing a preference not to have CPR when asked. Furthermore patients often have expressed values that are not concordant with their expressed wishes regarding resuscitation. Therefore it is hypothesized that fewer patients in the intervention group will have a documented order for CPR and they will have greater satisfaction with decision making about CPR than patients in the control group.
We will conduct sensitivity analyses to investigate whether the intervention is more effective among patients who remain in hospital longer after enrollment. We will measure the intervention effect among patients who remained in hospital for fewer than three days after enrollment, among patients who were in hospital for 3-7 days after enrollment, and among patients who remained in hospital for longer than 7 days post-enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible to receive CPR
- •Satisfying at least one of the following criteria groups
- •55 years of age or older with one or more of the following diagnoses:
- •Chronic obstructive lung disease (2 of the 3 of: baseline PaCO2 of > 45 torr, cor pulmonale; respiratory failure episode within the preceding year; forced expiratory volume in 1 sec <0.5 L)
- •Congestive heart failure (New York Heart Association class IV symptoms and left ventricular ejection fraction < 25%)
- •Cirrhosis (confirmed by imaging studies or documentation of esophageal varices and one of three conditions; hepatic coma, child's class C liver disease, or child's class B liver disease with gastrointestinal bleeding)
- •Cancer (metastatic cancer or stage IV lymphoma)
- •End-stage dementia (inability to perform all ADLs, mutism or minimal verbal output secondary to dementia, bed-bound state prior to acute illness).
- •80 years of age or older and admitted to hospital from the community for an acute medical or surgical condition.
- •If none of the above criteria are met, any patient whose death within the next 6 months would not surprise any member of their care team.
- •At least 55 years old and predicted risk of death in the next 12 months of >=10% as calculated with the HOMR Now! Score
排除标准
- •Patients or SDMs who do not speak English.
- •Patients or SDMs who do not provide informed consent.
研究组 & 干预措施
Intervention - Decision Support
In addition to the regular conversation about CPR that a patient's physician may have with them, participants will be given a two-part intervention. First, the participant will receive a values clarification tool which helps them rate and understand which relevant values are most important to them. There are two forms of this tool, a full and simplified version. All participants in this arm will receive both, in randomized order. The second aspect of the intervention is an educational video about the potential risks and benefits of CPR, which all participants in this arm will receive.
干预措施: Decision Support (Behavioral)
Control
Participants in this arm will receive usual care, the regular conversation about CPR that their physician may have with them.
结局指标
主要结局
CPR Orders
时间窗: 14 days post enrollment
The proportion of patients with an order for CPR in the medical record
次要结局
- Decisional Conflict(Immediately after intervention, or enrollment for control group)
- Health Resource Usage(From enrolment to 1 year after enrollment.)
- Number of emergency department visits(In the year following index admission)
- Quality of documented goals of care conversations(Between study enrollment and up to 14 days post enrollment)
- Number of hospital admissions(In the year following index admission)
- Number of hospital days(In the year following index admission)
- Number of documented goals of care conversations(Between study enrollment and up to 14 days post enrollment)
- SDM Self-efficacy(Immediately after intervention, or enrollment for control group)
- Number of participants with in-hospital mortality(In the year following index admission)
- Number of ICU days(In the year following index admission)
- Patient/Substitute Decision Maker (SDM) satisfaction with decision-making(Immediately after intervention, or enrollment for control group)
- Discharge Disposition(End of index admission)