A Randomized Controlled Trial of an Advanced Care Planning Video Decision Support Tool for Patients With End-Stage Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Eligible Participants Enrolled in the Study
研究概览
简要总结
The goal of this pilot randomized trial is to assess the feasibility and preliminary efficacy of an advanced care planning (ACP) video decision support tool for improving patients' knowledge regarding their goals of care options and end of life (EOL) decision-making in patients with end-stage liver disease (ESLD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •≥ 18 years of age with an established diagnosis of end-stage liver disease
- •Patient must have either 1) primary hepatologist at the MGH Liver Center or an MGH-affiliated primary care physician, or 2) a previous inpatient admission at MGH
- •Deemed ineligible for liver transplantation as determined by the primary hepatologist
- •Ability to communicate in English and provide informed consent
- •A score ≥ 7 on the Short Portable Mental Status Questionnaire
排除标准
- •Severe hepatic encephalopathy which the primary hepatologist believes prohibits informed consent or participation in the study
- •Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary hepatologist believes prohibits informed consent or participation in the study
- •Prior history of liver transplantation
- •Patient has been referred to or enrolled in hospice care
- •Patients who have been referred to palliative care
研究组 & 干预措施
Advanced Care Planning Video Decision Support Tool
We designed a 3-minute advance care planning video to provide patients with advanced liver disease general understanding of the types of medical care patients may receive at the end of life (EOL) and a description of medical interventions such as hospitalizations, intensive care unit (ICU) admission, cardiopulmonary resuscitation (CPR), and intubation. The video begins by addressing the importance of the patient's personal goals and perspectives by asking the viewer to reflect on their concerns about getting sick and their overall goals for their EOL care. The physician narrator then introduces a framework for choices of medical care at the EOL including: 1) life-prolonging care; 2) limited medical care; and 3) comfort care followed by visual images illustrating each of these EOL care choices. All three sequences of video images accompanying the narration attempt to help the viewer imagine the experience and likely outcomes of receiving these medical interventions at the EOL.
干预措施: Advance Care Planning Video Decision Support Tool (Behavioral)
Verbal Narrative Control
Immediately after completing baseline assessments and randomization, patients assigned to the verbal narrative control arm will listen to the same description of the 3 goals of care used in the video arm read out by a research assistant
干预措施: Verbal Narrative (Other)
结局指标
主要结局
Number of Eligible Participants Enrolled in the Study
时间窗: By 12 months
The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.
次要结局
- Code Status Documentation(By 12 months)
- Preferences for Life-prolonging Care, Preferences to Receive Cardiopulmonary Resuscitation (CPR), and Preferences to Receive Intubation(By 12 months)
- Changes in Knowledge Scores From Baseline to Post-intervention(Baseline and post-intervention, by 12 months)
- Number of Participants Who Answered That They Felt "Very Comfortable" Seeing the Video in Response to First Question of Acceptability Questionnaire (Acceptability - Comfort)(By 12 months)
- Number of Participants Who Answered That They Felt the Video Was "Very Helpful" in Response to Second Question of Acceptability Questionnaire (Acceptability - Helpful)(Within 12 months)
- Number of Participants Who Answered That They Would "Definitely Recommend" the Video to Other Patients in Response to Third Question on Acceptability Questionnaire (Acceptability - Recommend to Others)(within 12 months)
研究者
Nneka nnaoke Ufere
Assistant Professor
Massachusetts General Hospital