Improving Medical Decision Making for Older Patients With End Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 456
- 试验地点
- 9
- 主要终点
- Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation
研究概览
简要总结
The overall objective of this study is to reduce the burden of chronic kidney disease (CKD) and its consequences for an aging U.S. population. To accomplish this, the investigators propose to conduct a multi-center randomized trial of an advance care planning (ACP) video intervention (vs. usual care) among older patients with CKD.
详细描述
The video intervention consists of a video decision aid along with a video declaration (ViDec), which is recorded by the patient. The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet. The video will be shared with their nephrologist. The patient will have a copy of the video to take with them and share with their loved ones.
Patients will answer survey questions about their preferences, knowledge, decisional conflict, and ACP engagement. They will be surveyed every two months for one year or death (if they die before one year).
Potential participants will be recruited from 10 nephrology clinics: Massachusetts General Hospital (n=75), Brigham and Women's Hospital (n=75), University of Pittsburgh (n=75), University of Pennsylvania, Stanford University, Palo Alto Veterans Institute for Research, University of Washington, Renal & Transplant Associates of New England, University of New Mexico and Boston Medical Center.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age ≥70 are eligible if they have EITHER Advanced CKD defined as ONE eGFR value ≤ 30 ml/min/1.73m2 in the past 12 months NOT determined to be a result of AKI OR Have a diagnosis of CKD and less than a two-year prognosis from any cause, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?")
- •Patients age 65-69 are eligible if they have BOTH Advanced CKD defined as ONE eGFR value ≤ 30 ml/min/1.73m2 NOT determined to be a result of AKI AND Have less than a two-year prognosis, defined by the clinician answering "NO" to the Surprise Question ("Would you be surprised if this patients died in the next two years?")
- •Patients who have not had a nephrology visit in the past 12 months can be recruited from non-Nephrology Clinics per the above eligibility criteria
排除标准
- •listed for kidney transplantation or previous transplant recipient
- •already on or previously on dialysis (including emergent dialysis)
- •new patient visit
- •visually impaired beyond 20/200 corrected
- •psychological state not appropriate for ACP discussions as determined by the primary nephrologist
- •cognitive impairment
研究组 & 干预措施
Usual Care
Usual clinical care
Video Decision Aid
The video intervention consists of a video decision aid along with a video declaration (ViDec), which is recorded by the patient. The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet.
干预措施: Advance Care Planning Video Decision Aid (Behavioral)
结局指标
主要结局
Change in Advance Care Planning (ACP) in Electronic Health Record (EHR) Documentation
时间窗: Baseline, 12 months
Documentation in the electronic health record reflecting an ACP conversation (any of the following: completion of advance directive or physician order for life sustaining treatment (POLST); code status documentation; provider note reflecting ACP discussion).
次要结局
- Change in ACP Engagement(baseline, 12 months)
- Change in Kidney Disease (KD) Specific Quality of Life (QOL)(Baseline, 12 months)
- Change in CKD Care Preferences(Baseline, 12 months)
- Change in ACP Conversations(Baseline, 12 months)
- Change in Health Related Quality of Life (QoL)(Baseline, 12 months)
- Change in Decisional Conflict(Baseline, 12 months)
- Acceptability of video intervention(Baseline)
- Healthcare Costs(Baseline, 12 months)
- Change in ACP Preferences(Baseline, 12 months)