Impact of Advance Care Planning Coaching for Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 8
- 主要终点
- Advance directive in EHR
研究概览
简要总结
This project will develop and test a model intervention for Advance Care Planning (ACP) for patients with advanced chronic kidney disease (CKD) cared for in nephrology clinics that have the capacity to consult with or refer to palliative care. Specifically, we will compare the effectiveness of having a trained ACP coach meet in person with patients to discuss their goals and preferences vs. providing patients with a packet of material to review on their own and then discuss with their nephrologist at their initiation.
Hypothesis: In patients aged 55 or older with stage 3-5 Chronic Kidney Disease cared for in a CKD outpatient clinic, an advance care planning process that involves in-person meetings with a trained ACP coach will be more effective than providing patients with printed educational materials alone.
详细描述
BASELINE VISIT: After obtaining written informed consent, research staff will administer a baseline survey to assess ACP readiness as well as participant physical and emotional health. The participant will then be randomized to one of the study arms: intervention or control. Research staff will provide participants in both study arms with the advance care planning educational materials and instruct them that they are encouraged to discuss their thoughts and questions with the nephrologist, at their own initiation. Participants will be further encouraged to bring their advance directives (ADs) to the clinic to be scanned into the electronic health record (EHR) if they currently have ADs or complete them in the future.
ADVANCE CARE PLANNING COACHING SESSION (intervention arm only): Participants in the intervention arm will receive a 60-minute in-person coaching session. The advance care planning coach, trained in motivational interviewing, will use a flexible script and checklist to assess the participant's readiness to engage in advance care planning and guide the participant forward in the process, proceeding at the participant's pace. Some participants may complete advance directives while others will not get that far. The coach will document the clinical aspects of the discussion in the participant's medical chart according to clinic protocol and the research aspects in the participant tracking instruments. The ACP coach may arrange for one or more follow-up sessions as needed, typically conducted by telephone.
FOLLOW-UP ASSESSMENT SURVEY (both study arms): Approximately 14 weeks after the baseline visit, research staff will contact the participant to administer a follow-up assessment survey.
FOLLOW-UP CHART REVIEW: Approximately 16 weeks after the baseline visit, research staff will review the participant's medical chart to assess documentation of advance care planning activities, medical and health outcomes, and use of medical and palliative care services.
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
- •Chronic Kidney Disease (CKD) Stage 3-5
- •Age 55 or older
- •English speaking
- •Patient at participating CKD clinic
排除标准
- •Receiving dialysis
- •Kidney transplant recipient
- •Cognitively impaired or otherwise not competent to participate (as deemed by treating nephrologist and research staff)
- •Participation contra-indicated for patient's health (as deemed by treating nephrologist)
结局指标
主要结局
Advance directive in EHR
时间窗: 16 weeks after baseline
Proportion of participants with advance directive or POLST/MOLST in EHR
ACP readiness score
时间窗: 14 weeks after baseline
Mean ACP readiness score at follow-up survey
次要结局
- Medical decision maker documented in EHR(16 weeks after baseline)
- ACP conversation with nephrologist documented in EHR(16 weeks after baseline)
研究者
Dale Lupu
Associate Research Professor
George Washington University