A Pilot Study of The CKM JumpStart Tool
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Patient-provider discussion of CKM
研究概览
简要总结
This is a randomized pilot study to test the feasibility and acceptability of a tool to promote discussion about conservative kidney management (CKM) among older patients with advanced CKD and their providers.
详细描述
This study is a randomized pilot study to test the acceptability and feasibility of a novel communication tool, called the CKM Jumpstart Tool, to promote discussion of CKM between patients with advanced CKM and their healthcare providers, the investigators hypothesize that the Guide will be feasible and acceptable to patients and their healthcare providers as reflected in greater discussion of CKM between them following use of the Tool as compared with usual care. The investigators will enroll 76 patients aged 75 years and older with advanced CKD and their healthcare providers from University of Washington Medicine and Veterans Affairs Puget Sound Health Care System. Patients will be randomized together in a 1:1 fashion to receive the intervention or usual care. Data from participants will be collected at the time of enrollment (T1), within 2-weeks of their following clinic visit with their healthcare provider (T2), and approximately 3-month after this clinic visit (T3). The primary outcome measure and measure of feasibility is difference in patient-reported rates of discussion of CKM with a healthcare provider at T2 and T3. The investigators will also evaluate whether provider document in the medical chart of patients whether they had a discussion about CKM with the patient at T2 and T3. The investigators will also collect attrition rates at T2 and T3 as a measure of acceptability. The investigators will further assess user experience of the CKM JumpStart by performing a qualitative analysis of post-intervention interviews with patients and nephrologists, coding for themes elucidating pros, cons and other considerations with using the CKM JumpStart Tool and discussion about CKM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥75 years
- •Advanced CKD as defined as having at least 2 outpatient measures of eGFR <25 ml/min/1.73m2 separated by >90 days in the prior year and with at least 1 eGFR measure <
- •English-speaking
- •Receive care from a provider at UW Medicine or VA Puget Sound
- •Open to discussing their values and treatment options for kidney disease with their provider.
排除标准
- •Unable to complete the informed consent process
- •Currently receiving maintenance dialysis
- •Providers Inclusion
- •Their patient is a participant in the study.
- •Are a UW Medicine or VA Puget Sound provider or trainee.
研究组 & 干预措施
CKM Jumpstart Tool
Receives intervention
干预措施: CKM Jumpstart Tool (Behavioral)
Control
Does not receive intervention
结局指标
主要结局
Patient-provider discussion of CKM
时间窗: 3 months
We will ask patients whether they had discussed CKM with their healthcare provider at T2 and T3.
Attrition
时间窗: 3 months
We will record the proportion of participants in each study arm who withdraw from the study and the reasons why at T2 and T3. Study withdrawal would indicate that the Tool and/or study is unacceptable or burdensome to the participant.
次要结局
- Documentation of CKM Discussion(3 months)
- Treatment preference(3 months)
- Quality of Communication(3 months)
- Patient Post-Intervention Interview(2 weeks)
- Provider Use of CKM Jumpstart Tool(2 weeks)
研究者
Susan Wong
Associate Professor: School of Medicine
University of Washington