Multi-disciplinary Participatory Design of a Process to Deliver a CKD Diagnosis in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Level of perceived understanding of CKD as measured by the Perceived Kidney Knowledge Survey (PiKS)
研究概览
简要总结
This study will use an adapted education worksheet to support patient-centered chronic kidney disease (CKD) communication, shared decision making, and patient engagement and will test its impact on intermediate patient modifiable characteristics in a primary care practice with patients who have pre-dialysis CKD.
The study team will enroll up to 100 patients with chronic kidney disease (CKD) from a primary care clinic to start. Patients will receive the intervention, which consists of the physicians using the education worksheet during appointments with patients, and patients and providers will complete surveys about its use and to measure impact on knowledge and other areas related to patient outcomes.
Once initial user testing is complete, the study team plans to submit an amendment to expand on this trial and incorporate comparison sites. This will be submitted and receive IRB approval prior to participant involvement.
The study hypothesis is that patients who receive the intervention will have greater knowledge about their CKD diagnosis, higher satisfaction with provider communication, and higher scores related to managing CKD to keep themselves healthy compared to control populations.
详细描述
Amendment on 12/2018: The enrollment numbers were updated to include the control group.
Clarification 9/2021: After initial feasibility was assessed, the initial site was used additionally to enroll for the "second arm", rather than a new site as originally intended. A second site was then used for the control population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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 old or older
- •Have an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m2
- •Able to read and understand English without an interpreter
- •Diagnosed with chronic kidney disease on record
排除标准
- •Patients with renal transplant or on dialysis
- •Patients who have documented or provider known cognitive impairment or vision impairment that will prohibit meaningful interaction with education activation worksheet
- •Patients who are not aware of their CKD diagnosis
研究组 & 干预措施
Participatory design and intervention
Patients in this arm will receive the intervention of using an education worksheet during their appointment with their provider. They will be asked to complete post intervention surveys (for feasibility and feedback prior to actual trial enrollment). Providers and staff at this site have been involved in the design of the intervention process, to make it streamlined and efficient for application in practice.
干预措施: Education worksheet (Behavioral)
Intervention Only
This arm include new patients at the initial site that also received the intervention of using an education worksheet during their appointment and filled out post intervention surveys. Some of these providers/staff were not involved in the initial design of the intervention.
干预措施: Education worksheet (Behavioral)
Usual Care
A second site included usual care, which did not include the intervention. Participants were given post visit surveys similar to those in the two other study / intervention arms. This site served as a usual care comparison.
结局指标
主要结局
Level of perceived understanding of CKD as measured by the Perceived Kidney Knowledge Survey (PiKS)
时间窗: Length of doctor's appointment, e.g., 1-2 hours
This will measure subjective kidney knowledge. Score range is 1-4, where 1 is low level of perceived kidney knowledge, and 4 is high level of perceived kidney knowledge. The PiKS was developed by Dr. Wright.
Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)
时间窗: Length of doctor's appointment, e.g., 1-2 hours
This will measure objective kidney disease knowledge, based on a score of 0-100, where 0 means poor level of kidney knowledge, and 100 means good level of kidney knowledge. The KiKS was developed by Dr. Wright.
次要结局
- Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)(Length of doctor's appointment, e.g., 1-2 hours)
- Level of mental anxiety/stress related to condition as measured by the adapted NDBCSS scale(Length of doctor's appointment, e.g., 1-2 hours)
- Level of energy/fatigue and emotional well-being as measured by the SF-36 mental health component(4 weeks)
研究者
Julie Wright-Nunes
Associate Professor
University of Michigan