Setting the Agenda: An Open Pilot of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Feasibility Outcome: Intervention receipt
研究概览
简要总结
The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial.
The main questions the researchers aim to answer are:
- Do the steps for identifying eligible participants work?
- Do the steps for administering CKD Topics work?
- Do the steps to administer survey questions work?
详细描述
In this open pilot, the researchers will administer a novel structured agenda-setting tool (SAS) called Chronic Kidney Disease (CKD) Topics. The researchers will determine if their procedures for screening eligible participants, administering the intervention, and administering outcome and other questionnaires are appropriate. Learnings from the open pilot will feed forward into procedures in a larger planned pilot stepped wedge feasibility trial.
This study only has one arm, the intervention arm. The intervention, CKD Topics, will be administered as a quality improvement intervention.
Future Directions: This open pilot will inform procedural changes in an upcoming pilot stepped wedge feasibility trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adults >18 years old who have been diagnosed with advanced CKD (stages 4-5).
- •Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent
- •English-speaking
- •Able to provide informed consent
- •Patient must be attending outpatient visits *(in-person and/or telehealth allowable).
排除标准
- •Children under 18 years old will not be included
- •Non-English-speaking patients and/or care partners
- •Patients on dialysis
- •Individuals unable or unwilling to provide informed consent
研究组 & 干预措施
Arm 1 is Clinical Visit Agenda Setting Tool Intervention
The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, called Chronic Kidney Disease (CKD) Topics.
干预措施: Chronic Kidney Disease Structured Agenda-Setting Tool (Behavioral)
结局指标
主要结局
Primary Feasibility Outcome: Intervention receipt
时间窗: Day 1
Our primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.
次要结局
未报告次要终点
研究者
Catherine Hylas Saunders
Principal Scientist, Assistant Professor of Medicine and of Health Policy and Clinical Practice
Dartmouth-Hitchcock Medical Center