Setting the Agenda: A Pilot Stepped Wedge Cluster Randomized Trial of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease
Dartmouth-Hitchcock Medical Center
Summary
The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time. The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants. The main questions the researchers aim to answer are: * Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility * Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy
Description
This stepped-wedge pilot randomized controlled trial (RCT) is to test a new structured agenda-setting (SAS), called the Chronic Kidney Disease (CKD) Topics Agenda-Setting Tool, with patients, their care partners and their clinicians. This is a pilot study, so the researchers are collecting feasibility data to determine if a larger, fully-powered RCT can be moved forward. The researchers are also collecting preliminary efficacy data, which will help the design of a future study on the efficacy of clinical visits for people with advanced CKD. This study has two arms: 1) a usual care arm, and 2)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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). Exclusion Criteria: * 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
Interventions
- OtherChronic Kidney Disease Structured Agenda-Setting Tool
Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD living in rural areas. CKD Topics includes structured discussion topic areas.
Location
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire