Clinical trial NCT07024953: The Agenda-Setting for Kidney Disease Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Stage 4
Chronic Kidney Disease Stage 5
Keywords: Chronic Kidney Disease
Chronic kidney disease stage 4
Chronic kidney disease stage 5
Agenda-setting
Rural
Patient engagement
Randomized trial
Participatory research
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: University of Washington
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-06-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge randomized controlled trial with clustered cross-over assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

We 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 we collect in this trial will help us design a future trial with more participants.

The main questions we 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

Detailed 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 we are collecting feasibility data to determine if we can move forward with a larger, fully-powered RCT. We 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) an intervention arm where participants and their nephrology physicians will use CKD Topics during their visits. Physicians will initially be randomly assigned to one of three clusters, with two attending physicians and one fellow physician in each cluster. Each cluster will start out practicing usual care for at least eight months during the enrollment period. After that initial 8 months, one cluster will cross over to the intervention arm every four months, by using the CKD Topics tool in their visits, in what's called the rollout period. At 16 months into the trial, all clusters will be on the intervention arm, using CKD topics with patients, and will do so for the remaining 12 months of the trial.

Patient participants will be enrolled in the study arm to which their physicians have been randomized. Participation is expected to last 24 months for patients and clinicians, and participants may use CKD Topics more than once during the study period. We expect 108 patient participants, and nine clinicians will enroll in the study. Every participant will receive a baseline survey after enrollment and four subsequent surveys.

The procedures in this study will include screening patients for study eligibility, consenting them to participate in study activities such as filling out surveys. The intervention, CKD topics, itself will be administered as quality improvement so will not be included as a research activity needing consent.

Future Directions: Findings from this trial will forecast a range of participants required in the sample for a full-scale RCT and illustrate "proof of concept" for a future trial which will evaluate the intervention's impact on patient self-advocacy and clinical care outcomes in rural CKD populations.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Feasibility Outcome
timeFrame: From enrollment to the end of treatment at 16 months
Secondary outcomes:
measure: Secondary Feasibility Outcome
timeFrame: From enrollment to the end of treatment at 16 months
Other outcomes:
measure: Primary Process Outcome: Enrollment Rate
timeFrame: From enrollment to the end of treatment at 16 months
measure: Secondary Process Outcome: Loss to follow-up
timeFrame: From enrollment to the end of treatment at 16 months
measure: Patient Self-Advocacy Scale (PSAS)
timeFrame: From enrollment to the end of treatment at 16 months
measure: Patient self-efficacy
timeFrame: From enrollment to the end of treatment at 16 months
measure: Patient self-management
timeFrame: From enrollment to the end of treatment at 16 months
measure: Unplanned hospitalization or emergency department visit
timeFrame: From enrollment to the end of treatment at 16 months
measure: Serious Illness Experience
timeFrame: From enrollment to the end of treatment at 16 months
measure: Respect Experience Assessment
timeFrame: From enrollment to the end of treatment at 16 months
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
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