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

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) 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. The researchers 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.