Decision support training for chronic kidney disease dyads: the ImPart Study protocol

Individuals living with stage 4 chronic kidney disease and their caregivers face multiple health-related decisions as the disease progresses. The ImPart (Improving the decision-making PARTnership of chronic kidney disease dyads), community-informed, factorial pilot trial intervention aims to train members of the dyad in skills to enhance decision support for patients.

This single-site pilot 2³ factorial trial aims to evaluate the feasibility, acceptability, and preliminary efficacy of the ImPart decision-support training intervention components for individuals with stage 4 chronic kidney disease and their caregivers. Caregivers (n = 64) and patients (n = 64) will be randomly assigned to one of 8 combinations of 3 components with two levels each: (1) caregiver coaching on effective decision support (1 session vs. 3 sessions); (2) caregiver decision support communication training (1 session vs. no session); and (3) patient social support effectiveness psychoeducation (2 sessions vs. no sessions). The primary outcomes of this pilot study are feasibility and acceptability. Secondary outcomes will also be evaluated, including patient decision conflict, quality of life, patient and caregiver distress, and dyadic coping. Results will be used to create a version of ImPart for use in a future fully powered randomized controlled trial.

This protocol outlines a pilot factorial trial, guided by the multiphase optimization strategy, to evaluate a community-engaged, co-developed decision-support intervention for individuals with stage 4 chronic kidney disease and their caregivers.

NCT06173323.