Process Evaluation Alongside a Cluster-Randomized Trial of a Multicomponent Intervention Designed to Improve Patient...

In a cluster-randomized trial, we learned that a novel multicomponent intervention designed to improve access to kidney transplantation did not significantly increase the rate of completed steps toward receiving a kidney transplant. Alongside the trial, we conducted a process evaluation to help interpret our findings.

To determine whether the intervention addressed targeted barriers to transplant and whether the implementation occurred as planned.

Mixed-methods process evaluation informed by implementation science theories.

Chronic kidney disease (CKD) programs in Ontario, Canada. These programs, providing care to patients with advanced CKD, participated in the trial from November 1, 2017 to December 31, 2021 (either in the intervention or usual care group).

Health care providers (eg, nurses, managers) at Ontario's 27 CKD programs.

We conducted surveys (n = 114/162 [70.4%]) and semi-structured interviews (n = 17/26 [65.4%]) with providers in CKD programs in Ontario, Canada. In both the intervention-group and control-group surveys, using the Theoretical Domains Framework, we assessed perceived barriers to transplant and how barriers changed throughout the trial period. In the intervention-group surveys and interviews, using the normalization process theory, we assessed the extent to which the intervention was embedded into daily routines. In the intervention-group surveys, and by completing an implementation checklist, we assessed fidelity of implementation.

Perceived barriers to transplant did not substantially differ between providers in the intervention and usual care groups, and both groups reported disagreeing or feeling neutral that the targeted barriers impeded transplant access. Intervention-group providers reported that intervention activities were becoming a regular part of their work and that they engaged with its components. However, they also felt the intervention was complex and described needing more resources, a better execution plan, and more buy-in from frontline staff. Fidelity was high for administrative support, quality improvement teams, delivery of educational resources, and patient peer support. The use of performance reports was low.

We identified several possible reasons why the intervention was unsuccessful. Improving access to kidney transplantation remains a high priority for health care systems. We will continue to foster a quality improvement culture, and our results will guide future interventions.

Two of the 13 intervention-group CKD programs did not participate in this evaluation.

ClinicalTrials.gov Identifier: NCT03329521.