Embedding an Education Intervention about Shared Decision Making into an RCT: Ensuring competency and fidelity

Amy B Zelenski; Karlie Haug; Kyle J Bushaw; Anne Buffington; Taylor Bradley; Kristine L Kwekkeboom; Lily Stalter; Bret M Hanlon; Maureen J Wakeen; Roy A Jhagroo; Laura J Maursetter; Sara K Johnson; Toby C Campbell; Margaret L Schwarze

doi:10.1016/j.pecinn.2024.100260

Embedding an Education Intervention about Shared Decision Making into an RCT: Ensuring competency and fidelity

PEC Innov. 2024 Feb 2:4:100260. doi: 10.1016/j.pecinn.2024.100260. eCollection 2024 Dec.

Authors

Affiliations

¹ Department of Medicine, University of Wisconsin, Madison, WI, USA.
² Department of Surgery, University of Wisconsin, Madison, WI, USA.
³ School of Nursing, University of Wisconsin, Madison, WI, USA.
⁴ Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA.

Abstract

Objective: To describe the outcomes of training nephrology clinicians and clinical research participants, to use the Best Case/Worst Case Communication intervention, for discussions about dialysis initiation for patients with life-limiting illness, during a randomized clinical trial to ensure competency, fidelity to the intervention, and adherence to study protocols and the intervention throughout the trial.

Methods: We enrolled 68 nephrologists at ten study sites and randomized them to receive training or wait-list control. We collected copies of completed graphic aids (component of the intervention), used with study-enrolled patients, to measure fidelity and adherence.

Results: We trained 34 of 36 nephrologists to competence and 27 completed the entire program. We received 60 graphic aids for study-enrolled patients for a 73% return rate in the intervention arm. The intervention fidelity score for the graphic aid reflected completion of all elements throughout the study.

Conclusion: We successfully taught the Best Case/Worst Case Communication intervention to clinicians as research participants within a randomized clinical trial.

Innovation: Decisions about dialysis are an opportunity to discuss prognosis and uncertainty in relation to consideration of prolonged life supporting therapy. Our study reveals a strategy to evaluate adherence to a communication intervention in real time during a clinical study.

Keywords: Communication education; Kidney disease; Shared decision-making.