Best Case/Worst Case: protocol for a multisite randomised clinical trial of a scenario planning intervention for patients with kidney failure

Abstract

Introduction: Given the burdens of treatment and poor prognosis, older adults with kidney failure would benefit from improved decision making and palliative care to clarify goals, address symptoms, and reduce unwanted procedures. Best Case/Worst Case (BC/WC) is a communication tool that uses scenario planning to support patients' decision making. This article describes the protocol for a multisite, cluster randomised trial to test the effect of training nephrologists to use the BC/WC communication tool on patient receipt of palliative care, and quality of life and communication.

Methods and analysis: We are enrolling attending nephrologists, at 10 study sites in the USA, who see outpatients with advanced chronic kidney disease considering dialysis. We aim to enrol 320 patients with an estimated glomerular filtration rate of ≤24 mL/min/1.73 m2 who are age 60 and older and have a predicted survival of 18 months or less. Nephrologists will be randomised in a 1:1 ratio to receive training to use the communication tool (intervention) at study initiation or after study completion (wait-list control). Patients in the intervention group will receive care from a nephrologist trained to use the BC/WC communication tool. Patients in the control group will receive usual care. Using chart review and surveys of patients and caregivers, we will test the efficacy of the BC/WC intervention with receipt of palliative care as the primary outcome. Secondary outcomes include intensity of treatment at the end of life, the effect of the intervention on quality of communication (QOC) between nephrologists and patients (using the QOC scale), the change in quality of life (using the Functional Assessment of Chronic Illness Therapy-Palliative Care scale) and receipt of dialysis.

Ethics and dissemination: Approvals have been granted by the Institutional Review Board at the University of Wisconsin (ID: 2022-0193), with each study site ceding review to the primary IRB. All nephrologists will be consented and given a copy of the consent form. No patients or caregivers will be recruited or consented until their nephrology provider has chosen to participate in the study. Results will be disseminated via submission for publication in a peer-reviewed journal and at national meetings.

Trial registration number: NCT04466865.

Keywords: Adult nephrology; Adult palliative care; Chronic renal failure; Dialysis; End stage renal failure; MEDICAL ETHICS.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Example of the ‘Best Case/Worst Case’ graphic aid used by nephrologists as part of the communication tool. Vertical bars represent treatment options; their length shows the range of outcomes and the magnitude of the difference between the ‘best case’ (star) the ‘worst case’ (square) and a ‘most likely case’ (oval). Nephrologists write short notes for patients on the diagram while describing possible scenarios that are derived from clinical experience and data. The ‘most likely’ box is intentionally left blank for nephrologists to tailor to the patient.

Figure 2

Best Case/Worst Case skills checklist and observation form. Instructors evaluate 19 criteria to assess nephrologists’ performance after they have completed training. Competence is defined as achieving a score of at least 14/19.