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

Authors :
Anne Buffington
Daniel Lam
Amar D Bansal
Karlie Haug
Amy Zelenski
Bret M Hanlon
Lily Stalter
Kristine L Kwekkeboom
Paul Rathouz
Katharine Cheung
Deidra Crews
Rebecca Frazier
Holly Koncicki
Alvin Moss
Maya Rao
Dawn F Wolfgram
Jeniann Yi
Carrie Brill
Rachael Kendrick
Toby C Campbell
Roy Jhagroo
Margaret Schwarze
Source :
BMJ Open, Vol 12, Iss 11 (2022)
Publication Year :
2022
Publisher :
BMJ Publishing Group, 2022.

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.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
12
Issue :
11
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.026c9fe889f4110b33cfb2d1bbeda22
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2022-067258