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.
Subject(s)
Quality of Life , Renal Insufficiency , Humans , Aged , Middle Aged , Renal Dialysis , Palliative Care/methods , Communication , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Optimal management of chronic medications for patients with life-limiting illness is uncertain. Medication deprescribing may improve outcomes in this population, but patient concerns regarding deprescribing are unclear. OBJECTIVE: The aim of this study was to quantify the perceived benefits and concerns of statin discontinuation among patients with life-limiting illness. DESIGN: Baseline data from a multicenter, pragmatic clinical trial of statin discontinuation were used. SETTING/SUBJECTS: Cognitively intact participants with a life expectancy of 1-12 months receiving statin medications for primary or secondary prevention were enrolled. MEASUREMENTS: Responses to a 9-item questionnaire addressing patient concerns about discontinuing statins were collected. We used Pearson chi-square tests to compare responses by primary life-limiting diagnosis (cancer, cardiovascular disease, other). RESULTS: Of 297 eligible participants, 58% had cancer, 8% had cardiovascular disease, and 30% other primary diagnoses. Mean (standard deviation) age was 72 (11) years. Fewer than 5% of participants expressed concern that statin deprescribing indicated physician abandonment. About one in five participants reported being told to take statins for the rest of their life (18%) or feeling that discontinuation represented prior wasted effort (18%). Many participants reported benefits of stopping statins, including spending less money on medications (63%), potentially stopping other medications (34%), and having a better quality of life (25%). More participants with cardiovascular disease as a primary diagnosis perceived that quality-of-life benefits related to statin discontinuation (52%) than participants with cancer (27%) or noncardiovascular disease diagnoses (27%) [p = 0.034]. CONCLUSION: Few participants expressed concerns about discontinuing statins; many perceived potential benefits. Cardiovascular disease patients perceived greater potential positive impact from statin discontinuation.
