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

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.

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

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.

Lower Socioeconomic Status is Associated With Adverse Urinary Markers and Surgical Complexity in Kidney Stone Patients.

OBJECTIVE: To determine if socioeconomic status (SES) correlates with severity of kidney stone disease and 24-hour urine parameters. MATERIALS AND METHODS: An IRB approved prospectively maintained database for nephrolithiasis was retrospectively analyzed for both 24-hour urine results and surgical procedures performed from 2009 to 2019. Severely distressed communities (SDC) were categorized as those with a Distressed Communities Index (DCI), a composite measure of SES, score in the top quartile (lowest for SES). Univariate and multivariate analyses were performed to evaluate the strength of the association of DCI on: stone size at presentation, need for and type of surgical procedure, need for staged surgery and specific stone risk factors in 24-hour urine collections. RESULTS: Surgical procedures were performed on 3939 patients (1978 women) who were not from SDC and 200 (97 women) from SDC. Patients from SDC were older (57.1 years vs 54.2 years; P = .009). Patients from SDC were more likely to undergo proportionally more invasive procedures (17.5% vs 11.6%; P = .011) and require staged surgery at a higher rate (13.0% vs 8.5%; P = .028). Men from SDC had larger stones (12.5 mm vs 9.7 mm; P = .001). Among 24-hour urine results from 2454 patients (1187 women), DCI was not correlated with sodium, calcium, magnesium, volume, oxalate, phosphate, and pH levels. Higher DCI (lower SES) correlated with lower urine citrate (P = .001) and lower urine potassium (P = .002). CONCLUSION: SES correlates with larger stone burden at the time of urologic intervention, requires proportionally more invasive procedures and more staged procedures. Lower SES correlated with lower urine citrate and potassium.

Opportunities to Improve Shared Decision Making in Dialysis Decisions for Older Adults with Life-Limiting Kidney Disease: A Pilot Study.

Background: Lack of awareness about the life-limiting nature of renal failure is a significant barrier to palliative care for older adults with end-stage renal disease. Objective: To train nephrologists to use the best case/worst case (BC/WC) communication tool to improve shared decision making about dialysis initiation for older patients with limited life expectancy. Design: This is a pre-/postinterventional pilot study. Setting/Subjects: There were 16 nephrologists and 30 patients of age 70 years and older with estimated glomerular filtration rate (eGFR) <20 mL/min per 1.73 m2 in outpatient nephrology clinics, in Madison, WI. Measurements: Performance of tool elements, content of communication about dialysis, shared decision making, acceptability of the intervention, decisions to pursue dialysis, and palliative care referrals were measured. Results: Fifteen of 16 nephrologists achieved competence performing the BC/WC tool with standardized patients, executing at least 14 of 19 items. Nine nephrologists met with 30 patients who consented to audio record their clinic visit. Before training, clinic visits focused on laboratory results and preparation for dialysis. After training, nephrologists noted that declining kidney function was "bad news," presented dialysis and "no dialysis" as treatment options, and elicited patient preferences. Observer-measured shared decision-making (OPTION 5) scores improved from a median of 20/100 (interquartile range [IQR] 15-35) before training to 58/100 (IQR 55-65). Patients whose nephrologist used the BC/WC tool were less likely to make a decision to initiate dialysis and were more likely to be referred to palliative care. Conclusions: Nephrologists can learn to use the BC/WC tool with older patients to improve shared decision making about dialysis, which may increase access to palliative care.

Successful Diabetic Control as Measured by Hemoglobin A1c Is Associated with Lower Urine Risk Factors for Uric Acid Calculi.

INTRODUCTION AND OBJECTIVES: To examine the association of glycemic control, including strict glycemic control, with 24-hour urine risk factors for uric acid and calcium calculi. MATERIALS AND METHODS: With institutional review board (IRB) approval, we identified 183 stone formers (SFs) with 459 twenty-four-hour urine collections. Hemoglobin A1c (HgbA1c) measures were obtained within 3 months of the urine collection. Collections were categorized into normoglycemic (NG, HgbA1c < 6.5) and hyperglycemic (HG, HgbA1c ≥ 6.5) cohorts; 24-hour urine parameters were compared. The NG cohort was further divided into patients with and without a history of diabetes mellitus (DM) type 2. Variables were analyzed using chi-square, Welch's t-test and multivariate linear regression to adjust for clustering, body mass index (BMI), age, gender, thiazide use, and potassium citrate use. RESULTS: Patients in the HG group were older with higher BMI. Multivariate analysis of the total study population revealed that hyperglycemia correlated with lower pH, higher uric acid relative saturation (RS), lower brushite RS, and higher citrate. NG SFs with and without a history of DM had similar risk factors for uric acid stone formation. Among NG SFs, those with DM had higher urine calcium and calcium oxalate RS than those without DM. However, this difference may be related to other factors since neither parameter correlated with DM on multivariate regression (p > 0.05). CONCLUSIONS: Successful glycemic control may be associated with reduced urinary risk factors for uric acid stone formation. Patients with well-controlled DM had equivalent risk factors to those without DM. Glycemic control should be considered a target of the multidisciplinary medical management of stone disease.