Feasibility and preliminary effects of a nurse-led multi-component phosphate control intervention in patients on hemodialysis: a pilot randomized trial

AIMS: This pilot trial aimed to evaluate the feasibility of a nurse-led multicomponent intervention (Targeting Intake and Pills, TIPs) using serial phosphorus metrics for patients undergoing hemodialysis treatment, and to estimate variability to inform a future definitive trial. DESIGN: This was a pilot randomized controlled trial. METHODS: This 3-month trial, conducted in Shanghai, China, enrolled maintenance hemodialysis patients with persistent hyperphosphatemia (>1.78 mmol/L [5.5 mg/dL] over two consecutive quarters) who were receiving phosphate binder therapy. The intervention included dietary phosphate management, facilitation of binder adherence, and physician referral for dialysis adequacy optimization. Outcomes assessed included feasibility (recruitment and retention rates), serum phosphorus levels (using area-under-the-curve [AUC] and rolling averages), dietary consumption, and pruritus symptoms. RESULTS: Of 192 participants screened, 58 (30.21%) were eligible, and 30 (51.72%) were randomized (n = 15 per group). Participant retention was 86.67% (26/30). At follow-up, 88% of scheduled quarterly serum phosphorus measurements were completed. For the secondary, exploratory clinical outcomes, the estimated between-group difference in AUC was -0.33 (95% CI: -1.24 to 0.58), with a residual standard deviation of 1.21. For pruritus, the adjusted between-group difference was -1.53 (95% CI: -4.00 to 0.94). Dietary outcomes showed substantial variability, with residual standard deviations of 144.00 mg/day for phosphate intake, 12.67 g/day for protein intake, and 299.56 kcal/day for energy intake. CONCLUSIONS: This pilot study demonstrated the feasibility of recruitment and data collection in hemodialysis patients. The estimates of outcome variability and the influence of baseline values provide critical information for designing a fully powered randomized controlled trial. RELEVANCE TO CLINICAL PRACTICE: The nurse-led TIPs intervention appears feasible and acceptable for use in routine nephrology care settings. However, its comparative clinical effectiveness remains to be established in a larger definitive trial. TRIAL REGISTRATION: The trial was registered with the Chinese Clinical Trial Registry (ChiCTR) on 2020/04/03 (clinical trial registration number: ChiCTR2000031509).