Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease

Derek Kyte, Nicola Anderson, Jon Bishop, Andrew Bissell, Elizabeth Brettell, Melanie Calvert, Marie Chadburn, Paul Cockwell, Mary Dutton, Helen Eddington, Elliot Forster, Gabby Hadley, Natalie Rowland, Louise Jackson, Sonia O’Brien, Gary Price, Keeley Sharpe, Stephanie Stringer, Rav Verdi, Judi WatersAdrian Wilcockson

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Abstract

Objectives: The use of routine remote follow-up of patients with chronic kidney disease (CKD) is increasing exponentially. It has been suggested that online electronic patient-reported outcome measures (ePROMs) could be used in parallel, to facilitate real-time symptom monitoring aimed at improving outcomes. We tested the feasibility of this approach in a pilot trial of ePROM symptom monitoring versus usual care in patients with advanced CKD not on dialysis.

Design: A 12-month, parallel, pilot randomised controlled trial (RCT) and qualitative substudy.

Setting and participants: Queen Elizabeth Hospital Birmingham, UK. Adult patients with advanced CKD (estimated glomerular filtration rate ≥6 and ≤15 mL/min/1.73 m2, or a projected risk of progression to kidney failure within 2 years ≥20%).

Intervention: Monthly online ePROM symptom reporting, including automated feedback of tailored self-management advice and triggered clinical notifications in the advent of severe symptoms. Real-time ePROM data were made available to the clinical team via the electronic medical record.

Outcomes: Feasibility (recruitment and retention rates, and acceptability/adherence to the ePROM intervention). Health-related quality of life, clinical data (eg, measures of kidney function, kidney failure, hospitalisation, death) and healthcare utilisation.

Results: 52 patients were randomised (31% of approached). Case report form returns were high (99.5%), as was retention (96%). Overall, 73% of expected ePROM questionnaires were received. Intervention adherence was high beyond 90 days (74%) and 180 days (65%); but dropped beyond 270 days (46%). Qualitative interviews supported proof of concept and intervention acceptability, but highlighted necessary changes aimed at enhancing overall functionality/scalability of the ePROM system.

Limitations: Small sample size.

Conclusions: This pilot trial demonstrates that patients are willing to be randomised to a trial assessing ePROM symptom monitoring. The intervention was considered acceptable; though measures to improve longer-term engagement are needed. A full-scale RCT is considered feasible.

Trial registration number: ISRCTN12669006 and the UK NIHR Portfolio (CPMS ID: 36497).
Original languageEnglish
Article numbere050610
JournalBMJ open
Volume12
Issue number3
DOIs
Publication statusPublished - 18 Mar 2022

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