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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

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Kyte, Derek ORCID: https://orcid.org/0000-0002-7679-6741, Anderson, N., Bishop, J., Bissell, A., Brettell, E., Calvert, M., Chadburn, M., Cockwell, P., Dutton, M., Eddington, H., Forster, E., Hadley, G., Ives, N. J., Jackson, L. J., O'Brien, S., Price, G., Sharpe, K., Stringer, S., Verdo, R., Waters, J. and Wilcockson, A. (2022) 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. BMJ Open, 12 (e05061). ISSN Online: 2044-6055

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Official URL: https://bmjopen.bmj.com/content/12/3/e050610

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).

Item Type:	Article
Additional Information:	Data are available on reasonable request. The datasets used and/or analysed during the current study are available from the Birmingham Clinical Trials Unit on reasonable request via the corresponding author. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. Supplementary materials available: https://bmjopen.bmj.com/content/12/3/e050610
Divisions:	College of Health, Life and Environmental Sciences > School of Allied Health and Community
Related URLs:	Publisher
Copyright Info:	© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
Depositing User:	Derek Kyte
Date Deposited:	19 Apr 2022 15:04
Last Modified:	19 Apr 2022 15:09
URI:	https://worc-9.eprints-hosting.org/id/eprint/11961

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