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Randomized Controlled Trial
. 2022 Mar 18;12(3):e050610.
doi: 10.1136/bmjopen-2021-050610.

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  1   2 , Nicola Anderson  2   3 , Jon Bishop  4 , Andrew Bissell  5 , Elizabeth Brettell  4 , Melanie Calvert  2   6   7   8   9 , Marie Chadburn  4 , Paul Cockwell  3 , Mary Dutton  3 , Helen Eddington  3 , Elliot Forster  3 , Gabby Hadley  3 , Natalie J Ives  4 , Louise J Jackson  10 , Sonia O'Brien  5 , Gary Price  5 , Keeley Sharpe  5 , Stephanie Stringer  3 , Rav Verdi  5 , Judi Waters  5 , Adrian Wilcockson  4
Affiliations
Randomized Controlled Trial

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 et al. BMJ Open. .

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).

Keywords: clinical trials; end stage renal failure; nephrology.

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Conflict of interest statement

Competing interests: EB, MCh, NJI and JB report grants from NIHR. MCa is an NIHR Senior Investigator and receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR Applied Research Collaboration West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB Pharma and GSK. MC has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. DK reports grants from Macmillan Cancer Support, Innovate UK, the NIHR, NIHR Birmingham Biomedical Research Centre, and NIHR SRMRC at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, and personal fees from Merck outside the submitted work.

Figures

Figure 1
Figure 1
Flow of participants through the trial. CKD, chronic kidney disease; ePRO, electronic patient-reported outcome.
See this image and copyright information in PMC

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