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

Abstract

ObjectivesThe 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.DesignA 12-month, parallel, pilot randomised controlled trial (RCT) and qualitative substudy.Setting and participantsQueen 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%).InterventionMonthly 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.OutcomesFeasibility (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.Results52 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.LimitationsSmall sample size.ConclusionsThis 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 numberISRCTN12669006 and the UK NIHR Portfolio (CPMS ID: 36497).

Electronic patient-reported outcomes in chronic kidney disease

“…An evaluation of this intervention in routine practice is planned. The RePROM pilot trial demonstrated the feasibility of a RCT of ePRO symptom monitoring in patients with advanced CKD 10 . The intervention comprised real-time integration of ePRO symptom data into the electronic health record with automated alerting of the clinical team when participants reported severe symptoms.…”

Global use of electronic patient-reported outcome systems in nephrology: a mixed methods study

“…Studies from North America demonstrate the feasibility of ePRO collection in haemodialysis (HD) settings,16 19 20 while the Australian Symptom monitoring With Feedback Trial21 and Canadian EMPATHY studies22 are cluster randomised controlled trials exploring the usefulness of integrating PRO assessments in the clinical management of patients receiving HD. In advanced CKD populations, the use of an electronic Patient-Reported Outcome Measure in the Management of Patients with Advanced CKD (RePROM) study in the UK piloted the use, and established feasibility, of an ePRO for remote symptom monitoring in real time 9 23. The AmbuFlex telepro system is used in practice to manage renal outpatient follow-up in Denmark and as a complimentary tool in consultations24 25 and is currently being evaluated through the PRO-KID trial: a non-inferiority pragmatic randomised controlled trial investigating the effectiveness of the quality of care, use of resources and patient outcomes associated with PRO-based follow-up in patients with CKD 24…”