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. 2019 Sep 4;19(1):631.
doi: 10.1186/s12913-019-4461-y.

Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study - study protocol for a non-inferiority pragmatic randomised controlled trial

Birgith Engelst Grove  1 , Per Ivarsen  2 , Annette de Thurah  3   4 , Liv Marit Schougaard  5 , Derek Kyte  6 , Niels Henrik Hjøllund  5   7
Affiliations

Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study - study protocol for a non-inferiority pragmatic randomised controlled trial

Birgith Engelst Grove et al. BMC Health Serv Res. .

Abstract

Background: Outpatient care is steadily changing from hospital consultations to other platforms, such as phone consultation and online virtual clinics. It is prudent to maintain quality of care with such initiatives. Currently, patients with chronic kidney disease (CKD) have frequent scheduled visits, but it may be possible to optimise the frequency of hospital consultations using information from patient-reported outcome (PRO) questionnaires filled in at home (PRO-based follow-up). This approach may provide a more individually tailored follow-up based on actual needs for clinical attention. We aimed to evaluate the effectiveness of the quality of care, use of resources and patient outcomes associated with PRO-based follow-up in patients with CKD.

Methods: This study is a pragmatic, non-inferiority, randomised controlled trial in outpatients with CKD (Grove BE et al., Qual Life Res 27: S143, 2018). Newly referred patients with an estimated glomerular filtration rate (eGFR) of ≤40 ml/min 1.73m2 will be randomised to either: 1. PRO-based remote follow-up 2. PRO-based telephone consultation 3. Usual outpatient follow-up (control group) In the two intervention groups, a diagnosis-specific PRO questionnaire completed by the patient at home will substitute for usual outpatient follow-up visits. The PRO questionnaire will in part be used as a screening tool to identify patients in need of outpatient contact and to identify focus areas. Responses from the questionnaire will be processed according to a disease-specific algorithm and assigned green, yellow or red status according to patients' needs. The primary outcome will be loss of renal function evaluated by eGFR. Secondary outcomes are 1. Clinical outcomes, including initiation of acute dialyses, hospitalisation and mortality, 2. Utilisation of healthcare resources and 3. PRO measures, primarily quality of life (Euroqol EQ-5D) and illness perception (Brief Illness Perception Questionnaire (BIPQ).

Discussion: Benefits and possible drawbacks of the PRO-based follow-up will be evaluated. If PRO-based follow-up proves non-inferior to usual outpatient follow-up, a reorganisation of routine clinical practice in nephrology outpatient clinics may occur. Further, results may impact other patient groups with chronic conditions attending regular follow-up.

Trial registration: ClinicalTrials.gov identifier NCT03847766 (Retrospectively registered on January 23, 2019).

Keywords: Ambulatory care; Chronic kidney disease; Outpatient clinic; Patient-reported outcome measures; Randomised controlled trial.

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Conflict of interest statement

DK reports grants from Macmillan Cancer Support, Innovate UK, the National Institute for Health Research (NIHR), NIHR Birmingham Biomedical Research Centre and NIHR Surgical Reconstruction and Microbiology Research Centre (SRMRC) at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust and personal fees from Merck outside the submitted work.

Figures

Fig. 1
Fig. 1
Screen capture of the clinicians’ overview in the nephrology clinics accessed from the electronic health record of Central Denmark Region. Colours of the bars indicate the severity of the symptoms reported by the patient. A red or orange bar indicates a self-reported problem, a yellow bar some problem, and a green bar indicates no problems. Copyright by AmbuFlex with permission to reuse. Note: Labels were translated from Danish
Fig. 2
Fig. 2
Flowchart following patients from introduction through inclusion and to final data collection
See this image and copyright information in PMC

References

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