Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study

Abstract

Background: The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.

Methods: The study is a pragmatic, randomised, controlled trial in outpatients with epilepsy. Participants are randomly assigned to one of two follow-up activities: a) standard telePRO or b) open access telePRO. Inclusion criteria are age ≥ 15 years and previous referral to standard telePRO follow-up at Aarhus University Hospital, Denmark. Furthermore, patients must have answered the last questionnaire via the Internet. The number of contacts will be used as the primary outcome measure. Secondary outcome measures include well-being (WHO-5 Well-Being Index), general health, number of seizures, treatment side effects, mortality, health literacy (Health Literacy Questionnaire), self-efficacy (General Self-Efficacy scale), patient activation, confidence, safety, and satisfaction. In addition, the patient perspective will be explored by qualitative methods. Data will be collected at baseline and 18 month after randomisation. Inclusion of patients in the study started in January 2016. Statistical analysis will be performed on an intention-to-treat and per-protocol basis. For qualitative data, the interpretive description strategy will be used.

Discussion: The benefits and possible drawbacks of the PRO-based open access approach will be evaluated. The present study will provide important knowledge to guide future telePRO interventions in relation to effect on resource utilisation, quality of care, and the patient perspective.

Trial registration: ClinicalTrials.gov: NCT02673580 (Registration date January 28, 2016).

Keywords: Clinical practice; Open access; Outpatient clinic; Outpatient follow-up; Patient-reported outcomes; Randomised controlled trial; TelePRO.

Figures

Fig. 1

Screen capture of the clinicians’ overview in epilepsy clinics accessed from the Electronic Health Record of Central Denmark Region [13]. The colour dots in the upper row indicate the result of the automated PRO algorithm (red: definite need of contact, yellow: possible need of contact, green: no need of contact). Note that the colours of the bars have different meanings. 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. Note: Labels were translated from Danish

Fig. 2

The open access telePRO website “My Epilepsy”. Note: Labels were translated from Danish

Fig. 3

PRO response overview customised to outpatients with epilepsy. A red or orange bar indicates a self reported problem, a yellow bar some problem, and green bar indicates no problems. Note: Labels were translated from Danish

Fig. 4

Flowchart following patients from inclusion to final data collection