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BMC Health Services Research
Published in: BMC Health Services Research 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Liv Marit Valen Schougaard, Caroline Trillingsgaard Mejdahl, Klaus Hvam Petersen, Anne Jessen, Annette de Thurah, Per Sidenius, Kirsten Lomborg, Niels Henrik Hjollund

Published in: BMC Health Services Research | Issue 1/2017

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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)
Appendix
Available only for authorised users
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Metadata
Title
Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study
Authors
Liv Marit Valen Schougaard
Caroline Trillingsgaard Mejdahl
Klaus Hvam Petersen
Anne Jessen
Annette de Thurah
Per Sidenius
Kirsten Lomborg
Niels Henrik Hjollund
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2017
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/s12913-017-2015-8

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