title: Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov: NCT02673580 (Registration date January 28, 2016).
authors.affiliation: AmbuFlex, Regional Hospital West Jutland, Herning, Denmark. livschou@rm.dk.
authors.forename: Liv Marit Valen
authors.initials: LM
authors.lastname: Schougaard
authors.affiliation: The Research Programme in Patient involvement, Aarhus University Hospital, Aarhus, Denmark.|Department of Public Health, Aarhus University, Aarhus, Denmark.
authors.forename: Caroline Trillingsgaard
authors.initials: CT
authors.lastname: Mejdahl
authors.affiliation: AmbuFlex, Regional Hospital West Jutland, Herning, Denmark.
authors.forename: Klaus Hvam
authors.initials: KH
authors.lastname: Petersen
authors.affiliation: AmbuFlex, Regional Hospital West Jutland, Herning, Denmark.
authors.forename: Anne
authors.initials: A
authors.lastname: Jessen
authors.affiliation: The Research Programme in Patient involvement, Aarhus University Hospital, Aarhus, Denmark.|Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark.|Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
authors.forename: Annette
authors.initials: A
authors.lastname: de Thurah
authors.affiliation: Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Sidenius
authors.affiliation: The Research Programme in Patient involvement, Aarhus University Hospital, Aarhus, Denmark.|Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.|Department of Public Health, Aarhus University, Aarhus, Denmark.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Lomborg
authors.affiliation: AmbuFlex, Regional Hospital West Jutland, Herning, Denmark.|Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Niels Henrik
authors.initials: NH
authors.lastname: Hjollund
mesh_terms: D003718:Denmark; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010045:Outpatients; D010358:Patient Participation; D012017:Referral and Consultation; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires; D017216:Telemedicine
keywords: Clinical practice; Open access; Outpatient clinic; Outpatient follow-up; Patient-reported outcomes; Randomised controlled trial; TelePRO