Clinical trial NCT02673580: Tele-patient-reported Outcomes (telePRO) in Clinical Practice
Official title: Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
name: TrygFonden, Denmark
First posted: 2016-02-04
Enrollment: 593
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare quality of care and patient experiences in two outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and 2) Open Access telePRO (patient-initiated telePRO follow-up)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Males and females from Age 15 years
* Diagnosis of epilepsy
* Referred to standard telePRO by a clinician
* Access to internet (web-responders in standard telePRO)
* Can speak and understand Danish

Exclusion Criteria:

* Paper responders
* Referred to telePRO proxy questionnaire

Primary outcomes:
measure: Number of contacts
timeFrame: 18 months
Secondary outcomes:
measure: General health will be assessed by items from the SF-36 questionnaire
timeFrame: 18 months
measure: Well-being wil be assessed by the WHO-5 Well-being Index
timeFrame: 18 months
measure: Mortality
timeFrame: 18 months
measure: Number of seizures
timeFrame: 18 months
measure: Side effects
timeFrame: 18 months
measure: Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9)
timeFrame: 18 months
measure: Self-efficacy will be assessed by The General Self-Efficacy Scale
timeFrame: 18 months
measure: Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
timeFrame: 18 months
measure: Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
timeFrame: 18 months
measure: Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
timeFrame: 18 months
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Regional Hospital West Jutland
state: Central Denmark Region
Study officials:
affiliation: Regional Hospital West Jutland
name: Niels Henrik Hjollund, Professor
role: STUDY_DIRECTOR
References:
citation: Schougaard LMV, Mejdahl CT, Christensen J, Lomborg K, Maindal HT, de Thurah A, Hjollund NH. Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial. J Patient Rep Outcomes. 2019 Sep 13;3(1):61. doi: 10.1186/s41687-019-0151-0.
citation: Schougaard LM, Mejdahl CT, Petersen KH, Jessen A, de Thurah A, Sidenius P, Lomborg K, Hjollund NH. Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study. BMC Health Serv Res. 2017 Jan 26;17(1):83. doi: 10.1186/s12913-017-2015-8.