Tele-patient-reported Outcomes (telePRO) in Clinical Practice

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Other: Open Access telePRO; Other: Standard telePRO

• Registration Number: NCT02673580
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Status Verified: 2017-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 593

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

Read More

Exclusion Criteria

• Paper responders
• Referred to telePRO proxy questionnaire

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Access telePRO	Open Access telePRO	Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire.
Standard telePRO	Standard telePRO	No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals.

Primary Outcome Measures

Name	Time	Method
Number of contacts	18 months	Number of contacts includes all contacts with the outpatient clinic in the study follow-up period

Secondary Outcome Measures

Name	Time	Method
Mortality	18 months	Mortality will be measured after 18 months.
Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9)	18 months	Health literacy will be measured at baseline and after 18 months.
Self-efficacy will be assessed by The General Self-Efficacy Scale	18 months	Self-efficacy will be measured at baseline and after 18 months.
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire	18 months	Safety will be measured at baseline and after 18 months.
General health will be assessed by items from the SF-36 questionnaire	18 months	General health will be measured at baseline and after 18 months.
Well-being wil be assessed by the WHO-5 Well-being Index	18 months	Well-being will be measured at baseline and after 18 months.
Number of seizures	18 months	Difference number of seizures (start - end) and will be measured at baseline and after 18 months.
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire	18 months	Confidence will be measured at baseline and after 18 months.
Side effects	18 months	Side effects will be measured at baseline and after 18 months.
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire	18 months	Satisfaction will be measured at baseline and after 18 months.

Trial Locations

Locations (1)

Regional Hospital West Jutland; 🇩🇰 Herning, Central Denmark Region, Denmark