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

Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up

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)

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: Open Access telePRO; Other: Standard telePRO

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 Type: Interventional
• Enrollment (Actual): 593
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Herning, Central Denmark Region, Denmark, 7400
      • Regional Hospital West Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open Access telePRO; Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire.	Other: Open Access telePRO; In open access, contacts to the outpatient clinic are initiated solely by the patient. Contacts may be in the form of a PRO assessment like in standard telePRO, but at a time decided by the patient via the Danish National Health website "Sundhed.dk".
Other: Standard telePRO; No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals.	Other: Standard telePRO; Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of contacts	Number of contacts includes all contacts with the outpatient clinic in the study follow-up period	18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Central Denmark Region; TrygFonden, Denmark
• Investigators: Study Director: Niels Henrik Hjollund, Professor, Regional Hospital West Jutland

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: TELEPRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO