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

NCT ID: NCT02673580

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 593 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Open Access telePRO

Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire.

Group Type: OTHER

Open Access telePRO

Intervention Type: OTHER

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".

Standard telePRO

No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals.

Group Type: OTHER

Standard telePRO

Intervention Type: OTHER

Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.

Interventions

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".

Intervention Type: OTHER

Standard telePRO

Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Denmark Region

OTHER

Sponsor Role: collaborator

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels Henrik Hjollund, Professor

Role: STUDY_DIRECTOR

Regional Hospital West Jutland

Locations

Regional Hospital West Jutland

Herning, Central Jutland, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 31520247 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28122609 (View on PubMed)

Other Identifiers

TELEPRO

Identifier Type: -

Identifier Source: org_study_id