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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Other: Open Access telePRO
* Other: Standard telePRO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Access telePRO<br>Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire. | Other: Open Access telePRO<br>* 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.<br>|
| Other: Standard telePRO<br>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<br>* Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.<br>|

What is the study measuring?
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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 |