Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Study Overview
=================
Brief Summary
-----------------
Patients from 4 local communities in northern Norway referred (either new or follow up) to orthopaedic department, University hospital of Northern Norway for outpatient consultation, are randomly assigned to either remote consultation by use of telemedicine (camera and screen), or standard consultation at the hospital. There are x-ray facilities also at the remote site. The patients randomized to telemedicine consultation meet special trained nurses at the remote site, but doctor only by video conference. The patients will be followed for up to one year. The primary endpoint is quality of care achieved with the telemedicine consultation as compared to standard outpatient consultation (assessed by questionnaires filled out by the doctor involved). Secondary end points are patient satisfaction assessed by questionnaires and economic analyses. The study hypothesis is non-inferiority of telemedicine consultation vs. conventional, outpatient consultation.

Official Title
-----------------
Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Conditions
-----------------
Orthopedic Disorders

Intervention / Treatment
-----------------
* Other: Telemedicine consultation
* Other: Standard care in orthopaedic outpatient clinic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent given New referred patients to orthopaedic department (outpatient), UNN, for conditions suitable for telemedicine consultation Follow up consultation of trauma patients (operated/not operated) Follow up consultation after elective orthopaedic surgery (e.g hip prothesis) Follow up of other orthopaedic patients Exclusion Criteria: Senile dementia Soldiers, prisoners Patients not talking Norwegian, dependent on translator If specialized procedures are required during follow up (e.g. cat-scan, ultrasound etc) Patients requiring a specific doctor
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard consultation<br>Standard care in orthopaedic outpatient clinic | Other: Standard care in orthopaedic outpatient clinic<br>* Standard care in orthopedic outpatient clinic (usual care)<br>|
| Experimental: Telemedicine consultation<br>Orthopaedic care in outpatient clinic by use of telemedicine. | Other: Telemedicine consultation<br>* Outpatient consultation by help of telemedicine (video conference)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and quality of health care |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction will be measured based on a total score calculated on the basis of responses to satisfaction questionnaire. Questionnaires will be filled out at each visit/consultation and at 3 months or one year after last consultation. | up to 1 year after last consultation | 
| Cost value | Travel expenses, escort expenses, equipment and other costs related to patient consultation | up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote consultation/*methods, Orthopaedics methods, Telemedicine, Follow-up study, Ambulatory care