Clinical trial NCT00616837: Remote Orthopedic Outpatient Consultation by Help of Telemedicine
Official title: Remote Orthopedic Outpatient Consultation by Help of Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorders
Keywords: Remote consultation/*methods
Orthopaedics methods
Telemedicine
Follow-up study
Ambulatory care
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Helse Nord
First posted: 2008-02-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Safety and quality of health care
timeFrame: 1 year
Secondary outcomes:
measure: Patient satisfaction
timeFrame: up to 1 year after last consultation
measure: Cost value
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Tromso
country: Norway
facility: Orthopaedic department, Tromso University Hospital
Study officials:
affiliation: University Hospital North Norway
name: Astrid S Buvik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital North Norway
name: Arvid Smaabrekke, MD
role: STUDY_CHAIR
affiliation: University of Tromso
name: Jan Abel Olsen, PhD
role: STUDY_CHAIR
affiliation: University of Tromso, Norway
name: Tom Wilsgaard, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital NorthNorway
name: Gunnar Knutsen, MD, PhD
role: STUDY_CHAIR
References:
citation: Buvik A, Bergmo TS, Bugge E, Smaabrekke A, Wilsgaard T, Olsen JA. Cost-Effectiveness of Telemedicine in Remote Orthopedic Consultations: Randomized Controlled Trial. J Med Internet Res. 2019 Feb 19;21(2):e11330. doi: 10.2196/11330.
citation: Buvik A, Bugge E, Knutsen G, Smabrekke A, Wilsgaard T. Quality of care for remote orthopaedic consultations using telemedicine: a randomised controlled trial. BMC Health Serv Res. 2016 Sep 8;16(1):483. doi: 10.1186/s12913-016-1717-7.