Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Orthopedic Disorders Clinical Trial

Official title:

Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616837
• Other study ID #: P-REK-N-134/2006
• Secondary ID: Personvernombude
• Status: Completed
• Phase: N/A
• First received: January 22, 2008
• Last updated: December 16, 2015
• Start date: November 2007
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Orthopedic Disorders

Intervention

Other:
• Telemedicine consultation
Outpatient consultation by help of telemedicine (video conference)
• Standard care in orthopaedic outpatient clinic
Standard care in orthopedic outpatient clinic (usual care)

Locations

Country	Name	City	State
Norway	Orthopaedic department, Tromso University Hospital	Tromso

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	Helse Nord

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and quality of health care		1 year	No
Secondary	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	No
Secondary	Cost value	Travel expenses, escort expenses, equipment and other costs related to patient consultation	up to 1 year	No