NCT00616837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

4.9 years

First QC Date

January 22, 2008

Last Update Submit

December 16, 2015

Conditions

Orthopedic Disorders

Keywords

Remote consultation/*methodsOrthopaedics methodsTelemedicineFollow-up studyAmbulatory care

Outcome Measures

Primary Outcomes (1)

  • Safety and quality of health care

    1 year

Secondary Outcomes (2)

  • Patient satisfaction

    up to 1 year after last consultation

  • Cost value

    up to 1 year

Study Arms (2)

Standard consultation

ACTIVE COMPARATOR

Standard care in orthopaedic outpatient clinic

Other: Standard care in orthopaedic outpatient clinic

Telemedicine consultation

EXPERIMENTAL

Orthopaedic care in outpatient clinic by use of telemedicine.

Other: Telemedicine consultation

Interventions

Telemedicine consultationOTHER

Outpatient consultation by help of telemedicine (video conference)

Telemedicine consultation
Standard care in orthopaedic outpatient clinicOTHER

Standard care in orthopedic outpatient clinic (usual care)

Standard consultation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department, Tromso University Hospital

Tromsø, N-9038, Norway

Location

Related Publications (2)

  • 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.

    PMID: 30777845DERIVED

  • 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.

    PMID: 27608768DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Astrid S Buvik, MD

    University Hospital North Norway

    PRINCIPAL INVESTIGATOR

  • Arvid Smaabrekke, MD

    University Hospital North Norway

    STUDY CHAIR

  • Jan Abel Olsen, PhD

    University of Tromso

    STUDY CHAIR

  • Tom Wilsgaard, PhD

    University of Tromso, Norway

    STUDY DIRECTOR

  • Gunnar Knutsen, MD, PhD

    University Hospital NorthNorway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 15, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2012

Study Completion

October 1, 2014

Last Updated

December 17, 2015

Record last verified: 2015-12

Locations

NO(1)