Remote Orthopedic Outpatient Consultation by Help of Telemedicine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Helse Nord
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00616837
First received: January 22, 2008
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Orthopedic Disorders
Other: Telemedicine consultation
Other: Standard care in orthopaedic outpatient clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Safety and quality of health care [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: up to 1 year after last consultation ] [ Designated as safety issue: No ]
    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.

  • Cost value [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Travel expenses, escort expenses, equipment and other costs related to patient consultation


Estimated Enrollment: 400
Study Start Date: November 2007
Estimated Study Completion Date: October 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard consultation
Standard care in orthopaedic outpatient clinic
Other: Standard care in orthopaedic outpatient clinic
Experimental: Telemedicine consultation
Orthopaedic care in outpatient clinic by use of telemedicine.
Other: Telemedicine consultation
Outpatient consultation by help of telemedicine (video conference)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616837

Locations
Norway
Orthopaedic department, Tromso University Hospital
Tromso, Norway, N-9038
Sponsors and Collaborators
University Hospital of North Norway
Helse Nord
Investigators
Principal Investigator: Astrid S Buvik, MD University Hospital North Norway
Study Chair: Arvid Smaabrekke, MD University Hospital North Norway
Study Chair: Jan Abel Olsen, PhD University of Tromso
Study Director: Tom Wilsgaard, PhD University of Tromso, Norway
Study Chair: Gunnar Knutsen, MD, PhD University Hospital NorthNorway
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00616837     History of Changes
Other Study ID Numbers: P-REK-N-134/2006, Personvernombudet,UNN 05.12.06, P-REK-N-134/2006 (REK)
Study First Received: January 22, 2008
Last Updated: February 18, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:
Remote consultation/*methods
Orthopaedics methods
Telemedicine
Follow-up study
Ambulatory care

ClinicalTrials.gov processed this record on September 14, 2014