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Remote Orthopedic Outpatient Consultation by Help of Telemedicine

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ClinicalTrials.gov Identifier: NCT00616837
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : December 17, 2015
Sponsor:
Collaborator:
Helse Nord
Information provided by (Responsible Party):
University Hospital of North Norway

Study Description
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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.

Condition or disease Intervention/treatment Phase
Orthopedic Disorders Other: Telemedicine consultation Other: Standard care in orthopaedic outpatient clinic Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Remote Orthopedic Outpatient Consultation by Help of Telemedicine
Study Start Date : November 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard consultation
Standard care in orthopaedic outpatient clinic
 Other: Standard care in orthopaedic outpatient clinic
Standard care in orthopedic outpatient clinic (usual care)
Experimental: Telemedicine consultation
Orthopaedic care in outpatient clinic by use of telemedicine.
 Other: Telemedicine consultation
Outpatient consultation by help of telemedicine (video conference)


Outcome Measures
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Primary Outcome Measures :
  1. Safety and quality of health care [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: up to 1 year after last consultation ]
    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.

  2. Cost value [ Time Frame: up to 1 year ]
    Travel expenses, escort expenses, equipment and other costs related to patient consultation


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616837


Locations
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Norway
Orthopaedic department, Tromso University Hospital
Tromso, Norway, N-9038
Sponsors and Collaborators
University Hospital of North Norway
Helse Nord
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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 ( Other Identifier: University Hospital North Norway )
P-REK-N-134/2006 (REK) ( Registry Identifier: Regional ethic comittee, Region North )
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
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Musculoskeletal Diseases