Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Buvik A, Bugge E, Knutsen G, Småbrekke A, Wilsgaard T. Quality of care for remote orthopaedic consultations using telemedicine: a randomised controlled trial. BMC Health Serv Res. 2016 Sep 8;16:483. doi: 10.1186/s12913-016-1717-7.

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
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:

Musculoskeletal Diseases