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Remote Orthopedic Outpatient Consultation by Help of Telemedicine

Primary Purpose

Orthopedic Disorders

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Telemedicine consultation
Standard care in orthopaedic outpatient clinic
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Orthopedic Disorders focused on measuring Remote consultation/*methods, Orthopaedics methods, Telemedicine, Follow-up study, Ambulatory care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopaedic department, Tromso University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard consultation

Telemedicine consultation

Arm Description

Standard care in orthopaedic outpatient clinic

Orthopaedic care in outpatient clinic by use of telemedicine.

Outcomes

Primary Outcome Measures

Safety and quality of health care

Secondary Outcome Measures

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.
Cost value
Travel expenses, escort expenses, equipment and other costs related to patient consultation

Full Information

First Posted
January 22, 2008
Last Updated
December 16, 2015
Sponsor
University Hospital of North Norway
Collaborators
Helse Nord
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1. Study Identification

Unique Protocol Identification Number
NCT00616837
Brief Title
Remote Orthopedic Outpatient Consultation by Help of Telemedicine
Official Title
Remote Orthopedic Outpatient Consultation by Help of Telemedicine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Helse Nord

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorders
Keywords
Remote consultation/*methods, Orthopaedics methods, Telemedicine, Follow-up study, Ambulatory care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard consultation
Arm Type
Active Comparator
Arm Description
Standard care in orthopaedic outpatient clinic
Arm Title
Telemedicine consultation
Arm Type
Experimental
Arm Description
Orthopaedic care in outpatient clinic by use of telemedicine.
Intervention Type
Other
Intervention Name(s)
Telemedicine consultation
Intervention Description
Outpatient consultation by help of telemedicine (video conference)
Intervention Type
Other
Intervention Name(s)
Standard care in orthopaedic outpatient clinic
Intervention Description
Standard care in orthopedic outpatient clinic (usual care)
Primary Outcome Measure Information:
Title
Safety and quality of health care
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
up to 1 year after last consultation
Title
Cost value
Description
Travel expenses, escort expenses, equipment and other costs related to patient consultation
Time Frame
up to 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid S Buvik, MD
Organizational Affiliation
University Hospital North Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arvid Smaabrekke, MD
Organizational Affiliation
University Hospital North Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan Abel Olsen, PhD
Organizational Affiliation
University of Tromso
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tom Wilsgaard, PhD
Organizational Affiliation
University of Tromso, Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gunnar Knutsen, MD, PhD
Organizational Affiliation
University Hospital NorthNorway
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopaedic department, Tromso University Hospital
City
Tromso
ZIP/Postal Code
N-9038
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
30777845
Citation
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.
Results Reference
derived
PubMed Identifier
27608768
Citation
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.
Results Reference
derived

Learn more about this trial

Remote Orthopedic Outpatient Consultation by Help of Telemedicine

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