- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03106142
Knee Osteoarthritis Care: A Quality Improvement Intervention in General Practice
Improving Current General Practitioners Care: Feasibility and Effectiveness of a Simple Educational Intervention. Knee Osteoarthritis Care: a Quality Improvement in General Practice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Belgium, referral rates to physiotherapy of patients with knee osteoarthritis are low. A surveys shows that only 11% of the patients with knee osteoarthritis are referred for physiotherapy in an early stage of the disease process. Referral to physiotherapy is common after arthroplasty for revalidation, but not in early stage of the disease process. The aim of this study is to increase the referral rate for physiotherapy in an early stage of the disease process.
One to three times a year, a large part of Belgian GPs receive an academic detailing visit by an independent medical visitors of Farmaka. Farmaka is a non-profit organization, which is sponsored by the government. Each year, three medical and medication-related themes are developed to provide evidence-based and independent information for primary care management. A visit takes about 20 minutes.
The medical visitors of Farmaka will spend 5 minutes of their standard visit to inform GPs about the evidence-based conservative management of knee osteoarthritis with physiotherapy. The information will focus on the referral of patients with knee osteoarthritis to a physiotherapist in an early stage of the disease. To optimize the effect of the referral to physiotherapists, GPs are asked to specify their prescription by adding a clear therapy description 'exercise therapy with aerobic, muscle strengthening and functional exercises'.
This information will be summarized on a flyer. This flyer will be distributed to the GPs at the end of the academic detailing visit. The flyer gives more extended information about the approach and treatment of knee osteoarthritis. The information and flyer will only be distributed to the intervention group.
For the sample size calculation we want to optimize the referral rate to physiotherapists with 15%.
To detect an absolute difference of 15% in referral rate to physiotherapists we need 100 patients in each group ( with significance level of 5%, 1 on 1 allocation and power of 80%). The control group is composed of GPs, visited by Farmaka, who will not receive the additional information on knee osteoarthritis management.
After 6 months the GPs of the intervention and control group will receive two case vignettes on the management of knee osteoarthritis.
The number of referrals to a physiotherapist of the intervention group and the control group will be compared, as well as the number of specified well-directed prescriptions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- KU Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- active GP setting
- visited by independent medical visitors for academic detailing
Exclusion Criteria:
- not willing to participate
- not visited by independent medical visitors for academic detailing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Academic detailing visit arm
The GPs will receive an academic detailing visit by a medical visitor.
GPs will receive information on the conservative evidence-based management of knee osteoarthritis with physiotherapy.
The information will be summarized on a flyer for the GPs.
|
General Practitioners in the intervention group will receive one academic detailing visit.
During this visit the GPs will receive information about the importance of physical therapy in the non-surgical management of knee osteoarthritis.
The information will be summarized on an information leaflet for the GP.
|
|
No Intervention: control group
The two case vignettes will also be presented to GP who did not received the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of referrals to physical therapy of patients with knee osteoarthritis
Time Frame: 6 months after intervention
|
2 case vignettes were developed to assess GPs' referral rate
|
6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of technical investigations ordered by GPs for patients with knee osteoarthritis
Time Frame: 6 months after the intervention
|
2 case vignettes were developed to assess GPs' request of technical investigations
|
6 months after the intervention
|
|
Type of pain medication prescribed by GPs for patients with knee osteoarthritis
Time Frame: 6 months after the intervention
|
2 case vignettes were developed to assess GPs' medication prescriptions
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6 months after the intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Patrik Vankrunkelsven, Professor, KU Leuven
Publications and helpful links
General Publications
- Habraken H, Janssens I, Soenen K, van Driel M, Lannoy J, Bogaert M. Pilot study on the feasibility and acceptability of academic detailing in general practice. Eur J Clin Pharmacol. 2003 Jul;59(3):253-60. doi: 10.1007/s00228-003-0602-6. Epub 2003 May 22.
- May F, Simpson D, Hart L, Rowett D, Perrier D. Experience with academic detailing services for quality improvement in primary care practice. Qual Saf Health Care. 2009 Jun;18(3):225-31. doi: 10.1136/qshc.2006.021956.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S58815
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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