Knee OsteoarthritisNCT03106142
Knee Osteoarthritis Care: A Quality Improvement Intervention in General Practice
A study testing Academic detailing visit arm in people with Knee Osteoarthritis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to improve the referral rates to physiotherapy of patients with knee osteoarthritis. The intervention consists of one academic detailing visit directed to general practitioners (GPs) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Academic detailing visit arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- active GP setting
- visited by independent medical visitors for academic detailing
Who cannot join
- not willing to participate
- not visited by independent medical visitors for academic detailing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Current General Practitioners Care: Feasibility and Effectiveness of a Simple Educational Intervention. Knee Osteoarthritis Care: a Quality Improvement in General Practice
The aim of this study is to improve the referral rates to physiotherapy of patients with knee osteoarthritis. The intervention consists of one academic detailing visit directed to general practitioners (GPs)
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Academic detailing visit arm
- Keywords
- intervention, improvement strategy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic detailing visit armProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Academic detailing visit arm | Other | 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. Receives: Procedure: Academic detailing visit arm |
| control group | No intervention | The two case vignettes will also be presented to GP who did not received the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of referrals to physical therapy of patients with knee osteoarthritis
2 case vignettes were developed to assess GPs' referral rate
Measured: 6 months after intervention
Secondary outcomes (2)
Number of technical investigations ordered by GPs for patients with knee osteoarthritis
2 case vignettes were developed to assess GPs' request of technical investigations
Measured: 6 months after the intervention
Type of pain medication prescribed by GPs for patients with knee osteoarthritis
2 case vignettes were developed to assess GPs' medication prescriptions
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startSep 2014
- Primary completionNov 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group Control group (usual care)
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrik Vankrunkelsven, Professor, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106142
- Sponsor's protocol ID
- S58815
- Status last verified
- Mar 2017
- First submitted
- 26 Oct 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12761604May 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.
PubMed 19468007
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Current General Practitioners Care: Feasibility and Effectiveness of a Simple Educational Intervention. Knee Osteoarthritis Care: a Quality Improvement in General Practice
- ClinicalTrials.gov ID
- NCT03106142
- Acronym / sponsor ID
- S58815
- Conditions
- Knee Osteoarthritis
- Keywords
- intervention, improvement strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to improve the referral rates to physiotherapy of patients with knee osteoarthritis. The intervention consists of one academic detailing visit directed to general practitioners (GPs)
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group Control group (usual care)
| Arm | Type | Receives |
|---|---|---|
| Academic detailing visit arm | Other | Procedure: Academic detailing visit armThe 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. |
| control group | No intervention | –The two case vignettes will also be presented to GP who did not received the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- active GP setting
- visited by independent medical visitors for academic detailing
Key exclusion criteria (2 listed)
- not willing to participate
- not visited by independent medical visitors for academic detailing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Academic detailing visit armGeneral 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. | Procedure or surgery | Academic detailing visit arm |
Primary outcome
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
2 secondary outcomes
Number of technical investigations ordered by GPs for patients with knee osteoarthritis
Time frame: 6 months after the intervention
Type of pain medication prescribed by GPs for patients with knee osteoarthritis
Time frame: 6 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 12761604Habraken 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.
- Background: PubMed 19468007May 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.
Related trials for Knee Osteoarthritis
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Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrik Vankrunkelsven, Professor principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Academic detailing visit arm in people with Knee Osteoarthritis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of referrals to physical therapy of patients with knee osteoarthritis (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03106142, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.