Study Focus: Prescribing of DrugsNCT01761864
The Effect of Industry-independent Visits to Primary Care Physicians on Medication Prescribing for Pain Relief in Chronic Joint Pain.
A study testing academic detailing intervention in people with Study Focus: Prescribing of Drugs, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
Osteoarthritis is a common problem in primary care. Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief can lead to serious (gastro-intestinal, cardiovascular and renal) adverse events, that can even result in death. NSAIDs differ in their risk of side effects. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Study Focus: Prescribing of Drugs
- What is being tested?
- academic detailing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Jan 2016
- 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
- Professionally active GPs of all Belgian primary care practices that have received a visit before by Farmaka and are located in the regions where academic detailers are currently active. No age or gender restrictions.
Who cannot join
- GPs who are not professionally active (anymore) in a practice located in a region were an academic detailer operates in the period of the visits on analgesics; GP's who have never received an academic detailing visit before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Academic Detailing on Prescribing of Analgesics in Primary Care: a Randomised Controlled Trial
Osteoarthritis is a common problem in primary care. Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief can lead to serious (gastro-intestinal, cardiovascular and renal) adverse events, that can even result in death. NSAIDs differ in their risk of side effects. Opoid analgesics are sometimes used as an alternative for NSAIDs in patients with osteoarthritis. However, these drugs also can lead to serious adverse events. Simple analgesics are first line treatment in patients with osteoarthritis. NSAIDs and opoid analgesics should be avoided whenever possible.
Farmaka (www.farmaka.be) is a non-profit organisation that operates a nationwide academic detailing service in Belgium since 2006. The academic detailing exists of face-to-face educational visits to general practitioners in their practice by a trained visitor with a medical science degree. The aim of these visits is to improve the quality of drug prescribing in primary care. Small scale experiments in the past showed that academic detailing can indeed improve prescribing behavior.
Read more
The current study wants to examine if nationwide academic detailing on appropriate prescribing of analgesics for chronic pain in osteoarthritis results in a better GP's prescribing behavior.
Another research question is whether physician-visitors have more influence on prescribing than non-physician visitors.
It is also interesting to examine if the effect of a visit is larger if there exists a longstanding relationship between the academic detailer and the GP.
About 4.000 general practices are located in a region where academic detailers of Farmaka are operational and have received a visit at least once before. All these practices will be divided into two study groups in a random manner.
The first group of practices will belong to the treatment group. GP's from this group will be offered a face-to-face visit on appropriate prescribing of analgesics for chronic pain in osteoarthritis. The visits will take place between February and June 2013.
The second group of practices will serve as a control group. GP's from these practices won't be offered any visit at all during the year 2013.
Reimbursement data for all GP's are available by request from the Belgian Intermutualistic Agency (IMA). IMA data for 2013 will be available by the end of 2014. These data will allow comparison between the treatment and control group on the amound and type of prescriptions for analgesics in patients with chronic osteoarthritis pain.
A comparison of the prescriptions of practices that participate in the study and the prescriptions of in practices that don't participate is also possible.
The project is funded by the Federal Agency for Medicines and Health Products. We hypothesize that
- the academic detailing visits to GP practices on prescribing of analgesics for chronic pain in osteoarthritis will improve prescribing of analgesics by at least 5%
- the personal relation between the GP and the academic detailer, expressed as the number of previous visits, is an important effect modifier
- Conditions
- Study Focus: Prescribing of Drugs
- Being tested
- academic detailing intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
academic detailing interventionBehavioural
Also called academic detailing intervention on evidence-based prescribing of analgetics in chronic joint pain
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | academic detailing receiver Receives: Behavioral: academic detailing intervention |
| control group | No intervention | not receiving an academic detailing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
recommended prescribing of analgetics
Short-term (1 month), intermediate (6 months) and long-term (<= 1 year) use of
- paracetamol, ibuprofen , naproxen, oxicams, coxibs, nabumeton, tramadol, tilidine;
- recommended NSAIDs among those treated with NSAIDs expressed as percentage;
- PPI among those treated with NSAIDs expressed as percentage in insured individuals over 60 years of age and their relevant subgroups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Study Focus: Prescribing of DrugsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Verhoeven, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761864
- Sponsor's protocol ID
- FARMACA007
- Status last verified
- Sep 2021
- First submitted
- 2 Jan 2013
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bruyndonckx R, Verhoeven V, Anthierens S, Cornelis K, Ackaert K, Gielen B, Coenen S. The implementation of academic detailing and its effectiveness on appropriate prescribing of pain relief medication: a real-world cluster randomized trial in Belgian general practices. Implement Sci. 2018 Jan 10;13(1):6. doi: 10.1186/s13012-017-0703-8.
PubMed 29316945
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Academic Detailing on Prescribing of Analgesics in Primary Care: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01761864
- Acronym / sponsor ID
- FARMACA007
- Conditions
- Study Focus: Prescribing of Drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Jan 2013 (estimated)
- 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.
Osteoarthritis is a common problem in primary care. Long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief can lead to serious (gastro-intestinal, cardiovascular and renal) adverse events, that can even result in death. NSAIDs differ in their risk of side effects. Opoid analgesics are sometimes used as an alternative for NSAIDs in patients with osteoarthritis. However, these drugs also can lead to serious adverse events. Simple analgesics are first line treatment in patients with osteoarthritis. NSAIDs and opoid analgesics should be avoided whenever possible.
Farmaka (www.farmaka.be) is a non-profit organisation that operates a nationwide academic detailing service in Belgium since 2006. The academic detailing exists of face-to-face educational visits to general practitioners in their practice by a trained visitor with a medical science degree. The aim of these visits is to improve the quality of drug prescribing in primary care. Small scale experiments in the past showed that academic detailing can indeed improve prescribing behavior.
The current study wants to examine if nationwide academic detailing on appropriate prescribing of analgesics for chronic pain in osteoarthritis results in a better GP's prescribing behavior.
Another research question is whether physician-visitors have more influence on prescribing than non-physician visitors.
It is also interesting to examine if the effect of a visit is larger if there exists a longstanding relationship between the academic detailer and the GP.
About 4.000 general practices are located in a region where academic detailers of Farmaka are operational and have received a visit at least once before. All these practices will be divided into two study groups in a random manner.
The first group of practices will belong to the treatment group. GP's from this group will be offered a face-to-face visit on appropriate prescribing of analgesics for chronic pain in osteoarthritis. The visits will take place between February and June 2013.
The second group of practices will serve as a control group. GP's from these practices won't be offered any visit at all during the year 2013.
Reimbursement data for all GP's are available by request from the Belgian Intermutualistic Agency (IMA). IMA data for 2013 will be available by the end of 2014. These data will allow comparison between the treatment and control group on the amound and type of prescriptions for analgesics in patients with chronic osteoarthritis pain.
A comparison of the prescriptions of practices that participate in the study and the prescriptions of in practices that don't participate is also possible.
The project is funded by the Federal Agency for Medicines and Health Products. We hypothesize that
- the academic detailing visits to GP practices on prescribing of analgesics for chronic pain in osteoarthritis will improve prescribing of analgesics by at least 5%
- the personal relation between the GP and the academic detailer, expressed as the number of previous visits, is an important effect modifier
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: academic detailing interventionacademic detailing receiver |
| control group | No intervention | –not receiving an academic detailing intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Professionally active GPs of all Belgian primary care practices that have received a visit before by Farmaka and are located in the regions where academic detailers are currently active. No age or gender restrictions.
Key exclusion criteria (1 listed)
- GPs who are not professionally active (anymore) in a practice located in a region were an academic detailer operates in the period of the visits on analgesics; GP's who have never received an academic detailing visit before.
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 interventionAlso: academic detailing intervention on evidence-based prescribing of analgetics in chronic joint pain | Behavioural | intervention group |
Primary outcome
recommended prescribing of analgetics
Time frame: 1 year
Short-term (1 month), intermediate (6 months) and long-term (<= 1 year) use of * paracetamol, ibuprofen , naproxen, oxicams, coxibs, nabumeton, tramadol, tilidine; * recommended NSAIDs among those treated with NSAIDs expressed as percentage; * PPI among those treated with NSAIDs expressed as percentage in insured individuals over 60 years of age and their relevant subgroups.
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 1 Oct 2021.
- Derived from this study: PubMed 29316945Bruyndonckx R, Verhoeven V, Anthierens S, Cornelis K, Ackaert K, Gielen B, Coenen S. The implementation of academic detailing and its effectiveness on appropriate prescribing of pain relief medication: a real-world cluster randomized trial in Belgian general practices. Implement Sci. 2018 Jan 10;13(1):6. doi: 10.1186/s13012-017-0703-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 intervention in people with Study Focus: Prescribing of Drugs, run by Universiteit Antwerpen 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 1 inclusion and 1 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 1 Oct 2021. 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?
recommended prescribing of analgetics (time frame: 1 year). 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 NCT01761864, which also lists 1 linked publication.
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 1 Oct 2021.