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The Effect of Industry-independent Visits to Primary Care Physicians on Medication Prescribing for Pain Relief in Chronic Joint Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01761864
Recruitment Status : Unknown
Verified February 2014 by Veronique Verhoeven, Universiteit Antwerpen.
Recruitment status was:  Active, not recruiting
First Posted : January 7, 2013
Last Update Posted : February 17, 2014
Information provided by (Responsible Party):
Veronique Verhoeven, Universiteit Antwerpen

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 7, 2013
Last Update Posted Date February 17, 2014
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE The Effect of Industry-independent Visits to Primary Care Physicians on Medication Prescribing for Pain Relief in Chronic Joint Pain.
Official Title  ICMJE The Effect of Academic Detailing on Prescribing of Analgesics in Primary Care: a Randomised Controlled Trial
Brief 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. 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 ( 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Study Focus: Prescribing of Drugs
Intervention  ICMJE Behavioral: academic detailing intervention
Other Name: academic detailing intervention on evidence-based prescribing of analgetics in chronic joint pain
Study Arms  ICMJE
  • Experimental: intervention group
    academic detailing receiver
    Intervention: Behavioral: academic detailing intervention
  • No Intervention: control group
    not receiving an academic detailing intervention
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01761864
Other Study ID Numbers  ICMJE FARMACA007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Veronique Verhoeven, Universiteit Antwerpen
Study Sponsor  ICMJE Universiteit Antwerpen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universiteit Antwerpen
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP