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Impact on Antibiotic Prescriptions of a Bundle Intervention Conducted by Medical Representatives in General Practitioner Facilities, Based on Operational Demonstration of an Internet Decision Support Tool: Antibioclic (ACTION)

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ClinicalTrials.gov Identifier: NCT04028830
Recruitment Status : Recruiting
First Posted : July 23, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

At the international level, several experiments have been conducted to modify antibiotic prescribing practices in GPs. The mere development of training or the mere provision of information on the internet do not seem to change the practices when these interventions are conducted in isolation. On the other hand, various approaches involving communication training, specific educational interventions working on ideas received from examples, interventions at the point of care, and the use of electronic decision support systems have demonstrated beneficial effects on prescription. The fact of sending feedback on their prescribing practices back to GPs also showed an impact

The Antibioclic website was created in 2011. It is an internet tool for prescribing help developed for general practitioners. Every day, it is consulted on average by 9000 health professionals. One question is how far the use of the site makes it possible to modify prescribing practices, which would justify, if need be, to actively promote it to general practitioners who do not use it. (The council of the order of doctors counted a little more than 88000 general practitioners in 2018.)

One challenge would be to implement a strategy:

  • combining different actions that have shown their impact: visit to the place of care, awareness of antibiotic resistance, work on preconceived ideas, feedback on practices, use of decision support tools,
  • and generalizable nationally.

The proposed study will thus experiment with an intervention modality based on the visit of a medical representative in general practitioner facilities, with:

  • antibiotic resistance sensitization,
  • work on preconceived ideas,
  • feedback on prescriptions,
  • use of an Internet tool to assist in the prescription of antibiotics: Antibioclic.

The generalizability of the intervention will be based on the collaboration with the medical representatives , which already intervene in an operational and regular way on this topic on the whole France. The medical representatives, distributed throughout the country, provide regular visits to the GPs and promote good practices. This type of visit to GPs is original internationally, demonstrating its impact on practices is decisive.

The purpose of the research is to compare the effect on antibiotic prescriptions made by general practitioners after 12 months of follow-up, i) an intervention led by the medical representatives in general practitioner facilities, the intervention involving usual visit (antibiotic resistance sensitization, work on preconceived ideas, feedback on practices) and demonstration of the use of Antibioclic, ii) an intervention conducted on the same terms by the the medical representatives but without Antibioclic demonstration, iii) compared to usual practice.


Condition or disease Intervention/treatment Phase
Antibiotic Resistance Other: Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC Other: Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact on Antibiotic Prescriptions of a Bundle Intervention Conducted by Medical Representatives in General Practitioner Facilities, Based on Operational Demonstration of an Internet Decision Support Tool: Antibioclic
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Arm 1
Medical representative presentation with the help internet tool for decision ANTIBIOCLIC
Other: Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC
Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC

Experimental: Arm 2
Medical representative presentation without presentation of the internet tool for decision support
Other: Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support
Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support

No Intervention: Arm 3
Usual practice without intervention regarding the prescription of antibiotics



Primary Outcome Measures :
  1. The primary endpoint will be the overall volume of antibiotics delivered in Defined Daily Dose (DDD) per participating GP, after 12 months of follow-up. [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GPs practicing on one of the 5 departments of the study having seen at least 100 different patients (whatever the age) during the year preceding the evaluation.

Exclusion Criteria:

  • Will not be included attending GPs

    1. who will be identified as having a particular exercise. And / or
    2. that will already be integrated into an antibiotic prevention program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028830


Contacts
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Contact: Cedric RAT, Doctor 02.40.41.28.28 cedric.rat@univ-nantes.fr

Locations
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France
University Hospital Recruiting
Nantes, France, 44000
Contact: Cedric RAT, Doctor    02.40.41.28.28    cedric.rat@univ-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04028830    
Other Study ID Numbers: RC19_0459
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents