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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 : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date July 19, 2019
First Posted Date July 23, 2019
Last Update Posted Date January 28, 2020
Actual Study Start Date July 15, 2019
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2019)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04028830 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

All general GPs settled in the Pays de la Loire region, having seen more than 100 different patients in the year preceding the evaluation, will be eligible.

GPs with a particular mode of exercise (acupuncture, allergology, angiology) will be identified from the data of the health insurance and will be excluded.

Condition Antibiotic Resistance
Intervention 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
Study Groups/Cohorts
  • Arm 1
    Medical representative presentation with the help internet tool for decision ANTIBIOCLIC
    Intervention: Other: Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC
  • Arm 2
    Medical representative presentation without presentation of the internet tool for decision support
  • Arm 3
    Usual practice without intervention regarding the prescription of antibiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2019)
2900
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 15, 2020
Estimated Primary Completion Date July 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Cedric RAT, Doctor 02.40.41.28.28 cedric.rat@univ-nantes.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04028830
Other Study ID Numbers RC19_0459
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date July 2019