NCT04028830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,501

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

July 19, 2019

Last Update Submit

April 19, 2024

Conditions

Outcome Measures

Primary Outcomes (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.

    12 months

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Arm 2

EXPERIMENTAL

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

Arm 3

NO INTERVENTION

Usual practice without intervention regarding the prescription of antibiotics

Interventions

Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC

Arm 1

Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Will not be included attending GPs
  • who will be identified as having a particular exercise. And / or
  • that will already be integrated into an antibiotic prevention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

Related Publications (1)

  • Jeanmougin P, Larramendy S, Fournier JP, Gaultier A, Rat C. Effect of a Feedback Visit and a Clinical Decision Support System Based on Antibiotic Prescription Audit in Primary Care: Multiarm Cluster-Randomized Controlled Trial. J Med Internet Res. 2024 Dec 18;26:e60535. doi: 10.2196/60535.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 23, 2019

Study Start

July 15, 2019

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations