Opinion of the Infectious Disease Specialist Referent for the Good Use of AnTiBiotics

NCT04603313 | Completed

• 1 other identifier: 38RC18.073
• Study Type: observational
• Target: 4,138
• Locations: 1 country
• Sites: 13

Brief Summary

The increase in bacterial resistance and the overuse of antibiotics have led health authorities to propose incentives for the proper use of antibiotics. Among these measures, the introduction of referring physicians for antibiotic therapy and tele-advisory devices for infectious diseases have shown positive effects on antibiotic prescriptions in hospitals. Today, an increase is observed in the consumption of antibiotics linked to ambulatory prescriptions. The objective of the project is to deploy tele-advice devices for general practitioners and to evaluate the effects on ambulatory antibiotic dispensing. AIRBUS-ATB is a prospective, multi-center, population-based, interrupted time-series observational study with a control group with 12 points before and 24 points after the deployment of the intervention in voluntary territories.

Conditions

Communicable Diseases

Keywords

tele-advice system;; infectious disease; ambulatory medicine; good use of antibiotics

Outcome Measures

Primary Outcomes (1)

• Change from monthly outpatient antibiotic dispensation expressed in Defined Daily Dose (DDD) at 24 months

  Monthly outpatient antibiotic dispensation expressed in Defined Daily Dose (DDD) overall and by antibiotic classes in relation to the number of inhabitants per department present in the EGB.

  12 months before the deployment of telecommunication devices and 24 months after the deployment

Secondary Outcomes (6)

• Number of opinions given by participating infectious diseases specialists

  One year period

• Number of requesting GPs relative to the number of GPs in the health territories studied

  One year period

• Compliance with advice by GPs

  One year period

• Number of advice that has induced an action on the patient's care pathway

  One year period

• Time spent by the infectiologists to respond to the advice

  One year period

Study Arms (2)

Experimental group

12 departments in mainland France covered by the tele-advice system open to general practitioners

Other: tele-advice system

Control group

84 departments in mainland France not covered by the tele-advice system.

Interventions

tele-advice system OTHER

The intervention consists of setting up in each participating center an infectious disease tele-advice system available to general practitioners via a dedicated mobile telephone line.

Experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The main study population consists of the dispensations of systemic antibiotics recorded by the health insurance in the base of the general sample of beneficiaries (1 / 100th of patients protected) for 36 months: 12 months before the deployment of telecommunication devices and 24 months after the deployment. The secondary population of the study will be constituted by the opinions requested by a general practitioner from an infectiological tele-advice system. The opinions requested during 12 months, from September 2018 to August 2019 will be recorded in the AIRBUS database.

You may qualify if:

• Every patients included in the general sample of beneficiaries database (secondary use of an existing cohort of anonymized patients)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (13)

CH Notre Dame de la Miséricorde

Ajaccio, France

Location

CH Annecy Genevois

Annecy, France

Location

CH Métropole Savoie

Chambéry, France

Location

Olivier.rogeaux@ch-metropole_savoie.fr

Chambéry, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Chu de Grenoble Alpes

Grenoble, France

Location

Hospices civils de Lyon

Lyon, France

Location

MIIT Lyon

Lyon, France

Location

CH de Melun

Melun, France

Location

CHU de Nice

Nice, France

Location

Cochin, APHP

Paris, France

Location

CHU Rennes

Rennes, France

Location

CHU Saint Etienne

Saint-Etienne, France

Location

Related Publications (9)

• Gennai S, Francois P, Sellier E, Vittoz JP, Hincky-Vitrat V, Pavese P. Prospective study of telephone calls to a hotline for infectious disease consultation: analysis of 7,863 solicited consultations over a 1-year period. Eur J Clin Microbiol Infect Dis. 2011 Apr;30(4):509-14. doi: 10.1007/s10096-010-1111-z. Epub 2010 Nov 11.

  PMID: 21069405 BACKGROUND

• Sellier E, Labarere J, Gennai S, Bal G, Francois P, Pavese P. Compliance with recommendations and clinical outcomes for formal and informal infectious disease specialist consultations. Eur J Clin Microbiol Infect Dis. 2011 Jul;30(7):887-94. doi: 10.1007/s10096-011-1172-7. Epub 2011 Feb 11.

  PMID: 21311942 BACKGROUND

• Bal G, Sellier E, Gennai S, Caillis M, Francois P, Pavese P. Infectious disease specialist telephone consultations requested by general practitioners. Scand J Infect Dis. 2011 Dec;43(11-12):912-7. doi: 10.3109/00365548.2011.598874. Epub 2011 Aug 26.

  PMID: 21867475 BACKGROUND

• Lesprit P, Landelle C, Brun-Buisson C. Unsolicited post-prescription antibiotic review in surgical and medical wards: factors associated with counselling and physicians' compliance. Eur J Clin Microbiol Infect Dis. 2013 Feb;32(2):227-35. doi: 10.1007/s10096-012-1734-3. Epub 2012 Aug 24.

  PMID: 22918515 BACKGROUND

• Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.

  PMID: 26864410 BACKGROUND

• Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. 2017 Feb 1;46(1):348-355. doi: 10.1093/ije/dyw098.

  PMID: 27283160 BACKGROUND

• Pavese P, Sellier E, Laborde L, Gennai S, Stahl JP, Francois P. Requesting physicians' experiences regarding infectious disease consultations. BMC Infect Dis. 2011 Mar 14;11:62. doi: 10.1186/1471-2334-11-62.

  PMID: 21401916 BACKGROUND

• Borowsky SJ. What do we really need to know about consultation and referral? J Gen Intern Med. 1998 Jul;13(7):497-8. doi: 10.1046/j.1525-1497.1998.00150.x. No abstract available.

  PMID: 9686720 BACKGROUND

• Keating NL, Zaslavsky AM, Ayanian JZ. Physicians' experiences and beliefs regarding informal consultation. JAMA. 1998 Sep 9;280(10):900-4. doi: 10.1001/jama.280.10.900.

  PMID: 9739974 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia PAVESE, MD

  CHU de Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 26, 2020
• Study Start: April 15, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

FR (13)