NCT03265028

Brief Summary

Antibiotic resistance is a worldwide health care problem. Increasing use of antibiotics is associated with an increase in the prevalence of bacteria resistant to the antibiotic used. Reducing antibiotic use can be effected by improving antibiotic prescribing quality in two complementary ways. One is to limit antibiotic prescribing to those patients who will benefit from the treatment and two is to prescribe these patients the recommended antibiotic. International research has shown that a web-based communication training for the prescriber combined with an interactive booklet containing relevant patient information (Genomics to combat Resistance against Antibiotics for Community acquired LRTI in Europe INternet Training for Reducing antibiOtic use (GRACE INTRO)) can significantly and safely reduce antibiotic prescribing in adults presenting to primary care with acute cough/lower respiratory tract infections (LRTI). Quality assessment of antibiotic prescribing for respiratory infections in general practice has revealed the use of far too many (broad-spectrum) antibiotics in Belgium. In the proposed project, the investigators aspire to make Belgium the first European country to implement the most cost-effective part of the GRACE INTRO intervention (Translational Research on Antimicrobial resistance and Community-acquired infections in Europe (TRACE) e-learning, www.acutecough.org) at national level and to perform a scientifically sound assessment of the nationwide implementation on outpatient antibiotic use and societal cost.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15,802

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

11 active sites

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

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

August 25, 2017

Last Update Submit

August 27, 2019

Conditions

Keywords

primary careantibioticscommunication skillsgeneral practiceoutpatientambulatory careanti-bacterial agents

Outcome Measures

Primary Outcomes (1)

  • Antibiotic use (short term)

    Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day

    First 2 months after intervention

Secondary Outcomes (2)

  • Antibiotic use (intermediate term)

    3-6 months after intervention

  • Antibiotic use (long term)

    6-12 months after intervention

Other Outcomes (2)

  • Response rate (short term)

    First 2 months after intervention

  • Response rate (long term)

    First year after intervention

Study Arms (2)

Intervention

Invited to take the TRACE e-learning.

Behavioral: TRACE e-learning

Control

Not (yet) invited to take the TRACE e-learning.

Interventions

The TRACE e-learning (www.acutecough.org) is an educational web-based module including communication training for physicians, and includes patient booklets to be used interactively during the consultation.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all clinicians registered as General Practitioner in Belgium

You may qualify if:

  • all clinicians registered as General Practitioner in Belgium

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

GPs of Henegouwen

Mons, Henegouwen, Belgium

Location

GPs of Limburg

Hasselt, Limburg, Belgium

Location

GPS of Luik

Liège, Luik, Belgium

Location

Gps of Luxemburg

Arlon, Luxemburg, Belgium

Location

GPs of Namen

Namur, Namen, Belgium

Location

GPs of Oost-Vlaanderen

Ghent, Oost-Vlaanderen, Belgium

Location

GPs of Vlaams-Brabant

Leuven, Vlaams-Brabant, Belgium

Location

GPs of Waals-Brabant

Wavre, Waals-Brabant, Belgium

Location

GPs of West-Vlaanderen

Bruges, West-Vlaanderen, Belgium

Location

GPs of Antwerp

Antwerp, Belgium

Location

GPs of Brussels

Brussels, Belgium

Location

Related Publications (5)

  • Anthierens S, Tonkin-Crine S, Douglas E, Fernandez-Vandellos P, Krawczyk J, Llor C, Cals JW, Francis NA, Yardley L, Coenen S, Verheij T, Goossens H, Little P; GRACE INTRO study team. General practitioners' views on the acceptability and applicability of a web-based intervention to reduce antibiotic prescribing for acute cough in multiple European countries: a qualitative study prior to a randomised trial. BMC Fam Pract. 2012 Oct 11;13:101. doi: 10.1186/1471-2296-13-101.

    PMID: 23110756BACKGROUND
  • Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.

    PMID: 23915885BACKGROUND
  • Tonkin-Crine S, Anthierens S, Francis NA, Brugman C, Fernandez-Vandellos P, Krawczyk J, Llor C, Yardley L, Coenen S, Godycki-Cwirko M, Butler CC, Verheij TJ, Goossens H, Little P, Cals JW; GRACE INTRO team. Exploring patients' views of primary care consultations with contrasting interventions for acute cough: a six-country European qualitative study. NPJ Prim Care Respir Med. 2014 Jul 17;24:14026. doi: 10.1038/npjpcrm.2014.26.

    PMID: 25030621BACKGROUND
  • Anthierens S, Tonkin-Crine S, Cals JW, Coenen S, Yardley L, Brookes-Howell L, Fernandez-Vandellos P, Krawczyk J, Godycki-Cwirko M, Llor C, Butler CC, Verheij T, Goossens H, Little P, Francis NA; GRACE/CHAMP INTRO team. Clinicians' views and experiences of interventions to enhance the quality of antibiotic prescribing for acute respiratory tract infections. J Gen Intern Med. 2015 Apr;30(4):408-16. doi: 10.1007/s11606-014-3076-6. Epub 2014 Nov 6.

    PMID: 25373834BACKGROUND
  • D'Hulster L, Abrams S, Bruyndonckx R, Anthierens S, Adriaenssens N, Butler CC, Verheij T, Goossens H, Little P, Coenen S. Nationwide implementation of online communication skills training to reduce overprescribing of antibiotics: a stepped-wedge cluster randomized trial in general practice. JAC Antimicrob Resist. 2022 Jun 29;4(3):dlac070. doi: 10.1093/jacamr/dlac070. eCollection 2022 Jun.

Related Links

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Samuel Coenen, Prof

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 29, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations