TRACE E-learning Implementation in Belgium

Respiratory Tract Infections Clinical Trial

Official title:

National Implementation of a Multifaceted Web-based Communication Training to Reduce of Inappropriate Antibiotic Prescribing for (Lower) Respiratory Tract Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265028
• Other study ID #: TRACE Implementation
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2019
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

The envisaged research aims to implement the most cost-effective part of the GRACE INTRO intervention (TRACE e-learning, www.acutecough.org), i.e. a web-based communication training and an interactive patient booklet for adults presenting to primary care with LRTI, at national level. For that purpose the investigators will perform a stepped wedge cluster-randomised trial. Stepped wedge randomised trial designs involve sequential roll-out of an intervention to participants (individuals or clusters) over a number of time periods. By the end of the study, all participants will have received the intervention, although the order in which participants receive the intervention is determined at random. Over a period of one year all practices in the 10 Belgian provinces and Brussels (n=11 clusters) will get access to the intervention. The order in which the clusters receive the intervention is determined at random. The general practitioners (GPs) in the intervention phase will be invited to take an educational web-based module, including communication training, to improve prescribing of antibiotics for LRTI and will receive patient booklets to be used interactively during the consultation. The clusters not yet exposed to the intervention will serve as control group. The effect on prescribing behavior will be assessed using monthly Intermutualistic Agency (IMA, www.nic-ima.be) data. Hence, the outcome measurement will have complete response, and will not interfere with the normal routine of the eligible GPs, allowing a more valid estimate of any intervention effect. Since the training will be assessed, and not the eligible practices or GPs, IMA has the legal authority (Art. 153 of the coordinated Law of 14 July 1994) to perform the required analyses. The estimates of the efficacy of the intervention will at the same time describe its effectiveness in daily practice, which is unconventional for a randomized trial (on a behavioural intervention). Given the large sample size, the proposed trial will also provide very precise estimates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15802
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all clinicians registered as General Practitioner in Belgium

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections

Intervention

Behavioral:
• TRACE e-learning
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.

Locations

Country	Name	City	State
Belgium	GPs of Antwerp	Antwerp
Belgium	Gps of Luxemburg	Arlon	Luxemburg
Belgium	GPs of West-Vlaanderen	Brugge	West-Vlaanderen
Belgium	GPs of Brussels	Brussels
Belgium	GPs of Oost-Vlaanderen	Gent	Oost-Vlaanderen
Belgium	GPs of Limburg	Hasselt	Limburg
Belgium	GPs of Vlaams-Brabant	Leuven	Vlaams-Brabant
Belgium	GPS of Luik	Liège	Luik
Belgium	GPs of Henegouwen	Mons	Henegouwen
Belgium	GPs of Namen	Namur	Namen
Belgium	GPs of Waals-Brabant	Wavre	Waals-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Belgian Antibiotic Policy Coordination Committee (BAPCOC)

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response rate (short term)	The number of invited GPs taking the TRACE e-learning	First 2 months after intervention
Other	Response rate (long term)	The number of invited GPs taking the TRACE e-learning	First year after intervention
Primary	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	Antibiotic use (intermediate term)	Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day	3-6 months after intervention
Secondary	Antibiotic use (long term)	Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day	6-12 months after intervention

External Links

•   GRACE website
•   TRACE e-learning
•   TRACE website