Skip to main content
OpenTrials
Completed

NCT Number: NCT03265028

TRACE E-learning Implementation in Belgium

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Tract Infections Infections Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

GPs of Henegouwen, Mons, Henegouwen, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all clinicians registered as General Practitioner in Belgium

Exclusion criteria

  • none

Treatment and study plan

TRACE e-learning

Behavioral

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.

Primary outcomes

  1. Antibiotic use (short term)

    Time frame: First 2 months after intervention

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

Secondary outcomes

  1. Antibiotic use (intermediate term)

    Time frame: 3-6 months after intervention

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

  2. Antibiotic use (long term)

    Time frame: 6-12 months after intervention

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

Other outcomes

  1. Response rate (short term)

    Time frame: First 2 months after intervention

    The number of invited GPs taking the TRACE e-learning

  2. Response rate (long term)

    Time frame: First year after intervention

    The number of invited GPs taking the TRACE e-learning

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Belgian Antibiotic Policy Coordination Committee (BAPCOC)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Aug 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.