An observational study in Respiratory Tract Infections, sponsored by Universiteit Antwerpen. Completed at 11 sites in Belgium. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Universiteit Antwerpen · Observational
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.
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.
1,052 studies on the registry are indexed under Respiratory Tract Infections; 147 are open to participants now.
This study's enrollment of 15,802 is above the median of 300 across 299 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Universiteit Antwerpen is the lead sponsor of 132 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
all clinicians registered as General Practitioner in Belgium
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Invited to take the TRACE e-learning.
Behavioral: TRACE e-learning
Not (yet) invited to take the 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.
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
Time frame: First 2 months after intervention
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
Time frame: 3-6 months after intervention
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
Time frame: 6-12 months after intervention
Response rate (short term)
The number of invited GPs taking the TRACE e-learning
Time frame: First 2 months after intervention
Response rate (long term)
The number of invited GPs taking the TRACE e-learning
Time frame: First year after intervention
Plan to share: No
Ran from Sep 2017 to primary completion in Dec 2018, 15 months.
Of 106 non-industry observational studies under Respiratory Tract Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's 15 months is below that.
Counting every sponsor, half of 137 studies reached it within 20 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →