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Trial record 54 of 256 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

TRACE E-learning Implementation in Belgium

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ClinicalTrials.gov Identifier: NCT03265028
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Belgian Antibiotic Policy Coordination Committee (BAPCOC)
Information provided by (Responsible Party):
Niels Adriaenssens, Universiteit Antwerpen

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.


Condition or disease Intervention/treatment
Respiratory Tract Infections Behavioral: TRACE e-learning

Detailed 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 15802 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: National Implementation of a Multifaceted Web-based Communication Training to Reduce of Inappropriate Antibiotic Prescribing for (Lower) Respiratory Tract Infections
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Intervention
Invited to take the TRACE e-learning.
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.

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all clinicians registered as General Practitioner in Belgium
Criteria

Inclusion Criteria:

  • all clinicians registered as General Practitioner in Belgium

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265028


Locations
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Belgium
GPs of Henegouwen
Mons, Henegouwen, Belgium
GPs of Limburg
Hasselt, Limburg, Belgium
GPS of Luik
Liège, Luik, Belgium
Gps of Luxemburg
Arlon, Luxemburg, Belgium
GPs of Namen
Namur, Namen, Belgium
GPs of Oost-Vlaanderen
Gent, Oost-Vlaanderen, Belgium
GPs of Vlaams-Brabant
Leuven, Vlaams-Brabant, Belgium
GPs of Waals-Brabant
Wavre, Waals-Brabant, Belgium
GPs of West-Vlaanderen
Brugge, West-Vlaanderen, Belgium
GPs of Antwerp
Antwerp, Belgium
GPs of Brussels
Brussels, Belgium
Sponsors and Collaborators
Universiteit Antwerpen
Belgian Antibiotic Policy Coordination Committee (BAPCOC)
Investigators
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Principal Investigator: Samuel Coenen, Prof Universiteit Antwerpen

Additional Information:
Publications:

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Responsible Party: Niels Adriaenssens, Dr., Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT03265028     History of Changes
Other Study ID Numbers: TRACE Implementation
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niels Adriaenssens, Universiteit Antwerpen:
primary care
antibiotics
communication skills
general practice
outpatient
ambulatory care
anti-bacterial agents
Additional relevant MeSH terms:
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Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents