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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

Tracking Information
First Submitted Date August 25, 2017
First Posted Date August 29, 2017
Last Update Posted Date August 30, 2019
Actual Study Start Date September 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03265028 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 25, 2017)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 25, 2017)
  • Response rate (short term) [ Time Frame: First 2 months after intervention ]
    The number of invited GPs taking the TRACE e-learning
  • Response rate (long term) [ Time Frame: First year after intervention ]
    The number of invited GPs taking the TRACE e-learning
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title TRACE E-learning Implementation in Belgium
Official Title National Implementation of a Multifaceted Web-based Communication Training to Reduce of Inappropriate Antibiotic Prescribing for (Lower) Respiratory Tract Infections
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.

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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population all clinicians registered as General Practitioner in Belgium
Condition 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.
Study Groups/Cohorts
  • Intervention
    Invited to take the TRACE e-learning.
    Intervention: Behavioral: TRACE e-learning
  • Control
    Not (yet) invited to take the TRACE e-learning.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 27, 2019)
15802
Original Estimated Enrollment
 (submitted: August 25, 2017)
15000
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all clinicians registered as General Practitioner in Belgium

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03265028
Other Study ID Numbers TRACE Implementation
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Niels Adriaenssens, Universiteit Antwerpen
Study Sponsor Universiteit Antwerpen
Collaborators Belgian Antibiotic Policy Coordination Committee (BAPCOC)
Investigators
Principal Investigator: Samuel Coenen, Prof Universiteit Antwerpen
PRS Account Universiteit Antwerpen
Verification Date August 2019