Respiratory Tract InfectionsNCT03265028
TRACE E-learning Implementation in Belgium
An observational study of Respiratory Tract Infections, run by Universiteit Antwerpen at 11 sites in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- TRACE e-learning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15,802 participants
- Where
- 11 sitesBelgium
- Study dates
- 1 Sep 2017to 31 Dec 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all clinicians registered as General Practitioner in Belgium
Who may be able to join
- all clinicians registered as General Practitioner in Belgium
Who cannot join
- none
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Belgium11 sites
GPs of Antwerp
Antwerp
Gps of Luxemburg
Arlon, Luxemburg
GPs of West-Vlaanderen
Bruges, West-Vlaanderen
GPs of Brussels
Brussels
GPs of Oost-Vlaanderen
Ghent, Oost-Vlaanderen
GPs of Limburg
Hasselt, Limburg
GPs of Vlaams-Brabant
Leuven, Vlaams-Brabant
GPS of Luik
Liège, Luik
GPs of Henegouwen
Mons, Henegouwen
GPs of Namen
Namur, Namen
GPs of Waals-Brabant
Wavre, Waals-Brabant
About this study
Official title: National Implementation of a Multifaceted Web-based Communication Training to Reduce of Inappropriate Antibiotic Prescribing for (Lower) Respiratory Tract Infections
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.
Read the 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.
- Conditions
- Respiratory Tract Infections
- Being tested
- TRACE e-learning
- Keywords
- primary care, antibiotics, communication skills, general practice, outpatient, ambulatory care, anti-bacterial agents
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRACE e-learningBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Invited to take the TRACE e-learning. Receives: Behavioral: TRACE e-learning | |
| Control | Not (yet) invited to take the TRACE e-learning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First 2 months after intervention
Secondary outcomes (2)
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
Measured: 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
Measured: 6-12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 15,802 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Antibiotic Policy Coordination Committee (BAPCOC)
- Responsible party
- Principal investigator, Niels Adriaenssens, Universiteit Antwerpen
- Investigators
- Samuel Coenen, Prof, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265028
- Sponsor's protocol ID
- TRACE Implementation
- Status last verified
- Aug 2019
- First submitted
- 25 Aug 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23110756Little 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.
PubMed 23915885Tonkin-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.
PubMed 25030621Anthierens 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.
PubMed 25373834D'Hulster L, Abrams S, Bruyndonckx R, Anthierens S, Adriaenssens N, Butler CC, Verheij T, Goossens H, Little P, Coenen S. Nationwide implementation of online communication skills training to reduce overprescribing of antibiotics: a stepped-wedge cluster randomized trial in general practice. JAC Antimicrob Resist. 2022 Jun 29;4(3):dlac070. doi: 10.1093/jacamr/dlac070. eCollection 2022 Jun.
PubMed 35774072
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Implementation of a Multifaceted Web-based Communication Training to Reduce of Inappropriate Antibiotic Prescribing for (Lower) Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT03265028
- Acronym / sponsor ID
- TRACE Implementation
- Conditions
- Respiratory Tract Infections
- Keywords
- primary care, antibiotics, communication skills, general practice, outpatient, ambulatory care, anti-bacterial agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,802 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Belgian Antibiotic Policy Coordination Committee (BAPCOC)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: TRACE e-learningInvited to take the TRACE e-learning. |
| Control | – | –Not (yet) invited to take the TRACE e-learning. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all clinicians registered as General Practitioner in Belgium
Key inclusion criteria (1 listed)
- all clinicians registered as General Practitioner in Belgium
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRACE e-learningThe 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. | Behavioural | Intervention |
Primary outcome
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
2 secondary outcomes
Antibiotic use (intermediate term)
Time frame: 3-6 months after intervention
Antibiotic use (long term)
Time frame: 6-12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Background: PubMed 23110756Anthierens 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.
- Background: PubMed 23915885Little 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.
- Background: PubMed 25030621Tonkin-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.
- Background: PubMed 25373834Anthierens 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.
- Derived from this study: PubMed 35774072D'Hulster L, Abrams S, Bruyndonckx R, Anthierens S, Adriaenssens N, Butler CC, Verheij T, Goossens H, Little P, Coenen S. Nationwide implementation of online communication skills training to reduce overprescribing of antibiotics: a stepped-wedge cluster randomized trial in general practice. JAC Antimicrob Resist. 2022 Jun 29;4(3):dlac070. doi: 10.1093/jacamr/dlac070. eCollection 2022 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Coenen, Prof principal investigator
Universiteit Antwerpen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections, run by Universiteit Antwerpen at 11 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic use (short term) (time frame: First 2 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265028, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.