Antibiotic PrescriptionNCT04562571
Impact of a Communication Toolkit on Antibiotic Prescribed by General Practitioners: a Randomised Trial
A study testing Charter & patient information leaflets in people with Antibiotic Prescription, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Prescription
- What is being tested?
- Charter & patient information leaflets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 30 Sep 2019
- Phase
- Interventional
- 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
Who may be able to join
- working in the Lorraine region in France
- prescribing more than 25 antibiotic items per 100 patients without a chronic illness, aged 16 to 65 years
- proportion of patients treated with critical antibiotics exceeding 27% (among patients treated with antibiotics)
Who cannot join
- practicing exclusively alternative medicine, such as homeopathy or acupuncture
- GPs reaching the retirement age in the two years following the beginning of the intervention or who were not working two years before
- GPs who had already displayed a commitment charter promoting antibiotic stewardship in their practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Public Commitment Charter Associated With Patient Information Leaflets on Antibiotics Prescribed by General Practitioners
This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while the control group will be not aware of the intervention.
Read the detailed description
Antimicrobial resistance is a major public health threat and the overuse of antibiotics contributes to its development.
In France, outpatient antibiotic use remains above the European average. Ninety percent of antibiotics are prescribed to outpatients and 70% of these are prescribed by general practitioners.
- Conditions
- Antibiotic Prescription
- Being tested
- Charter & patient information leaflets
- Keywords
- antibiotic, antibiotic stewardship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charter & patient information leafletsOther
Public commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription
| Study group | Role | What they receive |
|---|---|---|
| Charter & patient information leaflets | Experimental | A public commitment charter promoting antibiotic stewardship, signed by the general practitioner (GP) and displayed in the practice waiting room; a non-prescription pad, to be distributed to patients when an antibiotic is not needed; and a patient information leaflet to be used when antibiotics were prescribed Receives: Other: Charter & patient information leaflets |
| Control | No intervention | No intervention, eligible general practitioners randomised in the control group not informed of the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription
prescription rate by all included GPs of all systemic antibiotics (J01 code according to the Anatomical Therapeutic Chemical - ATC - 2017 classification) between the "before" (2017-2018) and "after" (2018-2019) period using an auto regressive integrated moving average (ARIMA) model
Measured: 2 years
Secondary outcomes (5)
Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions
prescription rates by included GPs of amoxicillin-clavulanate (J01CR02), cephalosporins (J01DD) and fluoroquinolones (J01MA) for each eligible GP between the "before" and "after" period using an auto regressive integrated moving average (ARIMA) model
Measured: 2 years
Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use
ratio of the [number of prescriptions of all antibiotics / quinolones during the cold-weather season (January-March and October-December)] / [number of prescriptions of all antibiotics / quinolones during the hot-weather season (April-September)] - 1 x 100 Title: Broad-spectrum antibiotics' prescriptions between the "before" and "after" period using ANOVA models
Measured: 2 years
Adherence of GPs regarding the intervention: display of the public commitment charter
checking visually, without the GP being informed, during the opening hours of the practice, that the charter is effectively displayed in the waiting room at month 12
Measured: 1 years
Adherence of GPs regarding the intervention: use patient information leaflets
Estimating the number of patient information leaflets distributed to patients by GPs, from the number of pads ordered from the Regional Health Insurance
Measured: 1 years
Acceptability of the intervention by GPs
semi-structured individual interviews with a randomised sample of GPs from the intervention group and focus groups or individual interviews with patients of the included GPs, in order to assess their perceptions regarding the intervention
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic PrescriptionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine
- Responsible party
- Sponsor
- Investigators
- Céline Pulcini, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562571
- Sponsor's protocol ID
- 201701939
- Status last verified
- Sep 2019
- First submitted
- 6 Jul 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Essilini A, Le Dref G, Bocquier A, Kivits J, Welter A, Pulcini C, Thilly N; AntibioCharte scientific committee. French general practitioners' and patients' acceptability of a public commitment charter and patient information leaflets targeting unnecessary antibiotic use: a qualitative study. Antimicrob Resist Infect Control. 2022 Feb 8;11(1):32. doi: 10.1186/s13756-022-01065-3.
PubMed 35135624
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Public Commitment Charter Associated With Patient Information Leaflets on Antibiotics Prescribed by General Practitioners
- ClinicalTrials.gov ID
- NCT04562571
- Acronym / sponsor ID
- 201701939
- Conditions
- Antibiotic Prescription
- Keywords
- antibiotic, antibiotic stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University of Lorraine
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 24 Sep 2020 (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.
This study is a pragmatic, randomised, controlled, before-after interventional study conducted in one region in France in primary care. The GPs in the intervention group will receive a public commitment charter, a non prescription pad and a patient information leaflet to be used when antibiotics are prescribed, while the control group will be not aware of the intervention.
Detailed description
Antimicrobial resistance is a major public health threat and the overuse of antibiotics contributes to its development.
In France, outpatient antibiotic use remains above the European average. Ninety percent of antibiotics are prescribed to outpatients and 70% of these are prescribed by general practitioners.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Charter & patient information leaflets | Experimental | Other: Charter & patient information leafletsA public commitment charter promoting antibiotic stewardship, signed by the general practitioner (GP) and displayed in the practice waiting room; a non-prescription pad, to be distributed to patients when an antibiotic is not needed; and a patient information leaflet to be used when antibiotics were prescribed |
| Control | No intervention | –No intervention, eligible general practitioners randomised in the control group not informed of the intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- working in the Lorraine region in France
- prescribing more than 25 antibiotic items per 100 patients without a chronic illness, aged 16 to 65 years
- proportion of patients treated with critical antibiotics exceeding 27% (among patients treated with antibiotics)
Key exclusion criteria (3 listed)
- practicing exclusively alternative medicine, such as homeopathy or acupuncture
- GPs reaching the retirement age in the two years following the beginning of the intervention or who were not working two years before
- GPs who had already displayed a commitment charter promoting antibiotic stewardship in their practice
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 |
|---|---|---|
| Charter & patient information leafletsPublic commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription | Other | Charter & patient information leaflets |
Primary outcome
Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription
Time frame: 2 years
prescription rate by all included GPs of all systemic antibiotics (J01 code according to the Anatomical Therapeutic Chemical - ATC - 2017 classification) between the "before" (2017-2018) and "after" (2018-2019) period using an auto regressive integrated moving average (ARIMA) model
5 secondary outcomes
Impact of the public commitment charter associated with patient information leaflets on broad-spectrum antibiotics' prescriptions
Time frame: 2 years
Impact of the intervention on the seasonal variation of both total antibiotic use and quinolones' use
Time frame: 2 years
Adherence of GPs regarding the intervention: display of the public commitment charter
Time frame: 1 years
Adherence of GPs regarding the intervention: use patient information leaflets
Time frame: 1 years
Acceptability of the intervention by GPs
Time frame: 1 years
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 24 Sep 2020.
- Derived from this study: PubMed 35135624Essilini A, Le Dref G, Bocquier A, Kivits J, Welter A, Pulcini C, Thilly N; AntibioCharte scientific committee. French general practitioners' and patients' acceptability of a public commitment charter and patient information leaflets targeting unnecessary antibiotic use: a qualitative study. Antimicrob Resist Infect Control. 2022 Feb 8;11(1):32. doi: 10.1186/s13756-022-01065-3.
- 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.
Céline Pulcini principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charter & patient information leaflets in people with Antibiotic Prescription, run by Central Hospital, Nancy, France at 1 site in France.
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 3 inclusion and 3 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 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Impact of a public commitment charter associated with patient information leaflets on antibiotic's prescription (time frame: 2 years). 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 NCT04562571, which also lists 1 linked publication.
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 24 Sep 2020.