Respiratory Tract InfectionsPAAIR2NCT01107223
Long Term Effect of General Practitioner Education on Antibiotic Prescribing
A study testing Experimental: Training to antibiotic prescription and No education on antibiotic prescription rules. in people with Respiratory Tract Infections, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
Respiratory tract infections are the most common indication for antibiotic prescribing in primary care. Several studies have shown a strong relationship between antibiotic use and bacterial resistance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Experimental: Training to antibiotic prescription and No education on antibiotic prescription rules.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2004to Apr 2010
- 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
- General practitioners practicing in three departments of the Parisian area in France
- General practitioners attending a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Henri Mondor Hospital, department of general practice
Créteil, 94000
About this study
Official title: Long Term Effect of General Practitioner Education on Antibiotic Prescribing: a Large Scale Randomized Study
Respiratory tract infections are the most common indication for antibiotic prescribing in primary care. Several studies have shown a strong relationship between antibiotic use and bacterial resistance. The aim of this trial was to assess the long-term effect of a continuous education program on general practitioners antibiotic prescribing behaviour. 170 physicians were included in this study. Physicians randomized in the education group attended a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory tract infections. The intervention was limited at physicians level and did not target the patients.
- Conditions
- Respiratory Tract Infections
- Being tested
- Experimental: Training to antibiotic prescription, No education on antibiotic prescription rules.
- Keywords
- Antibiotic, Prescribing behaviour, Guidelines, Respiratory tract infections, Non-antibiotic prescription
- 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.
Experimental: Training to antibiotic prescriptionOther
GPs assigned to the intervention group attended a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.
No education on antibiotic prescription rules.Other
GPs assigned to control group received no specific recommendations on antibiotic prescription.
| Study group | Role | What they receive |
|---|---|---|
| Training to antibiotic prescription | Experimental | Physicians randomized in the education group attended a two days seminar focussed on evidence-based guidelines on antibiotic use in respiratory tract infections. Receives: Other: Experimental: Training to antibiotic prescription |
| control | Placebo comparator | Not described Receives: Other: No education on antibiotic prescription rules. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of prescriptions containing an antibiotic between control and intervention groups (seminar on the treatment of respiratory tract infections).
All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database. All data were compared to 2004 (baseline). Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections. The change (compared to baseline) in the percentage of prescriptions containing an antibiotic (antibiotic prescription rates) was compared between control and intervention groups.
Measured: Effect of the intervention 4 to 6 months after the educational training.
Change in the cost of antibiotic prescription between control and intervention groups (seminar on the treatment of respiratory tract infections).
All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database. All data were compared to 2004 (baseline). Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections. The change (compared to baseline) in the cost of antibiotic prescription was compared between control and intervention groups.
Measured: Effect of the intervention 4 to 6 months after the educational training.
Secondary outcomes (6)
Long term antibiotic prescription rates
Long term change in the percentage of antibiotic prescriptions between both groups
Measured: Effect of the intervention 28 to 30 months after the educational training.
Long term antibiotic cost.
Long term change in the cost of antibiotic prescriptions between both groups
Measured: Effect of the intervention 28 to 30 months after the educational training.
Symptomatic drug prescription rates
Prescription rates of symptomatic drug for respiratory infections between both groups
Measured: Effect of the intervention 28 to 30 months after the educational training.
Symptomatic drug cost.
Cost of symptomatic drug between both groups
Measured: Effect of the intervention 28 to 30 months after the educational training.
Effect of patient age.
Effect of patient age on antibiotic prescription between both groups
Measured: Effect of the intervention 28 to 30 months after the educational training.
Effect of a seminar on problem-solving strategy on prescriptions.
A second randomization was performed among the intervention group. In one subgroup, GPs attended an additional seminar on problem-solving strategies. Antibiotic prescription rates were compared between controls, evidence-based and problem-solving subgroups. Antibiotic cost was also compared between the both subgroups
Measured: Effect of the intervention 28 to 30 months after the educational training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startSep 2004
- Primary completionApr 2009
- Study completionApr 2010 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Clause Attali, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107223
- Sponsor's protocol ID
- PAAIR2
- Acronym
- PAAIR2
- Status last verified
- Feb 2010
- First submitted
- 4 Mar 2010
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferrat E, Le Breton J, Guery E, Adeline F, Audureau E, Montagne O, Roudot-Thoraval F, Attali C, Le Corvoisier P, Renard V. Effects 4.5 years after an interactive GP educational seminar on antibiotic therapy for respiratory tract infections: a randomized controlled trial. Fam Pract. 2016 Apr;33(2):192-9. doi: 10.1093/fampra/cmv107. Epub 2016 Jan 21.
PubMed 26797464
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effect of General Practitioner Education on Antibiotic Prescribing: a Large Scale Randomized Study
- ClinicalTrials.gov ID
- NCT01107223
- Acronym / sponsor ID
- PAAIR2 / PAAIR2
- Conditions
- Respiratory Tract Infections
- Keywords
- Antibiotic, Prescribing behaviour, Guidelines, Respiratory tract infections, Non-antibiotic prescription
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (estimated)
- First posted
- 20 Apr 2010 (estimated)
- 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.
Respiratory tract infections are the most common indication for antibiotic prescribing in primary care. Several studies have shown a strong relationship between antibiotic use and bacterial resistance. The aim of this trial was to assess the long-term effect of a continuous education program on general practitioners antibiotic prescribing behaviour. 170 physicians were included in this study. Physicians randomized in the education group attended a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory tract infections. The intervention was limited at physicians level and did not target the patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training to antibiotic prescription | Experimental | Other: Experimental: Training to antibiotic prescriptionPhysicians randomized in the education group attended a two days seminar focussed on evidence-based guidelines on antibiotic use in respiratory tract infections. |
| control | Placebo comparator | Other: No education on antibiotic prescription rules. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- General practitioners practicing in three departments of the Parisian area in France
- General practitioners attending a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.
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 |
|---|---|---|
| Experimental: Training to antibiotic prescriptionGPs assigned to the intervention group attended a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection. | Other | Training to antibiotic prescription |
| No education on antibiotic prescription rules.GPs assigned to control group received no specific recommendations on antibiotic prescription. | Other | control |
Primary outcome
Change in the percentage of prescriptions containing an antibiotic between control and intervention groups (seminar on the treatment of respiratory tract infections).
Time frame: Effect of the intervention 4 to 6 months after the educational training.
All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database. All data were compared to 2004 (baseline). Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections. The change (compared to baseline) in the percentage of prescriptions containing an antibiotic (antibiotic prescription rates) was compared between control and intervention groups.
Change in the cost of antibiotic prescription between control and intervention groups (seminar on the treatment of respiratory tract infections).
Time frame: Effect of the intervention 4 to 6 months after the educational training.
All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database. All data were compared to 2004 (baseline). Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections. The change (compared to baseline) in the cost of antibiotic prescription was compared between control and intervention groups.
6 secondary outcomes
Long term antibiotic prescription rates
Time frame: Effect of the intervention 28 to 30 months after the educational training.
Long term antibiotic cost.
Time frame: Effect of the intervention 28 to 30 months after the educational training.
Symptomatic drug prescription rates
Time frame: Effect of the intervention 28 to 30 months after the educational training.
Symptomatic drug cost.
Time frame: Effect of the intervention 28 to 30 months after the educational training.
Effect of patient age.
Time frame: Effect of the intervention 28 to 30 months after the educational training.
Effect of a seminar on problem-solving strategy on prescriptions.
Time frame: Effect of the intervention 28 to 30 months after the educational training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2010.
- Derived from this study: PubMed 26797464Ferrat E, Le Breton J, Guery E, Adeline F, Audureau E, Montagne O, Roudot-Thoraval F, Attali C, Le Corvoisier P, Renard V. Effects 4.5 years after an interactive GP educational seminar on antibiotic therapy for respiratory tract infections: a randomized controlled trial. Fam Pract. 2016 Apr;33(2):192-9. doi: 10.1093/fampra/cmv107. Epub 2016 Jan 21.
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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.
Clause Attali, MD principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Training to antibiotic prescription and No education on antibiotic prescription rules. in people with Respiratory Tract Infections, run by Henri Mondor University Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2010. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Change in the percentage of prescriptions containing an antibiotic between control and intervention groups (seminar on the treatment of respiratory tract infections). (time frame: Effect of the intervention 4 to 6 months after the educational training.). The study lists 2 primary outcomes in all. 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 NCT01107223, 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 20 Apr 2010.