Respiratory Tract InfectionsPhase 1/2NCT00272155
An Intervention to Reduce Inappropriate Prescriptions of Antibiotics for Respiratory Infections in General Practice
A Phase 1/2 study testing Educational intervention and Educational intervention program in people with Respiratory Tract Infections and Anti-Bacterial Agents, run by University of Oslo at 1 site in Norway.
Trial summary
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to improve antibiotic prescriptions for respiratory infections. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Anti-Bacterial Agents
- What is being tested?
- Educational intervention and Educational intervention program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 118,621 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to Mar 2007
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General practitioner
- Specialist in general practice
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Antibiotic Prescriptions in Respiratory Tract Infections be Improved? A Cluster Randomized Educational Intervention in General Practice
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to improve antibiotic prescriptions for respiratory infections.
- Being tested
- Educational intervention, Educational intervention program
- 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.
Educational interventionBehavioural
Educational outreach visits to the CME-groups, work-shops, audit and feedback
Educational intervention programBehavioural
The 433 recruited GPs had a total of 1336 717 office consultations of which 171 679 (12.8%) were RTIs encounters for 118 621 different patients. The GPs participated in peer continuing medical education (CME) groups in southern Norway. A multifaceted intervention was tailored, where key components were educational outreach visits to the CME-groups, work-shops, audit and feedback. Prescription Peer Academic Detailers conducted the educational outreach visits. During these visits, evidence-based recommendations of antibiotic prescriptions for RTIs were presented and software handed out for installation in participants PCs, enabling collection of prescription data. These data was linked to corresponding data from the Norwegian Prescription Database (NorPD). Main outcomes are baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline one year after the initiation of the tailored pedagogic intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antibiotic prescription patterns for respiratory infections
From the 1.336.717 office consultations, main outcomes data (baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline) was measured 1 year after the initiation of the tailored pedagogic intervention.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118,621 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Investigators
- Svein Gjelstad, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272155
- Sponsor's protocol ID
- 850657
- Status last verified
- Dec 2005
- First submitted
- 3 Jan 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Publications
Gjelstad S, Hoye S, Straand J, Brekke M, Dalen I, Lindbaek M. Improving antibiotic prescribing in acute respiratory tract infections: cluster randomised trial from Norwegian general practice (prescription peer academic detailing (Rx-PAD) study). BMJ. 2013 Jul 26;347:f4403. doi: 10.1136/bmj.f4403.
PubMed 23894178Fossum GH, Lindbaek M, Gjelstad S, Dalen I, Kvaerner KJ. Are children carrying the burden of broad-spectrum antibiotics in general practice? Prescription pattern for paediatric outpatients with respiratory tract infections in Norway. BMJ Open. 2013 Jan 7;3(1):e002285. doi: 10.1136/bmjopen-2012-002285.
PubMed 23299114Gjelstad S, Fetveit A, Straand J, Dalen I, Rognstad S, Lindbaek M. Can antibiotic prescriptions in respiratory tract infections be improved? A cluster-randomized educational intervention in general practice--the Prescription Peer Academic Detailing (Rx-PAD) Study [NCT00272155]. BMC Health Serv Res. 2006 Jun 15;6:75. doi: 10.1186/1472-6963-6-75.
PubMed 16776824
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Antibiotic Prescriptions in Respiratory Tract Infections be Improved? A Cluster Randomized Educational Intervention in General Practice
- ClinicalTrials.gov ID
- NCT00272155
- Acronym / sponsor ID
- 850657
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118,621 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 4 Jan 2006 (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.
This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to improve antibiotic prescriptions for respiratory infections.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- General practitioner
- Specialist in general practice
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Educational interventionEducational outreach visits to the CME-groups, work-shops, audit and feedback | Behavioural | – |
| Educational intervention programThe 433 recruited GPs had a total of 1336 717 office consultations of which 171 679 (12.8%) were RTIs encounters for 118 621 different patients. The GPs participated in peer continuing medical education (CME) groups in southern Norway. A multifaceted intervention was tailored, where key components were educational outreach visits to the CME-groups, work-shops, audit and feedback. Prescription Peer Academic Detailers conducted the educational outreach visits. During these visits, evidence-based recommendations of antibiotic prescriptions for RTIs were presented and software handed out for installation in participants PCs, enabling collection of prescription data. These data was linked to corresponding data from the Norwegian Prescription Database (NorPD). Main outcomes are baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline one year after the initiation of the tailored pedagogic intervention. | Behavioural | – |
Primary outcome
Change in antibiotic prescription patterns for respiratory infections
Time frame: 1 year
From the 1.336.717 office consultations, main outcomes data (baseline proportion of inappropriate antibiotic prescriptions for RTIs and change in prescription patterns compared to baseline) was measured 1 year after the initiation of the tailored pedagogic 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 27 Apr 2010.
- Derived from this study: PubMed 23894178Gjelstad S, Hoye S, Straand J, Brekke M, Dalen I, Lindbaek M. Improving antibiotic prescribing in acute respiratory tract infections: cluster randomised trial from Norwegian general practice (prescription peer academic detailing (Rx-PAD) study). BMJ. 2013 Jul 26;347:f4403. doi: 10.1136/bmj.f4403.
- Derived from this study: PubMed 23299114Fossum GH, Lindbaek M, Gjelstad S, Dalen I, Kvaerner KJ. Are children carrying the burden of broad-spectrum antibiotics in general practice? Prescription pattern for paediatric outpatients with respiratory tract infections in Norway. BMJ Open. 2013 Jan 7;3(1):e002285. doi: 10.1136/bmjopen-2012-002285.
- Derived from this study: PubMed 16776824Gjelstad S, Fetveit A, Straand J, Dalen I, Rognstad S, Lindbaek M. Can antibiotic prescriptions in respiratory tract infections be improved? A cluster-randomized educational intervention in general practice--the Prescription Peer Academic Detailing (Rx-PAD) Study [NCT00272155]. BMC Health Serv Res. 2006 Jun 15;6:75. doi: 10.1186/1472-6963-6-75.
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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.
Svein Gjelstad, MD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Educational intervention and Educational intervention program in people with Respiratory Tract Infections and Anti-Bacterial Agents, run by University of Oslo at 1 site in Norway.
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 0 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 27 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 Norway. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in antibiotic prescription patterns for respiratory infections (time frame: 1 year). 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 NCT00272155, which also lists 3 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 27 Apr 2010.