Antibiotics MisuseNCT02173509

An Educational Intervention to Improve the Use of Antibiotics in Portuguese Health Professional

A study testing Multidisciplinary and multifaceted educational intervention. in people with Antibiotics Misuse, run by Aveiro University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Antibiotics Misuse
What is being tested?: Multidisciplinary and multifaceted educational intervention.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,300 participants
Where: No sites listed yet
Study dates: May 2013to Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

All general practitioners working during the period of the study in the National System of Health (SNS)
All pharmacists working during the period study in the community pharmacies.

Who cannot join

None listed.

About this study

Official title: An Educational Intervention to Improve the Use of Antibiotics in Portuguese Health Professional: Cluster-randomized Trial

This is a cluster randomised controlled trial covering all general practitioners working in the National Health System (SNS) and all pharmacists working in community pharmacies in the area covered by the Health Region Administration of Center (ARS-C) . A specific educative intervention, designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance, will be carried out on the intervention group. The control group will not receive any specific intervention.

Hypotheses:

The attitudes and knowledge towards antibiotics generate habits of prescription by physicians
The attitudes and knowledge towards to antibiotics generate propensity to dispense antibiotics without prescription by pharmacists
The identification of the attitudes, knowledge and factors that generate habits of inadequate prescription will allow the design of specific educative interventions to improve the use of antibiotics
The identification of the attitudes, knowledge and factors that generate propensity to dispense antibiotics without prescription will allow the design of specific educative interventions to antibiotic use
The interventions designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance will improve the prescription and dispensation of antibiotics by physicians and pharmacists, respectively.
The intervention will collaborate in the control of the bacterial resistance.

Read the detailed description

The intervention will consist of group outreach visits (40 minutes), and will be targeted at changing the knowledge-attitudes previously found to be associated with poor prescribing of antibiotics in the case of physicians and propensity to dispense antibiotics without medical prescription in the case of pharmacists.. An observational cohort study of a sample of 1100 primary care physicians and 1200 community pharmacists will be carried out to identify knowledge-attitudes associated with inappropriate prescribing of antibiotics. The independent variables (knowledge-attitudes) will be assessed by a self-administered postal questionnaire and dependent variables are some quantity and quality indicators of the prescribing antibiotics, and consumption data.

Conditions: Antibiotics Misuse
Being tested: Multidisciplinary and multifaceted educational intervention.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multidisciplinary and multifaceted educational intervention.Other
Outreach visits (40 minutes) which included a PowerPoint presentation and impress materials: poster; flyers; participation certificate and articles mentioned in the presentation. This outreach visit aimed to change the knowledge-attitudes previously identified in a previous study as being associated with poor prescribing of antibiotics in the case of physicians and propensity to dispense antibiotics without medical prescription in the case of pharmacists.

Study groups in NCT02173509
Study group	Role	What they receive
Educational multifaceted intervention	Experimental	Multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense, in physicians and pharmacists. Receives: Other: Multidisciplinary and multifaceted educational intervention.
Control	No intervention	Physicians and pharmacists that not received the multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care
To quantify antibiotic drug consumption, we used monthly sales data sourced from IMS Health® and we used the quality indicators validated by Coenen S et al., (2007) to calculate monthly prescribing rates.
Measured: up to 18 months
Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates.
antibiotic monthly sales data, obtained from IMS and quality indicators monthly prescribing rates, according to the ESAC indicators.
Measured: May 2012- September 2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Dec 2017

First posted25 Jun 2014 (estimated)
Study startMay 2013
Primary completionOct 2013
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Antibiotics MisuseStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2,300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02173509
Sponsor's protocol ID: PTDC/SAU-ESA/105530/2008
Status last verified: Sep 2022
First submitted: 17 Jun 2014
Last updated: 18 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Teixeira Rodrigues A, Roque F, Pineiro-Lamas M, Falcao A, Figueiras A, Herdeiro MT. Effectiveness of an intervention to improve antibiotic-prescribing behaviour in primary care: a controlled, interrupted time-series study. J Antimicrob Chemother. 2019 Sep 1;74(9):2788-2796. doi: 10.1093/jac/dkz244.
PubMed 31257435
Roque F, Teixeira-Rodrigues A, Breitenfeld L, Pineiro-Lamas M, Figueiras A, Herdeiro MT. Decreasing antibiotic use through a joint intervention targeting physicians and pharmacists. Future Microbiol. 2016 Jul;11:877-86. doi: 10.2217/fmb-2016-0010. Epub 2016 Jul 14.
PubMed 27415585

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Educational Intervention to Improve the Use of Antibiotics in Portuguese Health Professional: Cluster-randomized Trial
ClinicalTrials.gov ID: NCT02173509
Acronym / sponsor ID: PTDC/SAU-ESA/105530/2008
Conditions: Antibiotics Misuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,300 participants (actual)
Lead sponsor: Aveiro UniversityUniversity, hospital or other
Collaborators: Fundação para a Ciência e a Tecnologia
Study start: May 2013
Primary completion: Oct 2013 (actual)
Study completion: Dec 2017 (actual)
First posted: 25 Jun 2014 (estimated)
Results: Posted 18 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypotheses:

The attitudes and knowledge towards antibiotics generate habits of prescription by physicians
The attitudes and knowledge towards to antibiotics generate propensity to dispense antibiotics without prescription by pharmacists
The identification of the attitudes, knowledge and factors that generate habits of inadequate prescription will allow the design of specific educative interventions to improve the use of antibiotics
The identification of the attitudes, knowledge and factors that generate propensity to dispense antibiotics without prescription will allow the design of specific educative interventions to antibiotic use
The interventions designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance will improve the prescription and dispensation of antibiotics by physicians and pharmacists, respectively.
The intervention will collaborate in the control of the bacterial resistance.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Educational multifaceted intervention	Experimental	Other: Multidisciplinary and multifaceted educational intervention.Multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense, in physicians and pharmacists.
Control	No intervention	–Physicians and pharmacists that not received the multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

All general practitioners working during the period of the study in the National System of Health (SNS)
All pharmacists working during the period study in the community pharmacies.

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
Multidisciplinary and multifaceted educational intervention.Outreach visits (40 minutes) which included a PowerPoint presentation and impress materials: poster; flyers; participation certificate and articles mentioned in the presentation. This outreach visit aimed to change the knowledge-attitudes previously identified in a previous study as being associated with poor prescribing of antibiotics in the case of physicians and propensity to dispense antibiotics without medical prescription in the case of pharmacists.	Other	Educational multifaceted intervention

Primary outcome

Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care
Time frame: up to 18 months
To quantify antibiotic drug consumption, we used monthly sales data sourced from IMS Health® and we used the quality indicators validated by Coenen S et al., (2007) to calculate monthly prescribing rates.
Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates.
Time frame: May 2012- September 2014
antibiotic monthly sales data, obtained from IMS and quality indicators monthly prescribing rates, according to the ESAC indicators.

Results and safety

Results posted to the registry on 18 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	1,679	1,679
Intervention Group	621	621

Primary outcome: Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care

Time frame: up to 18 months. Mean (95% Confidence Interval). Unit: PID-number of packages per 1000 inhabit

Measure	Educational Multifaceted Intervention n = 621	Control Group n = 1679
Value	1.71 (1.65 to 1.77)	2.01 (1.97 to 2.05)

Population analysed: The analysis was performed with the intention to treat and the PID was assessed. These values correspond to the post-intervention period.

Primary outcome: Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates.

Time frame: May 2012- September 2014. Mean (95% Confidence Interval). Unit: PID-number of packages per 1000 inhabit

Measure	Intervention Group n = 621	Control Group n = 1679
Value	1.71 (1.65 to 1.77)	2.01 (1.97 to 2.05)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 0	0 of 0	0
Control Group	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31257435Teixeira Rodrigues A, Roque F, Pineiro-Lamas M, Falcao A, Figueiras A, Herdeiro MT. Effectiveness of an intervention to improve antibiotic-prescribing behaviour in primary care: a controlled, interrupted time-series study. J Antimicrob Chemother. 2019 Sep 1;74(9):2788-2796. doi: 10.1093/jac/dkz244.
Derived from this study: PubMed 27415585Roque F, Teixeira-Rodrigues A, Breitenfeld L, Pineiro-Lamas M, Figueiras A, Herdeiro MT. Decreasing antibiotic use through a joint intervention targeting physicians and pharmacists. Future Microbiol. 2016 Jul;11:877-86. doi: 10.2217/fmb-2016-0010. Epub 2016 Jul 14.

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary and multifaceted educational intervention. in people with Antibiotics Misuse, run by Aveiro University.

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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline Antibiotic Consumption at 18 Months, in Primary Care (time frame: up to 18 months). 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 NCT02173509, which also lists 2 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 18 Aug 2023.