Respiratory InfectionsNCT02927743
Effect of Evidence-based Reminders on Use of Antibiotics
A study testing evidence-based online feedback in people with Respiratory Infections and Antibiotics, run by Gloria Cristina Cordoba at 1 site in Denmark.
Trial summary
Inappropriate use of antibiotics in primary care is associated with Development of antibiotic resistant strains. As part of a quality improvement program carried out in primary care in Uruguay, Argentina, Paraguay and Bolivia, a cluster randomized control trial was performed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infections, Antibiotics
- What is being tested?
- evidence-based online feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,053 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2015to Aug 2015
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General practitioners working in primary care
- Patients with suspected respiratory tract infection
Who cannot join
- Patients that have already started an antibiotic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Evidence-based Feed Back to Increase Appropriate Use of Antibiotics
Inappropriate use of antibiotics in primary care is associated with Development of antibiotic resistant strains. As part of a quality improvement program carried out in primary care in Uruguay, Argentina, Paraguay and Bolivia, a cluster randomized control trial was performed. The aim of the study was to assess whether the use of continuous evidence-based feedback about management of respiratory tract infections could decrease use of antibiotics in Acute bronchitis, common cold and acute otitis media.
Read the detailed description
Excessive and inappropriate use of antibiotics is one of the most important reasons for development of resistant bacteria.
One of the key strategies to curb the development of antibiotic resistance is to promote intervention at primary care level as more than 90% of antibiotics are prescribed by general practitioners - especially in patients suffering from respiratory tract infections.
The main bacteria causing respiratory tract infections are S. pneumoniae y Haemophilus influenzae. The first one is associated with a significant increase in morbidity and mortality in Latin America.
Approximately 80% of respiratory tract infections have a viral cause, are harmless and self-limiting and in most cases patients recover without specific treatment. Antibiotic treatment is superfluous and in some cases even harmful because of side effects.
Infections caused by resistant bacteria leads to increased mortality, prolonged hospital stay and social collateral damage. Therefore, in 2013 the World Economic Forum pointed out antibiotic resistance as one of the three most important threats to economic and social development.
The World Health Organisation (WHO) launched in 20121 a global strategy to hold back antimicrobial resistance. According to this strategy "the battle against infectious diseases is far from being over. Not only do they continue to cause a large number of infections and deaths, particularly in developing countries, but the emergence and spread of antimicrobial resistance is now also threatening to undermine our ability to treat infections and save lives". The WHO has proposed a number of initiatives against the emergence of resistant bacteria, including interventions to promote proper use of antibiotics.
HAPPY AUDIT II (HA-II) - PART OF THE SOLUTION
HAPPY AUDIT - II is the second phase of HAPPY AUDIT - I, which was a project funded by the European Union to promote appropriate use of antibiotics in 6 countries with a very heterogeneous pattern of consumption of antibiotics and prevalence of resistant strains.
440 general practitioners registered data in winter 2008 and 2009. Inappropriate antibiotic use was reduced by 10% and in pathologies such as acute bronchitis, there was a 50% reduction in use of antibiotics.
In Argentina, 48 general practitioners participated in the whole process and reached a 30% reduction of unnecessary prescriptions of antibiotics in patients with acute bronchitis, sinusitis and pharyngitis.
The positive experience of the first phase has shown the importance and the potential to spread the project to other provinces of Argentina and other South American countries. Our prior knowledge will be used in the HAPPY AUDIT II SOUTH AMERICA to plan interventions for patients and GPs through the methodology APO (Audit Project Odense) which is based on:
- self-reflection of physicians and group discussion on their prescription patterns,
- patient education,
- Development of a multi-faceted intervention.
The overall purpose of the project is to promote the rational use of antibiotics. This will be achieved through the following specific objectives:
- Preparation of intervention materials for patients and professionals.
- Implementation of APO cycles in 4 countries.
- Initial registration of GPs and use of antibiotics for their RTI patients.
- Analysis of the results of the first registration to identify quality problems in prescription.
- Development of a multifaceted intervention.
- Implementation of a cluster randomized control trial to assess the effect of the intervention.
- Final registration to evaluate the effect of the intervention.
PROJECT ORGANIZATION
180 GPs will participate: Argentina 80 physicians, Bolivia 30 physicians, Paraguay 40 physicians and Uruguay 30 physicians.
The investigators will use the APO methodology, which based on a "bottom-up" approach seeks to change practice behaviour among GPs. The GPs voluntarily participate and set their own quality criteria in order to improve the quality of their own service.
The APO method includes:
- Initial registration of GPs own activities (3 weeks)
- Intervention (online evidence-based reminders during final registration)
- Final registration and evaluation (3 weeks)
Schedule 2014
February - May 2014 - coordinators and researchers first meeting
June - August 2014 - First audit registration during 15 days.
October 2014 - Coordinators and researchers second meeting
March 2015 - Meeting with General Practitioners from all provinces and/ or countries. This meeting will be divided into two parts:
- Discussion of the results from the first registration;
- Discussion about the use of quality indicators to decrease inappropriate use of antibiotics.
June - August 2015 - Second registration, intervention (online weekly feedback on evidence-based management of respiratory tract infections)
November 2016 - Assessment of the intervention.
April 2017 - Publication of results
- Conditions
- Respiratory Infections, Antibiotics
- Being tested
- evidence-based online feedback
- 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.
evidence-based online feedbackBehavioural
GPs received during three months weekly mails about evidence-based practice and a small questionnaire to reflect about their practice and the new knowledge
| Study group | Role | What they receive |
|---|---|---|
| evidence-based online feedback | Active comparator | During three months GPs will receive weekly feedback about evidence-based management of respiratory tract infections. In order to control that they read the material, there is a questionnaire, they have to fill in every week Receives: Behavioral: evidence-based online feedback |
| control | No intervention | GPs will register data without receiving online feed-back |
What is being measured
The primary outcome is the main question the study is designed to answer.
20% difference in use of antibiotics in patients with suspected Acute bronchitis
Measured: 3 months
Secondary outcomes (1)
20% difference in the use of antibiotics in suspected acute otitis media
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory 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
- 8,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gloria Cristina Cordoba
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Medicin La Paz-Bolivia, University of Itapua, Paraguay, University of the Republic, Uruguay, Society of General and Family practice, Misiones- Argentina
- Responsible party
- Sponsor-investigator, Gloria Cristina Cordoba, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927743
- Sponsor's protocol ID
- HAPPY-AUDIT II/cRCT
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Evidence-based Feed Back to Increase Appropriate Use of Antibiotics
- ClinicalTrials.gov ID
- NCT02927743
- Acronym / sponsor ID
- HAPPY-AUDIT II/cRCT
- Conditions
- Respiratory Infections, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,053 participants (actual)
- Lead sponsor
- Gloria Cristina CordobaUniversity, hospital or other
- Collaborators
- Society of Family Medicin La Paz-Bolivia, University of Itapua, Paraguay, University of the Republic, Uruguay, Society of General and Family practice, Misiones- Argentina
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Oct 2016 (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.
Inappropriate use of antibiotics in primary care is associated with Development of antibiotic resistant strains. As part of a quality improvement program carried out in primary care in Uruguay, Argentina, Paraguay and Bolivia, a cluster randomized control trial was performed. The aim of the study was to assess whether the use of continuous evidence-based feedback about management of respiratory tract infections could decrease use of antibiotics in Acute bronchitis, common cold and acute otitis media.
Detailed description
Excessive and inappropriate use of antibiotics is one of the most important reasons for development of resistant bacteria.
One of the key strategies to curb the development of antibiotic resistance is to promote intervention at primary care level as more than 90% of antibiotics are prescribed by general practitioners - especially in patients suffering from respiratory tract infections.
The main bacteria causing respiratory tract infections are S. pneumoniae y Haemophilus influenzae. The first one is associated with a significant increase in morbidity and mortality in Latin America.
Approximately 80% of respiratory tract infections have a viral cause, are harmless and self-limiting and in most cases patients recover without specific treatment. Antibiotic treatment is superfluous and in some cases even harmful because of side effects.
Infections caused by resistant bacteria leads to increased mortality, prolonged hospital stay and social collateral damage. Therefore, in 2013 the World Economic Forum pointed out antibiotic resistance as one of the three most important threats to economic and social development.
The World Health Organisation (WHO) launched in 20121 a global strategy to hold back antimicrobial resistance. According to this strategy "the battle against infectious diseases is far from being over. Not only do they continue to cause a large number of infections and deaths, particularly in developing countries, but the emergence and spread of antimicrobial resistance is now also threatening to undermine our ability to treat infections and save lives". The WHO has proposed a number of initiatives against the emergence of resistant bacteria, including interventions to promote proper use of antibiotics.
HAPPY AUDIT II (HA-II) - PART OF THE SOLUTION
HAPPY AUDIT - II is the second phase of HAPPY AUDIT - I, which was a project funded by the European Union to promote appropriate use of antibiotics in 6 countries with a very heterogeneous pattern of consumption of antibiotics and prevalence of resistant strains.
440 general practitioners registered data in winter 2008 and 2009. Inappropriate antibiotic use was reduced by 10% and in pathologies such as acute bronchitis, there was a 50% reduction in use of antibiotics.
In Argentina, 48 general practitioners participated in the whole process and reached a 30% reduction of unnecessary prescriptions of antibiotics in patients with acute bronchitis, sinusitis and pharyngitis.
The positive experience of the first phase has shown the importance and the potential to spread the project to other provinces of Argentina and other South American countries. Our prior knowledge will be used in the HAPPY AUDIT II SOUTH AMERICA to plan interventions for patients and GPs through the methodology APO (Audit Project Odense) which is based on:
- self-reflection of physicians and group discussion on their prescription patterns,
- patient education,
- Development of a multi-faceted intervention.
The overall purpose of the project is to promote the rational use of antibiotics. This will be achieved through the following specific objectives:
- Preparation of intervention materials for patients and professionals.
- Implementation of APO cycles in 4 countries.
- Initial registration of GPs and use of antibiotics for their RTI patients.
- Analysis of the results of the first registration to identify quality problems in prescription.
- Development of a multifaceted intervention.
- Implementation of a cluster randomized control trial to assess the effect of the intervention.
- Final registration to evaluate the effect of the intervention.
PROJECT ORGANIZATION
180 GPs will participate: Argentina 80 physicians, Bolivia 30 physicians, Paraguay 40 physicians and Uruguay 30 physicians.
The investigators will use the APO methodology, which based on a "bottom-up" approach seeks to change practice behaviour among GPs. The GPs voluntarily participate and set their own quality criteria in order to improve the quality of their own service.
The APO method includes:
- Initial registration of GPs own activities (3 weeks)
- Intervention (online evidence-based reminders during final registration)
- Final registration and evaluation (3 weeks)
Schedule 2014
February - May 2014 - coordinators and researchers first meeting
June - August 2014 - First audit registration during 15 days.
October 2014 - Coordinators and researchers second meeting
March 2015 - Meeting with General Practitioners from all provinces and/ or countries. This meeting will be divided into two parts:
- Discussion of the results from the first registration;
- Discussion about the use of quality indicators to decrease inappropriate use of antibiotics.
June - August 2015 - Second registration, intervention (online weekly feedback on evidence-based management of respiratory tract infections)
November 2016 - Assessment of the intervention.
April 2017 - Publication of results
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| evidence-based online feedback | Active comparator | Behavioral: evidence-based online feedbackDuring three months GPs will receive weekly feedback about evidence-based management of respiratory tract infections. In order to control that they read the material, there is a questionnaire, they have to fill in every week |
| control | No intervention | –GPs will register data without receiving online feed-back |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- General practitioners working in primary care
- Patients with suspected respiratory tract infection
Key exclusion criteria (1 listed)
- Patients that have already started an antibiotic
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 |
|---|---|---|
| evidence-based online feedbackGPs received during three months weekly mails about evidence-based practice and a small questionnaire to reflect about their practice and the new knowledge | Behavioural | evidence-based online feedback |
Primary outcome
20% difference in use of antibiotics in patients with suspected Acute bronchitis
Time frame: 3 months
1 secondary outcome
20% difference in the use of antibiotics in suspected acute otitis media
Time frame: 3 months
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 7 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evidence-based online feedback in people with Respiratory Infections and Antibiotics, run by Gloria Cristina Cordoba at 1 site in Denmark.
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: finished, as of the sponsor's last update on 7 Oct 2016. 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 Denmark. 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?
20% difference in use of antibiotics in patients with suspected Acute bronchitis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2016.