Antibiotics Misuse
Conditions
Brief summary
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: 1. The attitudes and knowledge towards antibiotics generate habits of prescription by physicians 2. The attitudes and knowledge towards to antibiotics generate propensity to dispense antibiotics without prescription by pharmacists 3. 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 4. 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 5. 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. 6. The intervention will collaborate in the control of the bacterial resistance.
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.
Interventions
OTHERMultidisciplinary 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.
Sponsors
Fundação para a Ciência e a Tecnologia
Aveiro University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care | 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. | May 2012- September 2014 | antibiotic monthly sales data, obtained from IMS and quality indicators monthly prescribing rates, according to the ESAC indicators. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Intervention group (n\
309 GPs and n\
312 pharmacists). Attended to the intervention, (n\
197 GPs and n\
173 pharmacists). | 621 |
| Control Group Intervention group (n\
791 GPs and n\
888 pharmacists). | 1,679 |
| Total | 2,300 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Portugal | 621 participants | 1679 participants | 2300 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: May 2012- September 2014
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Educational Multifaceted Intervention | Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates. | 1.71 PID-number of packages per 1000 inhabit |
| Control Group | Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates. | 2.01 PID-number of packages per 1000 inhabit |
Primary
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.
Time frame: up to 18 months
Population: The analysis was performed with the intention to treat and the PID was assessed. These values correspond to the post-intervention period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Educational Multifaceted Intervention | Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care | 1.71 PID-number of packages per 1000 inhabit |
| Control Group | Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care | 2.01 PID-number of packages per 1000 inhabit |