Trial Outcomes & Findings for An Educational Intervention to Improve the Use of Antibiotics in Portuguese Health Professional (NCT NCT02173509)
NCT ID: NCT02173509
Last Updated: 2023-08-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2300 participants
Primary outcome timeframe
up to 18 months
Results posted on
2023-08-18
Participant Flow
Participant milestones
| Measure |
Control Group
Control group (n\~ 791 GPs and n\~888 pharmacists), not received the intervention.
|
Intervention Group
The intervention group (n\~ 309 GPs and n\~312 pharmacists). Received the intervention (n\~ 197 GPs and n\~173 pharmacists)
|
|---|---|---|
|
Overall Study
STARTED
|
1679
|
621
|
|
Overall Study
COMPLETED
|
1679
|
621
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not collected
Baseline characteristics by cohort
| Measure |
Intervention Group
n=621 Participants
Intervention group (n\~ 309 GPs and n\~312 pharmacists). Attended to the intervention, (n\~ 197 GPs and n\~173 pharmacists).
|
Control Group
n=1679 Participants
Intervention group (n\~ 791 GPs and n\~888 pharmacists).
|
Total
n=2300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
Data not collected
|
0 Participants
Data not collected
|
0 Participants
Data not collected
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
Data not collected
|
0 Participants
Data not collected
|
0 Participants
Data not collected
|
|
Sex: Female, Male
Female
|
0 Participants
data not collected
|
0 Participants
data not collected
|
0 Participants
data not collected
|
|
Age, Categorical
>=65 years
|
0 Participants
Data not collected
|
0 Participants
Data not collected
|
0 Participants
Data not collected
|
|
Sex: Female, Male
Male
|
0 Participants
data not collected
|
0 Participants
data not collected
|
0 Participants
data not collected
|
|
Region of Enrollment
Portugal
|
621 participants
n=621 Participants
|
1679 participants
n=1679 Participants
|
2300 participants
n=2300 Participants
|
PRIMARY outcome
Timeframe: up to 18 monthsPopulation: The analysis was performed with the intention to treat and the PID was assessed. These values correspond to the post-intervention period.
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.
Outcome measures
| Measure |
Educational Multifaceted Intervention
n=621 Participants
Multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense, in physicians and pharmacists.
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.
|
Control Group
n=1679 Participants
Did not received in the multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense.
|
|---|---|---|
|
Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care
|
1.71 PID-number of packages per 1000 inhabit
Interval 1.65 to 1.77
|
2.01 PID-number of packages per 1000 inhabit
Interval 1.97 to 2.05
|
PRIMARY outcome
Timeframe: May 2012- September 2014antibiotic monthly sales data, obtained from IMS and quality indicators monthly prescribing rates, according to the ESAC indicators.
Outcome measures
| Measure |
Educational Multifaceted Intervention
n=621 Participants
Multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense, in physicians and pharmacists.
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.
|
Control Group
n=1679 Participants
Did not received in the multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense.
|
|---|---|---|
|
Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates.
|
1.71 PID-number of packages per 1000 inhabit
Interval 1.65 to 1.77
|
2.01 PID-number of packages per 1000 inhabit
Interval 1.97 to 2.05
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place