Trial · NCT07893834
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of acute bronchitis episodes with a systemic antibiotic prescription | Month 36 after programme launch | Proportion of eligible acute bronchitis episodes (index visit plus related visits within 14 days for the same child) with at least one systemic antibiotic prescription, measured in Month 36 after programme launch (end of Step 3). Unit of measure: percentage of episodes. The intervention effect is reported as the absolute difference in percentage points, with 95% confidence interval, between the observed proportion and the counterfactual proportion projected from the pre-launch monthly series (published 2014 to 2020 series extended month by month to the month before launch), estimated by segmented binomial regression. Target: below 15% (minimum acceptable below 20%) from a baseline of 32%. |
| Primary | Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic | Month 36 after programme launch | Proportion of antibiotic-treated outpatient community-acquired pneumonia (CAP) episodes in which a non-first-line agent is prescribed, defined as any systemic antibiotic other than amoxicillin (ATC J01CA04); the non-first-line share is the complement of the amoxicillin share, measured in Month 36 after programme launch (end of Step 3). Unit of measure: percentage of antibiotic-treated CAP episodes. The intervention effect is reported as the absolute difference in percentage points, with 95% confidence interval, between the observed proportion and the counterfactual proportion projected from the pre-launch monthly series, estimated by segmented binomial regression. Corresponds to the target of increasing first-line amoxicillin from 65% to above 80% of antibiotic-treated CAP. |
| Secondary | Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 12 | Month 12 after programme launch | Same measurement and analysis as the first co-primary outcome, assessed in Month 12 after programme launch (end of Step 1). Unit of measure: percentage of episodes; effect reported as the absolute difference in percentage points from the counterfactual, with 95% confidence interval. |
| Secondary | Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 48 | Month 48 after programme launch | Same measurement and analysis as the first co-primary outcome, assessed in Month 48 after programme launch (end of the 1-year follow-up without new active intervention), as the measure of durability. Unit of measure: percentage of episodes; effect reported as the absolute difference in percentage points from the counterfactual, with 95% confidence interval. |
| Secondary | Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 12 | Month 12 after programme launch | Same measurement and analysis as the second co-primary outcome, assessed in Month 12 after programme launch (end of Step 1). Unit of measure: percentage of antibiotic-treated CAP episodes; effect reported as the absolute difference in percentage points from the counterfactual, with 95% confidence interval. |
| Secondary | Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 48 | Month 48 after programme launch | Same measurement and analysis as the second co-primary outcome, assessed in Month 48 after programme launch (end of the 1-year follow-up), as the measure of durability. Unit of measure: percentage of antibiotic-treated CAP episodes; effect reported as the absolute difference in percentage points from the counterfactual, with 95% confidence interval. |
| Secondary | Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes treated with amoxicillin | Month 36 after programme launch | Proportion of antibiotic-treated outpatient CAP episodes in which amoxicillin (ATC J01CA04) is the prescribed antibiotic, measured in Month 36 after programme launch. Unit of measure: percentage of antibiotic-treated CAP episodes. Analysed by segmented regression against the pre-launch counterfactual. Target: above 80%. |
| Secondary | Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a macrolide prescription | Month 36 after programme launch | Proportion of antibiotic-treated outpatient CAP episodes in which a macrolide (ATC J01FA) is prescribed, measured in Month 36 after programme launch. Unit of measure: percentage of antibiotic-treated CAP episodes. Analysed by segmented regression against the pre-launch counterfactual. Target: below 10%. |
| Secondary | Proportion of acute bronchitis episodes with a macrolide prescription | Month 36 after programme launch | Proportion of eligible acute bronchitis episodes in which a macrolide (ATC J01FA) is prescribed, measured in Month 36 after programme launch. Unit of measure: percentage of episodes. Analysed by segmented regression against the pre-launch counterfactual. |
| Secondary | Proportion of community-acquired pneumonia amoxicillin courses with a prescribed duration of 5 days or less | Month 36 after programme launch | Proportion of amoxicillin courses prescribed for outpatient CAP with a prescribed duration of 5 days or less (guideline-concordant duration), measured in Month 36 after programme launch. Unit of measure: percentage of CAP amoxicillin courses. Analysed by segmented regression against the pre-launch counterfactual. Target: above 50%. |
| Secondary | Median odds ratio between units for antibiotic prescribing in acute bronchitis | Step 3 period, Months 25 to 36 after programme launch | Median odds ratio (MOR) for the unit level from a three-level multilevel logistic regression (eligible acute bronchitis episodes within physicians within units) of systemic antibiotic prescribing, estimated for the Step 3 period. The same model is fitted to the pre-launch baseline period and to each study period so that the change in between-unit variation can be described. Unit of measure: odds ratio (dimensionless). |
| Secondary | Median odds ratio between physicians for antibiotic prescribing in acute bronchitis | Step 3 period, Months 25 to 36 after programme launch | Median odds ratio (MOR) for the physician level from the same three-level multilevel logistic regression of systemic antibiotic prescribing in eligible acute bronchitis episodes, estimated for the Step 3 period and, for comparison, for the pre-launch baseline period and each study period. Unit of measure: odds ratio (dimensionless). |
| Secondary | Median odds ratio between units for non-first-line antibiotic prescribing in community-acquired pneumonia | Step 3 period, Months 25 to 36 after programme launch | Median odds ratio (MOR) for the unit level from a three-level multilevel logistic regression (antibiotic-treated outpatient CAP episodes within physicians within units) of non-first-line agent prescribing, estimated for the Step 3 period and, for comparison, for the pre-launch baseline period and each study period. Unit of measure: odds ratio (dimensionless). |
| Secondary | Median odds ratio between physicians for non-first-line antibiotic prescribing in community-acquired pneumonia | Step 3 period, Months 25 to 36 after programme launch | Median odds ratio (MOR) for the physician level from the same three-level multilevel logistic regression of non-first-line agent prescribing in antibiotic-treated outpatient CAP episodes, estimated for the Step 3 period and, for comparison, for the pre-launch baseline period and each study period. Unit of measure: odds ratio (dimensionless). |
| Secondary | Proportion of lower respiratory tract infection episodes coded as pneumonia or unspecified lower respiratory tract infection | Month 36 after programme launch | Proportion of all eligible lower respiratory tract infection (LRTI) episodes coded as community-acquired pneumonia or unspecified LRTI rather than acute bronchitis, measured in Month 36 after programme launch, to detect shifts in diagnostic labelling during the intervention. Unit of measure: percentage of eligible LRTI episodes. Analysed by segmented regression against the pre-launch counterfactual. |
| Secondary | Proportion of lower respiratory tract infection episodes with diagnostic testing | Month 36 after programme launch | Proportion of eligible LRTI episodes in which any of C-reactive protein (CRP) testing, rapid viral or influenza testing, or chest radiography is ordered at the index visit, each episode counted once regardless of the number or type of tests, measured in Month 36 after programme launch. Unit of measure: percentage of eligible LRTI episodes. Analysed by segmented regression against the pre-launch counterfactual. |
| Secondary | Proportion of amoxicillin treatment among antibiotic-treated community-acquired pneumonia episodes with a documented penicil penicillin-class allergy label | Month 36 after programme launch | Among antibiotic-treated outpatient CAP episodes in which the child has a documented penicillin-class allergy label on file at the visit, the proportion treated with amoxicillin (ATC J01CA04), measured in Month 36 after programme launch. Unit of measure: percentage of allergy-labelled antibiotic-treated CAP episodes. Analysed by segmented regression against the pre-launch counterfactual. |
| Secondary | Total intervention cost | Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch | Prospectively logged cost of delivering the programme (micro-costing of personnel time, materials, EHR development and feedback activities), summed across components and steps from the start of the preparatory phase to the end of the follow-up year. Unit of measure: euros. Reported with a breakdown by component and step (provider perspective, CHEERS 2022). |
| Secondary | Net programme cost | Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch | Total intervention cost minus the direct antibiotic cost savings attributable to the programme, where savings are derived from the difference between observed and counterfactual antibiotic prescribing in the interrupted time series. Unit of measure: euros, with bootstrap 95% confidence interval (provider perspective). |
| Secondary | Cost per averted acute bronchitis antibiotic course | Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch | Net programme cost divided by the number of systemic antibiotic courses for acute bronchitis averted relative to the interrupted time series counterfactual over the same period (cost-consequence analysis, provider perspective). Unit of measure: euros per averted antibiotic course, with bootstrap 95% confidence interval. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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