Bronchitis, AcutePRACTICE-LRTINCT07893834
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
A study testing PRACTICE-LRTI multimodal antimicrobial stewardship programme in people with Bronchitis, Acute and Community-acquired Pneumonia, run by Tampere University at 1 site in Finland.
Trial summary
Children with lower respiratory tract infection (LRTI) are still often prescribed antibiotics in ways that depart from national guidelines. Acute viral bronchitis is treated with antibiotics although none are needed, and community-acquired pneumonia (CAP) is often treated with a second-choice antibiotic, most often a… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Bronchitis, Acute, Community-acquired Pneumonia, Respiratory Tract Infections
- What is being tested?
- PRACTICE-LRTI multimodal antimicrobial stewardship programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2027to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Patient-episode inclusion criteria:
- Age under 18 years at the visit
- Outpatient or primary-care visit at a clinic of the Terveystalo network in Finland
- Main or secondary ICD-10 diagnosis of acute bronchitis (J20 to J22) or community-acquired pneumonia or unspecified lower respiratory tract infection (J09 to J18.9 according to the protocol code list)
Patient-episode exclusion criteria:
- Concomitant bacterial diagnosis that independently warrants antibiotics (for example urinary tract infection or streptococcal pharyngitis), or LRTI complicated by acute otitis media or sinusitis
- Chronic condition requiring long-term or prophylactic antibiotics (for example cystic fibrosis, immunodeficiency, bronchiectasis)
- Records with critical missing structured fields (enumerated and reported)
Clinicians: all physicians who record an eligible LRTI visit in the network during the study period receive the programme; there are no clinician exclusion criteria. The intervention targets prescribing clinicians; outcomes are measured on patient episodes identified from routinely collected electronic health record data without recruitment or contact.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Terveystalo (nationwide network, about 300 clinics)
Helsinki, 00100
About this study
Official title: Promoting Rational Antibiotic Choices Through Targeted Intervention and Clinician Education: a Prospective Nationwide Multimodal Intervention to Improve Guideline-Concordant Outpatient Antibiotic Prescribing for Pediatric Lower Respiratory Tract Infections
Children with lower respiratory tract infection (LRTI) are still often prescribed antibiotics in ways that depart from national guidelines. Acute viral bronchitis is treated with antibiotics although none are needed, and community-acquired pneumonia (CAP) is often treated with a second-choice antibiotic, most often a macrolide, instead of first-line amoxicillin. In the Terveystalo network in Finland, about one third of bronchitis visits and one fifth of CAP visits in 2014 to 2020 led to an antibiotic prescription, and macrolides were the most commonly prescribed agent for bronchitis.
PRACTICE-LRTI is a nationwide quality-improvement and implementation study in which all clinics of the network receive a multimodal antimicrobial stewardship programme aimed at prescribing clinicians (paediatricians, general practitioners, ear, nose and throat specialists and other physicians). The programme combines (1) a concise local version of the Finnish Current Care Guideline for paediatric LRTI; (2) education for physicians and caregivers (printed and intranet materials, videos, webinars, unit-level meetings, online courses and commitment posters); (3) light-touch electronic health record reminders and a one-click supportive-care order set; and (4) a real-time prescribing dashboard with a structured feedback cascade that escalates over three years from network-wide progress reports to targeted outreach to non-improving units and, finally, personalised letters and phone calls to persistently non-concordant prescribers. A one-page guide prompts clinicians to question unverified penicillin-allergy labels.
Read more
The programme is delivered to the whole network at the same time, so no clinics are randomised to a control condition. Instead, prescribing is followed as a monthly time series from 2014 onward, and the change after each of three prespecified intervention steps is estimated by segmented regression against the projected pre-intervention trend. The co-primary outcomes are the proportion of acute bronchitis episodes in which a systemic antibiotic is prescribed and the proportion of antibiotic-treated outpatient CAP episodes in which a non-first-line agent is prescribed. The co-primary outcomes are assessed at Month 36 after launch; their Month 12 and Month 48 assessments are secondary outcomes. Other secondary outcomes include first-line amoxicillin and macrolide use, 5-day treatment duration, variation between units and physicians, diagnostic testing, first-line prescribing in children with a penicillin-allergy label, and intervention cost. Safety is monitored through 14-day respiratory revisits, hospital referrals and hospitalisations. The active intervention lasts 3 years and is followed by 1 year of follow-up to assess durability.
This is a quality-improvement and implementation study embedded in routine care, not a trial of a treatment. The intervention is directed at physicians; no child is recruited, contacted or examined outside routine care, and all outcome data come from the network's electronic health record.
Read the detailed description
Design. Prospective, pragmatic, multicentre quality-improvement and implementation study with a multi-step interrupted time-series (ITS) evaluation and continuous electronic health record (EHR) surveillance in a nationwide private healthcare network in Finland (about 300 clinics, about 300,000 paediatric outpatient visits per year). Cluster randomisation is not feasible because the network has centralised medical leadership, a unified EHR, shared quality surveillance and a common intranet, so company-wide materials would contaminate any control clusters; for the same reason the managerial components (unit feedback, outreach, letters and calls) cannot be staggered or randomised across units. The counterfactual is provided by an extended pre-intervention baseline (published 2014 to 2020 series plus a monthly series from January 2021 to December 2026, the month before Day 0) and segmented-regression modelling of level and trend.
Intervention. Four components delivered in three annual graduated steps. Step 1 (Months 1 to 12): company-wide launch of the local guideline, workflow aids, physician and caregiver videos, nationwide online meetings, in-person unit meetings, online courses, caregiver leaflet, EHR reminders, live dashboard, quarterly progress reports and a first round of direct feedback from the Head of Pediatrics and unit Chief Medical Officers. Step 2 (Months 13 to 24): targeted outreach to non-improving units and physicians, repeat unit meetings, intensified direct feedback. Step 3 (Months 25 to 36): personalised letters to persistently non-concordant prescribers, phone calls where letters do not change practice, recognition of high performers. Year 4 (Months 37 to 48): follow-up without new active push. Delivery of every component is logged prospectively and reported as process and fidelity measures alongside the outcome measures: online-course completion, webinar attendance and unit-meeting delivery (education reach), materials deployment, EHR reminder display and supportive-care order-set use, dashboard access, and the number and timing of direct feedback sessions, personalised letters and phone calls with the proportion of planned leadership acts delivered on schedule. From Month -6 every leadership act (report, meeting, letter, call) is recorded with timestamp, deliverer, recipient and planned date in a leadership log.
Unit of analysis. The LRTI episode: the index visit plus related visits within 14 days for the same child and diagnostic group. Children are analysed in three age groups (under 5, 5 to 9 and 10 to 17 years) and stratified by sex, physician specialty and unit or region.
Analysis. Primary analysis: segmented binomial regression of monthly proportions with a level-change indicator and trend-change term at Day 0 and prespecified secondary change points at Month 13, Month 25 and Month 37, harmonic seasonal terms, COVID-period indicators, and correction for autocorrelation (Newey-West or Prais-Winsten; ARIMA as robustness check). Primary estimand: absolute difference between observed and counterfactual proportions at Month 36, with 95% confidence intervals (delta method, verified by parametric bootstrap); the same estimand at Month 12 and Month 48 is secondary. The two co-primary outcomes are tested conjunctively at two-sided alpha 0.05 each. Secondary analyses: three-level multilevel logistic regression (episodes within physicians within units) with variance components summarised as intraclass correlation and median odds ratio; funnel plots and statistical process control charts; a prespecified physician-level dose-response analysis of educational exposure and a unit-level engagement-response analysis; matched before-after comparison of personalised-feedback recipients with negative-control selection in a baseline year; an explanatory leadership-effect analysis (within-clinician comparison across units for clinicians who work in more than one unit, leadership dose-response, and an event-study of the dates on which unit feedback was delivered); prespecified subgroup, sensitivity and quantitative bias analyses, including quarterly aggregation of the CAP series, an indicator term for the preparatory-phase months (July to December 2026), a placebo interruption date and a negative-control outcome (antibiotic prescribing for paediatric urinary tract infection). Balancing and safety outcomes (14-day respiratory revisit, hospital referral, 30-day LRTI hospitalisation, CRP testing or chest radiography in bronchitis episodes as a substitution signal, antibiotic-allergy labels, and visit-level patient satisfaction) are followed on monthly run charts with prespecified signal thresholds and analysed with the same ITS models. A prespecified health-economic evaluation (cost-consequence analysis with cost-effectiveness ratios, provider perspective, CHEERS 2022) quantifies intervention costs by component and step against antibiotic-related savings derived from the ITS counterfactual.
Sample size. All eligible episodes are included (about 10,000 bronchitis and 2,000 to 2,500 CAP episodes per year, of which about 450 to 560 CAP episodes are antibiotic-treated and form the denominator of the CAP co-primary outcome), giving precision to detect absolute changes of about 3 percentage points in bronchitis prescribing and about 5 points in CAP agent selection. No formal power calculation governs inclusion.
Registration and reporting. The statistical analysis plan (version 1.0) was frozen on 8 October 2026, before Day 0, and is attached to this record as a study document; the protocol is submitted as a protocol paper. Analyses are conducted by the principal investigator with Terveystalo's statistical team and the research group's statistician; the analysis plan, analysis code and co-intervention log are published with the results. Reporting follows SQUIRE 2.0, TIDieR and EPOC guidance for interrupted time series.
- Being tested
- PRACTICE-LRTI multimodal antimicrobial stewardship programme
- Keywords
- Antimicrobial stewardship, Antibiotic prescribing, Audit and feedback, Interrupted time series, Amoxicillin, Macrolides, Penicillin allergy, Children, Primary care, Quality improvement
- Medical subject headings
- Bronchitis, Community-Acquired Pneumonia, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRACTICE-LRTI multimodal antimicrobial stewardship programmeBehavioural
Also called Guideline reinforcement, Multimodal clinician and caregiver education, EHR reminders and supportive-care order sentence, Real-time prescribing dashboard with audit and feedback
Four components in three annual steps. (1) Guideline reinforcement: concise local version of the Finnish Current Care Guideline for paediatric LRTI (no antibiotics for bronchitis; amoxicillin 40 to 45 mg/kg/day for 5 days as first-line for uncomplicated CAP; macrolide only for suspected Mycoplasma; indications for CRP and chest radiography). (2) Multimodal education: printed and intranet materials, physician and caregiver videos, webinars, unit meetings, online courses, commitment posters, caregiver leaflet. (3) EHR support: non-blocking diagnosis-specific reminders, allergy-label prompt, one-click supportive-care order set. (4) Real-time dashboard and feedback cascade: physician-, unit- and network-level indicators on SPC charts; quarterly reports; direct feedback from the Head of Pediatrics and unit Chief Medical Officers; in Step 3, personalised letters and calls to persistently non-concordant prescribers. A one-page guide prompts questioning of unverified penicillin-allergy labels.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal stewardship programme (whole network) | Experimental | All prescribing clinicians and all clinics of the Terveystalo network receive the four-component programme in three graduated annual steps. Outcomes are measured on all eligible paediatric LRTI episodes recorded in the network's EHR before, during and after the intervention. Receives: Behavioral: PRACTICE-LRTI multimodal antimicrobial stewardship programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of acute bronchitis episodes with a systemic antibiotic prescription
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%.
Measured: Month 36 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic
Proportion of antibiotic-treated outpatient community-acquired pneumonia (CAP) episodes in which a non-first-line agent is prescribed (a macrolide, or a broad-spectrum agent without a documented indication; amoxicillin is first-line), 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.
Measured: Month 36 after programme launch
Secondary outcomes (19)
Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 12
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.
Measured: Month 12 after programme launch
Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 48
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.
Measured: Month 48 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 12
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.
Measured: Month 12 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 48
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.
Measured: Month 48 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes treated with amoxicillin
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%.
Measured: Month 36 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a macrolide prescription
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%.
Measured: Month 36 after programme launch
Proportion of acute bronchitis episodes with a macrolide prescription
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.
Measured: Month 36 after programme launch
Proportion of community-acquired pneumonia amoxicillin courses with a prescribed duration of 5 days or less
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%.
Measured: Month 36 after programme launch
Median odds ratio between units for antibiotic prescribing in acute bronchitis
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).
Measured: Step 3 period, Months 25 to 36 after programme launch
Median odds ratio between physicians for antibiotic prescribing in acute bronchitis
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).
Measured: Step 3 period, Months 25 to 36 after programme launch
Median odds ratio between units for non-first-line antibiotic prescribing in community-acquired pneumonia
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).
Measured: Step 3 period, Months 25 to 36 after programme launch
Median odds ratio between physicians for non-first-line antibiotic prescribing in community-acquired pneumonia
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).
Measured: Step 3 period, Months 25 to 36 after programme launch
Proportion of lower respiratory tract infection episodes coded as pneumonia or unspecified lower respiratory tract infection
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.
Measured: Month 36 after programme launch
Proportion of lower respiratory tract infection episodes with diagnostic testing
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.
Measured: Month 36 after programme launch
Proportion of first-line antibiotic treatment among lower respiratory tract infection episodes with a documented penicillin-class allergy label
Among eligible LRTI episodes in which the child has a documented penicillin-class allergy label on file at the visit, the proportion treated with amoxicillin or another first-line agent, measured in Month 36 after programme launch. Unit of measure: percentage of allergy-labelled LRTI episodes. Analysed by segmented regression against the pre-launch counterfactual.
Measured: Month 36 after programme launch
Total intervention cost
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).
Measured: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Net programme cost
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).
Measured: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Cost per averted acute bronchitis antibiotic course
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.
Measured: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Cost per additional first-line-treated community-acquired pneumonia episode
Net programme cost divided by the number of additional antibiotic-treated outpatient CAP episodes treated with a first-line agent relative to the interrupted time series counterfactual over the same period (cost-consequence analysis, provider perspective). Unit of measure: euros per additional first-line-treated episode, with bootstrap 95% confidence interval.
Measured: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bronchitis, AcuteStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All clinics of the network receive the programme simultaneously in three prespecified annual steps (Step 1 education and general feedback; Step 2 targeted outreach; Step 3 personalised feedback), followed by 1 year of follow-up. Evaluation is a multi-step interrupted time series with change points at Day 0, Month 13, Month 25 and Month 37, against an extended pre-intervention baseline.
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Terveystalo, Kuopio University Hospital
- Responsible party
- Principal investigator, Peter Csonka, Tampere University
- Investigators
- Péter Csonka, MD, PhD, Principal investigator, Tampere University; Terveystalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893834
- Sponsor's protocol ID
- PRACTICE-LRTI-2027
- Other IDs
- 2026-08-02
- Acronym
- PRACTICE-LRTI
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data are available at the protocol stage. Episode-level data are held by Terveystalo and cannot be shared by the investigators because they are confidential health data; third-party access to the underlying data is governed by Terveystalo and, where applicable, requires a Findata permit under the Finnish secondary-use act. The SAP, code lists, indicator definitions and intervention materials are provided as online supplemental material; analysis code will be provided at publication of results.
Publications
Korppi M, Heikkila P, Palmu S, Huhtala H, Csonka P. Antibiotic prescriptions for children with lower respiratory tract infections fell from 2014 to 2020, but misuse was still an issue. Acta Paediatr. 2022 Jun;111(6):1230-1237. doi: 10.1111/apa.16323. Epub 2022 Mar 11.
PubMed 35266193Poutanen R, Korppi M, Csonka P, Pauniaho SL, Renko M, Palmu S. Use of antibiotics contrary to guidelines for children's lower respiratory tract infections in different health care settings. Eur J Pediatr. 2023 Oct;182(10):4369-4377. doi: 10.1007/s00431-023-05099-6. Epub 2023 Jul 19.
PubMed 37464182Csonka P, Heikkila P, Koskela S, Palmu S, Lajunen N, Riihijarvi S, Huhtala H, Korppi M. Cough and cold medicine prescription rates can be significantly reduced by active intervention. Eur J Pediatr. 2022 Apr;181(4):1531-1539. doi: 10.1007/s00431-021-04344-0. Epub 2021 Dec 15.
PubMed 34913111Poutanen R, Virta T, Heikkila P, Pauniaho SL, Csonka P, Korppi M, Renko M, Palmu S. National Current Care Guidelines for paediatric lower respiratory tract infections reduced the use of chest radiographs but local variations were observed. Acta Paediatr. 2021 May;110(5):1594-1600. doi: 10.1111/apa.15692. Epub 2020 Dec 7.
PubMed 33247995Backman K, Helminen M, Kekalainen E, Mikkola I, Nieminen T, Nuolivirta K, Peltola V, Seuri R, Walle SM, Ruuska-Loewald T. Working group summary of the 2023 full update of the Finnish national guidelines for paediatric lower respiratory tract infections. Acta Paediatr. 2025 Feb;114(2):248-257. doi: 10.1111/apa.17481. Epub 2024 Nov 1.
PubMed 39487609
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Rational Antibiotic Choices Through Targeted Intervention and Clinician Education: a Prospective Nationwide Multimodal Intervention to Improve Guideline-Concordant Outpatient Antibiotic Prescribing for Pediatric Lower Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT07893834
- Acronym / sponsor ID
- PRACTICE-LRTI / PRACTICE-LRTI-2027
- Keywords
- Antimicrobial stewardship, Antibiotic prescribing, Audit and feedback, Interrupted time series, Amoxicillin, Macrolides, Penicillin allergy, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Terveystalo, Kuopio University Hospital
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Oct 2026 (actual)
- 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.
Children with lower respiratory tract infection (LRTI) are still often prescribed antibiotics in ways that depart from national guidelines. Acute viral bronchitis is treated with antibiotics although none are needed, and community-acquired pneumonia (CAP) is often treated with a second-choice antibiotic, most often a macrolide, instead of first-line amoxicillin. In the Terveystalo network in Finland, about one third of bronchitis visits and one fifth of CAP visits in 2014 to 2020 led to an antibiotic prescription, and macrolides were the most commonly prescribed agent for bronchitis.
PRACTICE-LRTI is a nationwide quality-improvement and implementation study in which all clinics of the network receive a multimodal antimicrobial stewardship programme aimed at prescribing clinicians (paediatricians, general practitioners, ear, nose and throat specialists and other physicians). The programme combines (1) a concise local version of the Finnish Current Care Guideline for paediatric LRTI; (2) education for physicians and caregivers (printed and intranet materials, videos, webinars, unit-level meetings, online courses and commitment posters); (3) light-touch electronic health record reminders and a one-click supportive-care order set; and (4) a real-time prescribing dashboard with a structured feedback cascade that escalates over three years from network-wide progress reports to targeted outreach to non-improving units and, finally, personalised letters and phone calls to persistently non-concordant prescribers. A one-page guide prompts clinicians to question unverified penicillin-allergy labels.
The programme is delivered to the whole network at the same time, so no clinics are randomised to a control condition. Instead, prescribing is followed as a monthly time series from 2014 onward, and the change after each of three prespecified intervention steps is estimated by segmented regression against the projected pre-intervention trend. The co-primary outcomes are the proportion of acute bronchitis episodes in which a systemic antibiotic is prescribed and the proportion of antibiotic-treated outpatient CAP episodes in which a non-first-line agent is prescribed. The co-primary outcomes are assessed at Month 36 after launch; their Month 12 and Month 48 assessments are secondary outcomes. Other secondary outcomes include first-line amoxicillin and macrolide use, 5-day treatment duration, variation between units and physicians, diagnostic testing, first-line prescribing in children with a penicillin-allergy label, and intervention cost. Safety is monitored through 14-day respiratory revisits, hospital referrals and hospitalisations. The active intervention lasts 3 years and is followed by 1 year of follow-up to assess durability.
This is a quality-improvement and implementation study embedded in routine care, not a trial of a treatment. The intervention is directed at physicians; no child is recruited, contacted or examined outside routine care, and all outcome data come from the network's electronic health record.
Detailed description
Design. Prospective, pragmatic, multicentre quality-improvement and implementation study with a multi-step interrupted time-series (ITS) evaluation and continuous electronic health record (EHR) surveillance in a nationwide private healthcare network in Finland (about 300 clinics, about 300,000 paediatric outpatient visits per year). Cluster randomisation is not feasible because the network has centralised medical leadership, a unified EHR, shared quality surveillance and a common intranet, so company-wide materials would contaminate any control clusters; for the same reason the managerial components (unit feedback, outreach, letters and calls) cannot be staggered or randomised across units. The counterfactual is provided by an extended pre-intervention baseline (published 2014 to 2020 series plus a monthly series from January 2021 to December 2026, the month before Day 0) and segmented-regression modelling of level and trend.
Intervention. Four components delivered in three annual graduated steps. Step 1 (Months 1 to 12): company-wide launch of the local guideline, workflow aids, physician and caregiver videos, nationwide online meetings, in-person unit meetings, online courses, caregiver leaflet, EHR reminders, live dashboard, quarterly progress reports and a first round of direct feedback from the Head of Pediatrics and unit Chief Medical Officers. Step 2 (Months 13 to 24): targeted outreach to non-improving units and physicians, repeat unit meetings, intensified direct feedback. Step 3 (Months 25 to 36): personalised letters to persistently non-concordant prescribers, phone calls where letters do not change practice, recognition of high performers. Year 4 (Months 37 to 48): follow-up without new active push. Delivery of every component is logged prospectively and reported as process and fidelity measures alongside the outcome measures: online-course completion, webinar attendance and unit-meeting delivery (education reach), materials deployment, EHR reminder display and supportive-care order-set use, dashboard access, and the number and timing of direct feedback sessions, personalised letters and phone calls with the proportion of planned leadership acts delivered on schedule. From Month -6 every leadership act (report, meeting, letter, call) is recorded with timestamp, deliverer, recipient and planned date in a leadership log.
Unit of analysis. The LRTI episode: the index visit plus related visits within 14 days for the same child and diagnostic group. Children are analysed in three age groups (under 5, 5 to 9 and 10 to 17 years) and stratified by sex, physician specialty and unit or region.
Analysis. Primary analysis: segmented binomial regression of monthly proportions with a level-change indicator and trend-change term at Day 0 and prespecified secondary change points at Month 13, Month 25 and Month 37, harmonic seasonal terms, COVID-period indicators, and correction for autocorrelation (Newey-West or Prais-Winsten; ARIMA as robustness check). Primary estimand: absolute difference between observed and counterfactual proportions at Month 36, with 95% confidence intervals (delta method, verified by parametric bootstrap); the same estimand at Month 12 and Month 48 is secondary. The two co-primary outcomes are tested conjunctively at two-sided alpha 0.05 each. Secondary analyses: three-level multilevel logistic regression (episodes within physicians within units) with variance components summarised as intraclass correlation and median odds ratio; funnel plots and statistical process control charts; a prespecified physician-level dose-response analysis of educational exposure and a unit-level engagement-response analysis; matched before-after comparison of personalised-feedback recipients with negative-control selection in a baseline year; an explanatory leadership-effect analysis (within-clinician comparison across units for clinicians who work in more than one unit, leadership dose-response, and an event-study of the dates on which unit feedback was delivered); prespecified subgroup, sensitivity and quantitative bias analyses, including quarterly aggregation of the CAP series, an indicator term for the preparatory-phase months (July to December 2026), a placebo interruption date and a negative-control outcome (antibiotic prescribing for paediatric urinary tract infection). Balancing and safety outcomes (14-day respiratory revisit, hospital referral, 30-day LRTI hospitalisation, CRP testing or chest radiography in bronchitis episodes as a substitution signal, antibiotic-allergy labels, and visit-level patient satisfaction) are followed on monthly run charts with prespecified signal thresholds and analysed with the same ITS models. A prespecified health-economic evaluation (cost-consequence analysis with cost-effectiveness ratios, provider perspective, CHEERS 2022) quantifies intervention costs by component and step against antibiotic-related savings derived from the ITS counterfactual.
Sample size. All eligible episodes are included (about 10,000 bronchitis and 2,000 to 2,500 CAP episodes per year, of which about 450 to 560 CAP episodes are antibiotic-treated and form the denominator of the CAP co-primary outcome), giving precision to detect absolute changes of about 3 percentage points in bronchitis prescribing and about 5 points in CAP agent selection. No formal power calculation governs inclusion.
Registration and reporting. The statistical analysis plan (version 1.0) was frozen on 8 October 2026, before Day 0, and is attached to this record as a study document; the protocol is submitted as a protocol paper. Analyses are conducted by the principal investigator with Terveystalo's statistical team and the research group's statistician; the analysis plan, analysis code and co-intervention log are published with the results. Reporting follows SQUIRE 2.0, TIDieR and EPOC guidance for interrupted time series.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All clinics of the network receive the programme simultaneously in three prespecified annual steps (Step 1 education and general feedback; Step 2 targeted outreach; Step 3 personalised feedback), followed by 1 year of follow-up. Evaluation is a multi-step interrupted time series with change points at Day 0, Month 13, Month 25 and Month 37, against an extended pre-intervention baseline.
| Arm | Type | Receives |
|---|---|---|
| Multimodal stewardship programme (whole network) | Experimental | Behavioral: PRACTICE-LRTI multimodal antimicrobial stewardship programmeAll prescribing clinicians and all clinics of the Terveystalo network receive the four-component programme in three graduated annual steps. Outcomes are measured on all eligible paediatric LRTI episodes recorded in the network's EHR before, during and after the intervention. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| PRACTICE-LRTI multimodal antimicrobial stewardship programmeAlso: Guideline reinforcement, Multimodal clinician and caregiver education, EHR reminders and supportive-care order sentence, Real-time prescribing dashboard with audit and feedbackFour components in three annual steps. (1) Guideline reinforcement: concise local version of the Finnish Current Care Guideline for paediatric LRTI (no antibiotics for bronchitis; amoxicillin 40 to 45 mg/kg/day for 5 days as first-line for uncomplicated CAP; macrolide only for suspected Mycoplasma; indications for CRP and chest radiography). (2) Multimodal education: printed and intranet materials, physician and caregiver videos, webinars, unit meetings, online courses, commitment posters, caregiver leaflet. (3) EHR support: non-blocking diagnosis-specific reminders, allergy-label prompt, one-click supportive-care order set. (4) Real-time dashboard and feedback cascade: physician-, unit- and network-level indicators on SPC charts; quarterly reports; direct feedback from the Head of Pediatrics and unit Chief Medical Officers; in Step 3, personalised letters and calls to persistently non-concordant prescribers. A one-page guide prompts questioning of unverified penicillin-allergy labels. | Behavioural | Multimodal stewardship programme (whole network) |
Primary outcome
Proportion of acute bronchitis episodes with a systemic antibiotic prescription
Time frame: 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%.
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic
Time frame: Month 36 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia (CAP) episodes in which a non-first-line agent is prescribed (a macrolide, or a broad-spectrum agent without a documented indication; amoxicillin is first-line), 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.
19 secondary outcomes
Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 12
Time frame: Month 12 after programme launch
Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 48
Time frame: Month 48 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 12
Time frame: Month 12 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 48
Time frame: Month 48 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes treated with amoxicillin
Time frame: Month 36 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a macrolide prescription
Time frame: Month 36 after programme launch
Proportion of acute bronchitis episodes with a macrolide prescription
Time frame: Month 36 after programme launch
Proportion of community-acquired pneumonia amoxicillin courses with a prescribed duration of 5 days or less
Time frame: Month 36 after programme launch
Median odds ratio between units for antibiotic prescribing in acute bronchitis
Time frame: Step 3 period, Months 25 to 36 after programme launch
Median odds ratio between physicians for antibiotic prescribing in acute bronchitis
Time frame: Step 3 period, Months 25 to 36 after programme launch
Median odds ratio between units for non-first-line antibiotic prescribing in community-acquired pneumonia
Time frame: Step 3 period, Months 25 to 36 after programme launch
Median odds ratio between physicians for non-first-line antibiotic prescribing in community-acquired pneumonia
Time frame: Step 3 period, Months 25 to 36 after programme launch
Proportion of lower respiratory tract infection episodes coded as pneumonia or unspecified lower respiratory tract infection
Time frame: Month 36 after programme launch
Proportion of lower respiratory tract infection episodes with diagnostic testing
Time frame: Month 36 after programme launch
Proportion of first-line antibiotic treatment among lower respiratory tract infection episodes with a documented penicillin-class allergy label
Time frame: Month 36 after programme launch
Total intervention cost
Time frame: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Net programme cost
Time frame: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Cost per averted acute bronchitis antibiotic course
Time frame: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Cost per additional first-line-treated community-acquired pneumonia episode
Time frame: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 35266193Korppi M, Heikkila P, Palmu S, Huhtala H, Csonka P. Antibiotic prescriptions for children with lower respiratory tract infections fell from 2014 to 2020, but misuse was still an issue. Acta Paediatr. 2022 Jun;111(6):1230-1237. doi: 10.1111/apa.16323. Epub 2022 Mar 11.
- Background: PubMed 37464182Poutanen R, Korppi M, Csonka P, Pauniaho SL, Renko M, Palmu S. Use of antibiotics contrary to guidelines for children's lower respiratory tract infections in different health care settings. Eur J Pediatr. 2023 Oct;182(10):4369-4377. doi: 10.1007/s00431-023-05099-6. Epub 2023 Jul 19.
- Background: PubMed 34913111Csonka P, Heikkila P, Koskela S, Palmu S, Lajunen N, Riihijarvi S, Huhtala H, Korppi M. Cough and cold medicine prescription rates can be significantly reduced by active intervention. Eur J Pediatr. 2022 Apr;181(4):1531-1539. doi: 10.1007/s00431-021-04344-0. Epub 2021 Dec 15.
- Background: PubMed 33247995Poutanen R, Virta T, Heikkila P, Pauniaho SL, Csonka P, Korppi M, Renko M, Palmu S. National Current Care Guidelines for paediatric lower respiratory tract infections reduced the use of chest radiographs but local variations were observed. Acta Paediatr. 2021 May;110(5):1594-1600. doi: 10.1111/apa.15692. Epub 2020 Dec 7.
- Background: PubMed 39487609Backman K, Helminen M, Kekalainen E, Mikkola I, Nieminen T, Nuolivirta K, Peltola V, Seuri R, Walle SM, Ruuska-Loewald T. Working group summary of the 2023 full update of the Finnish national guidelines for paediatric lower respiratory tract infections. Acta Paediatr. 2025 Feb;114(2):248-257. doi: 10.1111/apa.17481. Epub 2024 Nov 1.
- Individual participant dataSharing planned: No. No data are available at the protocol stage. Episode-level data are held by Terveystalo and cannot be shared by the investigators because they are confidential health data; third-party access to the underlying data is governed by Terveystalo and, where applicable, requires a Findata permit under the Finnish secondary-use act. The SAP, code lists, indicator definitions and intervention materials are provided as online supplemental material; analysis code will be provided at publication of results.
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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.
Péter Csonka, MD, PhD principal investigator
Tampere University; Terveystalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRACTICE-LRTI multimodal antimicrobial stewardship programme in people with Bronchitis, Acute and Community-acquired Pneumonia, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Péter Csonka, MD, PhD (+358 50 366 1103, peter.csonka@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of acute bronchitis episodes with a systemic antibiotic prescription (time frame: Month 36 after programme launch). 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 NCT07893834, which also lists 5 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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.