Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections (PRACTICE-LRTI)

29. Oktober 2026 aktualisiert von: Peter Csonka, Tampere University

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.

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.

Studienübersicht

Status

Status

Zeigt den aktuellen Rekrutierungsstatus oder den erweiterten Zugriffsstatus an.
Noch keine Rekrutierung

Bedingungen

Bedingungen

Die Krankheit, Störung, das Syndrom, die Krankheit oder die Verletzung, die untersucht wird. Auf ClinicalTrials.gov können die Bedingungen auch andere gesundheitsbezogene Themen wie Lebensdauer, Lebensqualität und Gesundheitsrisiken umfassen.

Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.

Detaillierte Beschreibung

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 Chief Medical Officer for Paediatrics 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 29 October 2026 on deposition with this record, before Day 0, and is attached as a study document; it is also published as a supplement to the 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.

Studientyp

Studientyp

Beschreibt die Art einer klinischen Studie. Zu den Studientypen gehören Interventionsstudien (auch klinische Studien genannt), Beobachtungsstudien (einschließlich Patientenregister) und erweiterter Zugang.
Interventionell

Einschreibung (Geschätzt)

Einschreibung

Die Anzahl der Teilnehmer an einer klinischen Studie. Die „erwartete“ Einschreibung ist die Zielzahl an Teilnehmern, die die Forscher für die Studie benötigen.
50000

Phase

Phase

Das Stadium einer klinischen Studie, in der ein Medikament oder ein biologisches Produkt untersucht wird, basierend auf Definitionen, die von der U.S. Food and Drug Administration (FDA) entwickelt wurden. Die Phase richtet sich nach dem Ziel der Studie, der Anzahl der Teilnehmer und anderen Merkmalen. Es gibt fünf Phasen: Frühe Phase 1 (früher als Phase 0 aufgeführt), Phase 1, Phase 2, Phase 3 und Phase 4. Nicht zutreffend wird verwendet, um Studien ohne von der FDA definierte Phasen zu beschreiben, einschließlich Studien zu Geräten oder Verhaltensinterventionen.
  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienkontakt

Der Name und die Kontaktinformationen der Person, die Fragen zur Registrierung für eine klinische Studie beantworten kann. Jeder Standort, an dem die Studie durchgeführt wird, kann auch einen bestimmten Ansprechpartner haben, der diese Fragen möglicherweise besser beantworten kann.

Studienorte

  • Finnland
      • Helsinki, Finnland, 00100
        • Terveystalo (nationwide network, about 300 clinics)

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Zulassungskriterien

Die wichtigsten Voraussetzungen, die Personen erfüllen müssen, die an einer klinischen Studie teilnehmen möchten, bzw. welche Eigenschaften sie mitbringen müssen. Auswahlkriterien bestehen sowohl aus Einschlusskriterien (die erforderlich sind, damit eine Person an der Studie teilnehmen kann) als auch aus Ausschlusskriterien (die eine Person an der Teilnahme hindern). Arten von Zulassungskriterien umfassen, ob eine Studie gesunde Freiwillige akzeptiert, Alters- oder Altersgruppenanforderungen hat oder durch das Geschlecht begrenzt ist.

Studienberechtigtes Alter

Nicht älter als 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm

Teilnehmergruppe / Arm

Eine Gruppe oder Untergruppe von Teilnehmern an einer klinischen Studie, die gemäß dem Protokoll der Studie eine bestimmte Intervention/Behandlung oder keine Intervention erhält.
Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.
Experimental: Multimodal stewardship programme (whole network)

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.
Verhalten: PRACTICE-LRTI multimodal antimicrobial stewardship programme

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.

Andere Namen:
  • Guideline reinforcement
  • Multimodal clinician and caregiver education
  • EHR reminders and supportive-care order sentence
  • Real-time prescribing dashboard with audit and feedback

Was misst die Studie?

Primäre Ergebnismessungen

Primäre Ergebnismessungen

Im Protokoll einer klinischen Studie die geplante Ergebnismessung, die für die Bewertung der Wirkung einer Intervention/Behandlung am wichtigsten ist. Die meisten klinischen Studien haben einen primären Endpunkt, aber einige haben mehr als einen.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of acute bronchitis episodes with a systemic antibiotic prescription
Zeitfenster: 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%.
Month 36 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic
Zeitfenster: 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.
Month 36 after programme launch

Sekundäre Ergebnismessungen

Sekundäre Ergebnismessungen

Im Protokoll einer klinischen Studie ein geplantes Ergebnismaß, das nicht so wichtig ist wie das primäre Ergebnismaß für die Bewertung der Wirkung einer Intervention, aber dennoch von Interesse ist. Die meisten klinischen Studien haben mehr als einen sekundären Endpunkt.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 12
Zeitfenster: 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.
Month 12 after programme launch
Proportion of acute bronchitis episodes with a systemic antibiotic prescription at Month 48
Zeitfenster: 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.
Month 48 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 12
Zeitfenster: 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.
Month 12 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a non-first-line antibiotic at Month 48
Zeitfenster: 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.
Month 48 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes treated with amoxicillin
Zeitfenster: 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%.
Month 36 after programme launch
Proportion of antibiotic-treated outpatient community-acquired pneumonia episodes with a macrolide prescription
Zeitfenster: 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%.
Month 36 after programme launch
Proportion of acute bronchitis episodes with a macrolide prescription
Zeitfenster: 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.
Month 36 after programme launch
Proportion of community-acquired pneumonia amoxicillin courses with a prescribed duration of 5 days or less
Zeitfenster: 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%.
Month 36 after programme launch
Median odds ratio between units for antibiotic prescribing in acute bronchitis
Zeitfenster: 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).
Step 3 period, Months 25 to 36 after programme launch
Median odds ratio between physicians for antibiotic prescribing in acute bronchitis
Zeitfenster: 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).
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
Zeitfenster: 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).
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
Zeitfenster: 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).
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
Zeitfenster: 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.
Month 36 after programme launch
Proportion of lower respiratory tract infection episodes with diagnostic testing
Zeitfenster: 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.
Month 36 after programme launch
Proportion of amoxicillin treatment among antibiotic-treated community-acquired pneumonia episodes with a documented penicil penicillin-class allergy label
Zeitfenster: 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.
Month 36 after programme launch
Total intervention cost
Zeitfenster: 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).
Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Net programme cost
Zeitfenster: 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).
Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch
Cost per averted acute bronchitis antibiotic course
Zeitfenster: 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.
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
Zeitfenster: Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch

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.
Cumulative from Month -6 (start of the preparatory phase) through Month 48 after programme launch

Andere Ergebnismessungen

Andere Ergebnismessungen

Bei klinischen Studien eine im Protokoll beschriebene geplante Messung, die verwendet wird, um die Wirkung einer Intervention/Behandlung auf die Teilnehmer zu bestimmen. Bei Beobachtungsstudien eine Messung oder Beobachtung, die verwendet wird, um Muster von Krankheiten oder Merkmalen oder Assoziationen mit Expositionen, Risikofaktoren oder Behandlungen zu beschreiben. Arten von Ergebnismaßen umfassen primäres Ergebnismaß und sekundäres Ergebnismaß.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of lower respiratory tract infection episodes with a respiratory revisit within 14 days (balancing outcome)
Zeitfenster: Month 36 after programme launch

Proportion of eligible LRTI episodes followed by a respiratory revisit within 14 days of the index visit, measured in Month 36 after programme launch. Unit of measure: percentage of eligible LRTI episodes. Followed monthly on run charts from launch and analysed by segmented regression against the pre-launch counterfactual. Prespecified safety signal: intervention-attributable absolute increase exceeding 1 percentage point.
Month 36 after programme launch
Proportion of lower respiratory tract infection episodes with a hospital referral (balancing outcome)
Zeitfenster: Month 36 after programme launch

Proportion of eligible LRTI episodes with a hospital referral at or after the index visit within the episode, measured in Month 36 after programme launch. Unit of measure: percentage of eligible LRTI episodes. Followed monthly on run charts from launch and analysed by segmented regression against the pre-launch counterfactual.
Month 36 after programme launch
Proportion of lower respiratory tract infection episodes with hospitalisation for lower respiratory tract infection within 30 days (balancing outcome)
Zeitfenster: Month 36 after programme launch

Proportion of eligible LRTI episodes followed by hospitalisation for LRTI within 30 days of the index visit, measured in Month 36 after programme launch. Unit of measure: percentage of eligible LRTI episodes. Followed monthly on run charts from launch and analysed by segmented regression against the pre-launch counterfactual. Any statistically significant intervention-attributable increase is a prespecified safety signal.
Month 36 after programme launch
Proportion of acute bronchitis episodes with C-reactive protein testing or chest radiography (substitution signal)
Zeitfenster: Month 36 after programme launch

Proportion of eligible acute bronchitis episodes in which CRP testing or chest radiography, or both, is ordered at the index visit, each episode counted once, measured in Month 36 after programme launch. Unit of measure: percentage of acute bronchitis episodes. An increase while antibiotic prescribing falls is interpreted as testing substituting for antibiotics rather than guideline-concordant care. Analysed by segmented regression against the pre-launch counterfactual.
Month 36 after programme launch
Proportion of lower respiratory tract infection episodes with a documented penicillin-class allergy label (balancing outcome)
Zeitfenster: Month 36 after programme launch

Proportion of eligible LRTI episodes in which the child has a documented penicillin-class allergy label on file at the visit, measured in Month 36 after programme launch. Unit of measure: percentage of eligible LRTI episodes. Followed monthly from launch and analysed by segmented regression against the pre-launch counterfactual.
Month 36 after programme launch
Mean Net Promoter Score for lower respiratory tract infection visits (balancing outcome)
Zeitfenster: Month 36 after programme launch

Mean of the Terveystalo visit-level Net Promoter Score question (0 to 10 scale, higher is more favourable) among eligible LRTI visits with a returned score, measured in Month 36 after programme launch. Unit of measure: score on a 0 to 10 scale. Followed monthly from launch and analysed by segmented regression against the pre-launch counterfactual.
Month 36 after programme launch
Proportion of promoters among lower respiratory tract infection visits (balancing outcome)
Zeitfenster: Month 36 after programme launch

Proportion of eligible LRTI visits with a returned Net Promoter Score of 9 or 10 (promoters), measured in Month 36 after programme launch. Unit of measure: percentage of LRTI visits with a returned score. Followed monthly from launch and analysed by segmented regression against the pre-launch counterfactual.
Month 36 after programme launch
Within-clinician difference in acute bronchitis antibiotic prescribing between units with and without prior unit-level leadership exposure (explanatory)
Zeitfenster: From programme launch through Month 36 after programme launch

Among clinicians with eligible acute bronchitis episodes in two or more units in the same calendar month, the difference in the proportion of episodes with a systemic antibiotic prescription between units in which unit-level leadership exposure (unit Chief Medical Officer feedback delivered or unit meeting held, from the prospective leadership log) has already occurred and units in which it has not, pooled over Months 1 to 36 with clinician fixed effects. Unit of measure: percentage points. Reported as an explanatory lower bound of the site-bound leadership effect.
From programme launch through Month 36 after programme launch
Within-clinician difference in non-first-line antibiotic prescribing in community-acquired pneumonia between units with and without prior unit-level leadership exposure (explanatory)
Zeitfenster: From programme launch through Month 36 after programme launch

Among clinicians with antibiotic-treated outpatient CAP episodes in two or more units in the same calendar month, the difference in the proportion of episodes with a non-first-line agent between units with and without prior unit-level leadership exposure (defined as above), pooled over Months 1 to 36 with clinician fixed effects. Unit of measure: percentage points. Reported as an explanatory lower bound of the site-bound leadership effect.
From programme launch through Month 36 after programme launch

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sponsor

Die Organisation oder Person, die die Studie initiiert und die Autorität und Kontrolle über die Studie hat.
Tampere University

Mitarbeiter

Mitarbeiter

Eine andere Organisation als der Sponsor, die eine klinische Studie unterstützt. Diese Unterstützung kann Aktivitäten im Zusammenhang mit Finanzierung, Design, Implementierung, Datenanalyse oder Berichterstattung umfassen.
Kuopio University Hospital
Terveystalo

Ermittler

Ermittler

Ein Forscher, der an einer klinischen Studie beteiligt ist. Zu den verwandten Begriffen gehören Studienleiter, Unterprüfer am Standort, Studienleiter, Studienleiter und Studienleiter.
  • Hauptermittler: Péter Csonka, MD, PhD, Tampere University; Terveystalo

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

Studienbeginn

Das tatsächliche Datum, an dem der erste Teilnehmer in eine klinische Studie aufgenommen wurde. Das „voraussichtliche“ Studienstartdatum ist das Datum, von dem die Forscher glauben, dass es das Studienstartdatum sein wird.
1. Januar 2027

Primärer Abschluss (Geschätzt)

Primärer Abschluss

Das Datum, an dem der letzte Teilnehmer einer klinischen Studie untersucht wurde oder eine Intervention erhalten hat, um endgültige Daten für das primäre Ergebnis zu sammeln. Ob die klinische Studie protokollgemäß endete oder beendet wurde, hat keinen Einfluss auf dieses Datum. Bei klinischen Studien mit mehr als einem primären Ergebnismaß mit unterschiedlichen Abschlussdaten bezieht sich dieser Begriff auf das Datum, an dem die Datenerhebung für alle primären Ergebnismaße abgeschlossen ist. Das „erwartete“ primäre Abschlussdatum ist das Datum, von dem die Forscher glauben, dass es das primäre Abschlussdatum für die Studie sein wird.
1. Dezember 2029

Studienabschluss (Geschätzt)

Studienabschluss

Das Datum, an dem der letzte Teilnehmer an einer klinischen Studie untersucht wurde oder eine Intervention/Behandlung erhielt, um endgültige Daten für die primären Ergebnismaße, sekundären Ergebnismaße und Nebenwirkungen zu sammeln (d. h. der letzte Besuch des letzten Teilnehmers). Das „voraussichtliche“ Abschlussdatum der Studie ist das Datum, von dem die Forscher glauben, dass es das Abschlussdatum der Studie sein wird.
1. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

Zuerst eingereicht

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht bei ClinicalTrials.gov eingereicht hat. Zwischen dem Datum der ersten Einreichung und der Verfügbarkeit des Datensatzes auf ClinicalTrials.gov (dem ersten veröffentlichten Datum) liegt in der Regel eine Verzögerung von einigen Tagen.
9. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht einreicht, der den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) entspricht. Der Sponsor oder Prüfer muss möglicherweise einen Studienbericht ein- oder mehrmals überarbeiten und einreichen, bevor die QC-Überprüfungskriterien von NLM erfüllt sind. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
16. Oktober 2026

Zuerst gepostet (Tatsächlich)

Zuerst gepostet

Das Datum, an dem der Studienbericht zum ersten Mal auf ClinicalTrials.gov verfügbar war, nachdem die Qualitätskontrolle (QC) der National Library of Medicine (NLM) abgeschlossen wurde. Zwischen dem Datum, an dem der Studiensponsor oder Prüfer den Studienbericht eingereicht hat, und dem ersten veröffentlichten Datum liegt in der Regel eine Verzögerung von einigen Tagen.
26. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

Letztes Update gepostet

Das letzte Datum, an dem Änderungen an einem Studienbericht auf ClinicalTrials.gov verfügbar gemacht wurden. Es kann eine Verzögerung zwischen der Übermittlung der Änderungen an ClinicalTrials.gov durch den Sponsor oder Prüfer der Studie (Datum der letzten eingereichten Aktualisierung) und dem Datum der letzten Veröffentlichung der Aktualisierung geben.
3. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Das letzte Datum, an dem der Studiensponsor oder Prüfer Änderungen an einem Studienbericht eingereicht hat, die mit den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) übereinstimmen. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
29. Oktober 2026

Zuletzt verifiziert

Zuletzt verifiziert

Das letzte Datum, an dem der Studiensponsor oder Prüfer die Informationen über eine klinische Studie auf ClinicalTrials.gov als richtig und aktuell bestätigt hat. Wenn eine Studie den Rekrutierungsstatus Recruiting hat; noch keine Rekrutierung; oder aktiv, keine Rekrutierung wurde innerhalb der letzten 2 Jahre nicht bestätigt, der Rekrutierungsstatus der Studie wird als unbekannt angezeigt.
1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

Andere Studien-ID-Nummern

Andere Identifikatoren oder ID-Nummern als die NCT-Nummer, die einer klinischen Studie vom Sponsor der Studie, Geldgebern oder anderen zugewiesen werden. Diese Nummern können eindeutige Kennungen von anderen Studienregistern und Zuschussnummern der National Institutes of Health enthalten.
  • PRACTICE-LRTI-2027
  • 2026-08-02 (Andere Kennung: Terveystalo Medical Executive Team approval)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Cookie-Einstellungen

Wir verwenden Cookies, um sicherzustellen, dass Sie auf unserer Website die bestmögliche Erfahrung machen. Weitere Informationen finden Sie in unserer Datenschutz- und Cookie-Richtlinien. ...>>>Sie können Ihre Einstellungen jederzeit ändern oder Ihre Einwilligung widerrufen, indem Sie die Cookies wie in der Richtlinie beschrieben von Ihrer Website oder Ihrem Computer löschen. Bitte akzeptieren Sie es und wählen Sie Ihre Einstellungen, indem Sie die entsprechenden Kästchen im Abschnitt "Einstellungen verwalten" unten ankreuzen. Bitte lesen Sie unsere Nutzungsbedingungen sorgfältig durch, bevor Sie einen Teil dieser Website nutzen.
«Einstellungen verwalten