NOT YET RECRUITING
NCT07893834
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With 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.
Gender: All
Ages: Any - 17 Years
Bronchitis, Acute
Community-acquired Pneumonia
Respiratory Tract Infections