Pediatric pulmonology · 2025
Improving Modulator Management and Side Effect Screening: A CF Learning Network Innovation Lab.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Lonabaugh Kevin P, Saulitis Anna, Boettinger Elizabeth, Brighton David, Akers Megan, Barber Andrew T, Gifford Alex H, Kubiak Sarah E, McNamara Sharon C, Ries Olivia, Schulke Daniel F, List Rhonda, Shen Shiyi, Horton Bethany J, Albon Dana, Ong Thida, Linnemann Rachel W, CF Learning Network modulator iLab working group
Аннотация
BACKGROUND: Despite eligibility of over 90% of people with cystic fibrosis (PwCF) for CFTR modulators, 12% of eligible PwCF are not prescribed these therapies. The CF Foundation CF Learning Network (CFLN) convened a quality improvement (QI) innovation lab (iLab) to investigate gaps in modulator use and identify best practices for modulator initiation, management, and side effect screening.
METHODS: Thirty-one CF centers used the Model for Improvement to adapt interventions to local context by Plan-Do-Study-Act cycles and approach aims in two phases: (1) increase documented elexacaftor-tezacaftor-ivacaftor or ivacaftor (ETI/I) use or co-produced deferral by 4% by 5/2023 and (2) increase side effect screening rates for PwCF taking ETI to 80% by 8/2024. Interventions included processes to track eligibility and facilitate safety assessments and tools like screener forms. Centers submitted weekly measures. We used control charts and run charts to analyze progress.
RESULTS: Of 4649 PwCF evaluated from 12/2022 to 5/2023, 98.5% on average had documentation of either ETI/I use (89.3%) or deferral (9.2%). The most common reason for deferral was previous side effects (39.0%). Across 3236 visits from 3/2024 to 8/2024, ETI side effect screening rates improved, with the centerline shifting from 67.1% to 80.8%. Potential side effects were identified in 24.5% of screenings, most commonly mood changes, inattention/brain fog, and weight gain.
CONCLUSIONS: Application of QI methods resulted in processes and tools for enhancing modulator management and improving side effect screening across multiple CFLN centers. Potential side effects, including those not listed in the prescribing information, were commonly reported, highlighting the importance of side effect screening and management by care teams. Interventions can be reproduced by other centers and applied to novel CF therapies.
METHODS: Thirty-one CF centers used the Model for Improvement to adapt interventions to local context by Plan-Do-Study-Act cycles and approach aims in two phases: (1) increase documented elexacaftor-tezacaftor-ivacaftor or ivacaftor (ETI/I) use or co-produced deferral by 4% by 5/2023 and (2) increase side effect screening rates for PwCF taking ETI to 80% by 8/2024. Interventions included processes to track eligibility and facilitate safety assessments and tools like screener forms. Centers submitted weekly measures. We used control charts and run charts to analyze progress.
RESULTS: Of 4649 PwCF evaluated from 12/2022 to 5/2023, 98.5% on average had documentation of either ETI/I use (89.3%) or deferral (9.2%). The most common reason for deferral was previous side effects (39.0%). Across 3236 visits from 3/2024 to 8/2024, ETI side effect screening rates improved, with the centerline shifting from 67.1% to 80.8%. Potential side effects were identified in 24.5% of screenings, most commonly mood changes, inattention/brain fog, and weight gain.
CONCLUSIONS: Application of QI methods resulted in processes and tools for enhancing modulator management and improving side effect screening across multiple CFLN centers. Potential side effects, including those not listed in the prescribing information, were commonly reported, highlighting the importance of side effect screening and management by care teams. Interventions can be reproduced by other centers and applied to novel CF therapies.