Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05608993 |
Other study ID # |
22-1528 |
Secondary ID |
1R01HS029153-01 |
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 2024 |
Est. completion date |
October 2027 |
Study information
Verified date |
March 2024 |
Source |
Denver Health and Hospital Authority |
Contact |
Amy Keith, MPH |
Phone |
303-602-7198 |
Email |
amy.keith[@]dhha.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The overarching goal of this study is to evaluate the effectiveness and implementation
outcomes of two low-cost interventions of different intensities to increase prescribing of
recommended short antibiotic durations for acute otitis media (AOM) for children 2 years of
age and older. A multi-center cluster randomized controlled trial using a hybrid type 2
implementation effectiveness design will be used to evaluate interventions. The
High-Intensity intervention will include clinician education, individualized clinician audit
and feedback with peer comparison, and electronic health record (EHR) changes of prescription
fields, whereas the Low-Intensity intervention will include clinician education and EHR
changes. In total, 46 community-based clinics and/or urgent care centers across two distinct
geographic regions in the United States will be randomized to one of the two interventions.
The Practical Robust Implementation and Sustainability Model (PRISM) will be used to guide
implementation and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM)
framework will be used to evaluate outcomes. A mixed-methods approach will be used in the
pre-implementation and evaluation phases and will utilize quantitative analyses,
semi-structured interviews, focus groups, surveys, and cost analyses. National stakeholders
at the American Academy of Pediatrics and the Centers for Disease Control and Prevention will
assist with dissemination of findings and scaling of interventions.
Description:
Acute otitis media (AOM) is the most commonly cited indication for antibiotics in children,
accounting for 24% of all pediatric antibiotic prescriptions and affecting 60% of children by
3 years of age. For most children ≥ 2 years of age with AOM, 5-7 days, rather than 10 days,
of antibiotics have been shown to be sufficient and result in fewer adverse drug events with
similar failure and recurrence rates. Thus, national guidelines recommend short durations of
antibiotics for non-severe AOM in this age group. Despite these recommendations, >94% of
children ≥2 years of age are prescribed longer than recommended antibiotic durations and over
41% of antibiotic exposure days for AOM in this age group are likely unnecessary. In a recent
pilot study that compared a low-cost High-intensity intervention with clinician education,
individualized clinician audit and feedback with peer comparison and electronic health record
(EHR) changes of prescription fields to a Low-intensity intervention with only EHR changes
prescribing of recommended short antibiotic durations increased significantly (76% and 50%,
absolute percentage). A definite study is needed to make appropriate recommendations on which
intervention to implement, while minimizing resource utilization.
The overarching goal of this study is to evaluate the effectiveness and implementation
outcomes of two low-cost pragmatic interventions of different intensities to increase
prescribing of recommended short antibiotic durations for AOM for children 2 years of age and
older. A multi-center cluster randomized controlled trial using a hybrid type 2
implementation effectiveness design will be used to evaluate interventions. The
High-intensity intervention will include clinician education, individualized clinician audit
and feedback with peer comparison, and EHR changes of prescription fields, whereas the
Low-intensity intervention will include clinician education and EHR changes. In total, 46
community-based clinics and/or urgent care centers across two distinct geographic regions in
the United States will be randomized to one of the two interventions. The Practical Robust
Implementation and Sustainability Model will be used to guide implementation and the Reach
Effectiveness Adoption Implementation Maintenance framework will be used to evaluate
outcomes. A mixed-methods approach will be used in the pre-implementation and evaluation
phases and will utilize quantitative analyses, semi-structured interviews, focus groups,
surveys, and cost analyses.