Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
DISAPEAR
DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
2 other identifiers
interventional
1,566
1 country
3
Brief Summary
This study aims to improve care and reduce unnecessary antibiotic prescribing for children with ear infections. The study will compare the effectiveness of a "gold standard" to a hybrid intervention combined with this gold standard, in order to identify steps to increase parent satisfaction for child ear infection care. The "gold standard" approach is a Health System Level Intervention. On its own, it involves clinician education, tools in electronic medical records, and audit and feedback reports for clinician prescribing habits. The hybrid intervention includes the elements of the health systems level intervention in addition to a Shared Decision-Making component, which allows for both an increase in the role parents play in their child's care, as well as clinician education for how to use this method. The goals of this work are to increase parent satisfaction, reduce antibiotics taken for childhood ear infections, align medical care with the current national guidelines, and evaluate differences in the two intervention groups. Both groups will be evaluated for implementation outcomes to improve dissemination and scalability for future use of these models in antibiotic prescribing for children with ear infections. This study will recruit a diverse group of patients and clinicians to complete surveys, parents to participate in focus groups, and clinicians and administrators to be interviewed in order to meet study aims and receive sufficient feedback on the interventions performed. There are two hypotheses for this research: 1. The Hybrid Intervention will have higher parent satisfaction and reduced antibiotic use compared to the Health-System Level Intervention and 2. The Hybrid Intervention will be more challenging to implement than the Health-System Level Intervention, but will be preferred by parents, clinicians, and administrators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
September 3, 2025
August 1, 2025
2.3 years
August 28, 2023
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Increase in Parent Satisfaction
Survey responses will be measured by the percentage of "Very Satisfied" or "Extremely Satisfied" responses from parents on a 7-point Likert Scale. The survey tool will be created from adaptations to the Pediatric Quality of Life Inventory (PedsQL) and the Acute Otitis Media Severity of Symptom Scale (AOM-SOS). In this survey, the higher scores on the Likert Scale will indicate more overall parent satisfaction.
10 days after clinic visit for ear infection
Percentage of Patients Taking an Antibiotic for AOM
Comparing electronic health record prescription data with parent yes/no survey responses to a question on whether or not their child took an antibiotic prescribed for treating their ear infection.
10 days after clinic visit for ear infection
Secondary Outcomes (8)
Shared Decision-Making
At time of clinic visit for ear infection (0 Days)
Pediatric Quality of Life
10 days after clinic visit for ear infection
Symptom and Severity Duration
0 and 10 days after clinic visit for ear infection
Missed Work/School/Daycare
10 days after clinic visit for ear infection
Adverse Drug Events
10 days after clinic visit for ear infection
- +3 more secondary outcomes
Study Arms (2)
Health System Level (HSL) Intervention
ACTIVE COMPARATORThe HSL Intervention is based on the CDC Core Elements of Stewardship and the HSL intervention is recommended by national guidelines. Sites randomized to this arm will require: 1. A change in their Electronic Health Record to their prescription fields to align with national guidelines 2. Individualized feedback report to their clinicians and clinic overall 3. And virtual learning sessions and continuing medical education credits for clinicians.
Hybrid Intervention
EXPERIMENTALThe Hybrid Intervention will be comprised of Shared Decision-Making (SDM) and the HSL Intervention. A previously validated SDM aid for ear infection care will be implemented. The aid was developed using the International Patient Decision Aid Standards and is freely available. Sites randomized to this arm will require all of the HSL components as well as: 1. Use of the Shared-Decision Aide 2. Clinician Education on SDM
Interventions
EHR changes will include minor changes to prescription fields to make it easier for clinicians to order "wait and see" antibiotics to be filled only if the child worsens or does not improve rather than antibiotics to take immediately.
Automated audit and feedback reports detailing participating clinicians' antibiotic prescribing habits for AOM both individually and in comparison to their peers will be shared with clinicians on a quarterly basis throughout the intervention period.
Virtual education sessions will be held for clinicians to learn more about national guidelines for antibiotic prescribing for AOM, etc. The sessions will be recorded and distributed to clinicians who were unable to attend. Attendance of these sessions will apply toward continuing medical education credits for participants.
A previously validated SDM aide for AOM will be used by clinicians during visits with children with AOM. The aide will be available online and in paper form.
Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.
Eligibility Criteria
You may qualify if:
- A. Implementation of Interventions 1. Clinic at a participating organization 2. Provides care to children with AOM 3. Administrative or local approval for participation
- B. Secondary Electronic Health Record Data
- Aged 6 months-17-years-old (inclusive)
- Diagnosis of AOM by ICD10 code
- C. Video recordings or direct observation of the use of a shared decision aid
- Parent participation:
- Child aged 6 months-17 years (inclusive)
- Diagnosed with AOM by clinician
- Parent or legal guardian is present and is \>=18 years or older
- Clinician Participation:
- Licensed clinician and not a medical trainee
- Age 18 \>= years or older
- D. Pre-implementation interviews of clinicians and administrators
- Licensed clinician (physician or advanced practice clinician) that cares for children with AOM at a participating organization or an administrator/manager at a participating organization.
- Aged \>=18 years-no maximum
- +11 more criteria
You may not qualify if:
- A. Implementation of Interventions
- \. Clinics that exclusively provide telehealth
- B. Secondary Electronic Health Record Data
- \. None
- C. Video recordings or direct observation of the use of a shared decision aid
- Parent participation:
- \. None
- Clinician Participation:
- \. None
- D. Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.)
- E. Pre-implementation focus groups of parents
- \. None
- F. Parents enrolled for surveys 1. Complicated or recurrent AOM as determined by the study team
- G. Post-intervention focus groups of parents 1. None
- H. Post-intervention surveys of clinicians and administrators
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intermountain Health Care, Inc.lead
- AllianceChicagocollaborator
- Mayo Cliniccollaborator
- Patient-Centered Outcomes Research Institutecollaborator
- Denver Health and Hospital Authoritycollaborator
Study Sites (3)
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
AllianceChicago
Chicago, Illinois, 60654, United States
Intermountain Health
Murray, Utah, 84107, United States
Related Publications (2)
Rinehart DJ, Gilbert A, Andersen LM, Gray TW, O'Leary S, Frost HM; DISAPEAR Study Group. Barriers and Facilitators to Implementing Watchful Waiting for Pediatric Acute Otitis Media. J Pediatr. 2025 Nov 13;289:114904. doi: 10.1016/j.jpeds.2025.114904. Online ahead of print.
PMID: 41241139DERIVEDJenkins TC, Keith A, Stein AB, Hersh AL, Narayan R, Eggleston A, Rinehart DJ, Patel PK, Walter E, Hargraves IG, Frost HM; DISAPEAR Study Group. Interventions to de-implement unnecessary antibiotic prescribing for ear infections (DISAPEAR Trial): protocol for a cluster-randomized trial. BMC Infect Dis. 2024 Jan 24;24(1):126. doi: 10.1186/s12879-023-08960-z.
PMID: 38267837DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holly Frost, MD
Intermountain Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2023
First Posted
September 13, 2023
Study Start
February 3, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2029
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared with other researchers.