Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections

Conditions

• Acute Otitis Media
• Ear Infection
• Pediatric Infectious Disease

Eligibility Criteria

Sex

ALL

Age

6 Months - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Changes to the electronic health record (EHR) — OTHER
  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.
• Individualized audit and feedback reporting for clinicians — OTHER
  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.
• Clinician education sessions — OTHER
  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.
• Use of a shared decision-making (SDM) aide — OTHER
  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.
• Shared decision-making (SDM) education — OTHER
  Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.

Study Details

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.

Key Dates

Start date

Feb 3, 2025

Status verified

Aug 2025

Primary completion

Jun 1, 2027

Completion

Jun 30, 2029

Study Design

Enrollment

1,566 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Health System Level (HSL) Intervention
  The 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.
• Experimental: Hybrid Intervention
  The 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

Primary Outcome Measure

Increase in Parent Satisfaction [ Time Frame: 10 days after clinic visit for ear infection ]

Central Contacts

• Theresa L Morin, MA
  802-881-9534
  [email protected]
• Holly M Frost, MD
  715-437-0270
  [email protected]

Locations (3)

Find similar trials in Denver, CO

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