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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ 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

⁃ E. Pre-implementation focus groups of parents

• Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.

• 18 years of age or older and able/willing to consent

⁃ F. Parents enrolled for surveys

⁃ 1\. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. Willing to participate and able to complete electronic surveys at enrollment and 10 days after enrollment. 3. Working phone 4. Age \>=18 years of age

⁃ G. Post-intervention focus groups of parents

• Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.

• 18 years of age or older and able/willing to consent

⁃ H. Post-intervention surveys 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

Locations
United States
Colorado
Denver Health and Hospital Authority
RECRUITING
Denver
Illinois
AllianceChicago
RECRUITING
Chicago
Utah
Intermountain Health
RECRUITING
Murray
Contact Information
Primary
Theresa L Morin, MA
theresa.morin@imail.org
802-881-9534
Backup
Holly M Frost, MD
holly.frost@imail.org
715-437-0270
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2029-06
Participants
Target number of participants: 1566
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, AllianceChicago, Denver Health and Hospital Authority, Patient-Centered Outcomes Research Institute
Leads: Intermountain Health Care, Inc.

This content was sourced from clinicaltrials.gov