RECRUITING

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

Conditions

Acute Otitis Media Ear Infection Pediatric Infectious Disease Shared Decision-Making Health-System Level Intervention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-03

Study Completion:2029-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06034080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Aged 6 months-17-years-old (inclusive) 2. Diagnosis of AOM by ICD10 code 1. Child aged 6 months-17 years (inclusive) 2. Diagnosed with AOM by clinician 3. Parent or legal guardian is present and is \>=18 years or older 1. Licensed clinician and not a medical trainee 2. Age 18 \>= years or older 1. 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. 2. Aged \>=18 years-no maximum 1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. 18 years of age or older and able/willing to consent 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 1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization. 2. 18 years of age or older and able/willing to consent 1. 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. 2. Aged \>=18 years-no maximum	1. Clinics that exclusively provide telehealth 1. None 1. None 1. None 1. None 1. Medical trainee (student, resident, fellow, etc.)

Inclusion Criteria

Exclusion Criteria

1. Aged 6 months-17-years-old (inclusive)
2. Diagnosis of AOM by ICD10 code
1. Child aged 6 months-17 years (inclusive)
2. Diagnosed with AOM by clinician
3. Parent or legal guardian is present and is \>=18 years or older
1. Licensed clinician and not a medical trainee
2. Age 18 \>= years or older
1. 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.
2. Aged \>=18 years-no maximum
1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
2. 18 years of age or older and able/willing to consent
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
1. Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
2. 18 years of age or older and able/willing to consent
1. 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.
2. Aged \>=18 years-no maximum

1. Clinics that exclusively provide telehealth
1. None
1. None
1. None
1. None
1. Medical trainee (student, resident, fellow, etc.)

Contacts and Locations

Study Contact

Theresa L Morin, MA

CONTACT

303-602-5423

theresa.morin@imail.org

Holly M Frost, MD

CONTACT

303-602-6461

holly.frost@imail.org

Principal Investigator

Holly Frost, MD

PRINCIPAL_INVESTIGATOR

Intermountain Health

Study Locations (Sites)

Denver Health and Hospital Authority

Denver, Colorado, 80204

United States

AllianceChicago

Chicago, Illinois, 60654

United States

Intermountain Health

Murray, Utah, 84107

United States

Collaborators and Investigators

Sponsor: Denver Health and Hospital Authority

Holly Frost, MD, PRINCIPAL_INVESTIGATOR, Intermountain Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-03

Study Completion Date2029-06

Study Record Updates

Study Start Date2025-02-03

Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

Shared Decision-Making
Health-System Level Intervention

Additional Relevant MeSH Terms

Acute Otitis Media
Ear Infection
Pediatric Infectious Disease