Recruiting

Antibiotic De-implementation

Sponsor:

Intermountain Health Care, Inc.

Code:

NCT06034080

Conditions

Acute Otitis Media

Ear Infection

Pediatric Infectious Disease

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Changes to the electronic health record (EHR)

Individualized audit and feedback reporting for clinicians

Clinician education sessions

Use of a shared decision-making (SDM) aide

Shared decision-making (SDM) education

Study Details

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.

Conditions

Acute Otitis Media

Ear Infection

Pediatric Infectious Disease

Study ID

NCT06034080

Start date

Feb 3, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

1. Aged 6 months-17-years-old (inclusive)
2. Diagnosis of AOM by ICD10 code

C. Video recordings or direct observation of the use of a shared decision aid

Parent participation:

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

Clinician Participation:

1. Licensed clinician and not a medical trainee
2. Age 18 >= years or older

D. Pre-implementation interviews of clinicians and administrators

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

E. Pre-implementation focus groups of parents

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

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

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

H. Post-intervention surveys of clinicians and administrators

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

Exclusion Criteria:

A. Implementation of Interventions

1\. Clinics that exclusively provide telehealth

B. Secondary Electronic Health Record Data

1\. None

C. Video recordings or direct observation of the use of a shared decision aid

Parent participation:

1\. None

Clinician Participation:

1\. None

D. Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.)

E. Pre-implementation focus groups of parents

1\. 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\. Medical trainee (student, resident, fellow, etc.)

Study Design

Enrollment

1566 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

Changes to the electronic health record (EHR)

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

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

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

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

Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.

Primary outcome measure

  • Increase in Parent Satisfaction [ Time Frame: 10 days after clinic visit for ear infection ]
  • Percentage of Patients Taking an Antibiotic for AOM [ Time Frame: 10 days after clinic visit for ear infection ]

Central Contacts and Locations

Central contacts

Theresa L Morin, MA

802-881-9534theresa.morin@imail.org

Holly M Frost, MD

715-437-0270holly.frost@imail.org

Locations

Denver Health and Hospital Authority

Recruiting

Denver, Colorado, United States, 80204

Contacts

Aiden Gilbert, MPA

303-602-2709aiden.gilbert@dhha.org

Timothy Jenkins, MD

303-602-5041timothy.jenkins@dhha.org

Principal Investigator:

Timothy C Jenkins, MD

AllianceChicago

Recruiting

Chicago, Illinois, United States, 60654

Contacts

Mirta Milanes, MPH

872-227-6673mmilanes@alliancechicago.org

Principal Investigator:

Rasmi Narayan, MD

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Theresa Morin, MA

802-881-9534theresa.morin@imail.org

Hannah Jensen

801-507-4910hannah.curtis@imail.org

Principal Investigator:

Payal Patel, MD

More Information

Sponsor

Intermountain Health Care, Inc.

Last update posted

Sep 3, 2025

Last verified

Aug, 2025

Keywords

  • Shared Decision-Making
  • Health-System Level Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Intermountain Health Care, Inc. on 2025-09-03.