NCT06034080 · Intermountain Health Care, Inc.
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
(DISAPEAR)
What this study is about
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.
View original scientific 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.
Interventions
OTHER
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.
OTHER
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.
OTHER
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.
OTHER
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.
OTHER
Shared decision-making (SDM) education
Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.
Primary outcome measures
Increase in Parent Satisfaction
Time frame: 10 days after clinic visit for ear infection
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.
Percentage of Patients Taking an Antibiotic for AOM
Time frame: 10 days after clinic visit for ear infection
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
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.)
Where
- Denver, Colorado
- Chicago, Illinois
- Murray, Utah
Collaborators
AllianceChicago, Mayo Clinic, Patient-Centered Outcomes Research Institute, Denver Health and Hospital Authority
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 3, 2025 · Source of record for eligibility and locations