Clinical trial NCT06034080: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
Official title: DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Otitis Media
Ear Infection
Pediatric Infectious Disease
Keywords: Shared Decision-Making
Health-System Level Intervention
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: AllianceChicago
name: Mayo Clinic
name: Patient-Centered Outcomes Research Institute
name: Intermountain Health Care, Inc.
First posted: 2023-09-13
Enrollment: 1566
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mutli-Center Cluster Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Acute otitis media (AOM), commonly referred to as an ear infection, is the most common reason children are prescribed antibiotics, affecting 5 million children and resulting in 10 million antibiotic prescriptions annually. By 3 years of age over 60% of children will have had AOM. Though 84% of AOM episodes resolve without antibiotics, antibiotics are prescribed to \>95% of children. The American Academy of Pediatrics (AAP) recommends that most children with AOM do not receive an immediate antibiotic (an antibiotic to take right away) and instead be managed with watchful waiting, where an antibiotic is used only if the child worsens or does not improve. In clinical trials watchful waiting reduced antibiotic use by over 62% and did not result in increased complications, reduced parent satisfaction, or increased symptoms. Unfortunately, despite these trials \<5% of children with AOM are managed with watchful waiting. The use of antibiotics when not needed contributes to the development of antibiotic resistant organisms, which makes future infections more difficult to treat. Additionally, unnecessary antibiotics reduce pediatric quality of life and over 26% of children who take an antibiotic experience an adverse drug event (ADE). Thus, for every 100 children with AOM who take an antibiotic at least 26 children experience harm; whereas only 5 children have symptomatic benefit.

This study aims to compare the effectiveness of two pragmatic interventions to improve patient-centered outcomes and reduce unnecessary antibiotics taken for AOM. Interventions will be conducted at 33 community-based clinics and/or urgent care centers across three distinct geographic regions in the United States. Randomization will occur at the clinic center level to either the gold standard approach or the hybrid intervention. The Practical Robust Implementation and Sustainability Model (PRISM) will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be used to evaluate outcomes. A mixed-methods approach will be used in the pre-implementation and evaluation phases and will utilize quantitative analyses, semi-structured interviews, focus groups, and surveys.

Eligibility criteria: 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.)

Primary outcomes:
measure: Increase in Parent Satisfaction
timeFrame: 10 days after clinic visit for ear infection
measure: Percentage of Patients Taking an Antibiotic for AOM
timeFrame: 10 days after clinic visit for ear infection
Secondary outcomes:
measure: Shared Decision-Making
timeFrame: At time of clinic visit for ear infection (0 Days)
measure: Pediatric Quality of Life
timeFrame: 10 days after clinic visit for ear infection
measure: Symptom and Severity Duration
timeFrame: 0 and 10 days after clinic visit for ear infection
measure: Missed Work/School/Daycare
timeFrame: 10 days after clinic visit for ear infection
measure: Adverse Drug Events
timeFrame: 10 days after clinic visit for ear infection
measure: Treatment Failure
timeFrame: 10 days after clinic visit for ear infection
measure: Management Strategy
timeFrame: At time of clinic visit for ear infection (0 Days)
measure: Antibiotic Prescription Filled
timeFrame: 10 days after clinic visit for ear infection
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Chicago
country: United States
facility: AllianceChicago
state: Illinois
city: Murray
country: United States
facility: Intermountain Health
state: Utah
Study officials:
affiliation: Intermountain Health
name: Holly Frost, MD
role: PRINCIPAL_INVESTIGATOR
References: