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

Acute Otitis Media Clinical Trial

— DISAPEAR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06034080
• Other study ID #: 23-1096
• Secondary ID: IHS-2022C2-28005
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: June 2029

Study information

• Verified date: July 2023
• Source: Denver Health and Hospital Authority
• Contact: Theresa L Morin, MA
• Phone: 303-602-5423
• Email: Theresa.Morin[@]dhha.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1450
• Est. completion date: June 2029
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Acute Otitis Media
• Communicable Diseases
• Ear Infection
• Infections
• Otitis
• Otitis Media
• Pediatric Infectious Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	AllianceChicago, Intermountain Health Care, Inc., Mayo Clinic, Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Parent Satisfaction	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.	10 days after clinic visit for ear infection
Primary	Percentage of Patients Taking an Antibiotic for AOM	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.	10 days after clinic visit for ear infection
Secondary	Shared Decision-Making	Summed score of the "Knowledge and Decisional Conflict Assessment" section of the Shared Decision-Making Questionnaire (SDM Q-9). The survey has a 6-Point Likert Scale ranging in values from "Completely Disagree" to "Completely Agree". For this survey, the higher the number on the Likert Scale, the better the outcome.	At time of clinic visit for ear infection (0 Days)
Secondary	Pediatric Quality of Life	Score on the PEDS-QL Survey. This survey has a 5-Point Likert Scale ranging from "Never a Problem" (0 points) to "Almost Always a Problem" (4 points). Higher scores on this scale indicate worse outcomes while lower scores indicate better outcomes.	10 days after clinic visit for ear infection
Secondary	Symptom and Severity Duration	Scores on a Likert scale from the AOM-Severity of Symptom scale survey on the following measures: Symptom Severity (at maximum and at 10 days); Time to Symptom Improvement (from onset); Time to All Symptom Resolution (from onset); Time to Ear Pain Resolution (from onset); Symptoms Resolved at Day 10 (yes/no)	0 and 10 days after clinic visit for ear infection
Secondary	Missed Work/School/Daycare	Numbers of days child missed school/daycare and/or number of days parent(s) missed work	10 days after clinic visit for ear infection
Secondary	Adverse Drug Events	Percentage of patients with adverse drug event(s)	10 days after clinic visit for ear infection
Secondary	Treatment Failure	Percentage that changed their medication management (i.e., took an antibiotic if initially trying watchful waiting or tried a new antibiotic if initially immediately tried antibiotics)	10 days after clinic visit for ear infection
Secondary	Management Strategy	Percentage of immediate antibiotic use	At time of clinic visit for ear infection (0 Days)
Secondary	Antibiotic Prescription Filled	Percentage of filled antibiotic prescriptions (even if not taken)	10 days after clinic visit for ear infection