Acute Otitis Media Clinical Trial
— DISAPEAROfficial title:
DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
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.
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.) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority | AllianceChicago, Intermountain Health Care, Inc., Mayo Clinic, Patient-Centered Outcomes Research Institute |
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 |
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