Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorIntermountain Health Care, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 6 months-17-years-old (inclusive)
Diagnosis of AOM by ICD10 code
Child aged 6 months-17 years (inclusive)
Diagnosed with AOM by clinician
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Changes to the electronic health record (EHR)
Other interventionEHR 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
Other interventionAutomated 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
Other interventionVirtual 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
Other interventionA 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
Other interventionClinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.
Treatment groups
1,566 Participants
are divided into 2 treatment groupsGroup A: Health System Level (HSL) InterventionActive comparator 3 interventions
Group B: Hybrid InterventionExperimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
10 days after clinic visit for ear infection2
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.
Time frame
10 days after clinic visit for ear infectionSecondary outcomes
1
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.
Time frame
At time of clinic visit for ear infection (0 Days)2
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.
Time frame
10 days after clinic visit for ear infection3
Symptom and Severity Duration
Scores on a Likert scale from the AOM-Severity of Symptom scale survey on the following measures: 1. Symptom Severity (at maximum and at 10 days) 2. Time to Symptom Improvement (from onset) 3. Time to All Symptom Resolution (from onset) 4. Time to Ear Pain Resolution (from onset) 5. Symptoms Resolved at Day 10 (yes/no)
Time frame
0 and 10 days after clinic visit for ear infection4
Missed Work/School/Daycare
Numbers of days child missed school/daycare and/or number of days parent(s) missed work
Time frame
10 days after clinic visit for ear infectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Intermountain Health Care, Inc.
Lead sponsor
AllianceChicago
Collaborator
Mayo Clinic
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Denver Health and Hospital Authority
Collaborator
Source ClinicalTrials.gov