Only 1044 spots left

~1044 spots leftby Jun 2027

Interventions for Ear Infections
(DISAPEAR Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byHolly Frost, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Denver Health and Hospital Authority

Disqualifiers: Telehealth clinics, Medical trainees, Complicated AOM, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It focuses on interventions for ear infections and does not mention any medication restrictions.

What data supports the effectiveness of the treatment Shared decision-making (SDM) education and Use of a shared decision-making (SDM) aide for ear infections?

Research shows that shared decision-making (SDM) can improve patient satisfaction and outcomes by involving patients and families in treatment decisions, which is beneficial in managing conditions like ear infections. Studies indicate that SDM can reduce the unnecessary use of antibiotics in children with ear infections, leading to better disease management.¹ ² ³ ⁴ ⁵

Is shared decision-making (SDM) safe for use in clinical settings?

Shared decision-making (SDM) is a process where patients, families, and doctors work together to make healthcare decisions. It is generally considered safe as it focuses on improving patient satisfaction and outcomes by involving patients in their own care decisions.¹ ² ³ ⁴ ⁶

How is the shared decision-making treatment for ear infections different from other treatments?

The shared decision-making (SDM) treatment for ear infections is unique because it involves patients, families, and clinicians working together to choose the best treatment plan, rather than just following a doctor's orders. This approach can improve patient satisfaction and outcomes by considering multiple treatment options and reducing the unnecessary use of antibiotics.¹ ² ³ ⁴ ⁶

Research Team

Holly Frost, MD

Principal Investigator

Intermountain Health

Eligibility Criteria

This trial is for children aged 6 months to 17 years with ear infections, and their parents or guardians who are at least 18. Clinicians treating these conditions can also participate. Participants must be part of a clinic that agrees to implement the study interventions.

Inclusion Criteria

You have been diagnosed with AOM according to the ICD10 code.

My parent or guardian is over 18 and can be present.

You are a certified professional and not an apprentice.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the Health System Level and Hybrid Interventions at clinic sites, including clinician education and shared decision-making components

Varies by clinic

Multiple visits (in-person and virtual)

Evaluation

Evaluation of intervention outcomes using surveys, focus groups, and interviews to assess parent satisfaction and antibiotic use

10 days after clinic visit

Follow-up surveys and interviews

Follow-up

Participants are monitored for adverse drug events and other outcomes post-intervention

10 days

Treatment Details

Interventions

Shared decision-making (SDM) education (Behavioural Intervention)
Use of a shared decision-making (SDM) aide (Behavioural Intervention)

Trial OverviewThe study tests two approaches: a 'gold standard' health system intervention (clinician education, EHR tools, audit reports) versus this plus Shared Decision-Making (SDM), which involves parent participation in care decisions.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Hybrid InterventionExperimental Treatment5 Interventions

The Hybrid Intervention will be comprised of Shared Decision-Making (SDM) and the HSL Intervention. A previously validated SDM aid for ear infection care will be implemented. The aid was developed using the International Patient Decision Aid Standards and is freely available. Sites randomized to this arm will require all of the HSL components as well as: 1. Use of the Shared-Decision Aide 2. Clinician Education on SDM

Group II: Health System Level (HSL) InterventionActive Control3 Interventions

The HSL Intervention is based on the CDC Core Elements of Stewardship and the HSL intervention is recommended by national guidelines. Sites randomized to this arm will require: 1. A change in their Electronic Health Record to their prescription fields to align with national guidelines 2. Individualized feedback report to their clinicians and clinic overall 3. And virtual learning sessions and continuing medical education credits for clinicians.