Interventions for Ear Infections

(DISAPEAR Trial)

Recruiting at 2 trial locations

Overseen By Holly M Frost, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1566 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for children with ear infections and reduce unnecessary antibiotic use. It compares a standard care approach, which includes clinician education and tools in medical records, to a new approach that adds a shared decision-making (SDM) element. This approach gives parents a larger role in deciding their child's ear infection treatment. The trial seeks parents of children diagnosed with ear infections by a doctor who are interested in participating in surveys or focus groups. The goal is to determine which method results in happier parents and less antibiotic use, aligning with national guidelines. As an unphased trial, this study offers a unique opportunity for parents to help improve treatment strategies for ear infections in children.

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 prior data suggests that these interventions are safe for children with ear infections?

Research has shown that making decisions together with doctors about treating children's ear infections is safe. Studies find that this approach helps parents learn more about their child's ear infection and become more involved in their care without causing additional problems. One study found that parents who used a decision-making tool felt more informed and satisfied, with no increase in negative side effects.

Additionally, using this tool has been linked to reduced antibiotic use without causing new health issues. This collaboration between parents and doctors can lead to safer care for children by selecting the best treatment for ear infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for ear infections because they focus on empowering patients and clinicians through education and decision-making tools. Unlike traditional treatments that rely solely on antibiotics, the use of a Shared Decision-Making (SDM) aid helps patients and doctors collaboratively decide the best course of action. Additionally, the Health System Level (HSL) Intervention aims to improve the prescription process by aligning it with national guidelines, providing feedback to clinicians, and offering virtual learning sessions. These methods not only enhance communication but also have the potential to reduce unnecessary antibiotic use, promoting better health outcomes and antibiotic stewardship.

What evidence suggests that this trial's interventions could be effective for ear infections?

This trial will compare two interventions for ear infections. One arm will use a Hybrid Intervention, which includes Shared Decision-Making (SDM) education and a validated SDM aid to involve parents in treatment decisions. Research has shown that involving parents in treatment decisions can help reduce unnecessary antibiotic use in children with ear infections. When parents participate in deciding on treatments, they often choose options that use fewer antibiotics, following expert guidelines. One study found that this approach increased parents' understanding and involvement, leading to fewer antibiotic prescriptions. A tool that guides conversations between doctors and parents has also improved these results. This method not only follows national guidelines but also increases parental satisfaction by involving them more in their child's care decisions. The other arm, the Health System Level (HSL) Intervention, will focus on aligning prescription practices with national guidelines through changes in Electronic Health Records and providing feedback and education to clinicians. ^{1 2 3 4 6}

Who Is on the Research Team?

Holly Frost, MD

Principal Investigator

Intermountain Health

Are You a Good Fit for This Trial?

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.

You are a certified professional and not an apprentice.

I am between 6 months and 17 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The 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.

How Is the Trial Designed?

Group I: Hybrid Intervention Experimental Treatment 5 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) Intervention Active Control 3 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.

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Denver Health & Hospital Authority

Collaborator

AllianceChicago

Collaborator

Trials

8

Recruited

18,700+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Denver Health and Hospital Authority

Collaborator

Trials

106

Recruited

403,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Shared decision making (SDM) enhances patient satisfaction and disease management by involving patients, families, and clinicians in creating a treatment plan when multiple options are available.

Implementing SDM can reduce decisional conflict and regret, making it particularly beneficial in managing chronic diseases and conditions in otolaryngology, although there are barriers to its widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Medicine in Otolaryngology Part 7: Introduction to Shared Decision Making. Ikeda, AK., Hong, P., Ishman, SL., et al.[2019]

Shared decision making (SDM) is a collaborative approach that enhances treatment planning when multiple reasonable options are available, involving patients, families, and clinicians.

Implementing SDM can improve healthcare utilization and patient satisfaction, while also addressing disparities related to race and ethnicity in clinical decision-making processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based Medicine in Otolaryngology, Part 8: Shared Decision Making-Impact, Incentives, and Instruments. Ikeda, AK., Hong, P., Ishman, SL., et al.[2019]

Parents exposed to a shared decision-making (SDM) model were significantly less likely to choose antibiotics for their child's acute otitis media (AOM) compared to those exposed to a paternalistic model, with an odds ratio of 4.9 indicating a strong preference for SDM.

Parental satisfaction was notably higher in the SDM groups (93% and 84%) compared to the paternalistic model group (76%), suggesting that involving parents in treatment decisions not only reduces unnecessary antibiotic use but also enhances their overall satisfaction with care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of the shared-decision model in parents of children with acute otitis media. Merenstein, D., Diener-West, M., Krist, A., et al.[2022]

In a study involving 96 children undergoing consultations for elective surgeries, pediatric otolaryngologists primarily focused on sharing information rather than fully engaging in shared decision-making (SDM) with parents, as indicated by low OPTION scores.

There was a notable tendency for clinicians to involve female children and those with prior surgical experiences more in the SDM process, but overall, parent and physician perceptions of SDM did not align with actual observed behaviors, highlighting a gap in effective collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision making during surgical consultations: An observational study in pediatric otolaryngology. Melong, J., Meier, J., Hong, P.[2019]

In a study of 117 parents and children undergoing elective surgical consultations, observed levels of shared decision-making (SDM) were low, with a median OPTION score of only 14 out of 48, indicating limited parental involvement in the decision-making process.

Despite the low observed SDM, both parents and surgeons reported higher perceived levels of SDM, suggesting a disconnect between actual involvement and how it is perceived, with longer consultations correlating with slightly better observed SDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and observations of shared decision making during pediatric otolaryngology surgical consultations. Evong, Y., Chorney, J., Ungar, G., et al.[2020]

A web-based conversation aid was developed to help parents and physicians make shared decisions regarding the management of non-severe acute otitis media (AOM) in children, addressing the overuse of antibiotics.

The tool includes sections on AOM causes, management options, and visual aids showing the effects of antibiotics on pain control and complication rates, aiming to enhance parental understanding and improve communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an electronic conversation aid to support shared decision making for children with acute otitis media. Anderson, JL., Oliveira J E Silva, L., Brito, JP., et al.[2022]

Citations

1. bmcemergmed.biomedcentral.com bmcemergmed.biomedcentral.com/articles/10.1186/s12873-025-01305-w

Shared decision-making for pediatric acute otitis media in the ... Outcomes included parental knowledge of AOM, clinician/parent engagement, interaction time, and antibiotic use. Results. One hundred-one parents ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40753428/

Shared decision-making for pediatric acute otitis media in ... Outcomes included parental knowledge of AOM, clinician/parent engagement, interaction time, and antibiotic use. Results: One hundred-one parents ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02872558

Shared Decision Making in Parents of Children With Acute ... This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis Media in the Emergency Department setting. Detailed Description.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8054029/

Development of an electronic conversation aid to support ... This study is part of the project entitled “Shared Decision Making in Parents of Children with Acute Otitis Media: The Acute Otitis Media Choice ...

5. researchgate.net researchgate.net/publication/394249667_Shared_decision-making_for_pediatric_acute_otitis_media_in_the_United_States_a_randomized_emergency_department_trial

(PDF) Shared decision-making for pediatric acute otitis ... Outcomes included parental knowledge of AOM, clinician/parent engagement, interaction time, and antibiotic use. Results One hundred-one parents ...

6. mayo.edu mayo.edu/research/clinical-trials/cls-20239993

Clinical Trials Data will be collected to see if the information and decision aide will significantly decrease the rate of antibiotic use with no increase in adverse events.