Acute Otitis MediaDISAPEARNCT06034080
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
A study testing Changes to the electronic health record (EHR), Individualized audit and feedback reporting for clinicians and Clinician education sessions in people with Acute Otitis Media and Ear Infection, run by Intermountain Health Care, Inc. at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Acute Otitis Media, Ear Infection, Pediatric Infectious Disease
- What is being tested?
- Changes to the electronic health record (EHR), Individualized audit and feedback reporting for clinicians and Clinician education sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,566 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Feb 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Implementation of Interventions 1. Clinic at a participating organization 2. Provides care to children with AOM 3. Administrative or local approval for participation
- Secondary Electronic Health Record Data
- Aged 6 months-17-years-old (inclusive)
- Diagnosis of AOM by ICD10 code
- Video recordings or direct observation of the use of a shared decision aid
- Parent participation:
Show all 26Show fewer
- Child aged 6 months-17 years (inclusive)
- Diagnosed with AOM by clinician
- Parent or legal guardian is present and is >=18 years or older
- Clinician Participation:
- Licensed clinician and not a medical trainee
- Age 18 >= years or older
- Pre-implementation interviews of clinicians and administrators
- 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.
- Aged >=18 years-no maximum
- Pre-implementation focus groups of parents
- Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
- 18 years of age or older and able/willing to consent
- 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
- Post-intervention focus groups of parents
- Parent or legal guardian of a child aged 6 months-17 years (inclusive) that has had AOM diagnosed at a participating organization.
- 18 years of age or older and able/willing to consent
- Post-intervention surveys of clinicians and administrators
- 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.
- Aged >=18 years-no maximum
Who cannot join
- Implementation of Interventions
- 1. Clinics that exclusively provide telehealth
- Secondary Electronic Health Record Data
- 1. None
- Video recordings or direct observation of the use of a shared decision aid
- Parent participation:
Show all 16Show fewer
- 1. None
- Clinician Participation:
- 1. None
- Pre-implementation interviews of clinicians and administrators 1. Medical trainee (student, resident, fellow, etc.)
- Pre-implementation focus groups of parents
- 1. None
- Parents enrolled for surveys 1. Complicated or recurrent AOM as determined by the study team
- Post-intervention focus groups of parents 1. None
- Post-intervention surveys of clinicians and administrators
- 1. Medical trainee (student, resident, fellow, etc.)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
AllianceChicago
Chicago, Illinois, 60654
Mirta Milanes, MPH, 872-227-6673, mmilanes@alliancechicago.org
Rasmi Narayan, MD
- Recruiting
Denver Health and Hospital Authority
Denver, Colorado, 80204
Aiden Gilbert, MPA, 303-602-2709, aiden.gilbert@dhha.org
Timothy Jenkins, MD, 303-602-5041, timothy.jenkins@dhha.org
- Recruiting
Intermountain Health
Murray, Utah, 84107
Theresa Morin, MA, 802-881-9534, theresa.morin@imail.org
Hannah Jensen, 801-507-4910, hannah.curtis@imail.org
About this study
Official 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.
Read the detailed 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.
- Being tested
- Changes to the electronic health record (EHR), Individualized audit and feedback reporting for clinicians, Clinician education sessions, Use of a shared decision-making (SDM) aide, Shared decision-making (SDM) education
- Keywords
- Shared Decision-Making, Health-System Level Intervention
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes to the electronic health record (EHR)Other
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 cliniciansOther
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 sessionsOther
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) aideOther
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) educationOther
Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.
| Study group | Role | What they receive |
|---|---|---|
| Health System Level (HSL) Intervention | Active comparator | 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. Receives: Other: Changes to the electronic health record (EHR); Other: Individualized audit and feedback reporting for clinicians; Other: Clinician education sessions |
| Hybrid Intervention | Experimental | 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 Receives: Other: Changes to the electronic health record (EHR); Other: Individualized audit and feedback reporting for clinicians; Other: Clinician education sessions; Other: Use of a shared decision-making (SDM) aide; Other: Shared decision-making (SDM) education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days after clinic visit for ear infection
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.
Measured: 10 days after clinic visit for ear infection
Secondary outcomes (8)
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.
Measured: At time of clinic visit for ear infection (0 Days)
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.
Measured: 10 days after clinic visit for ear infection
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)
Measured: 0 and 10 days after clinic visit for ear infection
Missed Work/School/Daycare
Numbers of days child missed school/daycare and/or number of days parent(s) missed work
Measured: 10 days after clinic visit for ear infection
Adverse Drug Events
Percentage of patients with adverse drug event(s)
Measured: 10 days after clinic visit for ear infection
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)
Measured: 10 days after clinic visit for ear infection
Management Strategy
Percentage of immediate antibiotic use
Measured: At time of clinic visit for ear infection (0 Days)
Antibiotic Prescription Filled
Percentage of filled antibiotic prescriptions (even if not taken)
Measured: 10 days after clinic visit for ear infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start3 Feb 2025
- Primary completion1 Jun 2027 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mutli-Center Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 1,566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- AllianceChicago, Mayo Clinic, Patient-Centered Outcomes Research Institute, Denver Health and Hospital Authority
- Responsible party
- Sponsor
- Investigators
- Holly Frost, MD, Principal investigator, Intermountain Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034080
- Sponsor's protocol ID
- 23-1096
- Other IDs
- IHS-2022C2-28005
- Acronym
- DISAPEAR
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Rinehart DJ, Gilbert A, Andersen LM, Gray TW, O'Leary S, Frost HM; DISAPEAR Study Group. Barriers and Facilitators to Implementing Watchful Waiting for Pediatric Acute Otitis Media. J Pediatr. 2026 Feb;289:114904. doi: 10.1016/j.jpeds.2025.114904. Epub 2025 Nov 13.
PubMed 41241139Jenkins TC, Keith A, Stein AB, Hersh AL, Narayan R, Eggleston A, Rinehart DJ, Patel PK, Walter E, Hargraves IG, Frost HM; DISAPEAR Study Group. Interventions to de-implement unnecessary antibiotic prescribing for ear infections (DISAPEAR Trial): protocol for a cluster-randomized trial. BMC Infect Dis. 2024 Jan 24;24(1):126. doi: 10.1186/s12879-023-08960-z.
PubMed 38267837
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
- ClinicalTrials.gov ID
- NCT06034080
- Acronym / sponsor ID
- DISAPEAR / 23-1096
- Keywords
- Shared Decision-Making, Health-System Level Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,566 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- AllianceChicago, Mayo Clinic, Patient-Centered Outcomes Research Institute, Denver Health and Hospital Authority
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mutli-Center Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Health System Level (HSL) Intervention | Active comparator | Other: Changes to the electronic health record (EHR), Other: Individualized audit and feedback reporting for clinicians, Other: Clinician education sessionsThe 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. |
| Hybrid Intervention | Experimental | Other: Changes to the electronic health record (EHR), Other: Individualized audit and feedback reporting for clinicians, Other: Clinician education sessions, Other: Use of a shared decision-making (SDM) aide, Other: Shared decision-making (SDM) educationThe 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 |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (26 listed)
- Implementation of Interventions 1. Clinic at a participating organization 2. Provides care to children with AOM 3. Administrative or local approval for participation
- Secondary Electronic Health Record Data
- Aged 6 months-17-years-old (inclusive)
- Diagnosis of AOM by ICD10 code
- Video recordings or direct observation of the use of a shared decision aid
Key exclusion criteria (16 listed)
- Implementation of Interventions
- 1. Clinics that exclusively provide telehealth
- Secondary Electronic Health Record Data
- 1. None
- Video recordings or direct observation of the use of a shared decision aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Health System Level (HSL) Intervention, Hybrid Intervention |
| Individualized audit and feedback reporting for cliniciansAutomated 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. | Other | Health System Level (HSL) Intervention, Hybrid Intervention |
| Clinician education sessionsVirtual 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. | Other | Health System Level (HSL) Intervention, Hybrid Intervention |
| Use of a shared decision-making (SDM) aideA 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. | Other | Hybrid Intervention |
| Shared decision-making (SDM) educationClinicians will receive education on SDM and how to use the aid via virtual, recorded sessions. | Other | Hybrid Intervention |
Primary outcome
Increase in Parent Satisfaction
Time frame: 10 days after clinic visit for ear infection
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.
Percentage of Patients Taking an Antibiotic for AOM
Time frame: 10 days after clinic visit for ear infection
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.
8 secondary outcomes
Shared Decision-Making
Time frame: At time of clinic visit for ear infection (0 Days)
Pediatric Quality of Life
Time frame: 10 days after clinic visit for ear infection
Symptom and Severity Duration
Time frame: 0 and 10 days after clinic visit for ear infection
Missed Work/School/Daycare
Time frame: 10 days after clinic visit for ear infection
Adverse Drug Events
Time frame: 10 days after clinic visit for ear infection
Treatment Failure
Time frame: 10 days after clinic visit for ear infection
Management Strategy
Time frame: At time of clinic visit for ear infection (0 Days)
Antibiotic Prescription Filled
Time frame: 10 days after clinic visit for ear infection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Derived from this study: PubMed 41241139Rinehart DJ, Gilbert A, Andersen LM, Gray TW, O'Leary S, Frost HM; DISAPEAR Study Group. Barriers and Facilitators to Implementing Watchful Waiting for Pediatric Acute Otitis Media. J Pediatr. 2026 Feb;289:114904. doi: 10.1016/j.jpeds.2025.114904. Epub 2025 Nov 13.
- Derived from this study: PubMed 38267837Jenkins TC, Keith A, Stein AB, Hersh AL, Narayan R, Eggleston A, Rinehart DJ, Patel PK, Walter E, Hargraves IG, Frost HM; DISAPEAR Study Group. Interventions to de-implement unnecessary antibiotic prescribing for ear infections (DISAPEAR Trial): protocol for a cluster-randomized trial. BMC Infect Dis. 2024 Jan 24;24(1):126. doi: 10.1186/s12879-023-08960-z.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holly Frost, MD principal investigator
Intermountain Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changes to the electronic health record (EHR), Individualized audit and feedback reporting for clinicians and Clinician education sessions in people with Acute Otitis Media and Ear Infection, run by Intermountain Health Care, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa L Morin, MA (802-881-9534, theresa.morin@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Parent Satisfaction (time frame: 10 days after clinic visit for ear infection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.