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Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections (DISAPEAR)

Primary Purpose

Acute Otitis Media, Ear Infection, Pediatric Infectious Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Otitis Media focused on measuring Shared Decision-Making, Health-System Level Intervention

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 Aged 6 months-17-years-old (inclusive) Diagnosis of AOM by ICD10 code C. Video recordings or direct observation of the use of a shared decision aid Parent participation: 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 D. 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 E. 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 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 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 H. 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 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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Health System Level (HSL) Intervention

    Hybrid Intervention

    Arm Description

    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: A change in their Electronic Health Record to their prescription fields to align with national guidelines Individualized feedback report to their clinicians and clinic overall And virtual learning sessions and continuing medical education credits for clinicians.

    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: Use of the Shared-Decision Aide Clinician Education on SDM

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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)
    Missed Work/School/Daycare
    Numbers of days child missed school/daycare and/or number of days parent(s) missed work
    Adverse Drug Events
    Percentage of patients with adverse drug event(s)
    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)
    Management Strategy
    Percentage of immediate antibiotic use
    Antibiotic Prescription Filled
    Percentage of filled antibiotic prescriptions (even if not taken)

    Full Information

    First Posted
    August 28, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Denver Health and Hospital Authority
    Collaborators
    AllianceChicago, Intermountain Health Care, Inc., Mayo Clinic, Patient-Centered Outcomes Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06034080
    Brief Title
    Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
    Acronym
    DISAPEAR
    Official Title
    DISAPEAR Trial: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2024 (Anticipated)
    Primary Completion Date
    April 2027 (Anticipated)
    Study Completion Date
    June 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Denver Health and Hospital Authority
    Collaborators
    AllianceChicago, Intermountain Health Care, Inc., Mayo Clinic, Patient-Centered Outcomes Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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 29 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Otitis Media, Ear Infection, Pediatric Infectious Disease
    Keywords
    Shared Decision-Making, Health-System Level Intervention

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Mutli-Center Cluster Randomized Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1450 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Health System Level (HSL) Intervention
    Arm Type
    Active Comparator
    Arm Description
    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: A change in their Electronic Health Record to their prescription fields to align with national guidelines Individualized feedback report to their clinicians and clinic overall And virtual learning sessions and continuing medical education credits for clinicians.
    Arm Title
    Hybrid Intervention
    Arm Type
    Experimental
    Arm Description
    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: Use of the Shared-Decision Aide Clinician Education on SDM
    Intervention Type
    Other
    Intervention Name(s)
    Changes to the electronic health record (EHR)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Individualized audit and feedback reporting for clinicians
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Clinician education sessions
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Use of a shared decision-making (SDM) aide
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Shared decision-making (SDM) education
    Intervention Description
    Clinicians will receive education on SDM and how to use the aid via virtual, recorded sessions.
    Primary Outcome Measure Information:
    Title
    Increase in Parent Satisfaction
    Description
    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 infection
    Title
    Percentage of Patients Taking an Antibiotic for AOM
    Description
    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 infection
    Secondary Outcome Measure Information:
    Title
    Shared Decision-Making
    Description
    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)
    Title
    Pediatric Quality of Life
    Description
    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 infection
    Title
    Symptom and Severity Duration
    Description
    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)
    Time Frame
    0 and 10 days after clinic visit for ear infection
    Title
    Missed Work/School/Daycare
    Description
    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 infection
    Title
    Adverse Drug Events
    Description
    Percentage of patients with adverse drug event(s)
    Time Frame
    10 days after clinic visit for ear infection
    Title
    Treatment Failure
    Description
    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)
    Time Frame
    10 days after clinic visit for ear infection
    Title
    Management Strategy
    Description
    Percentage of immediate antibiotic use
    Time Frame
    At time of clinic visit for ear infection (0 Days)
    Title
    Antibiotic Prescription Filled
    Description
    Percentage of filled antibiotic prescriptions (even if not taken)
    Time Frame
    10 days after clinic visit for ear infection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 Aged 6 months-17-years-old (inclusive) Diagnosis of AOM by ICD10 code C. Video recordings or direct observation of the use of a shared decision aid Parent participation: 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 D. 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 E. 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 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 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 H. 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 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.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Theresa L Morin, MA
    Phone
    303-602-5423
    Email
    Theresa.Morin@dhha.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Holly M Frost, MD
    Phone
    303-602-6461
    Email
    Holly.Frost@dhha.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Holly Frost, MD
    Organizational Affiliation
    Denver Health and Hospital Authority
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be shared with other researchers.

    Learn more about this trial

    Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections

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