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RELAX: Reducing Length of Antibiotics for Children With Ear Infections (RELAX)

Primary Purpose

Acute Otitis Media, Pediatric Infectious Disease, Ear Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Intervention
Low Intensity Intervention
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 Acute Otitis Media, Ear Infections, Pediatric Infectious Disease, Electronic Health Record, Antibiotic Stewardship

Eligibility Criteria

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

Inclusion Criteria: A. Secondary use data of encounters for children with AOM Aged 2-17-years-old (inclusive) Diagnosis of AOM by ICD10 code AOM is uncomplicated Prescribed an oral antibiotic B. Clinician and administrator interviews Licensed clinician (physician or advanced practice clinician) that cares for children with AOM Practices in an intervention study site Is not a medical trainee (student, resident, fellow, etc.) Aged >=18 years-no maximum C. Parent focus groups Parent or legal guardian of a child aged 2-17 years that has had AOM diagnosed at Vanderbilt University Medical Center or Washington University 18 years of age or older and able/willing to consent D. Clinician and administrator surveys Licensed clinician (physician or advanced practice clinician) that cares for children with AOM Practices in an intervention study site Is not a medical trainee (student, resident, fellow, etc.) Aged >=18 years-no maximum Exclusion Criteria: A. Secondary use data of encounters for children with AOM 1. Complicated infection (determined a priori) B. Clinician and administrator interviews 1. Medical trainee C. Parent focus groups Not parent or legal guardian Does not speak English or Spanish (focus groups can only be conducted in these languages). D. Clinician and administrator surveys 1. Medical trainee

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    High Intensity

    Low Intensity

    Arm Description

    Community-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention.

    Community-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention.

    Outcomes

    Primary Outcome Measures

    Proportion of children ≥ 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics.
    Determine the effectiveness of a High and Low intensity intervention to increase prescribing of recommended antibiotic durations (short, 5 days) for AOM in children ≥ 2 years of age.

    Secondary Outcome Measures

    Mean days of antibiotics prescribed
    Mean number of days of antibiotics prescribed for children ≥ 2 years of age with AOM
    Adverse drug event
    Number of adverse drug events among children ≥ 2 years of age prescribed antibiotics for AOM
    Treatment failure
    Treatment failure defined as a new antibiotic associated with an AOM encounter within 3-14 days of the initial encounter.
    Recurrence
    Recurrence defined as a new antibiotic associated with an AOM encounter within 15-30 days of initial encounter.

    Full Information

    First Posted
    October 24, 2022
    Last Updated
    February 27, 2023
    Sponsor
    Denver Health and Hospital Authority
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University Medical Center, Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05608993
    Brief Title
    RELAX: Reducing Length of Antibiotics for Children With Ear Infections
    Acronym
    RELAX
    Official Title
    RELAX: Reducing Length of Antibiotics for Children With Ear Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    April 2027 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Denver Health and Hospital Authority
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ), Vanderbilt University Medical Center, Washington University School of Medicine

    4. Oversight

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

    5. Study Description

    Brief Summary
    The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost interventions of different intensities to increase prescribing of recommended short antibiotic durations for acute otitis media (AOM) for children 2 years of age and older. A multi-center cluster randomized controlled trial using a hybrid type 2 implementation effectiveness design will be used to evaluate interventions. The High-Intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and electronic health record (EHR) changes of prescription fields, whereas the Low-Intensity intervention will include clinician education and EHR changes. In total, 46 community-based clinics and/or urgent care centers across two distinct geographic regions in the United States will be randomized to one of the two interventions. 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, surveys, and cost analyses. National stakeholders at the American Academy of Pediatrics and the Centers for Disease Control and Prevention will assist with dissemination of findings and scaling of interventions.
    Detailed Description
    Acute otitis media (AOM) is the most commonly cited indication for antibiotics in children, accounting for 24% of all pediatric antibiotic prescriptions and affecting 60% of children by 3 years of age. For most children ≥ 2 years of age with AOM, 5-7 days, rather than 10 days, of antibiotics have been shown to be sufficient and result in fewer adverse drug events with similar failure and recurrence rates. Thus, national guidelines recommend short durations of antibiotics for non-severe AOM in this age group. Despite these recommendations, >94% of children ≥2 years of age are prescribed longer than recommended antibiotic durations and over 41% of antibiotic exposure days for AOM in this age group are likely unnecessary. In a recent pilot study that compared a low-cost High-intensity intervention with clinician education, individualized clinician audit and feedback with peer comparison and electronic health record (EHR) changes of prescription fields to a Low-intensity intervention with only EHR changes prescribing of recommended short antibiotic durations increased significantly (76% and 50%, absolute percentage). A definite study is needed to make appropriate recommendations on which intervention to implement, while minimizing resource utilization. The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost pragmatic interventions of different intensities to increase prescribing of recommended short antibiotic durations for AOM for children 2 years of age and older. A multi-center cluster randomized controlled trial using a hybrid type 2 implementation effectiveness design will be used to evaluate interventions. The High-intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and EHR changes of prescription fields, whereas the Low-intensity intervention will include clinician education and EHR changes. In total, 46 community-based clinics and/or urgent care centers across two distinct geographic regions in the United States will be randomized to one of the two interventions. The Practical Robust Implementation and Sustainability Model will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance 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, surveys, and cost analyses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Otitis Media, Pediatric Infectious Disease, Ear Infection
    Keywords
    Acute Otitis Media, Ear Infections, Pediatric Infectious Disease, Electronic Health Record, Antibiotic Stewardship

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Intensity
    Arm Type
    Experimental
    Arm Description
    Community-based clinics and/or urgent care centers that are assigned to the high intensity arm will receive the high intensity intervention.
    Arm Title
    Low Intensity
    Arm Type
    Experimental
    Arm Description
    Community-based clinics and/or urgent care centers that are assigned to the low intensity arm will receive the low intensity intervention.
    Intervention Type
    Other
    Intervention Name(s)
    High Intensity Intervention
    Intervention Description
    The High Intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and electronic health record (EHR) changes of prescription fields.
    Intervention Type
    Other
    Intervention Name(s)
    Low Intensity Intervention
    Intervention Description
    The Low Intensity intervention will include clinician education and EHR changes only.
    Primary Outcome Measure Information:
    Title
    Proportion of children ≥ 2 years of age with AOM that are prescribed a short duration (5 days) of antibiotics.
    Description
    Determine the effectiveness of a High and Low intensity intervention to increase prescribing of recommended antibiotic durations (short, 5 days) for AOM in children ≥ 2 years of age.
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Mean days of antibiotics prescribed
    Description
    Mean number of days of antibiotics prescribed for children ≥ 2 years of age with AOM
    Time Frame
    5 years
    Title
    Adverse drug event
    Description
    Number of adverse drug events among children ≥ 2 years of age prescribed antibiotics for AOM
    Time Frame
    5 years
    Title
    Treatment failure
    Description
    Treatment failure defined as a new antibiotic associated with an AOM encounter within 3-14 days of the initial encounter.
    Time Frame
    5 years
    Title
    Recurrence
    Description
    Recurrence defined as a new antibiotic associated with an AOM encounter within 15-30 days of initial encounter.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A. Secondary use data of encounters for children with AOM Aged 2-17-years-old (inclusive) Diagnosis of AOM by ICD10 code AOM is uncomplicated Prescribed an oral antibiotic B. Clinician and administrator interviews Licensed clinician (physician or advanced practice clinician) that cares for children with AOM Practices in an intervention study site Is not a medical trainee (student, resident, fellow, etc.) Aged >=18 years-no maximum C. Parent focus groups Parent or legal guardian of a child aged 2-17 years that has had AOM diagnosed at Vanderbilt University Medical Center or Washington University 18 years of age or older and able/willing to consent D. Clinician and administrator surveys Licensed clinician (physician or advanced practice clinician) that cares for children with AOM Practices in an intervention study site Is not a medical trainee (student, resident, fellow, etc.) Aged >=18 years-no maximum Exclusion Criteria: A. Secondary use data of encounters for children with AOM 1. Complicated infection (determined a priori) B. Clinician and administrator interviews 1. Medical trainee C. Parent focus groups Not parent or legal guardian Does not speak English or Spanish (focus groups can only be conducted in these languages). D. Clinician and administrator surveys 1. Medical trainee
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amy Keith, MPH
    Phone
    303-602-7198
    Email
    amy.keith@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 M Frost, MD
    Organizational Affiliation
    Denver Health and Hospital Authority
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sophie E Katz, MD
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jason Newland, MD
    Organizational Affiliation
    Washington University School of Medicine
    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

    RELAX: Reducing Length of Antibiotics for Children With Ear Infections

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