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Reducing Antibiotic Prescribing in Family Practice

Primary Purpose

Acute Respiratory Tract Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DART QI Program Participation
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Tract Infection

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children or adults with acute respiratory tract infections (ARTIs) defined as bacterial (acute otitis media [AOM], pharyngitis, and sinusitis) or viral (bronchitis and viral upper respiratory infection [URI]) based on their common etiologies.
  2. Seven months old and older

Exclusion Criteria:

1. 0 - 6 months old

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention Group Providers

    Control Group Providers

    Arm Description

    DART QI Program Participation

    Usual Care

    Outcomes

    Primary Outcome Measures

    Overall antibiotic prescribing rates for pediatric and adult ARTIs.
    The primary outcome of overall antibiotic prescribing rates for ARTIs will be assessed by calculating the number of eligible ARTI visits occurring within a measurement period (measure denominator) where antibiotics were prescribed (numerator). This outcome will be assessed separately for the eligible pediatric (6 months to 17 years-old) and adult (> 18 years-old) patients.

    Secondary Outcome Measures

    First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs.
    The secondary outcome of first-line antibiotic prescribing rates for bacterial ARTIs will be assessed by calculating the number of eligible bacterial ARTI visits occurring within a measurement period (measure denominator) where first-line antibiotics were prescribed (numerator). This outcome will be assessed separately for the eligible pediatric (6 months to 17 years-old) and adult (> 18 years-old) patients.
    Net cost of delivering the DART QI program
    The net cost of delivering the intervention will be calculated as the difference between the total costs (sum of antibiotic prescription, intervention delivery, and return visit utilization costs) in the intervention and control groups.

    Full Information

    First Posted
    September 6, 2018
    Last Updated
    September 17, 2019
    Sponsor
    Seattle Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03674775
    Brief Title
    Reducing Antibiotic Prescribing in Family Practice
    Official Title
    Dialogue Around Respiratory Illness Treatment for Family Practice (DART -FP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seattle Children's Hospital

    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
    Antibiotic prescribing for childhood acute respiratory tract infections (ARTIs), including acute otitis media (AOM), pharyngitis, sinusitis, bronchitis, and upper respiratory infection (URI), is common in the United States (US). In the outpatient setting, more than 50% of children diagnosed with ARTIs receive antibiotic prescriptions. Considering that the estimated US prevalence of pediatric bacterial ARTIs is 27% (with the remainder of ARTIs caused by viruses) this represents a substantial degree of antibiotic overuse nationwide. Another troubling trend in antibiotic prescribing for ARTIs in children is the increased reliance on broad-spectrum, second-line agents for bacterial ARTIs. Unwarranted use of antibiotics, especially broad-spectrum agents, has been associated with increased resistance among several strains of bacteria that commonly cause ARTIs, posing risks to both individuals and communities.
    Detailed Description
    Provider-parent communication during ARTI visits often drives unwarranted antibiotic prescribing. Dr. Mangione-Smith (proposed principal investigator) and colleagues developed a quality improvement (QI) intervention for pediatric providers called the Dialogue Around Respiratory Illness Treatment (DART) program. The DART QI program is a multifaceted, web-based intervention that is delivered asynchronously over a 9-month period and takes a total of 2 hours to complete. DART's content is based on over a decade of observational research conducted by Mangione-Smith et al focused on optimizing provider-parent communication during pediatric ARTI visits in order to reduce unnecessary antibiotic prescribing while still maintaining parent satisfaction with care.[cites] The DART program also includes content related to evidence-based antibiotic prescribing with a particular focus on reducing the use of second-line, broad-spectrum antibiotics for bacterial ARTIs. Under funding from the Eunice Kennedy National Institute for Child Health and Human Development (NICHD), the investigators recently conducted a trial of the DART QI program with 55 providers from 20 practices belonging to one of two pediatric practice-based research networks: the Pediatric Research in Office Settings (PROS) and NorthShore University Health System networks. Exposure to the DART QI program resulted in an proportional decrease from for overall antibiotic prescribing rates for ARTIs and a proportional decrease from for the use of second-line antibiotics for bacterial ARTIs comparing the baseline to the post-intervention periods. The DART QI Program represents a new, innovative tool to address antibiotic over-use for ARTIs in the pediatric outpatient setting. However, it is unclear whether the program will be effective when disseminated to the family practice clinical setting where 23% of children receive their acute illness care nationally. It is also unclear how exposure to the communication strategies outlined in the DART QI program may influence provider-patient communication during adult encounters for ARTI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Tract Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    cluster randomized control trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group Providers
    Arm Type
    Active Comparator
    Arm Description
    DART QI Program Participation
    Arm Title
    Control Group Providers
    Arm Type
    No Intervention
    Arm Description
    Usual Care
    Intervention Type
    Other
    Intervention Name(s)
    DART QI Program Participation
    Intervention Description
    Antibiotic prescribing data will be collected at multiple time points both before and after the initiation of the intervention.
    Primary Outcome Measure Information:
    Title
    Overall antibiotic prescribing rates for pediatric and adult ARTIs.
    Description
    The primary outcome of overall antibiotic prescribing rates for ARTIs will be assessed by calculating the number of eligible ARTI visits occurring within a measurement period (measure denominator) where antibiotics were prescribed (numerator). This outcome will be assessed separately for the eligible pediatric (6 months to 17 years-old) and adult (> 18 years-old) patients.
    Time Frame
    The primary outcomewill be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
    Secondary Outcome Measure Information:
    Title
    First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs.
    Description
    The secondary outcome of first-line antibiotic prescribing rates for bacterial ARTIs will be assessed by calculating the number of eligible bacterial ARTI visits occurring within a measurement period (measure denominator) where first-line antibiotics were prescribed (numerator). This outcome will be assessed separately for the eligible pediatric (6 months to 17 years-old) and adult (> 18 years-old) patients.
    Time Frame
    The secondary outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
    Title
    Net cost of delivering the DART QI program
    Description
    The net cost of delivering the intervention will be calculated as the difference between the total costs (sum of antibiotic prescription, intervention delivery, and return visit utilization costs) in the intervention and control groups.
    Time Frame
    This outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children or adults with acute respiratory tract infections (ARTIs) defined as bacterial (acute otitis media [AOM], pharyngitis, and sinusitis) or viral (bronchitis and viral upper respiratory infection [URI]) based on their common etiologies. Seven months old and older Exclusion Criteria: 1. 0 - 6 months old
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rita Mangione-Smith, MD, MPH
    Phone
    206-884-8242
    Email
    Rita.Mangione-Smith@seattlechildrens.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rita Mangione-Smith, MD, MPH
    Organizational Affiliation
    Seattle Children's
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Links:
    URL
    https://clinicaltrials.gov/ct2/show/study/NCT02943551?term=Mangione-Smith&rank=1
    Description
    Mangione-Smith R. Dialogue Around Respiratory Treatment (DART). 2018; Accessed 07/31/18.
    URL
    http://www.cms.gov/apps/physician-fee-schedule/overview.aspx
    Description
    CMS Physician Fee Schedule. Accessed 9/14/18.

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    Reducing Antibiotic Prescribing in Family Practice

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