Reducing Antibiotic Prescribing in Family Practice

NCT03674775 | Not Yet Recruiting DMC

• 1 other identifier: 371934
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary outcomewill be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.

Secondary Outcomes (2)

• First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs.

  The secondary outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.

• Net cost of delivering the DART QI program

  This outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.

Study Arms (2)

Intervention Group Providers

ACTIVE COMPARATOR

DART QI Program Participation

Other: DART QI Program Participation

Control Group Providers

NO INTERVENTION

Usual Care

Interventions

DART QI Program Participation OTHER

Antibiotic prescribing data will be collected at multiple time points both before and after the initiation of the intervention.

Intervention Group Providers

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. 0 - 6 months old

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Related Publications (46)

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Related Links

• Mangione-Smith R. Dialogue Around Respiratory Treatment (DART). 2018; Accessed 07/31/18.
• CAHPS 2.0 Questionnaires. 2007
• CMS Physician Fee Schedule. Accessed 9/14/18.

Study Officials

• Rita Mangione-Smith, MD, MPH

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Mangione-Smith, MD, MPH

CONTACT

206-884-8242; Rita.Mangione-Smith@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief

Model Details: cluster randomized control trial

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 18, 2018
• Study Start: July 1, 2022
• Primary Completion: January 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share