Clinical trial NCT03674775: Reducing Antibiotic Prescribing in Family Practice
Official title: Dialogue Around Respiratory Illness Treatment for Family Practice (DART -FP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Respiratory Tract Infection
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall antibiotic prescribing rates for pediatric and adult ARTIs.
timeFrame: 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:
measure: First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs.
timeFrame: The secondary outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
measure: Net cost of delivering the DART QI program
timeFrame: This outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
Other outcomes:
Locations:
Study officials:
affiliation: Seattle Children's Hospital
name: Rita Mangione-Smith, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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