Reducing Antibiotic Prescribing in Family Practice

Acute Respiratory Tract Infection Clinical Trial

Official title:

Dialogue Around Respiratory Illness Treatment for Family Practice (DART -FP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03674775
• Other study ID #: 371934
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: June 2026

Study information

• Verified date: September 2019
• Source: Seattle Children's Hospital
• Contact: Rita Mangione-Smith, MD, MPH
• Phone: 206-884-8242
• Email: Rita.Mangione-Smith[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Other:
• DART QI Program Participation
Antibiotic prescribing data will be collected at multiple time points both before and after the initiation of the intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The secondary outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.
Secondary	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.	This outcome will be collected for all participating providers (both intervention and control) during a 30-month period beginning with baseline data collection.

External Links

•   Bureau of Labor Statistics National Compensation Survey. Accessed 9/14/18.
•   CAHPS 2.0 Questionnaires. 2007
•   Centers for Disaese Control and Prevention Antibiotic resistance threats in the United States, 2013. 2013; Accessed July 25, 2018.
•   CMS Physician Fee Schedule. Accessed 9/14/18.
•   Mangione-Smith R. Dialogue Around Respiratory Treatment (DART). 2018; Accessed 07/31/18.