Reducing Antibiotic Prescribing in Family Practice
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|ClinicalTrials.gov Identifier: NCT03674775|
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Tract Infection||Other: DART QI Program Participation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||cluster randomized control trial|
|Masking:||None (Open Label)|
|Official Title:||Dialogue Around Respiratory Illness Treatment for Family Practice (DART -FP)|
|Estimated Study Start Date :||July 2022|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||June 2026|
Active Comparator: Intervention Group Providers
DART QI Program Participation
Other: DART QI Program Participation
Antibiotic prescribing data will be collected at multiple time points both before and after the initiation of the intervention.
No Intervention: Control Group Providers
- Overall antibiotic prescribing rates for pediatric and adult ARTIs. [ 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. ]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.
- First-line antibiotic prescribing rates for pediatric and adult bacterial ARTIs. [ 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. ]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 [ 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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674775
|Contact: Rita Mangione-Smith, MD, MPH||206-884-8242||Rita.Mangione-Smith@seattlechildrens.org|
|Principal Investigator:||Rita Mangione-Smith, MD, MPH||Seattle Children's|