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Trial record 70 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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
Sponsor:
Information provided by (Responsible Party):
Rita Mangione-Smith, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Tract Infection Other: DART QI Program Participation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: cluster randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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
Usual Care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Contacts
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Contact: Rita Mangione-Smith, MD, MPH 206-884-8242 Rita.Mangione-Smith@seattlechildrens.org

Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Principal Investigator: Rita Mangione-Smith, MD, MPH Seattle Children's

Additional Information:
Publications:
Centers for Disaese Control and Prevention Antibiotic resistance threats in the United States, 2013. 2013; http://www.cdc.gov/drugresistance/threat Accessed July 25, 2018.
Merriam SB, Cafrrarella RS. Learing in Adulthood. San Francisco, CA: Jossey-Bass; 2008.
Ajzen I, Madden TJ. Prediction of goal-directed behavior: attitudes, intentions, and perceived behavioral control. Journal lof Experimental Social Psychology. 1986;22:453-474.
Gelman A, Hillman J. Data analysis using regression and multilevel/hierarchical models. Cambridge: Cambridge University Press; 2007.
Goldstein H. Multilevel statistical models. 4th ed: Wiley; 2010.
Raudenbush SW, Bryk AS. Heirarchical linear models: applications and data analysis methods. 2nd ed: Sage; 2002.
Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stodart GL. Methods of economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press; 2005.
Basu, A. Estimating costs and valuations of non-health benefits. 2nd ed. New York: Oxford University Press; 2017.
Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for Economic Evaluation of Health Care Programmes. New York: Oxford University Press; 2015.
Tang S. Profile of Pediatric Visits 2004-2007. American Academy of Pediatrics, 2010.

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Responsible Party: Rita Mangione-Smith, Professor and Chief, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03674775     History of Changes
Other Study ID Numbers: 371934
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents