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Clinical Trials/NCT02943551
NCT02943551
Unknown
Not Applicable

Dialogue Around Respiratory Illness Treatment

Seattle Children's Hospital20 sites in 1 country2,728 target enrollmentJuly 18, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Disease
Sponsor
Seattle Children's Hospital
Enrollment
2728
Locations
20
Primary Endpoint
Change in rates of overall antibiotic prescribing for all ARTI visits
Last Updated
6 years ago

Overview

Brief Summary

Unwarranted use of antibiotics for pediatric acute respiratory tract infections (ARTIs) and use of second-line, broad spectrum antibiotics for bacterial ARTIs has contributed to the rapid development of resistance in many strains of bacteria. Provider-parent communication during pediatric visits for ARTIs strongly influence antibiotic prescribing rates. The overall goal of this study is to develop and test a distance learning quality improvement (QI) program called Dialogue Around Respiratory Illness Treatment - DART. The DART program aims to improve provider communication practices and treatment decisions during pediatric ARTI visits, with the ultimate goal being to decrease rates of antibiotic prescribing for these illnesses in children.

Detailed Description

The specific aims of the study are:1) to test the DART program's effectiveness on a) overall antibiotic prescribing rates for all pediatric ARTIs and b) first-line antibiotic prescribing rates for bacterial ARTIs (acute otitis media, Group A Streptococcal pharyngitis, and sinusitis), 2) to test the DART program's effectiveness in changing providers' communication practices during ARTI visits, 3) to determine visit-specific satisfaction levels for parents of children seen by study providers and assess how satisfaction changes as a function of exposure to the DART program, and 4) to assess the cost of implementing the DART program and its impact on health care expenditures. To accomplish these aims, we propose a quasi-experimental study utilizing a stepped wedge design. In collaboration with two practice-based research networks: the electronic Pediatric Research in Office Settings (ePROS) network and the NorthShore Pediatric network, we will recruit 20 practices to participate. Over a 20 month period, the intervention will be sequentially deployed to 4 groups of practices (5 practices/group). Each practice will function as part of the control group until they receive the intervention. The DART program's effectiveness will be assessed by examining provider antibiotic prescribing rates for ARTIs (both overall and first-line), communication practices, and parent satisfaction both pre- and post-intervention exposure using survey and electronic health record data. If the DART program is effective for both reducing ARTI antibiotic prescribing to levels consistent with bacterial prevalence rates and increasing use of first-line antibiotics for bacterial ARTIs, we will have an innovative, highly disseminable QI intervention program to further address this critical public health problem.

Registry
clinicaltrials.gov
Start Date
July 18, 2016
End Date
June 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rita Mangione-Smith

Primary Investigator

Seattle Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Visits to enrolled providers by children aged 6 months to 10 years with an International Classification of Diseases-10 (ICD-10) diagnosis code for AOM, bronchitis, pharyngitis, sinusitis, or upper respiratory infection (URI) will be included in the study. Only systemic (oral) antibiotic prescriptions on the same date as the study visit will be included in prescribing measures for each ARTI.

Exclusion Criteria

  • ARTI visits will be excluded from measures of prescribing if there are any competing non-ARTI bacterial diagnoses (e.g. urinary tract infection) or any antibiotic prescriptions during the 30-days prior to the index visit. Visits by children with allergies to penicillin or cephalosporin antibiotics will be excluded from measures of second-line prescribing.

Outcomes

Primary Outcomes

Change in rates of overall antibiotic prescribing for all ARTI visits

Time Frame: Two years pre-intervention and, on average, a 15-month period during and post intervention

This outcome will determine whether rates of prescribing antibiotics during pediatric ARTI visits change as a function of the intervention. A baseline period will be compared to periods both during the intervention and post-intervention. For each time-period, the investigators will assess the number of ARTI visits (denominator) where antibiotics were prescribed (numerator).

Secondary Outcomes

  • Change in rates of antibiotic prescribing for pharyngitis(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Change in rates of antibiotic prescribing for viral ARTI(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Change in second-line prescribing rates for bacterial ARTIs(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Use of Combined Negative and Positive Treatment Recommendations(On average 6 months pre-intervention and, on average, 9 months during intervention exposure)
  • Use of Contingency plans(On average 6 months pre-intervention and, on average, 9 months during intervention exposure)
  • Cost of intervention implementation(Two years pre-intervention and, on average, a 15-month period during and post intervention)
  • Parent-Reported Satisfaction Scores(On average 6 months pre-intervention and, on average, 9 months during intervention exposure)
  • Change in health provider expenditures due to intervention(Two years pre-intervention and, on average, a 15-month period during and post intervention)

Study Sites (20)

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