Clinical trial NCT02943551: Dialogue Around Respiratory Illness Treatment
Official title: Dialogue Around Respiratory Illness Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Disease
Acute Respiratory Infection
Respiratory Infection
Upper Respiratory Infection
Keywords: Pediatrics
Respiratory disease
antibiotic use
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of California, Los Angeles
name: Portland State University
name: Endeavor Health
name: American Academy of Pediatrics
name: University of Washington
First posted: 2016-10-24
Enrollment: 2728
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in rates of overall antibiotic prescribing for all ARTI visits
timeFrame: Two years pre-intervention and, on average, a 15-month period during and post intervention
Secondary outcomes:
measure: Change in rates of antibiotic prescribing for viral ARTI
timeFrame: Two years pre-intervention and, on average, a 15-month period during and post intervention
measure: Change in rates of antibiotic prescribing for pharyngitis
timeFrame: Two years pre-intervention and, on average, a 15-month period during and post intervention
measure: Change in second-line prescribing rates for bacterial ARTIs
timeFrame: Two years pre-intervention and, on average, a 15-month period during and post intervention
measure: Use of Combined Negative and Positive Treatment Recommendations
timeFrame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
measure: Use of Contingency plans
timeFrame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
measure: Parent-Reported Satisfaction Scores
timeFrame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
measure: Cost of intervention implementation
timeFrame: Two years pre-intervention and, on average, a 15-month period during and post intervention
measure: Change in health provider expenditures due to intervention
timeFrame: Two years pre-intervention and, on average, a 15-month period during and post intervention
Other outcomes:
Locations:
city: Paragould
country: United States
facility: Paragould Pediatrics
state: Arkansas
city: Eureka
country: United States
facility: Eureka Pediatrics
state: California
city: Durango
country: United States
facility: Pediatric Partners of the Southwest
state: Colorado
city: Wallingford
country: United States
facility: Pediatric Medicine of Wallingford
state: Connecticut
city: Bradenton
country: United States
facility: Advance Preventive Care
state: Florida
city: Addison
country: United States
facility: A to Z Pediatric & Youth Healthcare
state: Illinois
city: Countryside
country: United States
facility: All Star Pediatrics
state: Illinois
city: Deerfield
country: United States
facility: Deerfield
state: Illinois
city: Evanston
country: United States
facility: Evanston (Central)
state: Illinois
city: Evanston
country: United States
facility: Evanston (Davis)
state: Illinois
city: Glenview
country: United States
facility: Glenview
state: Illinois
city: Gurnee
country: United States
facility: Gurnee
state: Illinois
city: Lincolnwood
country: United States
facility: Lincolnwood
state: Illinois
city: Skokie
country: United States
facility: Old Orchard
state: Illinois
city: Vernon Hills
country: United States
facility: Vernon Hills
state: Illinois
city: Wilmette
country: United States
facility: Plaza Del Lago
state: Illinois
city: East Hampton
country: United States
facility: East End
state: New York
city: Southampton
country: United States
facility: Hampton Pediatrics
state: New York
city: Crossville
country: United States
facility: Plateau Pediatrics
state: Tennessee
city: Seguin
country: United States
facility: Cornerstone Pediatrics
state: Texas
Study officials:
affiliation: Seattle Children's Hospital
name: Rita Mangione-Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mangione-Smith R, Robinson JD, Zhou C, Stout JW, Fiks AG, Shalowitz M, Gerber JS, Burges D, Hedrick B, Warren L, Grundmeier RW, Kronman MP, Shone LP, Steffes J, Wright M, Heritage J. Fidelity evaluation of the dialogue around respiratory illness treatment (DART) program communication training. Patient Educ Couns. 2022 Jul;105(7):2611-2616. doi: 10.1016/j.pec.2022.03.011. Epub 2022 Mar 14.
citation: Kronman MP, Gerber JS, Grundmeier RW, Zhou C, Robinson JD, Heritage J, Stout J, Burges D, Hedrick B, Warren L, Shalowitz M, Shone LP, Steffes J, Wright M, Fiks AG, Mangione-Smith R. Reducing Antibiotic Prescribing in Primary Care for Respiratory Illness. Pediatrics. 2020 Sep;146(3):e20200038. doi: 10.1542/peds.2020-0038. Epub 2020 Aug 3.