Dialogue Around Respiratory Illness Treatment
DART
1 other identifier
interventional
2,728
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2016
CompletedFirst Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
October 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJuly 16, 2019
July 1, 2019
3.9 years
August 23, 2016
July 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in rates of overall antibiotic prescribing for all ARTI visits
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).
Two years pre-intervention and, on average, a 15-month period during and post intervention
Secondary Outcomes (8)
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 rates of antibiotic prescribing for pharyngitis
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
- +3 more secondary outcomes
Study Arms (2)
Providers
OTHERPhysicians, pediatric nurse practitioners and physician assistants (referred to as providers from here forward) will be recruited from 20 practices, with a maximum of four providers participating from a single practice, for a maximum of 80 providers. Providers will receive an online tutorials, interactive group webinars, simulated booster sessions as well as feedback reports.
Parents
OTHERThe number of parents who participate will depend on the number of providers who agree to participate at each of the 20 practices. The total could range from a minimum of 1800 parents to a maximum of 7200 parents. Throughout the study, parents at participating practice sites will be offered the opportunity to complete a DART Parent Survey after their child's visit.
Interventions
For each group of practices, during the first month of intervention participation, study staff at Seattle Children's Research Institute will send each participating provider within a group/wedge, via email, a password to access the online tutorial. Participants will be asked to view the 40-minute tutorial at a time that is convenient for them but prior to the first webinar. Investigators will be able to track whether and how often participants access the online tutorial as a measure of engagement in the intervention. PROS will follow up, via email or phone, with providers who have not completed the tutorial within a three week timeframe.
The first webinar, focused on making appropriate antibiotic choices for bacterial ARTIs, will be held at the beginning of month 2 of intervention participation, and the second webinar, focused on recommended communication practices during visits for ARTIs, will be held at the beginning of month 3 of intervention participation. Due to webinar faculty time constraints, we will establish dates/times for the webinar prior to recruitment. Providers will be given information on webinar dates in both the randomization email, as well as include the dates in the study box letter. The webinars will be recorded to facilitate attendance for those who are unable to make the scheduled date/time. Included in the recording will be the presentation and any questions and answers from participants.
An online link to the first booster video vignette will be sent to practice participants via email at the beginning of month 5 of intervention participation for each group/wedge. The link will lead to a website in which the provider will need to create a user name and password to access the booster videos. Two additional booster vignettes will be made available for viewing at the beginning of months 7 and 9 of intervention participation. For each of the three booster sessions, up to three reminders to complete viewing the video vignette will be sent over a 2-week period. The study team will be able to monitor whether participants access and complete the questions at the end of each vignette.
During the intervention phase, providers will also receive 6 audit and feedback reports given by parents. The first report will have two parts: * The first part will focus on the provider's overall antibiotic prescribing rates for all ARTIs (viral and bacterial) and rates of using second-line antibiotics for bacterial ARTIs. * The second part will report the rates at which the provider uses the targeted communication practices as well as their average satisfaction scores.
Throughout the study, parents at participating practice sites will be offered the opportunity to complete a DART Parent Survey after their child's visit.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- Children's Hospital of Philadelphiacollaborator
- University of California, Los Angelescollaborator
- Portland State Universitycollaborator
- Endeavor Healthcollaborator
- American Academy of Pediatricscollaborator
- University of Washingtoncollaborator
Study Sites (20)
Paragould Pediatrics
Paragould, Arkansas, 72450, United States
Eureka Pediatrics
Eureka, California, 95503, United States
Pediatric Partners of the Southwest
Durango, Colorado, 81301, United States
Pediatric Medicine of Wallingford
Wallingford, Connecticut, 06492, United States
Advance Preventive Care
Bradenton, Florida, 34203, United States
A to Z Pediatric & Youth Healthcare
Addison, Illinois, 60101, United States
All Star Pediatrics
Countryside, Illinois, 60525, United States
Deerfield
Deerfield, Illinois, 60015, United States
Evanston (Central)
Evanston, Illinois, 60201, United States
Evanston (Davis)
Evanston, Illinois, 60201, United States
Glenview
Glenview, Illinois, 60026, United States
Gurnee
Gurnee, Illinois, 60031, United States
Lincolnwood
Lincolnwood, Illinois, 60712, United States
Old Orchard
Skokie, Illinois, 60077, United States
Vernon Hills
Vernon Hills, Illinois, 60061, United States
Plaza Del Lago
Wilmette, Illinois, 60091, United States
East End
East Hampton, New York, 11968, United States
Hampton Pediatrics
Southampton, New York, 11968, United States
Plateau Pediatrics
Crossville, Tennessee, 38555, United States
Cornerstone Pediatrics
Seguin, Texas, 78155, United States
Related Publications (2)
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.
PMID: 35341612DERIVEDKronman 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.
PMID: 32747473DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rita Mangione-Smith, M.D.
Seattle Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
August 23, 2016
First Posted
October 24, 2016
Study Start
July 18, 2016
Primary Completion
May 30, 2020
Study Completion
June 30, 2020
Last Updated
July 16, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The data will be provided after all analyses are completed for a period of 5 years.
- Access Criteria
- A data use agreement will be required between Seattle Children's Research Institute and any entity requesting access to the data. Those requesting access to the data will be required to provide a detailed plan for their use of the data. This agreement will also require that the requesting investigator/entity obtain permission to publish results based on these data from Seattle Children's Research Institute and the Principal Investigator prior to submission for any such publication.
If requested and criteria for receipt are met, data will be shared with investigators outside the DART project team when all planned data collection and analyses are completed. The data shared will be limited to visit-based prescribing rates, patient characteristics, and dummy variables for clinic site (de-identified). No protected health information for study participants will be shared. Data will be provided as a CSV file with a data dictionary defining all variables included in the file. Additional analytic tools will not be provided. Data will be transferred using a secure file transfer protocol.