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Dialogue Around Respiratory Illness Treatment (DART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02943551
Recruitment Status : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
University of California, Los Angeles
Portland State University
NorthShore University HealthSystem
American Academy of Pediatrics
University of Washington
Information provided by (Responsible Party):
Rita Mangione-Smith, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Respiratory Disease Acute Respiratory Infection Respiratory Infection Upper Respiratory Infection Other: Online Tutorial Other: Webinars Other: Booster Sessions Other: Feedback Reports Other: Parent Survey Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2728 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Dialogue Around Respiratory Illness Treatment
Actual Study Start Date : July 18, 2016
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Providers

Physicians, 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.

Other: Online Tutorial
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.

Other: Webinars

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.


Other: Booster Sessions

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.


Other: Feedback Reports

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.

Parents

The 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.

Other: Parent Survey
Throughout the study, parents at participating practice sites will be offered the opportunity to complete a DART Parent Survey after their child's visit.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in rates of antibiotic prescribing for viral ARTI [ 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 visits for viral ARTI (bronchitis, non-streptococcal pharyngitis, or viral upper respiratory infection) 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 viral ARTI visits (denominator) where antibiotics were prescribed (numerator).

  2. Change in rates of antibiotic prescribing for pharyngitis [ 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 visits for pharyngitis (both non-streptococcal and streptococcal) 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 visits for pharyngitis (denominator) where antibiotics were prescribed (numerator).

  3. Change in second-line prescribing rates for bacterial ARTIs [ Time Frame: Two years pre-intervention and, on average, a 15-month period during and post intervention ]
    These outcomes will determine whether rates of prescribing second-line antibiotics during pediatric visits for streptococcal pharyngitis, sinusitis, and acute otitis media 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 assessed, the investigators will assess the number of visits for streptococcal pharyngitis, sinusitis, or acute otitis media (denominators) where second-line antibiotics were prescribed (numerators).

  4. Use of Combined Negative and Positive Treatment Recommendations [ Time Frame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure ]
    During exposure to the intervention, provider use of combined negative and positive treatment recommendations will increase during visits for ARTI compared to baseline. Investigators will pool parent survey data and calculate rates of positive and negative treatment recommendations for each eligible visit for each period.

  5. Use of Contingency plans [ Time Frame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure ]
    During exposure to the intervention, provider use of contingency plans will increase during visits for ARTI compared to baseline. Investigators will pool parent survey data and calculate rates of contingency plan use for each eligible visit for each period.

  6. Parent-Reported Satisfaction Scores [ Time Frame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure ]
    Providers exposed to the intervention will have higher parent-reported visit-specific satisfaction scores during exposure to the intervention compared to baseline. To measure satisfaction the investigators will use an adapted version of the 3-item communication composite and the 1-item global visit satisfaction scale from the Consumer Assessment of Healthcare Providers and Systems Clinician and Groups (CG-CAHPS®) Survey. The survey items were adapted so that they are addressed to parents of patients rather than patients themselves. Both the 3-item composite and the 1-item global visit satisfaction scale range from 0-100 with higher scores indicating higher levels of satisfaction.

  7. Cost of intervention implementation [ Time Frame: Two years pre-intervention and, on average, a 15-month period during and post intervention ]
    The cost of implementing the DART intervention and the cost of any resulting utilization changes will be offset by decreased expenditures on antibiotic prescriptions.

  8. Change in health provider expenditures due to intervention [ Time Frame: Two years pre-intervention and, on average, a 15-month period during and post intervention ]
    The cost of implementing the DART intervention and the cost of any resulting utilization changes will be offset by decreased expenditures on antibiotic prescriptions.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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): NCT02943551


Locations
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United States, Arkansas
Paragould Pediatrics
Paragould, Arkansas, United States, 72450
United States, California
Eureka Pediatrics
Eureka, California, United States, 95503
United States, Colorado
Pediatric Partners of the Southwest
Durango, Colorado, United States, 81301
United States, Connecticut
Pediatric Medicine of Wallingford
Wallingford, Connecticut, United States, 06492
United States, Florida
Advance Preventive Care
Bradenton, Florida, United States, 34203
United States, Illinois
A to Z Pediatric & Youth Healthcare
Addison, Illinois, United States, 60101
All Star Pediatrics
Countryside, Illinois, United States, 60525
Deerfield
Deerfield, Illinois, United States, 60015
Evanston (Central)
Evanston, Illinois, United States, 60201
Evanston (Davis)
Evanston, Illinois, United States, 60201
Glenview
Glenview, Illinois, United States, 60026
Gurnee
Gurnee, Illinois, United States, 60031
Lincolnwood
Lincolnwood, Illinois, United States, 60712
Old Orchard
Skokie, Illinois, United States, 60077
Vernon Hills
Vernon Hills, Illinois, United States, 60061
Plaza Del Lago
Wilmette, Illinois, United States, 60091
United States, New York
East End
East Hampton, New York, United States, 11968
Hampton Pediatrics
Southampton, New York, United States, 11968
United States, Tennessee
Plateau Pediatrics
Crossville, Tennessee, United States, 38555
United States, Texas
Cornerstone Pediatrics
Seguin, Texas, United States, 78155
Sponsors and Collaborators
Seattle Children's Hospital
Children's Hospital of Philadelphia
University of California, Los Angeles
Portland State University
NorthShore University HealthSystem
American Academy of Pediatrics
University of Washington
Investigators
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Principal Investigator: Rita Mangione-Smith, M.D. Seattle Children's

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Responsible Party: Rita Mangione-Smith, Primary Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02943551     History of Changes
Other Study ID Numbers: R01HD084547 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.
Keywords provided by Rita Mangione-Smith, Seattle Children's Hospital:
Pediatrics
Respiratory disease
antibiotic use
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents