Respiratory DiseaseDARTNCT02943551
Dialogue Around Respiratory Illness Treatment
A study testing Online Tutorial, Webinars and Booster Sessions in people with Respiratory Disease and Acute Respiratory Infection, run by Seattle Children's Hospital at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Respiratory Disease, Acute Respiratory Infection, Respiratory Infection
- What is being tested?
- Online Tutorial, Webinars and Booster Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,728 participants
- Where
- 20 sitesUnited States
- Study dates
- 18 Jul 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
A to Z Pediatric & Youth Healthcare
Addison, Illinois, 60101
Advance Preventive Care
Bradenton, Florida, 34203
All Star Pediatrics
Countryside, Illinois, 60525
Plateau Pediatrics
Crossville, Tennessee, 38555
Deerfield
Deerfield, Illinois, 60015
Pediatric Partners of the Southwest
Durango, Colorado, 81301
East End
East Hampton, New York, 11968
Eureka Pediatrics
Eureka, California, 95503
Evanston (Central)
Evanston, Illinois, 60201
Evanston (Davis)
Evanston, Illinois, 60201
Glenview
Glenview, Illinois, 60026
Gurnee
Gurnee, Illinois, 60031
Lincolnwood
Lincolnwood, Illinois, 60712
Paragould Pediatrics
Paragould, Arkansas, 72450
Cornerstone Pediatrics
Seguin, Texas, 78155
Old Orchard
Skokie, Illinois, 60077
Hampton Pediatrics
Southampton, New York, 11968
Vernon Hills
Vernon Hills, Illinois, 60061
Pediatric Medicine of Wallingford
Wallingford, Connecticut, 06492
Plaza Del Lago
Wilmette, Illinois, 60091
About this study
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.
Read the 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.
- Conditions
- Respiratory Disease, Acute Respiratory Infection, Respiratory Infection, Upper Respiratory Infection
- Being tested
- Online Tutorial, Webinars, Booster Sessions, Feedback Reports, Parent Survey
- Keywords
- Pediatrics, Respiratory disease, antibiotic use
- Medical subject headings
- Respiration Disorders, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online TutorialOther
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.
WebinarsOther
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.
Booster SessionsOther
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.
Feedback ReportsOther
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.
Parent SurveyOther
Throughout the study, parents at participating practice sites will be offered the opportunity to complete a DART Parent Survey after their child's visit.
| Study group | Role | What they receive |
|---|---|---|
| Providers | Other | 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. Receives: Other: Online Tutorial; Other: Webinars; Other: Booster Sessions; Other: Feedback Reports |
| Parents | Other | 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. Receives: Other: Parent Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Two years pre-intervention and, on average, a 15-month period during and post intervention
Change in rates of antibiotic prescribing for pharyngitis
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).
Measured: Two years pre-intervention and, on average, a 15-month period during and post intervention
Change in second-line prescribing rates for bacterial ARTIs
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).
Measured: Two years pre-intervention and, on average, a 15-month period during and post intervention
Use of Combined Negative and Positive Treatment Recommendations
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.
Measured: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
Use of Contingency plans
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.
Measured: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
Parent-Reported Satisfaction Scores
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.
Measured: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
Cost of intervention implementation
The cost of implementing the DART intervention and the cost of any resulting utilization changes will be offset by decreased expenditures on antibiotic prescriptions.
Measured: Two years pre-intervention and, on average, a 15-month period during and post intervention
Change in health provider expenditures due to 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.
Measured: Two years pre-intervention and, on average, a 15-month period during and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start18 Jul 2016
- Primary completion30 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of California, Los Angeles, Portland State University, Endeavor Health, American Academy of Pediatrics, University of Washington
- Responsible party
- Principal investigator, Rita Mangione-Smith, Seattle Children's Hospital
- Investigators
- Rita Mangione-Smith, M.D., Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943551
- Sponsor's protocol ID
- R01HD084547
- Acronym
- DART
- Status last verified
- Jul 2019
- First submitted
- 23 Aug 2016
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35341612Kronman 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.
PubMed 32747473
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialogue Around Respiratory Illness Treatment
- ClinicalTrials.gov ID
- NCT02943551
- Acronym / sponsor ID
- DART / R01HD084547
- Conditions
- Respiratory Disease, Acute Respiratory Infection, Respiratory Infection, Upper Respiratory Infection
- Keywords
- Pediatrics, Respiratory disease, antibiotic use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,728 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of California, Los Angeles, Portland State University, Endeavor Health, American Academy of Pediatrics, University of Washington
- Study start
- 18 Jul 2016 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Providers | Other | Other: Online Tutorial, Other: Webinars, Other: Booster Sessions, Other: Feedback ReportsPhysicians, 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 | Other | Other: Parent SurveyThe 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. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online TutorialFor 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 | Providers |
| WebinarsThe 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 | Providers |
| Booster SessionsAn 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 | Providers |
| Feedback ReportsDuring 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. | Other | Providers |
| Parent SurveyThroughout the study, parents at participating practice sites will be offered the opportunity to complete a DART Parent Survey after their child's visit. | Other | Parents |
Primary outcome
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).
8 secondary outcomes
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
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
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
Use of Combined Negative and Positive Treatment Recommendations
Time frame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
Use of Contingency plans
Time frame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
Parent-Reported Satisfaction Scores
Time frame: On average 6 months pre-intervention and, on average, 9 months during intervention exposure
Cost of intervention implementation
Time frame: Two years pre-intervention and, on average, a 15-month period during and post intervention
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Derived from this study: PubMed 35341612Mangione-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.
- Derived from this study: PubMed 32747473Kronman 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Mangione-Smith, M.D. principal investigator
Seattle Children's Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Tutorial, Webinars and Booster Sessions in people with Respiratory Disease and Acute Respiratory Infection, run by Seattle Children's Hospital at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943551, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.