- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06087809
Improving Short Course Treatment for Common Pediatric Infections
October 17, 2023 updated by: Louis Vernacchio, Boston Children's Hospital
Improving Short Course Treatment for Common Pediatric Infections: A Randomized Quality Improvement Trial
Randomized quality improvement trial to improve the proportion of cases of community-acquired pneumonia (CAP) treated with no more than 5 days of antibiotics the proportion of cases of skin and soft tissue infections (SSTI) treated with no more than 7 days of antibiotics by primary care clinicians (PCC) within the Pediatric Physicians' Organization at Children's (PPOC), a state-wide pediatric primary care network.
Interventions include education and feedback; clinical decision support (CDS) delivered at the point of care; and the combination of the two.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
INCLUSION CRITERIA
- Primary care clinician practicing within a PPOC primary care pediatric practice
- Treated at least one case of pneumonia or skin and soft tissue infection in calendar year 2022
EXCLUSION CRITERIA
-None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention
|
|
Experimental: Education and feedback
Clinicians within practices assigned to the Education/Feedback group received a personal email from one of the authors at the outset of the project explaining that the Committee on Infectious Diseases of the American Academy of Pediatrics (the "Red Book Committee") recommends limiting the duration of antibiotic treatment for uncomplicated CAP to 5 days and for uncomplicated SSTI to 5-7 days.
The email also shared data on the performance of the individual PCC and their practice for CAP and SSTI for the baseline period and the goals for each-50% for CAP and 67% for SST.
An infographic was also attached to the email which could be printed and displayed in the PCC's work area.
One month and two months into the project period, each PCC in the Education/Feedback group received an email reminding them of the recommendations and updating them on their performance since the previous email.
|
Clinicians within practices assigned to the Education/Feedback group received a personal email from one of the authors at the outset of the project explaining that the Committee on Infectious Diseases of the American Academy of Pediatrics (the "Red Book Committee") recommends limiting the duration of antibiotic treatment for uncomplicated CAP to 5 days and for uncomplicated SSTI to 5-7 days.
The email also shared data on the performance of the individual PCC and their practice for CAP and SSTI for the baseline period and the goals for each-50% for CAP and 67% for SST.
An infographic was also attached to the email which could be printed and displayed in the PCC's work area.
One month and two months into the project period, each PCC in the Education/Feedback group received an email reminding them of the recommendations and updating them on their performance since the previous email.
|
Experimental: Clinical decision support
Clinicians within practices assigned to the CDS group did not receive education or any performance feedback relative to the initiative.
If they prescribed an antibiotic linked to a diagnosis of CAP with a duration of greater than 5 days, or to a diagnosis of SSTI with a duration greater than 7 days, they received a pop-up advisory when they attempted to sign the prescription alerting them to the relevant recommendation (eFigure 3).
The alert was a "hard stop", meaning that the prescriber was required to respond in some way to continue their work.
Options included altering the prescription to comply with the recommended duration or acknowledging the alert and sending the prescription with the originally selected duration.
|
Clinicians within practices assigned to the CDS group did not receive education or any performance feedback relative to the initiative.
If they prescribed an antibiotic linked to a diagnosis of CAP with a duration of greater than 5 days, or to a diagnosis of SSTI with a duration greater than 7 days, they received a pop-up advisory when they attempted to sign the prescription alerting them to the relevant recommendation (eFigure 3).
The alert was a "hard stop", meaning that the prescriber was required to respond in some way to continue their work.
Options included altering the prescription to comply with the recommended duration or acknowledging the alert and sending the prescription with the originally selected duration.
|
Experimental: Combined group
Clinicians within practices assigned to the combined group received both interventions as described above.
|
Clinicians within practices assigned to the Education/Feedback group received a personal email from one of the authors at the outset of the project explaining that the Committee on Infectious Diseases of the American Academy of Pediatrics (the "Red Book Committee") recommends limiting the duration of antibiotic treatment for uncomplicated CAP to 5 days and for uncomplicated SSTI to 5-7 days.
The email also shared data on the performance of the individual PCC and their practice for CAP and SSTI for the baseline period and the goals for each-50% for CAP and 67% for SST.
An infographic was also attached to the email which could be printed and displayed in the PCC's work area.
One month and two months into the project period, each PCC in the Education/Feedback group received an email reminding them of the recommendations and updating them on their performance since the previous email.
Clinicians within practices assigned to the CDS group did not receive education or any performance feedback relative to the initiative.
If they prescribed an antibiotic linked to a diagnosis of CAP with a duration of greater than 5 days, or to a diagnosis of SSTI with a duration greater than 7 days, they received a pop-up advisory when they attempted to sign the prescription alerting them to the relevant recommendation (eFigure 3).
The alert was a "hard stop", meaning that the prescriber was required to respond in some way to continue their work.
Options included altering the prescription to comply with the recommended duration or acknowledging the alert and sending the prescription with the originally selected duration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of cases of CAP and SSTI treated with short course antibiotic treatment
Time Frame: 3 months
|
Proportion of cases of CAP and SSTI treated with short course antibiotic treatment (<=5 days for CAP, <=7 days for SSTI)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of cases of CAP treated with short course antibiotic treatment
Time Frame: 3 months
|
Proportion of cases of CAP treated with short course antibiotic treatment (<=5 days)
|
3 months
|
Proportion of cases of SSTI treated with short course antibiotic treatment
Time Frame: 3 months
|
Proportion of cases of SSTI treated with short course antibiotic treatment (<=7 days)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2023
Primary Completion (Actual)
May 14, 2023
Study Completion (Actual)
May 14, 2023
Study Registration Dates
First Submitted
September 14, 2023
First Submitted That Met QC Criteria
October 17, 2023
First Posted (Actual)
October 18, 2023
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPOC-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Community-acquired Pneumonia
-
GlaxoSmithKlineTerminated
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineTerminated
-
GlaxoSmithKlineCompleted
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of MedicineUnknownCommunity Acquired Pneumonia | Ventilator Associated Pneumonia | Hospital Acquired PneumoniaSlovenia
-
Basilea PharmaceuticaCompletedCommunity-acquired Pneumonia (CAP) | Hospital-acquired Pneumonia (HAP)Bulgaria, Hungary, Georgia, Romania
-
Liverpool University Hospitals NHS Foundation TrustLiverpool School of Tropical MedicineCompletedCommunity Acquired Pneumonia | Lower Respiratory Tract Infection | Hospital Acquired PneumoniaUnited Kingdom
-
Future University in EgyptRecruitingCommunity-acquired PneumoniaEgypt
-
Nordsjaellands HospitalRecruitingCommunity-acquired PneumoniaDenmark
Clinical Trials on Education and feedback
-
Seoul National University HospitalUnknownGastric Cancer | Intestinal Metaplasia | Gastritis, AtrophicKorea, Republic of
-
Institute for Clinical Evaluative SciencesCompleted
-
Pope Research CorporationAbbott; Academic Medical Organization of Southwestern OntarioCompleted
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
British Urology Researchers in Surgical TrainingUniversity College, London; Photocure; University of Aberdeen; KARL STORZ Endoscopy-America... and other collaboratorsCompleted
-
Philips RespironicsCompleted
-
Centre for Addiction and Mental HealthCompleted
-
Beaumont HospitalRoyal College of Surgeons, IrelandCompletedPulmonary Disease, Chronic Obstructive | AsthmaIreland
-
Tianjin HospitalCompletedLumbar Disc HerniationChina
-
Brigham and Women's HospitalNovo Nordisk A/SCompleted