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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06087809
Other study ID # PPOC-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2023
Est. completion date May 14, 2023

Study information

Verified date October 2023
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date May 14, 2023
Est. primary completion date May 14, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Behavioral:
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.
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.

Locations

Country Name City State
United States Children's Hospital Boston Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of cases of CAP and SSTI treated with short course antibiotic treatment Proportion of cases of CAP and SSTI treated with short course antibiotic treatment (<=5 days for CAP, <=7 days for SSTI) 3 months
Secondary Proportion of cases of CAP treated with short course antibiotic treatment Proportion of cases of CAP treated with short course antibiotic treatment (<=5 days) 3 months
Secondary Proportion of cases of SSTI treated with short course antibiotic treatment Proportion of cases of SSTI treated with short course antibiotic treatment (<=7 days) 3 months
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