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Improving Short Course Treatment for Common Pediatric Infections

Primary Purpose

Community-acquired Pneumonia, Skin Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and feedback
Clinical decision support
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia

Eligibility Criteria

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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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Education and feedback

Clinical decision support

Combined group

Arm Description

No intervention

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.

Clinicians within practices assigned to the combined group received both interventions as described above.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Proportion of cases of CAP treated with short course antibiotic treatment
Proportion of cases of CAP treated with short course antibiotic treatment (<=5 days)
Proportion of cases of SSTI treated with short course antibiotic treatment
Proportion of cases of SSTI treated with short course antibiotic treatment (<=7 days)

Full Information

First Posted
September 14, 2023
Last Updated
October 17, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06087809
Brief Title
Improving Short Course Treatment for Common Pediatric Infections
Official Title
Improving Short Course Treatment for Common Pediatric Infections: A Randomized Quality Improvement Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
May 14, 2023 (Actual)
Study Completion Date
May 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Skin Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Education and feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinical decision support
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined group
Arm Type
Experimental
Arm Description
Clinicians within practices assigned to the combined group received both interventions as described above.
Intervention Type
Behavioral
Intervention Name(s)
Education and feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clinical decision support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of cases of CAP and SSTI treated with short course antibiotic treatment
Description
Proportion of cases of CAP and SSTI treated with short course antibiotic treatment (<=5 days for CAP, <=7 days for SSTI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of cases of CAP treated with short course antibiotic treatment
Description
Proportion of cases of CAP treated with short course antibiotic treatment (<=5 days)
Time Frame
3 months
Title
Proportion of cases of SSTI treated with short course antibiotic treatment
Description
Proportion of cases of SSTI treated with short course antibiotic treatment (<=7 days)
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Short Course Treatment for Common Pediatric Infections

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