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CompletedNCT06087809Updated Oct 18, 2023

Improving Short Course Treatment for Common Pediatric Infections

An interventional study of Education and feedback and Clinical decision support in Community-acquired Pneumonia and Skin Infection, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2023, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Community-acquired Pneumonia
  • Skin Infection
03

In context

Community-Acquired Pneumonia

90 studies on the registry are indexed under Community-Acquired Pneumonia; 53 are open to participants now.

This study's enrollment of 75 is below the median of 297 across 58 interventional studies indexed under Community-Acquired Pneumonia.

Browse Community-Acquired Pneumonia studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 607 studies on the registry; 148 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 19 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

EXCLUSION CRITERIA

-None

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • 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.

    Behavioral: Education and feedback

  • 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.

    Behavioral: Clinical decision support

  • Experimental
    Combined group

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

    Behavioral: Education and feedback · Behavioral: Clinical decision support

Interventions

  • BehavioralEducation 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.

  • BehavioralClinical 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 3 months

Secondary outcomes

  1. Proportion of cases of CAP treated with short course antibiotic treatment

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

    Time frame: 3 months

  2. Proportion of cases of SSTI treated with short course antibiotic treatment

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

    Time frame: 3 months

07

Study locations

1 site
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Vernacchio L, Hatoun J, Patane LB, O'Donnell H, Herigon JC. Improving Short Course Treatment of Pediatric Infections: A Randomized Quality Improvement Trial. Pediatrics. 2024 Jan 1;153(2):e2023063691. doi: 10.1542/peds.2023-063691. PubMed 38168832 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2023 to primary completion in May 2023, 2 months.

Of 20 interventional studies with no phase under Community-Acquired Pneumonia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 59. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2023
First posted
Oct 18, 2023
StartActual
Feb 15, 2023
Primary completionActual
May 14, 2023
CompletionActual
May 14, 2023
Last update
Oct 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06087809
Responsible party
Louis Vernacchio (Director of Research, PPOC, Boston Children's Hospital) — Principal investigator
First posted
Oct 18, 2023
Start date
Feb 15, 2023
Primary completion
May 14, 2023
Completion
May 14, 2023
Last update
Oct 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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