Improving Short Course Treatment for Common Pediatric Infections

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06087809
Collaborator
(none)
75
1
4
2.9
25.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education and feedback
  • Behavioral: Clinical decision support
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improving Short Course Treatment for Common Pediatric Infections: A Randomized Quality Improvement Trial
Actual Study Start Date :
Feb 15, 2023
Actual Primary Completion Date :
May 14, 2023
Actual Study Completion Date :
May 14, 2023

Arms and Interventions

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.

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.

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
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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of cases of CAP and SSTI treated with short course antibiotic treatment [3 months]

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

Secondary Outcome Measures

  1. Proportion of cases of CAP treated with short course antibiotic treatment [3 months]

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

  2. Proportion of cases of SSTI treated with short course antibiotic treatment [3 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital Boston Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Louis Vernacchio, Director of Research, PPOC, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT06087809
Other Study ID Numbers:
  • PPOC-1
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2023