NCT06087809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 14, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

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)

    3 months

Secondary Outcomes (2)

  • Proportion of cases of CAP treated with short course antibiotic treatment

    3 months

  • Proportion of cases of SSTI treated with short course antibiotic treatment

    3 months

Study Arms (4)

Control

NO INTERVENTION

No intervention

Education and feedback

EXPERIMENTAL

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

Clinical decision support

EXPERIMENTAL

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

Combined group

EXPERIMENTAL

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

Behavioral: Education and feedbackBehavioral: Clinical decision support

Interventions

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.

Combined groupEducation and feedback

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.

Clinical decision supportCombined group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Community-Acquired PneumoniaCellulitis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesSkin Diseases, InfectiousSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, PPOC

Study Record Dates

First Submitted

September 14, 2023

First Posted

October 18, 2023

Study Start

February 15, 2023

Primary Completion

May 14, 2023

Study Completion

May 14, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations