Improving Short Course Treatment for Common Pediatric Infections

October 17, 2023 updated by: Louis Vernacchio, Boston Children's Hospital

Improving Short Course Treatment for Common Pediatric Infections: A Randomized Quality Improvement Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of cases of CAP and SSTI treated with short course antibiotic treatment
Time Frame: 3 months
Proportion of cases of CAP and SSTI treated with short course antibiotic treatment (<=5 days for CAP, <=7 days for SSTI)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of cases of CAP treated with short course antibiotic treatment
Time Frame: 3 months
Proportion of cases of CAP treated with short course antibiotic treatment (<=5 days)
3 months
Proportion of cases of SSTI treated with short course antibiotic treatment
Time Frame: 3 months
Proportion of cases of SSTI treated with short course antibiotic treatment (<=7 days)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PPOC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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