Community-acquired PneumoniaNCT06087809
Improving Short Course Treatment for Common Pediatric Infections
A study testing Education and feedback and Clinical decision support in people with Community-acquired Pneumonia and Skin Infection, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community-acquired Pneumonia, Skin Infection
- What is being tested?
- Education and feedback and Clinical decision support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2023to 14 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: 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.
- Conditions
- Community-acquired Pneumonia, Skin Infection
- Being tested
- Education and feedback, Clinical decision support
- Medical subject headings
- Community-Acquired Pneumonia, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and feedbackBehavioural
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.
Clinical decision supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Clinical decision support |
| Combined group | Experimental | Clinicians within practices assigned to the combined group received both interventions as described above. Receives: Behavioral: Education and feedback; Behavioral: Clinical decision support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (2)
Proportion of cases of CAP treated with short course antibiotic treatment
Proportion of cases of CAP treated with short course antibiotic treatment (<=5 days)
Measured: 3 months
Proportion of cases of SSTI treated with short course antibiotic treatment
Proportion of cases of SSTI treated with short course antibiotic treatment (<=7 days)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Feb 2023
- Primary completion14 May 2023
- Study completion14 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Vernacchio, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087809
- Sponsor's protocol ID
- PPOC-1
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Short Course Treatment for Common Pediatric Infections: A Randomized Quality Improvement Trial
- ClinicalTrials.gov ID
- NCT06087809
- Acronym / sponsor ID
- PPOC-1
- Conditions
- Community-acquired Pneumonia, Skin Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 14 May 2023 (actual)
- Study completion
- 14 May 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Education and feedback | Experimental | Behavioral: Education and feedbackClinicians 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. |
| Clinical decision support | Experimental | Behavioral: Clinical decision supportClinicians 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. |
| Combined group | Experimental | Behavioral: Education and feedback, Behavioral: Clinical decision supportClinicians within practices assigned to the combined group received both interventions as described above. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and feedbackClinicians 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. | Behavioural | Combined group, Education and feedback |
| Clinical decision supportClinicians 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. | Behavioural | Clinical decision support, Combined group |
Primary outcome
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)
2 secondary outcomes
Proportion of cases of CAP treated with short course antibiotic treatment
Time frame: 3 months
Proportion of cases of SSTI treated with short course antibiotic treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 38168832Vernacchio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and feedback and Clinical decision support in people with Community-acquired Pneumonia and Skin Infection, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases of CAP and SSTI treated with short course antibiotic treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.