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Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions (EMPOWER)

Primary Purpose

Community-acquired Pneumonia, Acute Otitis Media, Pharyngitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mixed methods intervention
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Community-acquired Pneumonia focused on measuring Antibiotic stewardship, Implementation Science, Antibiotic Use, Outpatient antibiotic prescribing, Inpatient antibiotic prescribing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Inclusion Criteria: Diagnosis of one of four conditions based on ICD-10 diagnostic codes. Patient Exclusion Criteria: Presence of specific complex chronic conditions Use of immunocompromising medications Transfer from another health facility. Clinician Inclusion Criteria: Prescribing clinicians (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) at one of the participating outpatient practices or inpatient units. Age ≥ 18 years old Employed by one of the participating sites Clinician Exclusion Criteria: Volunteers or other non-employee hospital staff Limited English proficiency

Sites / Locations

  • Children's Hospital of PhiladelphiaRecruiting
  • University of Pennsylvania Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Prescribing Clinicians

Patients diagnosed with conditions of interest during study period

Arm Description

During the pre-intervention period which will last up to approximately 24 months, investigators will retrospectively collect data on appropriate antibiotic prescribing for the conditions. In the post-intervention period of approximately 24 months, investigators will implement a provider-focused intervention, consisting of feedback reports to providers using the validated metrics of antibiotic prescribing. These measures are based on national guidelines for appropriate antibiotic prescribing. Following implementation of the intervention, the investigative team will collect the same measures.

Interactions between investigators and patients will be limited to review of existing EHR data. Investigators will have no direct contact with patients. The data from the University of Pennsylvania Health System (UPHS) and Children's Hospital of Philadelphia (CHOP) will be extracted from data warehouses that store data from the electronic health record. These data will be used in feedback report generation as well as in outcome assessment. An estimated total of 10,000 inpatients with CAP (adult and pediatric) will be recruited. Similarly, about 500,000 patients (adult pharyngitis and pediatric acute otitis media combined) will be recruited in the outpatient setting.

Outcomes

Primary Outcome Measures

Guideline-concordant antibiotic Use for adult pharyngitis
This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).
Guideline-concordant antibiotic Use for pediatric acute otitis media
This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).
Guideline-concordant antibiotic Use for CAP
Percentage of CAP encounters with guideline-concordant antibiotic use for both the duration and choice metrics.

Secondary Outcome Measures

Guideline-concordant decision to prescribe antibiotics for adult pharyngitis
Percentage of patients for which the decision to prescribe an antibiotic was correct.
Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis
Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for adult pharyngitis
Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media
Percentage of patients for which the decision to prescribe an antibiotic was correct.
Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media
Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for acute otitis media
Guideline-concordant antibiotic choice
Percentage of patients who received guideline-concordant antibiotic choice for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media.
Guideline-concordant antibiotic duration
Percentage of patients who received guideline-concordant antibiotic duration for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media
Return to the emergency department
Percentage of patients who return to the emergency department within 14 days of discharge following hospitalization for CAP.
Return to the clinic
Percentage of patients who return for an outpatient visit within 7 days of being diagnosed with adult pharyngitis or pediatric acute otitis media.
Readmissions within 14 days of the index visit for CAP
Percentage of inpatients with CAP who are readmitted within 14 days of the index visit for the same or related condition.
New antibiotic prescription within 7 days of the index visit
Percentage of patients who receive a new antibiotic prescription within 7 days of the index visit.

Full Information

First Posted
August 14, 2023
Last Updated
September 6, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT06027593
Brief Title
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
Acronym
EMPOWER
Official Title
Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main goal of this study is to use automated electronic reports to assess and improve guideline-concordant antibiotic use for: 1) adult inpatients with community-acquired pneumonia (CAP); 2) pediatric inpatients with CAP; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media. There are two cohorts in this study: Patients with one of the aforementioned conditions who meet inclusion criteria, and the clinicians providing clinical care to these patients.
Detailed Description
Antibiotic stewardship (AS) has been shown to improve patient outcomes, decrease adverse events, and decrease antibiotic resistance. This group of investigators previously partnered with collaborators at the Centers for Disease Control and Prevention (CDC) and conducted relevant pilot work in developing and validating electronic indicators of inappropriate antibiotic prescribing for 8 conditions, amongst which are the four conditions of interest in this study: adult inpatients with CAP; pediatric inpatients with CAP; adult outpatients with acute pharyngitis; and pediatric outpatients with acute pharyngitis). Methods were developed to generate automatic, routine reports to identify elements of inappropriate antibiotic use including; 1) the decision to initiate antibiotic therapy; 2) the choice of antibiotic agent; and 3) the duration of antibiotic use. The purpose of this project is to assess the impact of these developed electronic indicators on supporting AS efforts to improve the appropriateness of antibiotic use, as well as the acceptability and feasibility of delivering these reports to prescribers. The investigators aim to: Refine and validate indicators of appropriate antibiotic use by utilizing Electronic Health Record (EHR) data, including International Classification of Diseases (ICD-10) codes, medications, laboratory data, comorbid medical conditions, site of care, clinical documentation, prior hospitalizations, and medication exposure. The researchers will validate the definitions of the various conditions and appropriateness captured electronically with a manual chart review of clinical documentation. Implement a scalable and sustainable AS feedback report-based intervention for these four conditions informed by a rapid user-centered design process. Track the impact of stewardship interventions and report to key stakeholders, including prescribers. Create a publicly available toolkit based on the findings of this project that includes: (i) analytic tools and resources for using the automated reports of key indicators to target stewardship interventions and (ii) an implementation guide to inform the application of automated reports to stewardship in the inpatient and outpatient settings. If proven effective, these EHR-based approaches hold the promise to greatly enhance the effectiveness and efficiency of AS initiatives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Acute Otitis Media, Pharyngitis
Keywords
Antibiotic stewardship, Implementation Science, Antibiotic Use, Outpatient antibiotic prescribing, Inpatient antibiotic prescribing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
511000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prescribing Clinicians
Arm Type
Other
Arm Description
During the pre-intervention period which will last up to approximately 24 months, investigators will retrospectively collect data on appropriate antibiotic prescribing for the conditions. In the post-intervention period of approximately 24 months, investigators will implement a provider-focused intervention, consisting of feedback reports to providers using the validated metrics of antibiotic prescribing. These measures are based on national guidelines for appropriate antibiotic prescribing. Following implementation of the intervention, the investigative team will collect the same measures.
Arm Title
Patients diagnosed with conditions of interest during study period
Arm Type
No Intervention
Arm Description
Interactions between investigators and patients will be limited to review of existing EHR data. Investigators will have no direct contact with patients. The data from the University of Pennsylvania Health System (UPHS) and Children's Hospital of Philadelphia (CHOP) will be extracted from data warehouses that store data from the electronic health record. These data will be used in feedback report generation as well as in outcome assessment. An estimated total of 10,000 inpatients with CAP (adult and pediatric) will be recruited. Similarly, about 500,000 patients (adult pharyngitis and pediatric acute otitis media combined) will be recruited in the outpatient setting.
Intervention Type
Behavioral
Intervention Name(s)
Mixed methods intervention
Other Intervention Name(s)
Quasi experimental intervention
Intervention Description
Investigators will implement the intervention at the completion of the rapid user-centered design process and consultation with CDC collaborators. During the rapid user-centered design process, the team will engage key stakeholders to create and optimize feedback reports that will fit the prescribing context, and determine appropriate implementation supports that will be needed to accompany the introduction of the feedback reports to each setting. Following the initial awareness-building activities, investigators will circulate the antibiotic prescribing feedback reports. After the first 3 months (approximately) of report dissemination, the team will assess the feasibility and acceptability of the reports and implementation activities by administering a brief survey to prescribers and also conducting interviews with them. No direct identifiers will be collected.
Primary Outcome Measure Information:
Title
Guideline-concordant antibiotic Use for adult pharyngitis
Description
This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).
Time Frame
Up to 4 years
Title
Guideline-concordant antibiotic Use for pediatric acute otitis media
Description
This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).
Time Frame
Up to 4 years
Title
Guideline-concordant antibiotic Use for CAP
Description
Percentage of CAP encounters with guideline-concordant antibiotic use for both the duration and choice metrics.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Guideline-concordant decision to prescribe antibiotics for adult pharyngitis
Description
Percentage of patients for which the decision to prescribe an antibiotic was correct.
Time Frame
Up to 4 years
Title
Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis
Description
Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for adult pharyngitis
Time Frame
Up to 4 years
Title
Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media
Description
Percentage of patients for which the decision to prescribe an antibiotic was correct.
Time Frame
Up to 4 years
Title
Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media
Description
Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for acute otitis media
Time Frame
Up to 4 years
Title
Guideline-concordant antibiotic choice
Description
Percentage of patients who received guideline-concordant antibiotic choice for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media.
Time Frame
Up to 4 years
Title
Guideline-concordant antibiotic duration
Description
Percentage of patients who received guideline-concordant antibiotic duration for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media
Time Frame
Up to 4 years
Title
Return to the emergency department
Description
Percentage of patients who return to the emergency department within 14 days of discharge following hospitalization for CAP.
Time Frame
Up to 2 years
Title
Return to the clinic
Description
Percentage of patients who return for an outpatient visit within 7 days of being diagnosed with adult pharyngitis or pediatric acute otitis media.
Time Frame
Up to 2 years
Title
Readmissions within 14 days of the index visit for CAP
Description
Percentage of inpatients with CAP who are readmitted within 14 days of the index visit for the same or related condition.
Time Frame
Up to 2 years
Title
New antibiotic prescription within 7 days of the index visit
Description
Percentage of patients who receive a new antibiotic prescription within 7 days of the index visit.
Time Frame
Up to 2 years
Other Pre-specified Outcome Measures:
Title
Measure of feasibility of intervention
Description
Feasibility, the extent to which the intervention can be carried out in the clinical setting, will be determined in collaboration with our local stakeholders but may include the proportion of clinicians who attend educational sessions and/or unit-based meetings during which antibiotic use data is reviewed.
Time Frame
Up to 2 years
Title
Acceptability of intervention
Description
Acceptability, how well the intervention was received by the prescribing clinicians will be measured during surveys and structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patient Inclusion Criteria: Diagnosis of one of four conditions based on ICD-10 diagnostic codes. Patient Exclusion Criteria: Presence of specific complex chronic conditions Use of immunocompromising medications Transfer from another health facility. Clinician Inclusion Criteria: Prescribing clinicians (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) at one of the participating outpatient practices or inpatient units. Age ≥ 18 years old Employed by one of the participating sites Clinician Exclusion Criteria: Volunteers or other non-employee hospital staff Limited English proficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Chiotos, MD, MSCE
Phone
215-590-5505
Email
chiotosk@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Dutcher, MD, MSCE
Phone
215-662-6932
Email
ldutcher@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebbing Lautenbach, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Chiotos, MD, MSCE
Phone
215-590-5505
Email
chiotosk@chop.edu
First Name & Middle Initial & Last Name & Degree
Didien Meyahnwi, MD, MPH
Phone
215-590-5505
Email
meyahnwid@chop.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Gerber, MD, PhD
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Dutcher, MD, MSCE
Phone
215-662-6932
Email
ldutcher@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Anne Jaskowiak-Barr, MSW
Phone
215-898-8188
Email
annejask@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Keith Hamilton, MD
First Name & Middle Initial & Last Name & Degree
Julia Szymczak, PhD
First Name & Middle Initial & Last Name & Degree
Ebbing Lautenbach, MD, MSCE

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.
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Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions

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