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Electronic Data Intervention for Respiratory and Ear Infections (EMPOWER Trial)
N/A
Recruiting
Led By Ebbing Lautenbach, MD, MSCE
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
EMPOWER Trial Summary
This trial aims to use electronic data to improve antibiotic use in patients with pneumonia, pharyngitis, and ear infections, and the care provided by clinicians.
Who is the study for?
This trial is for both adults and children with certain infections: community-acquired pneumonia, sore throat (acute pharyngitis), or ear infection (acute otitis media). Participants must have a diagnosis based on specific codes. Those with complex chronic conditions, on immunosuppressants, or transferred from other facilities can't join.Check my eligibility
What is being tested?
The study aims to improve the use of antibiotics in line with guidelines by using automated electronic reports. It involves adult and pediatric inpatients with pneumonia and outpatients with sore throats or ear infections, along with their healthcare providers.See study design
What are the potential side effects?
Since this trial focuses on improving antibiotic use through reporting rather than testing new drugs, it does not directly involve side effects from interventions. However, general antibiotic-related side effects may include digestive issues, allergic reactions, or increased resistance.
EMPOWER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Guideline-concordant antibiotic Use for CAP
Guideline-concordant antibiotic Use for adult pharyngitis
Guideline-concordant antibiotic Use for pediatric acute otitis media
Secondary outcome measures
Guideline-concordant antibiotic choice
Guideline-concordant antibiotic duration
Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis
+7 moreOther outcome measures
Acceptability of intervention
Measure of feasibility of intervention
EMPOWER Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Prescribing CliniciansExperimental Treatment1 Intervention
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.
Group II: Patients diagnosed with conditions of interest during study periodActive Control1 Intervention
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.
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,072,020 Total Patients Enrolled
University of PennsylvaniaOTHER
2,005 Previous Clinical Trials
42,371,283 Total Patients Enrolled
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
21,966,402 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open opportunities to participate in this research endeavor?
"Clinicaltrials.gov data suggests that this trial is actively recruiting participants, having first been posted on October 18th 2022 and last updated on September 6th 2023."
Answered by AI
What goals does this experiment seek to accomplish?
"As the primary appraised outcome, this trial seeks to measure over a 4 year period Guideline-concordant antibiotic Use for pediatrics with acute otitis media. Secondary outcomes of interest include determining the rate of correct decision making when deciding whether or not antibiotics should be prescribed for adult pharyngitis and pediatric cases of acute otitis media."
Answered by AI
What is the enrollment capacity for this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov shows that this medical research is currently enrolling participants, having been posted on October 18th 2022 and most recently updated on September 6th 2023. The study needs to recruit 511000 patients at two separate sites."
Answered by AI
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