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INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections
N/A
Waitlist Available
Led By Susan Huang, MD, MPH
Research Sponsored by Harvard Pilgrim Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing whether real-time, precision medicine computerized physician order entry (CPOE) smart prompts can help improve antibiotic stewardship practices for skin and soft tissue infections in adults.
Who is the study for?
The INSPIRE trial is for HCA Healthcare hospitals using MEDITECH electronic health records, admitting non-critically ill adults with skin and soft tissue infections. It's not about individual patients but the hospital practices.Check my eligibility
What is being tested?
This study compares routine care against a new 'Stewardship Bundle' that uses smart software prompts to guide antibiotic use, aiming to improve treatment by predicting resistant infections in real-time.See study design
What are the potential side effects?
Since this trial focuses on hospital procedures rather than direct patient interventions, it doesn't involve typical medication side effects. However, changes in practice could impact patient recovery times and infection management.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Empiric Extended-Spectrum Antibacterial Days of Therapy (Empiric ES-DOT)
Secondary outcome measures
Antipseudomonal Antibiotic Days of Therapy per Empiric Day
Other outcome measures
Empiric and Total Antibiotic Costs
Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibiotic Treatment after Empiric Period
Incidence of Hospital-Onset C. difficile
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Arm 2: INSPIRE Stewardship BundleActive Control1 Intervention
Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.
Group II: Arm 1: Routine CareActive Control1 Intervention
Continuation of routine antibiotic stewardship strategies.
Find a Location
Who is running the clinical trial?
Harvard Pilgrim Health CareLead Sponsor
54 Previous Clinical Trials
27,780,876 Total Patients Enrolled
University of California, IrvineOTHER
542 Previous Clinical Trials
1,921,899 Total Patients Enrolled
HCA Healthcare, IncUNKNOWN
1 Previous Clinical Trials
102 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The facility uses MEDITECH as its electronic health record system.The study is not being conducted at a location convenient for you.I am admitted to a HCA Healthcare hospital for a skin or soft tissue infection.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: INSPIRE Stewardship Bundle
- Group 2: Arm 1: Routine Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Skin and Soft Tissue Infection Patient Testimony for trial: Trial Name: NCT05423756 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial actively recruiting participants?
"Right, the information located on clinicaltrials.gov demonstrates that this particular medical experiment is actively searching for participants. It was first announced on August 2nd 2022 and most recently updated on August 29th 2022. Around 102 people must be recruited from 100 sites in total."
Answered by AI
Are there any medical centers in North America conducting this clinical investigation?
"The approved list of clinical trial sites contains 100 hospitals, including Englewood Community Hospital in Englewood, Medical City Fortworth in Fort Worth and Trident Medical Center in Charleston."
Answered by AI
What is the maximum capacity for participants in this investigation?
"Affirmative. According to clinicaltrials.gov, this scientific study is presently recruiting participants with initial postings dating back to August 2nd 2022 and last updated on the 29th of the same month. 102 individuals are needed for enrollment across 100 sites worldwide."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Methodist Hospital | Northeast
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have had soft tissue infections on both lower legs BTK. Nothing seems to work and the condition is chronic. Have been admitted and placed on antibiotics.
PatientReceived no prior treatments
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