- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05602896
Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program
June 12, 2024 updated by: Washington University School of Medicine
This study will advance the knowledge in the field by determining the effectiveness of discharge education regarding prevention of a new infection which is the highest cause of readmission for sepsis patient.
In evaluating the impact care teams will develop a clearer link between specific home-based education interventions and infection prevention.
This study is an exploratory study designed to identify whether patient education through an innovative teaching method can have an impact on readmissions.
This study may the first of several based on findings from this initial, exploratory study.
Study Overview
Study Type
Interventional
Phase
- 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
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Missouri
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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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
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Oncology patients discharged to home following a diagnosis of sepsis, severe sepsis or septic shock
- Patient must have a mobile phone/device
- English speakers
- Age range 18 - 85 years
Exclusion Criteria:
- Less than 18 years of age and older than 85 years of age
- No mobile phone/device
- Non-English speaking
- No diagnosis of sepsis, severe sepsis, or septic shock
- Non-Oncology patient
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: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sepsis Education
The patient will receive a daily notification via their mobile phone and conduct the daily activity for 30 days.
The program is interactive and aimed at measures that prevent exposure to infection sources in the environment, as well as recognition of early signs of infection and possible sepsis.
Each session takes approximately 2 minutes or less.
Each scenario or session has the user identify where germs may be present and then asks the user to perform a simple action to remove the germs (e.g. with an antiseptic wipe).
The range of activities include cleaning of surfaces, proper mask use, and hand sanitizing.
This includes areas of their home such as the kitchen, bathroom, living room/family room.
The program also addresses common community areas such as public transit, grocery stores, and restaurants
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The education program has been reviewed and approved by BJH Center for Practice Excellence
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Readmission rates
Time Frame: 4 months
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4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC, BJC HealthCare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Estimated)
March 31, 2024
Primary Completion (Estimated)
July 31, 2025
Study Completion (Estimated)
July 31, 2025
Study Registration Dates
First Submitted
October 27, 2022
First Submitted That Met QC Criteria
October 27, 2022
First Posted (Actual)
November 2, 2022
Study Record Updates
Last Update Posted (Actual)
June 14, 2024
Last Update Submitted That Met QC Criteria
June 12, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202207066
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.