SepsisNCT05602896
Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program
A study testing Sepsis education in people with Sepsis, run by Washington University School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Sepsis education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2024to 31 Jul 2025
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Sepsis
- Being tested
- Sepsis education
- Keywords
- sepsis, education, cancer
- Medical subject headings
- Sepsis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sepsis educationOther
The education program has been reviewed and approved by BJH Center for Practice Excellence
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Education | Experimental | 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 Receives: Other: Sepsis education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission rates
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start31 Mar 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Why it stopped: PI decided to table the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- BJC HealthCare, Viven Health
- Responsible party
- Sponsor
- Investigators
- Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC, Principal investigator, BJC HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602896
- Sponsor's protocol ID
- 202207066
- Status last verified
- Jun 2024
- First submitted
- 27 Oct 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing 30-Day Sepsis Readmissions: Impact of a Post Discharge Education Program
- ClinicalTrials.gov ID
- NCT05602896
- Acronym / sponsor ID
- 202207066
- Conditions
- Sepsis
- Keywords
- sepsis, education, cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided to table the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- BJC HealthCare, Viven Health
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 2 Nov 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis Education | Experimental | Other: Sepsis educationThe 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Sepsis educationThe education program has been reviewed and approved by BJH Center for Practice Excellence | Other | Sepsis Education |
Primary outcome
Readmission rates
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Nancy Bickel, MSN, APRN, ANCP-BC, ACNS-BC principal investigator
BJC HealthCare
Questions about this trial
What is this clinical trial studying?
A study testing Sepsis education in people with Sepsis, run by Washington University School of Medicine.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Readmission rates (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2024.