Written Sepsis Education for Patients (NCT07415096) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Written Sepsis Education for Patients
30 participantsStarted 2026-02
Plain-language summary
This pilot feasibility randomized controlled trial (RCT) aims to determine if it feasible to recruit, deliver, and evaluate a written discharge educational material (a brochure) to adult Intensive Care Unit (ICU) patients diagnosed with sepsis.
The main questions it aims to answer are:
1. Feasibility to identify and enroll \>80% of eligible participants
2. Feasibility to recruit 30 participants over a 6-month period
3. Fidelity of intervention, assessed as \>75% of participants receiving assigned intervention Researchers will assess the feasibility of comparing two groups: (1) Control - usual ICU discharge care, and (2) Intervention - usual ICU discharge care plus the receipt of an educational sepsis brochure and an explicit opportunity to ask questions about sepsis, answered by a trained intensive care unit (ICU) Registered Nurse.
Participants will receive intervention or control just prior to their discharge from ICU. They will complete online or phone survey assessments 24-48 hours post ICU discharge and 15-days post hospital discharge. Mortality and readmission data will additionally be assessed at 30-days post-discharge.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed diagnosis of sepsis based on the sepsis-3 definition (infection + Sequential Organ Failure Assessment \[SOFA\] increase \>2)
* Admitted to an ICU
* At least 18 years old at study commencement
Exclusion Criteria:
* Unable to read basic English
* Despite available accommodations, they lack the cognitive, mental, or physical capacity to complete study assessments by ICU discharge
* Readmitted to ICU during their index hospital stay
* Hospital length of stay surpasses 30 days.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still listed as 'not yet recruiting' — do you know when it's expected to open, and would it even be realistic for me to consider it given where I am right now in my care?
2Since this study is measuring whether the trial itself is feasible to run — rather than testing a new drug or procedure — can you help me understand what actually happens to participants, and whether joining would change my medical treatment in any way?
3The trial involves written sepsis education for patients in the ICU — what does that education actually look like in practice, and is there any concern that participating could feel overwhelming during what's already an incredibly stressful time?
4Because this is a feasibility study with no listed phase, what does that mean for what we'd learn from it, and how does it differ from trials that are testing whether a treatment actually works?
5Are there other ways I could get reliable information about sepsis and recovery outside of this trial, especially if enrollment hasn't started yet and I need support now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Enrollment
Timeframe: 6 months or until 30 participants are recruited
2
Feasibility of Recruitment
Timeframe: 6 months
3
Fidelity of Intervention
Timeframe: From enrolment to 30 days post-discharge