Written Sepsis Education for Patients
Starting soon · Not applicable
Conditions studied: Sepsis, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
In brief
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.
Key facts
- Study ID
- NCT07415096
- Run by
- McMaster University
- People needed
- 30
- Starts
- 2026-02-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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