About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Written Discharge Education
- Usual Care
Treatment groups
Locations
Sponsors and collaborators
McMaster University
Lead sponsor
Sepsis Canada Network
Collaborator