Written Sepsis Education for Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University

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

30 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

McMaster University

Lead sponsor

Sepsis Canada Network

Collaborator