MedTrace Logo

Written Sepsis Education for Patients

NCT07415096 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Sepsis and Septic Shock
  • Sepsis at Intensive Care Unit

Interventions

OTHER

Written Discharge Education

Just prior to discharge from intensive care, this group will: 1. be provided with the Health Quality British Columbia Recovery After Sepsis Pamphlet. This pamphlet contains information on sepsis, post-sepsis syndrome, infection prevention, recovery, and links to online sepsis resources; and 2. be explicitly asked by a trained intensive care Registered Nurse if they have any questions on sepsis/sepsis recovery.

OTHER

Usual Care

This group will receive usual intensive care unit (ICU) discharge care. Usual practice at the study site involves communication of diagnoses with basic education occasionally provided at the discretion of providers. Patients and/or their family members are typically asked if they have questions related to their general care or medical conditions when updates are provided by the healthcare team during their ICU stay but are not directly asked if they have questions about sepsis.

Sponsors & Collaborators

Principal Investigators

  • Alison Fox-Robichaud, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-09-30
Completion
2026-09-30

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415096 on ClinicalTrials.gov