Written Sepsis Education for Patients

Setting Up For Success: A Pilot Feasibility Randomized Controlled Trial of Written Education for Sepsis Survivors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis; Sepsis and Septic Shock; Sepsis at Intensive Care Unit
• Intervention / Treatment: Other: Written Discharge Education; Other: Usual Care

Detailed Description

Sepsis is a disease caused by a dysregulated host response to infection resulting in life-threatening organ dysfunction. While surviving sepsis is no small feat, it is only the first of many challenges that individuals are likely to face. Significant rates of critical illness, cognitive impairment, physical disability, thrombotic events, and poor mental health are commonplace among survivors, contributing to significant rehospitalization rates, high healthcare utilization, and marked healthcare spending. Appropriate discharge care, such as the provision of evidence-based discharge education, is essential for preparing patients to transition out of the hospital - a period marked by increased vulnerability and risk for deterioration. This is particularly important for patient populations with complex health needs. Sepsis survivors undoubtedly meet this criterion, yet many report inadequate - and often absent - discharge education. As such, this study 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.

This study will take place at Hamilton General Hospital (HGH) located in Hamilton, Ontario. A sample of adults with sepsis who have been admitted to any of the four ICUs at HGH will be sought (n=30). Recruitment will commence immediately after ethical approval and conclude upon enrollment of 30 participants or at 6 months, whichever comes first. Potential participants will be identified and pre-screened for eligibility through their electronic medical records (EMR). Consenting participants will be randomly assigned 1:1 to receive either the intervention or usual practice. ICU RNs at HGH, already knowledgeable on sepsis, will receive additional educational sessions on sepsis and post-sepsis syndrome prior to and throughout the study period, further equipping them to answer sepsis-related questions. Directions and materials corresponding to each participant's assigned allocation (intervention/control) will be placed in a labeled and sealed envelope located in their bedside chart. A reminder for the ICU RN to open and follow the directions within envelope on ICU discharge will be inputted into the electronic medical record EMR of all participants.

All participants will be given a demographic survey to complete on enrolment. Basic demographic health information will additionally be extracted from their EMRs. In the 24-72 hours following delivery of the pamphlet, the intervention group will additionally receive the Patient Education Materials Assessment for printed materials (PMET-P). At 15 days post-discharge, a final survey will be sent to each participant consisting of 1. The Patient Activation Measure (PAM), 2. The World Health Organization Quality of Life- Brief (WHOQOL-BREF), and 3. Questions assessing intervention fidelity. All study surveys will be delivered in the form of an electronic REDCap survey link delivered to the participants' email. If a participant is unable to complete the online emailed surveys (for instance, due to lack of literacy, internet access, etc.), a research team member, blinded to which group they have been assigned, will be able to assist them over the phone to complete the survey. The study questions will be asked last, once the other surveys are complete and submitted as the final question asks if they received the intervention or not, unblinding the researcher. At 30-days post discharge, the research team will assess completeness of survey data, mortality, and readmission rates. Survey completeness will be determined using REDCap while readmission/mortality data will be determined first by calling participants asking them if they required readmission, or if unable to get ahold of them via. phone, through screening of EMRs.

SPSS version 29 will be used for data analysis. Descriptive statistics will be used to summarize the characteristics of participants and to report on both primary and secondary study objectives. Investigators conducting data analysis will be blinded to the allocation of participants. Pre-specified feasibility thresholds will be compared against observed values to determine whether progression to a larger RCT is warranted.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rheya A Z Hanning, BNSc; Phone Number: 647-898-3835; Email: Hanninra@mcmaster.ca
• Study Contact Backup: Name: Alison Fox-Robichaud, MD, MSc; Phone Number: 40742 905-525-9140; Email: afoxrob@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This is the intervention arm. They will receive the educational pamphlet and be asked if they have questions about sepsis or sepsis recovery from a trained intensive care Registered Nurse on ICU discharge. It will be used to access intervention acceptability and fidelity.	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.
Active Comparator: Usual Care; This group will receive usual intensive care unit (ICU) discharge care. This arm provides a standard-care comparison and enables assessment of potential contamination in the pilot trial.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Enrollment	Feasibility to identify and enroll >80% of eligible participants	6 months or until 30 participants are recruited
Feasibility of Recruitment	Feasibility to recruit 30 participants over a 6-month period.	6 months
Fidelity of Intervention	Fidelity of intervention, assessed as >75% of participants receiving assigned intervention	From enrolment to 30 days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Study Assessments	Completion of all study assessments - demographic questionnaires, demographic log, Patient Activation Measure (PAM), Patient Education Material Assessment Tool- Print (PMET-P), World Health Organization Quality of Life-Brief (WHOQOL-BREF), & study-specific questions - in >75% of participants within 30 days post hospital discharge.	Within 30 days post-hospital discharge.
Availability of Readmission Data	30-day readmission data available for >75% of participants within 30 days post hospital discharge.	within 30 days post hospital discharge
Availability of Mortality Data	30-day mortality data available for >75% of participants within 30 days post hospital discharge.	Within 30 days post hospital discharge

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Sepsis Canada Network
• Investigators: Principal Investigator: Alison Fox-Robichaud, MD, MSc, McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Sepsis; Patient Education; Care Transitions; Post-Sepsis Syndrome; Sepsis Rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic
• Other Study ID Numbers: 19557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared. As this is a small pilot feasibility trial, the dataset will be limited in size and data will not be suitable for secondary analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No