Written Sepsis Education for Patients

NCT07415096 | Not Yet Recruiting

• 1 other identifier: 19557
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Feasibility to identify and enroll \>80% of eligible participants
2. 2.Feasibility to recruit 30 participants over a 6-month period
3. 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.

Conditions

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

Keywords

Sepsis; Post-Sepsis Syndrome; Patient Education; Sepsis Rehabilitation; Care Transitions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Completion of Study Assessments

  Within 30 days post-hospital discharge.

• Availability of Readmission Data

  within 30 days post hospital discharge

• Availability of Mortality Data

  Within 30 days post hospital discharge

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Written Discharge Education OTHER

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.

Intervention

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• McMaster University: lead
• Sepsis Canada Network: collaborator

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Alison Fox-Robichaud, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rheya A Z Hanning, BNSc

CONTACT

647-898-3835; Hanninra@mcmaster.ca

Alison Fox-Robichaud, MD, MSc

CONTACT

905-525-9140; afoxrob@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share