SepsisNCT07415096
Written Sepsis Education for Patients
A study testing Written Discharge Education in people with Sepsis and Sepsis and Septic Shock, run by McMaster University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Sepsis and Septic Shock, Sepsis at Intensive Care Unit
- What is being tested?
- Written Discharge Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- Feasibility to identify and enroll >80% of eligible participants
- Feasibility to recruit 30 participants over a 6-month period
- 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.
Read the 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.
- Being tested
- Written Discharge Education, Usual Care
- Keywords
- Sepsis, Post-Sepsis Syndrome, Patient Education, Sepsis Rehabilitation, Care Transitions
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Discharge EducationOther
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment
Feasibility to identify and enroll >80% of eligible participants
Measured: 6 months or until 30 participants are recruited
Feasibility of Recruitment
Feasibility to recruit 30 participants over a 6-month period.
Measured: 6 months
Fidelity of Intervention
Fidelity of intervention, assessed as >75% of participants receiving assigned intervention
Measured: From enrolment to 30 days post-discharge
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Within 30 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Sepsis Canada Network
- Responsible party
- Principal investigator, Alison Fox-Robichaud, McMaster University
- Investigators
- Alison Fox-Robichaud, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415096
- Sponsor's protocol ID
- 19557
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting Up For Success: A Pilot Feasibility Randomized Controlled Trial of Written Education for Sepsis Survivors
- ClinicalTrials.gov ID
- NCT07415096
- Acronym / sponsor ID
- 19557
- Keywords
- Sepsis, Post-Sepsis Syndrome, Patient Education, Sepsis Rehabilitation, Care Transitions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Sepsis Canada Network
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Feasibility to identify and enroll >80% of eligible participants
- Feasibility to recruit 30 participants over a 6-month period
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Written Discharge EducationThis 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. |
| Usual Care | Active comparator | Other: Usual CareThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written Discharge EducationJust 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 | Intervention |
| Usual CareThis 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. | Other | Usual Care |
Primary outcome
Feasibility of Enrollment
Time frame: 6 months or until 30 participants are recruited
Feasibility to identify and enroll >80% of eligible participants
Feasibility of Recruitment
Time frame: 6 months
Feasibility to recruit 30 participants over a 6-month period.
Fidelity of Intervention
Time frame: From enrolment to 30 days post-discharge
Fidelity of intervention, assessed as >75% of participants receiving assigned intervention
3 secondary outcomes
Completion of Study Assessments
Time frame: Within 30 days post-hospital discharge.
Availability of Readmission Data
Time frame: within 30 days post hospital discharge
Availability of Mortality Data
Time frame: Within 30 days post hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison Fox-Robichaud, MD, MSc principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Written Discharge Education in people with Sepsis and Sepsis and Septic Shock, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rheya A Z Hanning, BNSc (647-898-3835, Hanninra@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment (time frame: 6 months or until 30 participants are recruited). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.