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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Written Discharge Education
Other interventionJust 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 Care
Other interventionThis 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Enrollment
Feasibility to identify and enroll \>80% of eligible participants
Time frame
6 months or until 30 participants are recruited2
Feasibility of Recruitment
Feasibility to recruit 30 participants over a 6-month period.
Time frame
6 months3
Fidelity of Intervention
Fidelity of intervention, assessed as \>75% of participants receiving assigned intervention
Time frame
From enrolment to 30 days post-dischargeSecondary outcomes
1
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.
Time frame
Within 30 days post-hospital discharge.2
Availability of Readmission Data
30-day readmission data available for \>75% of participants within 30 days post hospital discharge.
Time frame
within 30 days post hospital discharge3
Availability of Mortality Data
30-day mortality data available for \>75% of participants within 30 days post hospital discharge.
Time frame
Within 30 days post hospital dischargeLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
McMaster University
Lead sponsor
Sepsis Canada Network
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: