A Pilot Randomized Controlled Trial of Written Sepsis Education

Overview

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.

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.