An interventional study of Standard of Care and Delirium Education, Prevention, and Management in Delirium, Intensive Care Unit Delirium and Post Intensive Care Unit Syndrome, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Calgary · Not applicable, Interventional, and Prevention
Almost half of critically ill patients experience delirium. Delirium is associated with impaired cognition, mortality, and increased healthcare costs. Family members of critically ill patients are also at risk for adverse consequences such as depression and anxiety.
One strategy that may help to improve outcomes is to engage family members in the prevention, detection, and management of delirium. This study will employ an educational module to educate families on delirium symptoms, how delirium can be identified, and how to prevent and manage delirium using non-pharmacological strategies.
Family member delirium detection may result in earlier and more accurate recognition of delirium as well as meaningful family involvement, and ultimately the potential for better patient and family outcomes. This study aims to determine the efficacy of employing family-administered delirium prevention, detection, and management in the critically ill, compared to standard of care. We hypothesize that family-administered delirium prevention, detection, and management in the critically ill will be superior to standard of care in:
This study is a fourteen-site Canadian stepped-wedge cluster randomized controlled trial. The unit of randomization is a cluster, with each cluster comprising two ICUs. Fourteen ICUs will be grouped into seven clusters and randomized to one of seven sequences to determine the timing of crossover from the control condition to intervention condition. The study is comprised of eight three-month periods, during which clusters will sequentially cross over until all clusters have implemented the intervention. The order in which ICUs enter the intervention condition will be randomized prior to enrolment of the first study patient. Eligible patients admitted to eight Canadian ICUs, with at least one family member present, will be identified by discussion with the most responsible attending physician and bedside nurse. Once enrolled in the study, patients will be assessed for eligibility daily (see Eligibility section). If patients meet eligibility criteria, study procedures will proceed. If patients do not meet eligibility, the study will be paused, and study days (the up to five days where participation occurs) will not accumulate until they become eligible for the intervention again (they will be reassessed the following day).
All eligible and consenting patients and family members will receive standard of care, which varies by site, but includes guideline-recommended interventions. Patients and family members in both the control and intervention groups will complete demographic questionnaires, whereas only family members will complete the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7), Short Form Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE), and a family presence questionnaire. The PHQ-9, GAD-7, and family presence questionnaire will be completed daily for a maximum of five study days, which may not be consecutive in nature.
Family members in the intervention group will receive an ICU delirium bundle, which will include education on delirium management, prevention, and detection. Family members will receive delirium education by watching a six-minute video or reading a booklet detailing the signs and symptoms of delirium, who is at risk, and how delirium can be managed and prevented. They will practice identifying delirium using the Family ICU Delirium Detection Instrument (FIDDI) with case vignettes of hypothetical ICU patients. Delirium prevention and management will include a daily checklist of non-pharmacological methods to prevent delirium, completed by the family member. This will include an orientation protocol (e.g., provide visual and hearing aids, orientation of day/time/location, bringing in familiar objects from home, etc.), mobility protocol (e.g., cognitive activities depending on the patient's abilities), and an environmental protocol (e.g., lights off at night and on during the day, ear plugs, noise reduction during the night, etc.). The checklist will be completed daily for a maximum of five study days, which may not be consecutive in nature.
Family members in both the control and intervention groups will also complete follow-up questionnaires (PHQ-9 and GAD-7) 3-months following the discharge for their loved one from the ICU. In order to maintain participant engagement, biweekly check-ins and monthly newsletters with study updates will be implemented, starting from the time from which the patient is discharged from the ICU.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 1,344 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Family Inclusion Criteria:
Patient Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients and family caregivers will receive standard of care, which varies by study site, but includes guideline-recommended interventions by the clinical team to prevent and manage delirium.
Behavioral: Standard of Care
Patients and family caregivers will receive standard of care, which varies by study site, but includes guideline-recommended interventions by the clinical team to prevent and manage delirium. Additionally, they will receive a family-partnered delirium care intervention comprised of two components: 1) Education and 2) Family administered delirium prevention, detection, and management activities.
Behavioral: Standard of Care · Behavioral: Delirium Education, Prevention, and Management
Patients and family caregivers will receive standard of care, which varies by study site, but includes guideline-recommended interventions by the clinical team to prevent and manage delirium.
Patients and family caregivers will be provided with a validated education module on the signs and risk factors of delirium, in addition to delirium detection, prevention, and management strategies. The material will be provided as a six-minute video or as a paper booklet. Families will practice identifying delirium with the Family ICU Delirium Detection Instrument (FIDDI), using previously validated case vignettes of hypothetical ICU patients. Family caregivers will also be provided with a daily checklist to complete, detailing non-pharmacological strategies to prevent and manage delirium (i.e., orientation, mobility, and environmental cues). Delirium detection by family caregivers will be assessed by the FIDDI and communicated to the bedside nurse.
Family member symptoms of depression and anxiety
Change in the proportion of major depressive disorder and generalized anxiety symptamology in family members of critical ill patients measured by the Patient Health Questionnaire-Anxiety and Depression Scale (PHQ-ADS) scores, compared between control and intervention
Time frame: 3-months post-ICU discharge
Clinically significant depression symptoms (family)
Change in proportion of major depressive disorder symptamology in family members of critically ill patients measured by the Patient Health Questionnaire-9 (PHQ-9) scores, compared between control and intervention
Time frame: Up to five days and at 3-months post patient ICU discharge
Clinically significant symptoms anxiety (family)
Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by the Generalized Anxiety Disorder-7 (GAD-7) scores, compared between the control group and the intervention
Time frame: Up to five days and at 3-months post patient ICU discharge
Delirium or coma free days (patients)
Clinical delirium assessment measured by the Confusion Assessment Method for the ICU (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC) scores, compared between control and intervention Coma free days measured by the number of days after enrolment that a patient is alive without delirium or coma, compared between control and intervention
Time frame: Up to five days
Time to both ICU and hospital discharge (patients)
Number of days between ICU admission and discharge from the ICU and/or hospital, compared between control and intervention
Time frame: Up to five days
Cumulative dose of pain medications, antipsychotics, and sedatives (patients)
Medications measured in milligrams per 24 hours, compared between control and intervention
Time frame: Up to five days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2030, 36 months later.
Of 219 non-industry interventional studies with no phase under Delirium, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 36 months is above that.
Counting every sponsor, half of 222 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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