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NOT YET RECRUITING
NCT07896356
NA

Family-partnered Delirium Prevention, Detection, and Management in the ICU

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

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: 1. Reducing psychological distress in family members, 2. Reducing the prevalence, duration, and severity of delirium in critically ill patients, 3. Increasing delirium identification in medical charts, 4. Increasing delirium knowledge in family members of critically ill patients, and 5. Reducing the burden of delirium experienced by family members and caregivers

Official title: Family-partnered Delirium Prevention, Detection, and Management in the ICU: A Stepped-wedge Cluster Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1344

Start Date

2027-02-01

Completion Date

2030-02-01

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

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.

BEHAVIORAL

Delirium Education, Prevention, and Management

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.

Locations (1)

Foothills Medical Centre

Calgary, Alberta, Canada