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Not Yet Recruiting NCT07896356

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

Conditions: Delirium, Intensive Care Unit Delirium, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1344
Sponsor: University of Calgary

Location: Foothills Medical Centre Calgary Alberta

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

Eligibility Criteria

Patient Inclusion Criteria: * 18 years of age or older * Richmond Agitation-Sedation Scale (RASS) score of equal to or greater than -3 * Anticipated to remain admitted to the ICU for at least a further 48 hours to complete study assessments at least once * Family involvement * Able to communicate with research staff (in English or French, or with the assistance of a translator or interpreter) * Able to provide informed consent (surrogate consent possible) Family Inclusion Criteria: * 18 years of age or older * Able to communicate with research staff (in English or French, or with the assistance of a translator or interpreter) * Available at least once daily for up to five study days (study days do not have to be continuous) Patient Exclusion Criteria: * Deep sedation or coma (RASS score of -4 or -5) * Anticipated to remain admitted to the ICU for less than 48 hours * Moderate or severe traumatic brain injury (as judged by the most responsible physician or a designated clinical physician involved in the patient's care) * Already admitted to the ICU during study control or intervention periods (i.e., no readmissions) * Moribund

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07896356). StuddyBuddy aggregates publicly available trial information.