Partnering With Family Members to Prevent, Detect and Manage Delirium in Critically Ill Patients.

NCT04099472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-01-28

No results posted yet for this study

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 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 to identify delirium, and how to prevent and manage delirium using non-pharmacological strategies.

Family delirium detection may result in earlier and more accurate recognition of delirium and meaningful family involvement, and therein the potential for better patient and family outcomes. We aim to determine the efficacy of employing family-administered delirium prevention, detection, and management in the critically ill, compared to usual 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.

Conditions

  • Delirium
  • Intensive Care Unit Delirium
  • Post Intensive Care Unit Syndrome
  • Post Intensive Care Unit Syndrome Family

Interventions

BEHAVIORAL

Delirium Education, Prevention, and Management

Patients and families will have a choice of either watching a 6-minute video or reading an educational booklet with a competent research assistant on the signs of delirium, risk factors, and prevention and management strategies. Caregivers will practice identifying delirium with the Sour Seven questionnaire, using previously validated case vignettes of hypothetical ICU patients. Family members will also complete a daily checklist of non-pharmacological interventions (ie. orientation, mobility, and environmental cues). Delirium detection by family caregivers will be assessed by the Sour Seven Questionnaire and communicated to the bedside nurse.

BEHAVIORAL

Standard Care

Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • University of Calgary

    lead OTHER

Principal Investigators

  • Kirsten Fiest, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04099472 on ClinicalTrials.gov