Family-Partnered Care for ICU Delirium

(ACTIVATE Trial)

KK
OM
Overseen ByOlivia Morassutti, M.Sc.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

KF

Kirsten Fiest, Ph.D.

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for critically ill patients in the ICU and their family members. Patients must be at risk for or experiencing delirium. Family members should be willing to participate in education and care activities related to delirium prevention, detection, and management.

Inclusion Criteria

I am 18 years old or older.
Patient Richmond Agitation-Sedation Scale (RASS) score of equal to or greater than -3
I am 18 years old or older.
See 6 more

Exclusion Criteria

Patient moribund
Patient deep sedation or coma (RASS score of -4 or -5)
Patient anticipated to remain admitted to the ICU for less than 48 hours
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Delirium Education, Prevention, and Management

Trial Overview

The study compares standard ICU care with an added program where families receive training on how to spot, prevent, and help manage delirium using non-drug methods. The goal is to see if involving families improves outcomes for both patients and their loved ones.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment2 Interventions
Group II: Control GroupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

University of Alberta

Collaborator

Trials
957
Recruited
437,000+