Clinical trial NCT04099472: Partnering With Family Members to Prevent, Detect and Manage Delirium in Critically Ill Patients.
Official title: Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Intensive Care Unit Delirium
Post Intensive Care Unit Syndrome
Post Intensive Care Unit Syndrome Family
Keywords: delirium
intensive care unit
critically ill
delirium detection
delirium prevention
delirium education
delirium management
psychological distress
post intensive care syndrome
post intensive care syndrome family
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-09-23
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All consecutively enrolled dyads (patient and caregiver) will be randomly assigned to either the control or intervention group. Both groups will receive standard care. The intervention group will receive additional ICU delirium education.
Primary purpose: PREVENTION

Brief 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.

Detailed description: This study will be a parallel-group randomized control trial with a 1:1 allocation ratio. Consecutive, eligible patients admitted to 4 ICUs in Calgary, Alberta, Canada with at least one family member present will be identified by discussion with the most responsible attending physician and bedside nurse. All eligible and consenting family members will receive standard care, which is an informational pamphlet on ICU delirium presented to all patients and families upon admission. Participants in both the intervention and control groups will also complete a demographics questionnaire, the Critical Care Family Needs Inventory (CCFNI), the Barriers to Care Questionnaire in the ICU (BCQ-ICU), the Caregiver Coping Strategies (CSS) questionnaire, and the Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) upon enrollment. Additionally, all family members will complete the Delirium Burden (DEL-B) questionnaire, Kessler Psychological Distress Scale (KPDS-10), Patient Health Questionnaire 9 (PHQ-9), Generalized Anxiety Disorder 7 (GAD-7) daily for a maximum of five days.

Family members randomized to the intervention group will receive additional ICU delirium education, whereas the control group will not. The intervention includes components of delirium education, prevention/management and detection. Family members will receive education by watching a 6-minute education video or reading an education booklet with a trained research assistant on the signs of delirium, who is at risk, and what they can do to prevent and manage it. They will practice identifying delirium with the Sour Seven questionnaire using previously validated case vignettes of hypothetical ICU patients. Delirium prevention and management will include a daily checklist of non-pharmacological interventions to be completed by the family member. This will include an orientation protocol (e.g., provide visual and hearing aids, orientation of day/time/location, familiar objects from home, television during the day with daily news, non-verbal music), mobility protocol (cognitive activities depending on the patient's ability), and an environmental protocol (lights off at night and on during the day, ear plugs, noise reduction during the night). In addition to non-pharmacological delirium prevention and management, this list will have a checkbox indicating if the family caregiver notified any member of the bedside care team about symptoms of delirium.

Family members in both intervention and control groups will also complete follow-up questionnaires at 1-month and 3-months through an online link to a REDCap survey. These questionnaires will include the Family Satisfaction for the Intensive Care Unit (FSICU), KPDS-10, GAD-7, PHQ-9, and CIDKQ .

Eligibility criteria: Inclusion Criteria:

* Intensive care unit (ICU) patients aged 18+ anticipated to remain admitted in the ICU for at least a further 24 hours to complete the intervention and all assessments at least once
* ICU patient has a caregiver (i.e., family member or friend) present
* Richmond Agitation Sedation Scale (RASS) ≥-3
* The ability to provide informed consent (both patient and family member; surrogate consent possible)
* The ability to communicate with research staff (fluent in English, no hearing or visual impairment that precludes communication)

Exclusion Criteria:

* Primary direct brain injury (e.g., traumatic brain injury, subarachnoid hemorrhage) with a Glasgow Coma Scale score of \<9

Primary outcomes:
measure: Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
timeFrame: Up to 5 days
measure: Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
timeFrame: At 1-month follow-up post patient ICU discharge
measure: Change in proportion of major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9) compared between control and intervention.
timeFrame: At 3-month follow-up post patient ICU discharge
measure: Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
timeFrame: Up to 5 days
measure: Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
timeFrame: At 1-month follow-up post patient ICU discharge
measure: Change in proportion of generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) compared between control and intervention.
timeFrame: At 3-month follow-up post patient ICU discharge
Secondary outcomes:
measure: The change in prevalence of delirium in critically ill patients measured by the Intensive Care Delirium Screening Checklist (ICDSC) pre- and post-intervention
timeFrame: Immediately before and after intervention
measure: The duration of delirium in critically ill patients measured by the mean days with delirium as determined by the ICDSC
timeFrame: Through ICU stay, an average of 2 weeks
measure: The change in the severity of delirium in critically ill patients measured by the most severe ICDSC scores pre- and post-intervention.
timeFrame: Throughout ICU stay, an average of 2 weeks
measure: Identification of patient delirium in the medical charts
timeFrame: Through study completion, an average of 1 year
measure: The change in delirium knowledge in family members of critically ill patients measured by Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) pre- and post-intervention
timeFrame: Immediately pre- and post- intervention (within the day of intervention), at 1- and 3-month follow-up post ICU discharge.
measure: Burden of delirium experienced by family members of critically ill patients measured by Caregiver Delirium Burden Instrument (DEL-B)
timeFrame: Up to 5 days
measure: Psychological distress in family members of critically ill patients measured by Kessler Psychological Distress Scale (KPDS-10)
timeFrame: Up to 5 days, and at 1-month and 3-month follow-up post patient ICU discharge
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Centre ICU
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: University of Calgary
name: Kirsten Fiest, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiest KM, Krewulak KD, Sept BG, Spence KL, Davidson JE, Ely EW, Soo A, Stelfox HT. A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study. BMC Health Serv Res. 2020 May 24;20(1):453. doi: 10.1186/s12913-020-05281-8.