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

Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control 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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delirium; Post Intensive Care Unit Syndrome; Intensive Care Unit Delirium; Post Intensive Care Unit Syndrome Family
• Intervention / Treatment: Behavioral: Standard Care; Behavioral: Delirium Education, Prevention, and Management

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 .

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kara Plotnikoff, MPH; Phone Number: 403-944-0768; Email: kara.plotnikoff@ucalgary.ca
• Study Contact Backup: Name: Karla Krewulak, PhD; Phone Number: 403-944-0768; Email: kkrewula@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre
    • Calgary, Alberta, Canada, T2V 1P9
      • Rockyview General Hospital
    • Calgary, Alberta, Canada, T3M 1M4
      • South Health Campus
    • Calgary, Alberta, Canada, T2N 1N4
      • Peter Lougheed Centre ICU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. The intervention group will also receive the same pamphlet.	Behavioral: Standard Care; Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission.
Experimental: Intervention Group; Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission. Additionally, they will receive delirium education on prevention and management of delirium.	Behavioral: Standard Care; Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9-item questionnaire administered to caregivers to determine depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe	Up to 5 days
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.	9-item questionnaire administered to caregivers to determine depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe	At 1-month follow-up post patient ICU discharge
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.	9-item questionnaire administered to caregivers to determine depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe	At 3-month follow-up post patient ICU discharge
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.	A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)	Up to 5 days
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.	A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)	At 1-month follow-up post patient ICU discharge
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.	A 7-item questionnaire administered to caregivers with scores ranging from 0-21. Scores indicate anxiety severity: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety)	At 3-month follow-up post patient ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in prevalence of delirium in critically ill patients measured by the Intensive Care Delirium Screening Checklist (ICDSC) pre- and post-intervention	ICDSC is an 8-item checklist to be administered by a clinician. Scores range from 0-8. Patients with scores equal to greater than 4 require clinical assessment for a delirium diagnosis.	Immediately before and after intervention
The duration of delirium in critically ill patients measured by the mean days with delirium as determined by the ICDSC	ICDSC is an 8-item checklist to be administered by a clinician. Scores range from 0-8. Patients with scores equal to greater than 4 require clinical assessment for a delirium diagnosis.	Through ICU stay, an average of 2 weeks
The change in the severity of delirium in critically ill patients measured by the most severe ICDSC scores pre- and post-intervention.	ICDSC is an 8-item checklist to be administered by a clinician. Scores range from 0-8. Patients with scores equal to greater than 4 require clinical assessment for a delirium diagnosis.	Throughout ICU stay, an average of 2 weeks
Identification of patient delirium in the medical charts	Evaluated through retrospective review of medical charts	Through study completion, an average of 1 year
The change in delirium knowledge in family members of critically ill patients measured by Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) pre- and post-intervention	21-item multiple choice questionnaire on delirium risk factors, actions (prevention and management), and symptoms. The scores range from 0-21. Higher scores indicate higher level of delirium knowledge.	Immediately pre- and post- intervention (within the day of intervention), at 1- and 3-month follow-up post ICU discharge.
Burden of delirium experienced by family members of critically ill patients measured by Caregiver Delirium Burden Instrument (DEL-B)	The DEL-B is an 8-item questionnaire administered to caregivers. Scores range from 0-40. Higher scores indicate higher burden.	Up to 5 days
Psychological distress in family members of critically ill patients measured by Kessler Psychological Distress Scale (KPDS-10)	10-item questionnaire administered to caregivers with the likelihood of having a mental disorder: likely to be well (scores between 10-19), likely to have a mild disorder (20-24), moderate disorder (25-29), or severe disorder (30-50).	Up to 5 days, and at 1-month and 3-month follow-up post patient ICU discharge

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Kirsten Fiest, PhD, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Estimated): February 8, 2024
• Study Completion (Estimated): February 8, 2024

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: intensive care unit; delirium; critically ill; psychological distress; post intensive care syndrome; delirium detection; delirium prevention; delirium education; delirium management; post intensive care syndrome family
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease Attributes; Disease; Delirium; Syndrome; Critical Illness
• Other Study ID Numbers: REB19-1000; 423947 (Other Grant/Funding Number: Canadian Institutes of Health Research); 10020187 (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No