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

NCT04099472 | Completed

• 3 other identifiers: REB19-100042394710020187
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 4

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. 1.reducing psychological distress in family members,
2. 2.reducing the prevalence, duration, and severity of delirium in critically ill patients,
3. 3.increasing delirium identification in medical charts,
4. 4.increasing delirium knowledge in family members of critically ill patients, and
5. 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

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• The change in prevalence of delirium in critically ill patients measured by the Intensive Care Delirium Screening Checklist (ICDSC) pre- and post-intervention

  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

  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.

  Throughout ICU stay, an average of 2 weeks

• Identification of patient delirium in the 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

  Immediately pre- and post- intervention (within the day of intervention), at 1- and 3-month follow-up post ICU discharge.

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Intervention Group

EXPERIMENTAL

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: Delirium Education, Prevention, and Management; Behavioral: Standard Care

Interventions

Delirium Education, Prevention, and Management BEHAVIORAL

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.

Intervention Group

Standard Care BEHAVIORAL

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Peter Lougheed Centre ICU

Calgary, Alberta, T2N 1N4, Canada

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Rockyview General Hospital

Calgary, Alberta, T2V 1P9, Canada

Location

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

Related Publications (2)

• Fiest KM, Krewulak KD, Sept BG, Davidson JE, Ely EW, Lee CH, Soo A, Stelfox HT. A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Family-Partnered Delirium Prevention, Detection, and Management in Critically Ill Adults: The Activating Family Caregivers in the Identification Prevention and Management of Delirium (ACTIVATE) Study. Crit Care Explor. 2025 Aug 22;7(9):e1287. doi: 10.1097/CCE.0000000000001287. eCollection 2025 Sep 1.

  PMID: 40844707 DERIVED

• 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.

  PMID: 32448187 DERIVED

MeSH Terms

Conditions

Delirium; Critical Illness; postintensive care syndrome

Interventions

Therapeutics; Standard of Care

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kirsten Fiest, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study data will be collected, de-identified and managed using REDCap electronic data capture tools hosted and supported by the University of Calgary. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies.The data will be coded according to group assignment for the individual conducting the data analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 23, 2019
• Study Start: January 13, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)