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Completed

NCT Number: NCT04099472

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

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.

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Key information

Conditions

Delirium Confusion Critical Illness Disease Attributes Intensive Care Unit Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Post Intensive Care Unit Syndrome Post Intensive Care Unit Syndrome Family Signs and Symptoms postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Care

Behavioral

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

Primary outcomes

  1. 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.

    Time frame: Up to 5 days

    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

  2. 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.

    Time frame: At 1-month follow-up post patient ICU discharge

    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

  3. 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.

    Time frame: At 3-month follow-up post patient ICU discharge

    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

  4. 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.

    Time frame: Up to 5 days

    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)

  5. 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.

    Time frame: At 1-month follow-up post patient ICU discharge

    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)

  6. 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.

    Time frame: At 3-month follow-up post patient ICU discharge

    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)

Secondary outcomes

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

    Time frame: Immediately before and after 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.

  2. The duration of delirium in critically ill patients measured by the mean days with delirium as determined by the ICDSC

    Time frame: Through ICU stay, an average of 2 weeks

    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.

  3. The change in the severity of delirium in critically ill patients measured by the most severe ICDSC scores pre- and post-intervention.

    Time frame: Throughout ICU stay, an average of 2 weeks

    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.

  4. Identification of patient delirium in the medical charts

    Time frame: Through study completion, an average of 1 year

    Evaluated through retrospective review of medical charts

  5. The change in delirium knowledge in family members of critically ill patients measured by Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ) pre- and post-intervention

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

    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.

  6. Burden of delirium experienced by family members of critically ill patients measured by Caregiver Delirium Burden Instrument (DEL-B)

    Time frame: Up to 5 days

    The DEL-B is an 8-item questionnaire administered to caregivers. Scores range from 0-40. Higher scores indicate higher burden.

  7. Psychological distress in family members of critically ill patients measured by Kessler Psychological Distress Scale (KPDS-10)

    Time frame: Up to 5 days, and at 1-month and 3-month follow-up post patient ICU discharge

    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).

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2019
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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