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

Study Overview
=================
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: reducing psychological distress in family members, reducing the prevalence, duration, and severity of delirium in critically ill patients, increasing delirium identification in medical charts, increasing delirium knowledge in family members of critically ill patients, and 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 .

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

Conditions
-----------------
Delirium, Intensive Care Unit Delirium, Post Intensive Care Unit Syndrome, Post Intensive Care Unit Syndrome Family

Intervention / Treatment
-----------------
* Behavioral: Delirium Education, Prevention, and Management
* Behavioral: Standard Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>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<br>* Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission.<br>|
| Experimental: Intervention Group<br>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<br>* 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.<br>Behavioral: Standard Care<br>* Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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