Delirium Clinical Trial
Official title:
Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control Trial
Verified date | December 2023 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 198 |
Est. completion date | February 8, 2024 |
Est. primary completion date | February 8, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Peter Lougheed Centre ICU | Calgary | Alberta |
Canada | Rockyview General Hospital | Calgary | Alberta |
Canada | South Health Campus | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Identification of patient delirium in the medical charts | Evaluated through retrospective review of medical charts | Through study completion, an average of 1 year | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | 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 |
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