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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099472
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Kirsten Fiest, University of Calgary

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. 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.

Condition or disease Intervention/treatment Phase
Delirium Intensive Care Unit Delirium Post Intensive Care Unit Syndrome Post Intensive Care Unit Syndrome Family Behavioral: Delirium Education, Prevention, and Management Behavioral: Standard Care Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control Trial
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : February 8, 2021
Estimated Study Completion Date : February 8, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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: 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.


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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099472


Contacts
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Contact: Karla Krewulak, PhD 403-944-0768 kkrewula@ucalgary.ca

Locations
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Canada, Alberta
Peter Lougheed Centre Not yet recruiting
Calgary, Alberta, Canada, T1Y 6J4
Contact: Karla Krewulak, PhD    403-944-0768    kkrewula@ucalgary.ca   
Principal Investigator: Kirsten Fiest, PhD         
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Karla Krewulak, PhD    403-944-0768    kkrewula@ucalgary.ca   
Principal Investigator: Kirsten Fiest, PhD         
Rockyview General Hospital Not yet recruiting
Calgary, Alberta, Canada, T2V 1P9
Contact: Karla Krewulak, PhD    708-944-0768    kkrewula@ucalgary.ca   
Principal Investigator: Kirsten Fiest, PhD         
South Health Campus Not yet recruiting
Calgary, Alberta, Canada, T3M 1M4
Contact: Karla Krewulak, PhD    403-403-0768    kkrewula@ucalgary.ca   
Principal Investigator: Kirsten Fiest, PhD         
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Kirsten Fiest, PhD University of Calgary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirsten Fiest, Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT04099472    
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 )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirsten Fiest, University of Calgary:
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
Additional relevant MeSH terms:
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Delirium
Syndrome
Critical Illness
Disease
Pathologic Processes
Disease Attributes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders