Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE September 17, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date February 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Psychological distress in family members of critically ill patients measured by Kessler Psychological Distress Scale (KPDS-10) [ Time Frame: Up to 5 days ]
    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).
  • Major depressive disorder symptomatology in family members of critically ill patients measured by Patient Health Questionnaire-9 (PHQ-9). [ 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
  • Generalized anxiety symptomatology in family members of critically ill patients measured by Generalized Anxiety Disorder-7 (GAD-7) [ 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • 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.
  • 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.
  • 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.
  • 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
  • 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 ]
    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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partnering With Family Members to Prevent, Detect and Manage Delirium in Critically Ill Patients.
Official Title  ICMJE Family-administered Delirium Prevention, Detection, and Management in the Critically Ill: a Randomized Control Trial
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.
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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Delirium
  • Intensive Care Unit Delirium
  • Post Intensive Care Unit Syndrome
  • Post Intensive Care Unit Syndrome Family
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Standard Care
  • 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.
    Interventions:
    • Behavioral: Delirium Education, Prevention, and Management
    • Behavioral: Standard Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 21, 2020)
198
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2019)
360
Estimated Study Completion Date  ICMJE February 8, 2021
Estimated Primary Completion Date February 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karla Krewulak, PhD 403-944-0768 kkrewula@ucalgary.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04099472
Other Study ID Numbers  ICMJE REB19-1000
423947 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
10020187 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kirsten Fiest, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Kirsten Fiest, PhD University of Calgary
PRS Account University of Calgary
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP