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Family ICU Delirium Detection Study (FIDDS)

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ClinicalTrials.gov Identifier: NCT03379129
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Calgary

Tracking Information
First Submitted Date December 15, 2017
First Posted Date December 20, 2017
Last Update Posted Date May 16, 2019
Actual Study Start Date November 6, 2017
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2019)
  • Eleven item Family Confusion Assessment Method (FAM-CAM) family caregiver administered delirium detection tool [ Time Frame: up to 5 days ]
    To be completed by a family caregiver once per day. The FAM-CAM is considered positive if acute onset (Question 1,10) or fluctuating course (question 9) AND inattention (question 2) AND either disorganized thinking (question 3,5,6) or altered consciousness (question 4) are present. This tool will be validated against intensive care unit (ICU) registered nurse (RN) reference standard ratings for delirium.
  • Seven item Sour Seven family caregiver administered delirium detection tool [ Time Frame: up to 5 days ]
    To be completed by a family caregiver once per day. Possible delirium is indicated by a score of 4 and higher. Any score of 9 or higher indicates delirium is present. This tool will be validated against ICU RN reference standard ratings for delirium.
Original Primary Outcome Measures
 (submitted: December 15, 2017)
  • Eleven item FAM-CAM family caregiver administered delirium detection tool [ Time Frame: up to 5 days ]
    To be completed by a family caregiver once per day. The FAM-CAM is considered positive if acute onset (Question 1,10) or fluctuating course (question 9) AND inattention (question 2) AND either disorganized thinking (question 3,5,6) or altered consciousness (question 4) are present. This tool will be validated against ICU RN reference standard ratings for delirium.
  • Seven item Sour Seven family caregiver administered delirium detection tool [ Time Frame: up to 5 days ]
    To be completed by a family caregiver once per day. Possible delirium is indicated by a score of 4 and higher. Any score of 9 or higher indicates delirium is present. This tool will be validated against ICU RN reference standard ratings for delirium.
Change History
Current Secondary Outcome Measures
 (submitted: May 14, 2019)
  • Seven item General Anxiety Disorder (GAD-7) questionnaire to detect signs of anxiety in the family caregivers at the bedside [ Time Frame: up to 5 days ]
    Scores of 5, 10 and 15 indicate signs of mild, moderate and sever anxiety, respectively
  • Nine item Patient Health Questionnaire (PHQ-9) questionnaire to detect signs of depression in the family caregiver at the bedside [ Time Frame: up to 5 days ]
    Depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Original Secondary Outcome Measures
 (submitted: December 15, 2017)
  • Seven item GAD-7 questionnaire to detect signs of anxiety in the family caregivers at the bedside [ Time Frame: up to 5 days ]
    Scores of 5, 10 and 15 indicate signs of mild, moderate and sever anxiety, respectively
  • Nine item PHQ-9 questionnaire to detect signs of depression in the family caregiver at the bedside [ Time Frame: up to 5 days ]
    Depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Family ICU Delirium Detection Study
Official Title Validation of Family-Administered Delirium Detection Tools for the Identification of Delirium in Critically Ill Patients
Brief Summary To evaluate the validity, reliability, and acceptability of employing family-administered delirium detection tools in the critically ill. The ultimate goal of this project is to improve the care of critically ill patients by creating valid, earlier, and patient and family-centered prevention, recognition, and management of delirium.
Detailed Description

Delirium is a major problem in critically ill patients, affecting almost half of this population. Delirium is associated with substantial persistent impaired cognition and psychiatric comorbidity, attributable mortality, and increased healthcare costs. Family members of critically ill patients are also at risk for developing adverse consequences including anxiety and depression. One strategy that may help both patients and families is to engage family members in the detection of delirium. The Facilitated Sensemaking model (of family member/patient engagement in critical care) is the theoretical framework underpinning the proposed work. Facilitated Sensemaking engages families by providing opportunities to participate in communication, decision-making, and bedside care, with the understanding that a sense of purpose derived from active participation in care can serve as a protective mechanism to reduce stress-related complications among families of critically ill patients, known as Post-Intensive Care Syndrome-Family. 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. Family-administered tools to measure delirium exist, but they have not been explored in the intensive care unit (ICU) context; the ICU is unique in terms of the patient population served and the invasiveness of therapies employed. We propose to evaluate the validity and reliability of using family-administered tools to detect delirium in critically ill patients and to explore perceptions and experiences of family members' participation in the detection of delirium.

Aim 1: To assess the validity and reliability of the Family Confusion Assessment Method (FAM-CAM) and Sour Seven to detect delirium in critically ill patients (Phase 1).

Aim 2: To explore stakeholder (former ICU patients and family members, nurse, physician) perceptions and experiences of family-administered delirium detection in critically ill patients (Phase 2).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients and family members in the largest adult ICU in Calgary, Alberta (Foothills Medical Centre, FMC) will be recruited.
Condition Delirium
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 14, 2019)
147
Original Estimated Enrollment
 (submitted: December 15, 2017)
180
Actual Study Completion Date September 14, 2018
Actual Primary Completion Date September 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Richmond Agitation Sedation Scale (RASS) ≥-3
  • able to communicate with study team (understand English, no significant hearing impairment)
  • located in ICU

Exclusion Criteria:

  • Significant primary direct brain injury with a Glasgow Coma Score (GCS) of <9
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03379129
Other Study ID Numbers REB-16-2060
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: Undecided
Responsible Party University of Calgary
Study Sponsor University of Calgary
Collaborators Alberta Health Services
Investigators
Principal Investigator: Kirsten M Fiest, PhD University of Calgary
Principal Investigator: Henry T Stelfox, MD, PhD University of Calgary
PRS Account University of Calgary
Verification Date November 2017