Family ICU Delirium Detection Study (FIDDS)

• ClinicalTrials.gov Identifier: NCT03379129
• Recruitment Status: Completed
• First Posted: December 20, 2017
• Last Update Posted: May 16, 2019
• Sponsor: University of Calgary
• 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.

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 *

• Poulin TG, Krewulak KD, Rosgen BK, Stelfox HT, Fiest KM, Moss SJ. The impact of patient delirium in the intensive care unit: patterns of anxiety symptoms in family caregivers. BMC Health Serv Res. 2021 Nov 5;21(1):1202. doi: 10.1186/s12913-021-07218-1.
• Parsons Leigh J, Krewulak KD, Zepeda N, Farrier CE, Spence KL, Davidson JE, Stelfox HT, Fiest KM. Patients, family members and providers perceive family-administered delirium detection tools in the adult ICU as feasible and of value to patient care and family member coping: a qualitative focus group study. Can J Anaesth. 2021 Mar;68(3):358-366. doi: 10.1007/s12630-020-01866-3. Epub 2020 Nov 18.
• Krewulak KD, Sept BG, Stelfox HT, Ely EW, Davidson JE, Ismail Z, Fiest KM. Feasibility and acceptability of family administration of delirium detection tools in the intensive care unit: a patient-oriented pilot study. CMAJ Open. 2019 Apr 26;7(2):E294-E299. doi: 10.9778/cmajo.20180123. Print 2019 Apr-Jun.

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

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