Family ICU Delirium Detection Study

NCT03379129 | Completed

• 1 other identifier: REB-16-2060
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (2)

• Eleven item Family Confusion Assessment Method (FAM-CAM) family caregiver administered delirium detection tool

  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.

  up to 5 days

• Seven item Sour Seven family caregiver administered delirium detection tool

  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.

  up to 5 days

Secondary Outcomes (2)

• Seven item General Anxiety Disorder (GAD-7) questionnaire to detect signs of anxiety in the family caregivers at the bedside

  up to 5 days

• Nine item Patient Health Questionnaire (PHQ-9) questionnaire to detect signs of depression in the family caregiver at the bedside

  up to 5 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Significant primary direct brain injury with a Glasgow Coma Score (GCS) of \<9

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator

Study Sites (1)

Foothills Hospital ICU

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (3)

• 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.

  PMID: 34740349 DERIVED

• 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.

  PMID: 33210217 DERIVED

• 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.

  PMID: 31028053 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kirsten M Fiest, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Henry T Stelfox, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: November 6, 2017
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: May 16, 2019

Record last verified: 2017-11

Locations

CA (1)