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Family ICU Delirium Detection Study (FIDDS)

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

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.

Condition or disease
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 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
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Family-Administered Delirium Detection Tools for the Identification of Delirium in Critically Ill Patients
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : May 6, 2019
Estimated Study Completion Date : May 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Richmond Agitation Sedation Scale ≥-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 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): NCT03379129


Contacts
Contact: Karla D Krewulak, PhD 403-944-8768 kkrewula@ucalgary.ca

Locations
Canada, Alberta
Foothills Hospital ICU Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Karla D Krewulak, PhD    4039448768    kkrewula@ucalgary.ca   
Principal Investigator: Kirsten M Fiest, PhD         
Principal Investigator: Henry T Stelfox, MD, PhD         
Sponsors and Collaborators
University of Calgary
Alberta Health Services
Investigators
Principal Investigator: Kirsten M Fiest, PhD University of Calgary
Principal Investigator: Henry T Stelfox, MD, PhD University of Calgary

Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03379129     History of Changes
Other Study ID Numbers: REB-16-2060
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders