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
|Condition or disease|
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|
|Actual Enrollment :||147 participants|
|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|
|Actual Primary Completion Date :||September 14, 2018|
|Actual Study Completion Date :||September 14, 2018|
- 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.
- 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
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
|Foothills Hospital ICU|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Kirsten M Fiest, PhD||University of Calgary|
|Principal Investigator:||Henry T Stelfox, MD, PhD||University of Calgary|