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
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Tracking Information | |||||||
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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 |
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Original Primary Outcome Measures |
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Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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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). |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
147 | ||||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Current Responsible Party | University of Calgary | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | University of Calgary | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators | Alberta Health services | ||||||
Investigators |
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PRS Account | University of Calgary | ||||||
Verification Date | November 2017 |