- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03379129
Family ICU Delirium Detection Study (FIDDS)
Validation of Family-Administered Delirium Detection Tools for the Identification of Delirium in Critically Ill Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Hospital ICU
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Eleven item Family Confusion Assessment Method (FAM-CAM) family caregiver administered delirium detection tool
Tidsramme: up to 5 days
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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.
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up to 5 days
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Seven item Sour Seven family caregiver administered delirium detection tool
Tidsramme: up to 5 days
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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.
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up to 5 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Seven item General Anxiety Disorder (GAD-7) questionnaire to detect signs of anxiety in the family caregivers at the bedside
Tidsramme: up to 5 days
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Scores of 5, 10 and 15 indicate signs of mild, moderate and sever anxiety, respectively
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up to 5 days
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Nine item Patient Health Questionnaire (PHQ-9) questionnaire to detect signs of depression in the family caregiver at the bedside
Tidsramme: up to 5 days
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Depression severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe
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up to 5 days
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kirsten M Fiest, PhD, University of Calgary
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REB-16-2060
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Delirium
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Alexandria UniversityAfsluttetClozapinforgiftning | Hypoaktivt delirium | Tricyklisk antidepressiv forgiftning | Antikolinerg delirium | Antipsykotisk Toksicitet | CNS-depression | Procyclidininduceret deliriumEgypten
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Duke UniversityIkke rekrutterer endnuDelirium Forvirringstilstand | Hyperaktivt delirium | Delirium på intensivafdelingen | Agiteret deliriumForenede Stater
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Efficacy Care R&D LtdHadassah Medical OrganizationUkendtDelirium | Delirium, årsag ukendt | Delirium af blandet oprindelse | Delirium Forvirringstilstand | Delirium lægemiddel-induceretIsrael
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicAfsluttetDelirium i alderdommen | Delirium af blandet oprindelse | Delirium overlejret på demens | Delirium ForvirringstilstandNorge
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Sengkang General HospitalRekrutteringDelirium og postoperativ kognitiv dysfunktion (POCD) | Delirium, postoperativt | Delirium - PostoperativtSingapore
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Universitat de LleidaHospital d'IgualadaIkke rekrutterer endnuDelirium i alderdommen | Delirium behandling | Delirium ForvirringstilstandSpanien
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Johns Hopkins UniversityNational Institute on Aging (NIA)AfsluttetDelirium | Delirium på Emergence | Høretab | Høretab, højfrekvent | Høretab, sensorineural | Delirium, årsag ukendt | Høretab, bilateralt | Hørehandicap | Delirium i alderdommen | Delirium af blandet oprindelse | Delirium overlejret på demens | Delirium Forvirringstilstand | Delirium med demens | Høretab, Funktionel | Høretab... og andre forholdForenede Stater
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Universidad de SantanderUkendtDelirium af blandet oprindelse | Hypoaktivt delirium | Hyperaktivt deliriumColombia
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Wonkwang University HospitalAfsluttet
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Beth Israel Deaconess Medical CenterMassachusetts General Hospital; Columbia University; Ohio State UniversityRekrutteringDelirium i alderdommen | Delirium, postoperativtForenede Stater