- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03379129
Family ICU Delirium Detection Study (FIDDS)
Validation of Family-Administered Delirium Detection Tools for the Identification of Delirium in Critically Ill Patients
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Alberta
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Calgary, Alberta, Kanada, T2N 2T9
- Foothills Hospital ICU
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Eleven item Family Confusion Assessment Method (FAM-CAM) family caregiver administered delirium detection tool
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Seven item General Anxiety Disorder (GAD-7) questionnaire to detect signs of anxiety in the family caregivers at the bedside
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kirsten M Fiest, PhD, University of Calgary
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REB-16-2060
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Kliniska prövningar på Delirium
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Alexandria UniversityAvslutadKlozapinförgiftning | Hypoaktivt delirium | Tricyklisk antidepressiv förgiftning | Antikolinergt delirium | Antipsykotisk Toxicitet | CNS-depression | Procyclidininducerad deliriumEgypten
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Duke UniversityHar inte rekryterat ännuDelirium Förvirringstillstånd | Hyperaktivt delirium | Delirium på intensivvårdsavdelningen | Agiterat deliriumFörenta staterna
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Efficacy Care R&D LtdHadassah Medical OrganizationOkändDelirium | Delirium, orsak okänd | Delirium av blandat ursprung | Delirium Förvirringstillstånd | Läkemedelsinducerad deliriumIsrael
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Johns Hopkins UniversityNational Institute on Aging (NIA)AvslutadDelirium | Delirium vid uppkomst | Hörselnedsättning | Hörselnedsättning, högfrekvent | Hörselnedsättning, sensorineural | Delirium, orsak okänd | Hörselnedsättning, bilateral | Hörselnedsättning | Delirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium Förvirringstillstånd | Delirium... och andra villkorFörenta staterna
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicAvslutadDelirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium FörvirringstillståndNorge
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Sengkang General HospitalRekryteringDelirium och postoperativ kognitiv dysfunktion (POCD) | Delirium, postoperativt | Delirium - PostoperativtSingapore
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Universitat de LleidaHospital d'IgualadaHar inte rekryterat ännuDelirium i ålderdom | Delirium behandling | Delirium FörvirringstillståndSpanien
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Universidad de SantanderOkändDelirium av blandat ursprung | Hypoaktivt delirium | Hyperaktivt deliriumColombia
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Wonkwang University HospitalAvslutad
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University of Novi SadRekryteringIntensivvårdsavdelning DeliriumSerbien