- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03379129
Family ICU Delirium Detection Study (FIDDS)
Validation of Family-Administered Delirium Detection Tools for the Identification of Delirium in Critically Ill Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 2T9
- Foothills Hospital ICU
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Eleven item Family Confusion Assessment Method (FAM-CAM) family caregiver administered delirium detection tool
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Seven item General Anxiety Disorder (GAD-7) questionnaire to detect signs of anxiety in the family caregivers at the bedside
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kirsten M Fiest, PhD, University of Calgary
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REB-16-2060
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Delirio
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Jubilee Mission Medical College and Research InstituteINCRE fellowship from DBT, govt of IndiaTerminadoSíntomas de abstinencia de alcohol | Delirium Tremens (DT)
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Denver Health and Hospital AuthorityTerminadoDelirio por abstinencia de alcohol | Hiperactividad autonómica asociada a la abstinencia de alcohol | Alucinosis por abstinencia de alcohol | Delirium Tremens inducido por abstinencia de alcoholEstados Unidos