Family-authored Digital ICU Diary Intervention to Support Bereaved Family Members in Intensive Care Unit: A Pilot Mixed Methods Study (ICU-Diary-HK)
Feasibility, Acceptability and Efficacy of a Family-authored Digital ICU Diary Intervention for Bereaved Family Members in Hong Kong Intensive Care Units: A Pilot Randomised Controlled Trial With Qualitative Process Evaluation
Objectives: To assess the feasibility, acceptability and appropriateness of a family-authored digital ICU diary intervention for bereaved family members in Hong Kong ICUs, and to explore family members' experiences of writing digital diaries during and following patient death.
Hypothesis: The ICU digital diary intervention will prove feasible, acceptable and potentially efficacious in reducing bereaved family members' PTSD, anxiety and depression at 1 and 3 months post-patient death compared with baseline measurements.
Design and Subjects: A two-arm, assessor-blind pilot randomised controlled trial with subsequent qualitative process evaluation. Forty family members of ICU patients receiving life-sustaining treatment will be recruited from three Hong Kong public hospitals and randomised 1:1 to intervention or control groups.
Instruments: Feasibility of Intervention Measure (FIM), Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Impact of Event Scale-Revised (IES-R), Posttraumatic Stress Syndrome-14 (PTSS-14) and Hospital Anxiety and Depression Scale (HADS).
Intervention: Family-authored digital ICU diary via WhatsApp, commencing when a patient's treatment is deemed life-sustaining, continuing through death and a one-month bereavement period.
Main Outcome Measures: Primary: recruitment rate, retention rate, compliance, feasibility, acceptability and appropriateness. Secondary: symptoms of PTSD, anxiety and depression.
Data Analysis: Descriptive statistics for feasibility outcomes; repeated measures ANOVA and linear mixed effects models for psychological outcomes; thematic analysis for qualitative data.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hye Ri Choi
- Número de teléfono: 852-6349-0524
- Correo electrónico: hyeripc@hku.hk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- One family member (closest to patient: spouse, grown child, or parent) of adult ICU patients whose treatment is considered life-sustaining
- Patient admitted to adult ICU for minimum 48 hours
- Patient dies in adult ICU without transfer to other inpatient units
- Able to read, write and communicate effectively in Chinese or English
Exclusion Criteria:
- Currently diagnosed with psychiatric disease and taking psychotropic medication
- Currently participating in any psychological intervention
- Cognitive impairment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervención
|
From medical consideration of life-sustaining treatment through patient death + 1 month post-death (approximately 4 weeks active writing, then wound down)
Standard care without the digital ICU diary intervention
|
|
Comparador activo: Control
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Standard care without the digital ICU diary intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of the Digital ICU Diary Intervention
Periodo de tiempo: Month 1 and Month 3 after patient's death
|
Feasibility assessed using the Feasibility of Intervention Measure (FIM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree).
Higher scores indicate greater perceived feasibility.
|
Month 1 and Month 3 after patient's death
|
|
Acceptability of the Digital ICU Diary Intervention
Periodo de tiempo: Month 1 and Month 3 after patient's death
|
Acceptability assessed using the Acceptability of Intervention Measure (AIM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree).
Higher scores indicate greater perceived acceptability.
|
Month 1 and Month 3 after patient's death
|
|
Appropriateness of the Digital ICU Diary Intervention
Periodo de tiempo: Month 1 and Month 3 after patient's death
|
Appropriateness assessed using the Intervention Appropriateness Measure (IAM), a 4-item, 5-point Likert scale (1=Completely disagree to 5=Completely agree).
Higher scores indicate greater perceived appropriateness.
|
Month 1 and Month 3 after patient's death
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)
Periodo de tiempo: Baseline, Month 1, and Month 3 after patient's death
|
IES-R, a 22-item self-report scale rated on a 5-point scale (0=not at all to 4=extremely).
Total score ranges from 0 to 88.
Higher scores indicate greater severity of post-traumatic stress symptoms.
|
Baseline, Month 1, and Month 3 after patient's death
|
|
Post-Traumatic Stress Symptoms as Measured by PTSS-14
Periodo de tiempo: Baseline, Month 1, and Month 3 after patient's death
|
Posttraumatic Stress Syndrome-14 (PTSS-14), a 14-item self-report scale rated on a 7-point Likert scale (1=never to 7=always).
Total score ranges from 14 to 98. Higher scores indicate greater severity of post-traumatic stress symptoms.
|
Baseline, Month 1, and Month 3 after patient's death
|
|
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS-A)
Periodo de tiempo: Baseline, Month 1, and Month 3 after patient's death
|
HADS anxiety subscale, 7 items scored 0-3 each.
Subscale score ranges from 0 to 21.
Higher scores indicate greater severity of anxiety symptoms.
|
Baseline, Month 1, and Month 3 after patient's death
|
|
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS-D)
Periodo de tiempo: Baseline, Month 1, and Month 3 after patient's death
|
HADS depression subscale, 7 items scored 0-3 each.
Subscale score ranges from 0 to 21.
Higher scores indicate greater severity of depression symptoms.
|
Baseline, Month 1, and Month 3 after patient's death
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos relacionados con el trauma y el estrés
- Desordenes mentales
- Síntomas de comportamiento
- Trastornos de Estrés, Traumáticos
- Comportamiento
- Desórdenes de ansiedad
- Depresión
- Trastornos de estrés postraumático
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- HMRF23242771
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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