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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hye Ri Choi
- Numéro de téléphone: 852-6349-0524
- E-mail: hyeripc@hku.hk
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
|
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
|
|
Comparateur actif: Contrôler
|
Standard care without the digital ICU diary intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of the Digital ICU Diary Intervention
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles liés aux traumatismes et aux facteurs de stress
- Les troubles mentaux
- Symptômes comportementaux
- Troubles de stress, traumatiques
- Comportement
- Troubles anxieux
- La dépression
- Troubles de stress, post-traumatique
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
Autres numéros d'identification d'étude
- HMRF23242771
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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