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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
40
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
Feasibility of the Digital ICU Diary Intervention
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.
Time frame: Month 1 and Month 3 after patient's death
Acceptability of the Digital ICU Diary Intervention
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.
Time frame: Month 1 and Month 3 after patient's death
Appropriateness of the Digital ICU Diary Intervention
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.
Time frame: Month 1 and Month 3 after patient's death
Post-Traumatic Stress Symptoms as Measured by the Impact of Event Scale-Revised (IES-R)
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.
Time frame: Baseline, Month 1, and Month 3 after patient's death
Post-Traumatic Stress Symptoms as Measured by PTSS-14
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.
Time frame: Baseline, Month 1, and Month 3 after patient's death
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS-A)
HADS anxiety subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of anxiety symptoms.
Time frame: Baseline, Month 1, and Month 3 after patient's death
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS-D)
HADS depression subscale, 7 items scored 0-3 each. Subscale score ranges from 0 to 21. Higher scores indicate greater severity of depression symptoms.
Time frame: Baseline, Month 1, and Month 3 after patient's death
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