About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Currently diagnosed with psychiatric disease and taking psychotropic medication
Currently participating in any psychological intervention
Cognitive impairment
Trial design
Parallel
Treatments tested in this trial
Family-authored Digital ICU Diary Intervention
BehavioralFrom medical consideration of life-sustaining treatment through patient death + 1 month post-death (approximately 4 weeks active writing, then wound down)
Standard Care
Other interventionStandard care without the digital ICU diary intervention
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Locations
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