Family-authored Digital ICU Diary Intervention to Support Bereaved Family Members in Intensive Care Unit: A Pilot Mixed Methods Study

ConditionBereavement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Family-authored Digital ICU Diary Intervention

    Behavioral

    From medical consideration of life-sustaining treatment through patient death + 1 month post-death (approximately 4 weeks active writing, then wound down)

  • Standard Care

    Other intervention

    Standard care without the digital ICU diary intervention

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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