ICU BEREAVE: Feasibility of a Multi-component Bereavement Support Intervention to Prevent Severe Grief Reaction

NCT03985592 | Terminated

• 1 other identifier: 1466
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Nearly 1% of the Canadian population dies every year. When people die, their bereaved family members (FMs) normally experience grief that diminishes over time and without serious psychological or medical impairment. However, some FMs experience a severe grief reaction (SGR) with intense symptoms and impairment lasting months or years; this is more common among FMs of those who die in the Intensive Care Unit (ICU). Many bereaved FMs would like to have bereavement support, and many ICU organizations identify bereavement support as a clinical and research priority, yet few ICUs provide routine support. In order to determine the feasibility and acceptability of a complex support intervention for bereaved FMs, the investigators will pilot a multi-component bereavement intervention through a mixed-methods study. Methods will include a series of semi-structured interviews, questionnaires and narrative therapy sessions. The target population for this study is both ICU clinical staff (e.g. physicians, registered nurses \[RN\], allied health professionals) and FMs of relatives who died in the ICU. The intervention is premised on a robust series of educational modules aimed at increasing ICU staff members' knowledge of and level of comfort with bereavement support ICU FMs. In a previous study, the investigators have established that SGRs can be predicted using screening tools early after the loss, and that ICU-based clinicians are eager to provide bereavement support. There are effective treatments for SGRs once they have been diagnosed after 6 months, but this can mean many months of suffering for the FM. In this project, the investigators plan to develop and test the feasibility of an early bereavement support program that follows bereaved FMs after a loss, provides information and support, and uses effective therapies aimed at preventing the development of a SGR.

Conditions

Severe Grief Reaction

Outcome Measures

Primary Outcomes (5)

• The Inventory of Complicated Grief-Revised (ICG-r)

  Indicates rate of pathological grief. A total of 19 questions. Respondents rate the frequency with which they experience each item on a 5-point scale (0-4), ranging from "never" to "always." Respondents with ICG scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG scores less than or equal to 25. Higher scores result in higher likelihood of CG.

  At 6 months post death

• Brief Grief Questionnaire (BGQ)

  A self reporting instrument assessing complicated grief. A total of 5 questions on a 3 point scale. A total score of 10 is possible. Higher scores result in higher likelihood of CG.

  At 6 months post death

• Impact of Events Scale - Revised (IES-r)

  A self reporting instrument that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales. Higher scores are linked with a greater likelihood of distress

  At 6 months post death

• Patient Health Questionnaire-9 (PHQ-9)

  A multipurpose instrument for screening for severity of depression. A total of 9 questions. Respondents answer from "0" to "4" for each question. The total range is from 0 to 36. A higher score is correlated with greater level of depression.

  At 6 months post death

• Bereavement Dependency Scale (BDS)

  Used as a predictor of enduring and complicated grief. A total of 6 questions. Items are rated on a 5 point scale from "1" to "5". A higher score is linked to dependency on deceased.

  At 6 months post death

Study Arms (4)

Educational Intervention for ICU-Based Clinicians

OTHER

ICU-based clinicians (e.g. physicians, RNs, and social workers) will be provided with educational modules related to bereavement support for family members. Following the modules a survey will be provided to participants to assess their perceived usefulness of the modules.

Behavioral: Education

Educational material and personalized card of condolence

EXPERIMENTAL

Members of the ICU team who cared for deceased ICU patients will be asked to send a letter of condolence to family members listed as the patient's primary contact and provide them with educational modules related to bereavement support for family members.

Behavioral: Education

Virtual meeting with the care team to address unmet needs

EXPERIMENTAL

At 8-12 weeks post-death, the study team will contact FMs and invite them to meet virtually with the care team. Our observational studies indicated that the most common need reported by bereaved FMs was the desire to meet with the care team to review events during the ICU stay and particularly the events that led to death, and that this was the type of support that ICU clinicians were most comfortable providing.

Behavioral: Education

Offering a facilitated storytelling intervention session

EXPERIMENTAL

At six months post-death, the study team will contact FMs and administer the Inventory of Complicated Grief-Revised (ICG-r), Brief Grief Questionnaire (BGQ), Impact of Events Scale - Revised (IES-r), Patient Health Questionnaire-9 (PHQ-9), and the Bereavement Dependency Scale (BDS). FMs who complete all questionnaires will be invited to participate in a 1-2-hour narrative exploration of their grief and bereavement experience, regardless of the severity of their symptoms. Those with severe symptoms will be notified of symptom severity, and offered to participate in the narrative exploration of their grief and bereavement experience. Storytelling interventions require specialized resources but the results of Barnato et al., as well as the response to our qualitative interviews, suggest that this intervention may only be helpful for selected FMs. Storytelling interventions have been shown to reduce healthcare utilization and improve subjective health following a traumatic experience.

Behavioral: Education

Interventions

Education BEHAVIORAL

Intervention description provided in elaboration on arms of the study.

Also known as: Bereavement support, social, and SGR risk assessment

Educational Intervention for ICU-Based Clinicians; Educational material and personalized card of condolence; Offering a facilitated storytelling intervention session; Virtual meeting with the care team to address unmet needs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A family member of a recently deceased patient at the Ottawa Hospital ICU

You may not qualify if:

• Non-Family Member
• Death not in ICU

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Virtual Hospice: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• James Downar, MD

  Physician

  PRINCIPAL INVESTIGATOR

• Brandi Vanderspank-Wright, Phd,RN

  Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Division of Palliative Care

Model Details: The multi-component intervention aims to evaluate the feasibility as well as success of imparting educational knowledge and applied techniques to ICU clinicians (i.e., physicians, RNs, social workers) on how to support bereaved FMs. The overall purpose of the intervention is to optimize preemptive strategies in reducing SGRs in FMs. To determine the effectiveness of this intervention a series of standardized and validated measures of wellbeing will be given to FMs after the typical bereavement period ends. The intervention is designed to be implementable in any ICU setting across Canada and potentially abroad.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 13, 2019
• Study Start: February 2, 2020
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)