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

NCT ID: NCT03985592

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-02
• Study Completion Date: 2024-02-07

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.

Detailed Description

Almost 1% of the population dies annually. When people die, it is normal for their bereaved family members (FMs) to experience grief. This grief usually diminishes, but in some cases FMs suffer from severe grief reaction (SGR) with intense yearning or separation distress, as well as emotional, cognitive and functional impairment lasting months or years. SGRs are linked with declining health, increased use of healthcare resources, and even death. ICU deaths are associated with a higher incidence of SGR2 - symptoms of psychiatric illness and have been reported in 34-67% of surviving FMs with 22% experiencing significant social distress.

As grieving death is an expected human response, SGRs cannot be diagnosed until >6 months after a loss, but the investigators found that a SGR at 6 months can be accurately predicted by screening tests 3 months after a death. Early identification provides opportunity for early intervention with the hope of preventing or reducing the severity of SGRs. There are effective treatments for established SGRs (i.e. >6 months post-death), including psychotherapy tailored to SGR. This therapy works through 3 mechanisms: (1) by encouraging exposure to reminders and situations that the FM is avoiding, (2) restructuring through reconstructing an understanding of the loss and grief experience, and (3) behavioural activation to re-establish social interaction. Some ICU-based support interventions administered pre-death are effective in reducing psychological morbidity, while others have shown no effect or even harm.

Many bereaved FMs would appreciate bereavement support, and ICU organizations have identified bereavement support as a clinical and research priority. Yet few ICUs have devoted resources toward bereavement screening or support. Our previous multi-centre study found that only 16% of Canadian ICU clinicians follow up with FMs after a death, and bereaved FMs rarely, if ever, report being contacted after the death of their loved one. Few ICU clinicians have received formal training in bereavement support and many report "not knowing what to say" in response to strong emotions.

Currently, less than half of Canadian ICU clinicians (physicians and registered nurses [RN]) are comfortable providing any form of bereavement support to FMs at the time of death, and fewer than 18% perceive that FMs may have social or informational needs following a death. Similarly, FMs are often unwilling or unable to access bereavement support even when resources are available with over half of eligible participants declining participation in ICU-based bereavement interventions.

Single interventions are not effective for preventing SGRs in unselected populations of bereaved FMs (thought may benefit high-risk populations). Thus our pilot project will combine several promising scalable and low-resource interventions in a "bundle", to improve the chances of meeting these needs and overcoming these barriers. As a research-based intervention, this study will examine the feasibility of implementing measures to reduce SGRs while also determining the best methods to address the social and educational needs of clinicians and FM.

Conditions

Severe Grief Reaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Educational Intervention for ICU-Based Clinicians

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.

Group Type: OTHER

Education

Intervention Type: BEHAVIORAL

Intervention description provided in elaboration on arms of the study.

Educational material and personalized card of condolence

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

Intervention description provided in elaboration on arms of the study.

Virtual meeting with the care team to address unmet needs

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

Intervention description provided in elaboration on arms of the study.

Offering a facilitated storytelling intervention session

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

Intervention description provided in elaboration on arms of the study.

Interventions

Education

Intervention description provided in elaboration on arms of the study.

Intervention Type: BEHAVIORAL

Other Intervention Names

Bereavement support, social, and SGR risk assessment

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Non-Family Member
• Death not in ICU

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Virtual Hospice

UNKNOWN

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

James Downar

Head of the Division of Palliative Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Downar, MD

Role: PRINCIPAL_INVESTIGATOR

Physician

Brandi Vanderspank-Wright, Phd,RN

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

1466

Identifier Type: -

Identifier Source: org_study_id