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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Severe Grief Reaction

Intervention / Treatment
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* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A family member of a recently deceased patient at the Ottawa Hospital ICU Exclusion Criteria: Non-Family Member Death not in ICU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Educational Intervention for ICU-Based Clinicians<br>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<br>* Intervention description provided in elaboration on arms of the study.<br>* Other names: Bereavement support, social, and SGR risk assessment;|
| Experimental: Educational material and personalized card of condolence<br>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<br>* Intervention description provided in elaboration on arms of the study.<br>* Other names: Bereavement support, social, and SGR risk assessment;|
| Experimental: Virtual meeting with the care team to address unmet needs<br>At 8-12 weeks post-death, we 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<br>* Intervention description provided in elaboration on arms of the study.<br>* Other names: Bereavement support, social, and SGR risk assessment;|
| Experimental: Offering a facilitated storytelling intervention session<br>At six months post-death, we 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, with a suggestion 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<br>* Intervention description provided in elaboration on arms of the study.<br>* Other names: Bereavement support, social, and SGR risk assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |