Clinical trial NCT03985592: ICU BEREAVE: Feasibility of a Multi-component Bereavement Support Intervention to Prevent Severe Grief Reaction
Official title: ICU BEREAVE: Feasibility of a Multi-component Bereavement Support Intervention to Prevent Severe Grief Reaction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe Grief Reaction
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Virtual Hospice
First posted: 2019-06-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The Inventory of Complicated Grief-Revised (ICG-r)
timeFrame: At 6 months post death
measure: Brief Grief Questionnaire (BGQ)
timeFrame: At 6 months post death
measure: Impact of Events Scale - Revised (IES-r)
timeFrame: At 6 months post death
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At 6 months post death
measure: Bereavement Dependency Scale (BDS)
timeFrame: At 6 months post death
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Physician
name: James Downar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Investigator
name: Brandi Vanderspank-Wright, Phd,RN
role: PRINCIPAL_INVESTIGATOR
References: