Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT03985592 |
| Other study ID # |
1466 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2, 2020 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Ottawa Hospital Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
