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

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ClinicalTrials.gov Identifier: NCT03985592
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Canadian Virtual Hospice
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Severe Grief Reaction Behavioral: Education Not Applicable

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 distinct from other psychiatric illness that is directly 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 decline 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
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 (physicians and RNs) 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)
Primary Purpose: Prevention
Official Title: ICU BEREAVE: Feasibility of a Multi-component Bereavement Support Intervention to Prevent Severe Grief Reaction
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bereavement

Arm Intervention/treatment
Educational Intervention for ICU-Based Clinicians
ICU-based clinicians (e.g. physicians and RNs) are ideally situated to provide support for FMs experiencing acute grief at the time of death particularly because of pre-established therapeutic relationships. However, ICU clinician-related barriers to bereavement support for FMs identified in our previous studies included lack of comfort, skill and knowledge regarding bereavement needs and support. To address this barrier, in partnership with Canadian Virtual Hospice (CVH), we are developing and will deliver bilingual educational material aimed at improving the knowledge, skill and comfort of ICU-based clinicians providing acute grief and bereavement support. CVH established a pan-Canadian team of grief experts to develop four evidence-based, interactive online learning modules for ICU-based clinicians. The modules are specific to the ICU context and are grounded in the lived experience of FMs and clinicians who experience death in the ICU.
Behavioral: Education
Intervention description provided in elaboration on arms of the study.
Other Name: Bereavement support, social, and SGR risk assessment

Experimental: Educational material and personalized letter of condolence
To address the need for normalization and education around bereavement, we will use an award-winning scalable, web-based resource offered by CVH (MyGrief.ca). The nine learning modules cover anticipatory loss and grief for the bereft. Topics include exploring the nature of relationships between survivors and the ill/deceased, challenging family dynamics, managing grief triggers and self-care.
Behavioral: Education
Intervention description provided in elaboration on arms of the study.
Other Name: Bereavement support, social, and SGR risk assessment

Experimental: Meeting with the care team to address unmet needs
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. At the same time, 52-58% of bereaved FMs would want support for social issues (e.g. transportation, making financial arrangements), and this is an area in which clinicians have been found to be uncomfortable providing support. The purpose of this meeting is to (1) clarify misunderstandings and to help the FM explore their grief and reconstruct their experience with the loss ("meaning-making"); and (2) identify unmet social needs and arrange support. Participating clinicians will be able to use knowledge and insight from the CVH educational modules (from component #1) in this meeting.
Behavioral: Education
Intervention description provided in elaboration on arms of the study.
Other Name: Bereavement support, social, and SGR risk assessment

Experimental: Identifying FMs at high risk of SGRs
At 10-12 weeks post-death, we will contact FMs and administer the Inventory of Complicated Grief-Revised (ICG-r), Brief Grief Questionnaire (BGQ)34, Impact of Events Scale - Revised (IES-r), Patient Health Questionnaire-9 (PHQ-9), and the Bereavement Dependency Scale (BDS). If these results suggest a 10% or greater risk of developing Complicated Grief (CG), we will offer and encourage the FM to participate in a 1-2 hour narrative exploration of their grief and bereavement experience. Narrative interventions require specialized resources and are less scalable than components #1 and #2, but the results of Barnato et al., as well as the response to our qualitative interviews, suggest that this intervention may be helpful for selected FMs. Narrative interventions have been shown to reduce healthcare utilization and improve subjective health following a traumatic experience.
Behavioral: Education
Intervention description provided in elaboration on arms of the study.
Other Name: Bereavement support, social, and SGR risk assessment




Primary Outcome Measures :
  1. The Inventory of Complicated Grief-Revised (ICG-r) [ Time Frame: At 6 months post death ]
    Indicates rate of pathological grief

  2. Brief Grief Questionnaire (BGQ) [ Time Frame: At 6 months post death ]
    A self reporting instrument assessing complicated grief

  3. Impact of Events Scale - Revised (IES-r) [ Time Frame: At 6 months post death ]
    A self reporting instrument that assesses subjective distress caused by traumatic events

  4. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: At 6 months post death ]
    A multipurpose instrument for screening for severity of depression

  5. Bereavement Dependency Scale (BDS) [ Time Frame: At 6 months post death ]
    Used as a predictor of enduring and complicated grief



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985592


Contacts
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Contact: Antoine Przybylak-Brouillard, MA 5149279357 aprzybylak@ohri.ca

Locations
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Canada, Ontario
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Antoine Przybylak-Brouillard, MA    5149279357    aprzybylak@ohri.ca   
Contact: Brandi Vanderspank-Wright, PhD    613-562-5800 ext 1014    bvanders@uottawa.ca   
Principal Investigator: Brandi Vanderspank-Wright, PhD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Virtual Hospice
Investigators
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Principal Investigator: James Downar, MD Physician
Principal Investigator: Brandi Vanderspank-Wright, Phd,RN Investigator

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03985592     History of Changes
Other Study ID Numbers: 1466
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All participant data will be kept securely by the research team and de-identified for any future publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No