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Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic

Primary Purpose

Bereavement, Severe Grief Reaction

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bereavement Virtual Support Group
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bereavement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Family Members of deceased patients from The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort

Exclusion Criteria:

  • Anyone who is unable to participate in a virtual intervention

Sites / Locations

  • Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Support Group Arm

Non-Virtual Support Group Arm

Arm Description

Those with severe symptoms (indicated by an ICG-r score >25) will be notified that their symptoms are considered to be severe, with a suggestion to attend the virtual support groups. A recent meta-analysis of psychological interventions for grief found higher effect sizes in studies of participants who were >6 months post-loss, and those with higher baseline symptom levels. However, no participant in our study will be randomized to any treatment assignment, and the decision to attend the VSG will be left to the family members.

Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm

Outcomes

Primary Outcome Measures

The Inventory for Complicated Grief-revised (ICG-r) score at 6 months post-death
This tool, used to detect pathological grief, has 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-r scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG-r scores less than or equal to 25. Higher scores result in higher likelihood of CG.
The Inventory for Complicated Grief-revised (ICG-r) score at 12 months post-death
Participating FMs will have a repeat ICG-r assessment (as described for primary outcome #1) at 12 months post-death.
Change in ICG-r score from 6 months to 12 months post-death
The relative changes in ICG scores between 6 and 12 months of family members who participate in the VSGs vs. those who do not will be compared as a measure of the efficacy of the VSG intervention
Qualitative Interviews Post-Virtual Support Group
Interviews with family member participants upon completion of virtual support group intervention to determine usefulness for family members' bereavement process. This is a qualitative method of data collection so there is no scale or score

Secondary Outcome Measures

Full Information

First Posted
October 8, 2020
Last Updated
February 26, 2021
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04588415
Brief Title
Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
Official Title
Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a feasibility study taking place at The Ottawa Hospital (TOH), Hôpital Montfort, and Queensway Carleton Hospital that seeks to evaluate the impact of the COVID-19 pandemic on family member bereavement and study the effect of virtual support groups on reducing risk of developing Severe Grief Reaction (SGR). This project is inviting family members of deceased patients at either of the three before mentioned sites to enroll in this study.
Detailed Description
Background: Severe grief reactions (SGR), or complicated grief (CG), are experienced by 2-3% of the population after the loss of a loved one, and can be associated with declining health, social distress, increased use of healthcare resources and higher mortality. SGR can be related to the circumstances of the patient at the end of life, particularly in deaths that were unexpected or traumatic, when the family member was unprepared or unsupported. The COVID-19 pandemic has affected many aspects of end-of-life care. For example, infection control measures may reduce interactions between long-term care residents and family members, and have often limited in-person family visiting to the final hours of life, or no visiting at all for patients with COVID-19. Anecdotally, this disruption of normal interactions has been difficult for patients and families alike, and it is known that isolation and lack of closure with a loved one can contribute to the risk of SGR. The prevalence of SGR is expected to rise amid increased challenges in supporting a surge of people with SGR due to physical distancing and limited bereavement resources. Methods: The proposed mixed methods explanatory study includes both retrospective and prospective data collection. The quantitative components will principally consist of natural experiments to identify patient/FM characteristics indicating a high risk of SGR during the COVID-19 pandemic. The qualitative components will deepen an understanding of the impact of COVID-19 on bereavement, while providing a formative evaluation for the virtual support groups. Study subjects will include all patients who died in an acute care facility in Ottawa (The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort) from January 1, 2020 until June 30, 2020, and their primary contact (as indicated in their medical record). Significance: Early identification of FMs at risk of SGR provides an opportunity for early intervention with the hope of preventing or reducing the severity of the SGR, but it also enables prioritization of those in greatest need, should demand exceed resources. Moreover, because it is still early in the pandemic, the study will be able to collect clinical data about the circumstances of the death, and consistently collect bereavement data for family members of people who died before and after the pandemic struck, and before and after the availability of virtual support groups. Therefore have a unique opportunity to conduct two natural experiments- studying the impact of the COVID pandemic on bereavement, and studying the effect of virtual support groups on symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bereavement, Severe Grief Reaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants in the prospective bereavement data collection component of this study will be invited to participate in the virtual support group (VSG) intervention, regardless of the severity of their symptoms. Those with severe symptoms (indicated by an ICG-r score >25) will be notified that their symptoms are considered to be severe, with a suggestion to attend the VSGs. A recent meta-analysis of psychological interventions for grief found higher effect sizes in studies of participants who were >6 months post-loss, and those with higher baseline symptom levels. However, no participant in the study will be randomized to any treatment assignment, and the decision to attend the VSG will be left to the participants.
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Support Group Arm
Arm Type
Experimental
Arm Description
Those with severe symptoms (indicated by an ICG-r score >25) will be notified that their symptoms are considered to be severe, with a suggestion to attend the virtual support groups. A recent meta-analysis of psychological interventions for grief found higher effect sizes in studies of participants who were >6 months post-loss, and those with higher baseline symptom levels. However, no participant in our study will be randomized to any treatment assignment, and the decision to attend the VSG will be left to the family members.
Arm Title
Non-Virtual Support Group Arm
Arm Type
No Intervention
Arm Description
Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm
Intervention Type
Other
Intervention Name(s)
Bereavement Virtual Support Group
Intervention Description
Family members who experience loss will be invited to attend a virtual support group (VSG) led by Bereaved Families of Ontario- Ottawa (BFO). In pre-COVID-19 times, BFO presented monthly "Support and Share" nights with guest speakers, followed by breakout peer support groups for all different types of losses: loss of child, spouse, parent, loss by suicide, etc. These groups are facilitated by trained volunteers with a shared loss and include between 75 and 150 participants. These Support and Share Nights serve as intake sessions- interested participants from the breakout groups can attend "Closed Groups" where a smaller group of participants (up to 12) explore their grief more deeply. These run over 8-10 consecutive weeks with the same group of participants. They are led by trained facilitators who have experienced similar losses. Each week has a different theme, based on evidence-based components of bereavement support (e.g. writing a letter to the deceased).
Primary Outcome Measure Information:
Title
The Inventory for Complicated Grief-revised (ICG-r) score at 6 months post-death
Description
This tool, used to detect pathological grief, has 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-r scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG-r scores less than or equal to 25. Higher scores result in higher likelihood of CG.
Time Frame
at 6 months post-death
Title
The Inventory for Complicated Grief-revised (ICG-r) score at 12 months post-death
Description
Participating FMs will have a repeat ICG-r assessment (as described for primary outcome #1) at 12 months post-death.
Time Frame
at 12 months post-death
Title
Change in ICG-r score from 6 months to 12 months post-death
Description
The relative changes in ICG scores between 6 and 12 months of family members who participate in the VSGs vs. those who do not will be compared as a measure of the efficacy of the VSG intervention
Time Frame
at 12 months post-death relative to 6 months post-death
Title
Qualitative Interviews Post-Virtual Support Group
Description
Interviews with family member participants upon completion of virtual support group intervention to determine usefulness for family members' bereavement process. This is a qualitative method of data collection so there is no scale or score
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Family Members of deceased patients from The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort Exclusion Criteria: Anyone who is unable to participate in a virtual intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Downar, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter G Lawlor, MD
Organizational Affiliation
Bruyere Continuing Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrique Parsons, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data will be de-identified prior to entering analysis with anyone outside of the research team

Learn more about this trial

Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic

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