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

• ClinicalTrials.gov Identifier: NCT04588415
• Recruitment Status: Enrolling by invitation
• First Posted: October 19, 2020
• Last Update Posted: March 1, 2021
• Sponsor: Ottawa Hospital Research Institute
• Information provided by (Responsible Party): Peter Lawlor, Ottawa Hospital Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Bereavement; Severe Grief Reaction	Other: Bereavement Virtual Support Group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
• Actual Study Start Date: January 3, 2021
• Estimated Primary Completion Date: December 1, 2021
• Estimated Study Completion Date: January 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Virtual Support Group Arm; 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.	Other: Bereavement Virtual Support Group; 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).
No Intervention: Non-Virtual Support Group Arm; Family members that choose not to participate in the Virtual Support Group will be part of this non-intervention arm

Outcome Measures

Primary Outcome Measures :

1. The Inventory for Complicated Grief-revised (ICG-r) score at 6 months post-death [ Time Frame: 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.
2. The Inventory for Complicated Grief-revised (ICG-r) score at 12 months post-death [ Time Frame: 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.
3. Change in ICG-r score from 6 months to 12 months post-death [ Time Frame: at 12 months post-death relative to 6 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
4. Qualitative Interviews Post-Virtual Support Group [ Time Frame: Through study completion, an average of 1 year ]
   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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Canada, Ontario

Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

Investigators

• Study Chair: James Downar, MD; Ottawa Hospital Research Institute
• Principal Investigator: Peter G Lawlor, MD; Bruyere Continuing Care
• Principal Investigator: Henrique Parsons, MD; The Ottawa Hospital

More Information

• Responsible Party: Peter Lawlor, Clinician Investigator, Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT04588415
• Other Study ID Numbers: 20200653-01H
• First Posted: October 19, 2020
• Last Update Posted: March 1, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

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

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

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases