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

Bereavement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04588415
• Other study ID #: 20200653-01H
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 3, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2021
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bereavement
• Severe Grief Reaction

Intervention

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).

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 6 months post-death
Primary	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.	at 12 months post-death
Primary	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	at 12 months post-death relative to 6 months post-death
Primary	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	Through study completion, an average of 1 year