Bereavement, Severe Grief Reaction
Conditions
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.
Interventions
OTHERBereavement 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).
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death | 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 | 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 | at 12 months post-death relative to 6 months post-death | The relative changes in ICG-r scores (change in mean score with SD) 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 | Through study completion, an average of 1 year | The data for this primary outcome could not be collected due to no participants completing the virtual support group intervention. As a result, no interviews could be conducted. Interviews with family member participants upon completion of the virtual support group intervention were to be conducted to determine usefulness for family members' bereavement process. This is a qualitative method of data collection so there is no scale or score. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. No participant will be randomized to any treatment assignment. The decision to attend the VSG is left to the family members.
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- participants from the breakout groups can attend Closed Groups where a smaller group of participants (up to 12) explore 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). | 0 |
| 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 | 121 |
| Total | 121 |
Baseline characteristics
| Characteristic | Non-Virtual Support Group Arm | Total |
|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 14.7 | 58.4 years STANDARD_DEVIATION 14.7 |
| Brief Family Relationship Scale (Total score) | 14.0 units on a scale STANDARD_DEVIATION 2.2 | 14.0 units on a scale STANDARD_DEVIATION 2.2 |
| Days in hospital | 12.0 days STANDARD_DEVIATION 18 | 12.0 days STANDARD_DEVIATION 18 |
| Death disposition ICU | 33 Participants | 33 Participants |
| Death disposition Medicine | 88 Participants | 88 Participants |
| Decedent age | 80.1 years STANDARD_DEVIATION 13.1 | 80.1 years STANDARD_DEVIATION 13.1 |
| Decedent sex Female | 54 Participants | 54 Participants |
| Decedent sex Male | 67 Participants | 67 Participants |
| ICU admission No | 82 Participants | 82 Participants |
| ICU admission Yes | 39 Participants | 39 Participants |
| Intubation No | 96 Participants | 96 Participants |
| Intubation Yes | 25 Participants | 25 Participants |
| Participant education Did not complete high school | 1 Participants | 1 Participants |
| Participant education High school (some or all) | 26 Participants | 26 Participants |
| Participant education Post-secondary education | 94 Participants | 94 Participants |
| Participant marital status Common-law | 11 Participants | 11 Participants |
| Participant marital status Divorced | 8 Participants | 8 Participants |
| Participant marital status Married | 53 Participants | 53 Participants |
| Participant marital status Separated | 4 Participants | 4 Participants |
| Participant marital status Single | 20 Participants | 20 Participants |
| Participant marital status Widowed | 25 Participants | 25 Participants |
| Phone call interaction between the team and family in the last 5 days of life | 2.3 Number of interactions STANDARD_DEVIATION 2.4 | 2.3 Number of interactions STANDARD_DEVIATION 2.4 |
| Physical/in person interaction between the team and family in the last 5 days of life | 3 Number of interactions STANDARD_DEVIATION 3.3 | 3 Number of interactions STANDARD_DEVIATION 3.3 |
| Physical presence of family in the last 48 h of life No | 26 Participants | 26 Participants |
| Physical presence of family in the last 48 h of life Yes | 95 Participants | 95 Participants |
| Race/Ethnicity, Customized African, Caribbean, or non-specified Black | 7 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 13 Participants |
| Race/Ethnicity, Customized Caucasian | 92 Participants | 92 Participants |
| Race/Ethnicity, Customized Indigenous (First Nations, Métis, non-status) | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Latin, Central, and South American | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Mixed (Jamaican and French, German and Jamaican) | 2 Participants | 2 Participants |
| Region of Enrollment Canada | 121 participants | 121 participants |
| Relationship to deceased Child | 75 Participants | 75 Participants |
| Relationship to deceased Friend | 2 Participants | 2 Participants |
| Relationship to deceased Other | 11 Participants | 11 Participants |
| Relationship to deceased Sibling | 9 Participants | 9 Participants |
| Relationship to deceased Spouse/partner | 24 Participants | 24 Participants |
| Sex: Female, Male Female | 80 Participants | 80 Participants |
| Sex: Female, Male Male | 41 Participants | 41 Participants |
| Virtual interaction between the team and family in the last 5 days of life | 0.2 Number of interactions STANDARD_DEVIATION 0.7 | 0.2 Number of interactions STANDARD_DEVIATION 0.7 |
| Virtual presence of family in the last 48 h of life No | 103 Participants | 103 Participants |
| Virtual presence of family in the last 48 h of life Yes | 18 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 121 |
| other Total, other adverse events | 0 / 0 | 0 / 121 |
| serious Total, serious adverse events | 0 / 0 | 0 / 121 |
Outcome results
Primary
Change in ICG-r Score From 6 Months to 12 Months Post-death
The relative changes in ICG-r scores (change in mean score with SD) 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
Population: No participants indicated they attended a virtual support group. Of the 121 participants who completed the baseline grief assessment, 111 completed the follow-up assessment at 12-months post death.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Virtual Support Group Arm | Change in ICG-r Score From 6 Months to 12 Months Post-death | -0.01 score on a scale | Standard Deviation 8.5 |
Primary
Qualitative Interviews Post-Virtual Support Group
The data for this primary outcome could not be collected due to no participants completing the virtual support group intervention. As a result, no interviews could be conducted. Interviews with family member participants upon completion of the virtual support group intervention were to be conducted 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
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.
Time frame: at 12 months post-death
Population: No participants indicated they attended a virtual support group. Of the 121 participants who completed the baseline grief assessment, 111 completed the follow-up assessment at 12-months post death.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-Virtual Support Group Arm | The Inventory for Complicated Grief-revised (ICG-r) Score at 12 Months Post-death | ICG >25 at follow-up | 32 Participants |
| Non-Virtual Support Group Arm | The Inventory for Complicated Grief-revised (ICG-r) Score at 12 Months Post-death | ICG ≤25 at follow-up | 79 Participants |
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.
Time frame: at 6 months post-death
Population: No participants indicated they attended a virtual support group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Non-Virtual Support Group Arm | The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death | ICG total score >25 | 35 Participants |
| Non-Virtual Support Group Arm | The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death | ICG total score ≤ 25 | 86 Participants |