Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
Phase: NA
Conditions: Bereavement, Severe Grief Reaction
Sponsor: Ottawa Hospital Research Institute

 
 
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Version 4 dated November 11th, 2021 
Supporting Family Members with severe grief reaction during the COVID-19 Pandemic 
NCT04588415 
 
Principal Investigators: 
 
Peter Lawlor MB FRCPI MMedSc 
Clinician Investigator, Ottawa Hospital Research Insitute, Bruyère Research Institute 
Professor, University of Ottawa  
plawlor@bruyere.org  
 
Henrique Parsons MD MSc 
Clinician Investigator, Ottawa Hospital Research Insitute, Bruyère Research Institute 
Associate Professor, University of Ottawa  
hparsons@toh.ca  
 
Co-Investigators: 
 
Dr. James Downar MDCM MHSc  
Head of the Division of Palliative Care, Department of Medicine, University of Ottawa 
Associate Professor, University of Ottawa 
Department of Palliative Care, Élisabeth Bruyère Hospital  
 
Dr. Brandi Vanderspank – Wright Ph.D. RN CNCC(C) 
Associate Professor, University of Ottawa 
 
Dr. Peter Tanuseputro MD MHSc CCFP FRCPC 
Scientist, Clinical Epidemiology Program, Ottawa Hospital Research Institute 
 
Investigator, Bruyère Research Institute 
Associate Professor, University of Ottawa 
 
 
 
 
 
Dr. Shirley Bush MBBS DRCOG DCH MRCGP Dip Pall Med FAChPM  
 
 
 
Clinician Investigator, Bruyère Research Institute 
Associate Professor, University of Ottawa 
 
Dr. Akshai Iyengar  MSc MD FRCPC 
Medical Director, Department of Critical Care Medicine, Queensway Carleton Hospital  
Assistant Professor, University of Ottawa 
 
Dr. Claire Dyason, MD CFPC  
Palliative Care Physician, Department of Critical Care Medicine, Queensway Carleton Hospital  
Lecturer, University of Ottawa 
 
 
 
 
 
 
 
 
Dr. Khadija Bhimji MD BSc(H) MSc FCFP  
Palliative Care Physician, Department of Critical Care Medicine, Queensway Carleton Hospital  
Assistant Professor, University of Ottawa  
 
 
 
 
 
 
 
 
Dr. Isabelle Desjardin MD 

 
 
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Clinician Educator, Department of Medicine, University of Ottawa  
 
 
 
 
 
 
Dr. Valérie Gratton MD 
Palliative Care Physician, Montfort Hospital 
Assistant Professor, University of Ottawa  
 
 
 
 
 
 
 
 
 
Dr. Paula Enright MD  
 
 
 
 
 
 
Palliative Care Physician, Department of Critical Care Medicine, The Ottawa Hospital 
 
Assistant Professor, University of Ottawa  
 
 
Dr. Krista Wooller MD MSc  
 
 
 
 
 
 
Palliative Care Physician, Department of Critical Care Medicine, The Ottawa Hospital 
 
Assistant Professor, University of Ottawa 
 
Dr. Rebekah Murphy MD 
 
 
 
 
 
 
Palliative Care Physician, Department of Critical Care Medicine, The Ottawa Hospital 
 
Dr. Sarina Isenberg, Ph.D  
 
 
 
 
 
 
 
 
Investigator and Chair in Mixed Methods Palliative Care Research, Bruyere Research Institute 
 
Knowledge Users: 
Shelly Cory MA 
Executive Director, Canadian Virtual Hospice 
 
Antoine Babinsky 
Director, Bereaved Families of Ontario – Ottawa 
 
Tara Cohen 
Program Manager, Champlain Hospice Palliative Care Program  
 
Primary Study Staff Contacts: 
 
Henrique Parsons, MD MSc 
Co-Principal Investigator 
hparsons@toh.ca 
 
Julie Lapenskie, MSc 
Research Associate 
jlapenskie@ohri.ca  
 
Additional Study Staff 
 
Monisha Kabir, Research Associate 
Koby Anderson, Research Assistant 
Brandon Heidinger, Research Coordinator 
 
 
 

 
 
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Abstract 
 
Background: Severe grief reactions (SGR), or complicated grief, 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 we know 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 our understanding of the impact of COVID-19 on bereavement, 
while providing 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 November 1 1, 2019 until August 31, 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 we are still early in the 
pandemic, we are 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. We 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. 
 
 
 

 
 
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BACKGROUND AND RATIONALE 
 
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.1 SGRs have been variously labelled as Complicated Grief (CG)2, Prolonged Grief 
Disorder (PGD)3, or Persistent Complex Bereavement-Related Disorder (PCBRD4, included in the 
Diagnostic Services Manual ver. 5), and may also feature other psychiatric morbidity such as 
depression or post-traumatic stress disorder (PTSD). SGRs are linked with declining health, use of 
healthcare resources, and even death.5,6  
 
The COVID-19 pandemic has affected many aspects of end-of-life care, even for those who die of 
illnesses other than COVID-19. For those admitted to acute or long-term care, visitor restrictions have 
significantly impacted family presence in the final hours of life. Videoconferencing and telephone 
interactions are not feasible for many elderly or dying patients, and are not recommended when 
patients are actively dying.7 Supportive interactions from healthcare providers are also limited by 
infection control measures. COVID-19 can also enhance feelings of guilt; FMs may have unwittingly 
transmitted COVID-19 during a visit, or the FMs may feel guilt for not having taken them out of a 
Long-Term Care facility prior to an outbreak.8 All of these factors will likely increase the risk of SGR. 
Moreover, despite the increase in mortality rate caused by a pandemic, the disruption in normal 
services (e.g. cancer care) actually results in reduced use of hospice and palliative care9, which are 
known to protect against SGR.10  
 
Many bereaved FMs would appreciate bereavement support4,11,12, and bereavement support has been 
identified as a clinical and research priority.13,14 Yet few acute or long-term care settings (where most 
death occurs in Canada) have devoted resources toward bereavement screening or support,15 so many 
FMs seek support from therapists or community-based bereavement groups outside of the public 
healthcare system.  
 
There are effective treatments for established SGRs (i.e. >6 months post-death),16 including individual 
psychotherapy tailored to Complicated Grief.17 Group therapy may also be beneficial, as illustrated in 
a naturalistic controlled trial of bereavement counselling delivered through a community-based 
organization.18 But these therapies may not be as effective during the pandemic; Glickman et al. found 
that feelings of guilt and avoidance were two of the most important mediating factors mediating the 
response to complicated grief treatment.19 Since feelings of guilt appear to be common in COVID-19 
deaths, and social distancing rules have the potential to reinforce avoidant behaviour, these could 
undermine the effectiveness of standard therapies.20 More importantly, SGR treatments are usually 
based on in-person sessions; these are limited resources that may not be able to accommodate a major 
surge in SGR incidence triggered by the pandemic, and physical distancing rules would preclude their 
use in a pandemic. 
 
Internet-based interventions have shown promise in preventing mental disorders22 and treating 
symptoms of post-traumatic stress.23 A randomized controlled trial of an email-based intervention was 
shown to improve complicated grief symptoms24, with a high acceptance and low drop-out rate. 
Internet-based self-help interventions have also improved grief symptoms in bereaved older adults.25 
However, there is little data on the use of virtual group sessions as part of a bereavement support 
program- this is a critical gap in the literature, given that group therapy is one of the more accessible 
and scalable options available. Many community-based organizations are planning to provide their 

 
 
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usual support group sessions virtually, including Bereaved Families of Ontario, which has been 
supporting bereaved FMs for more than 40 years. 
 
 
RESEARCH OBJECTIVES 
 
1. Determine the impact of the COVID-19 pandemic on the bereavement experience of FMs. 
2. Identify patient/FM characteristics indicating a high risk of SGR during the COVID-19 pandemic.  
3. Assess the feasibility, acceptability and preliminary efficacy of virtual support groups (VSG). 
 
METHODS 
 
Design 
 
We propose a mixed methods explanatory design, including both retrospective and prospective data 
collection. The quantitative components will principally consist of natural experiments to address 
objectives #1, #2, and #3. The qualitative components will deepen our understanding of the impact of 
COVID-19 on bereavement (Objective #1), while a providing formative evaluation for the VSG 
(Objective #3).  
 
Study Setting 
 
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 November 1st, 2019 to August 
31st, 2020, and their contacts (as indicated in their medical record). The Virtual support groups will be 
organized by Bereaved Families of Ontario – Ottawa through a virtual platform.  
 
Study Participants  
 
We will collect retrospective data from approximately 550 deceased patients. We plan to recruit 
approximately 200 FMs for the prospective portion of the study with an expected 100 FMs 
participating in the VSG and 20 FMs in the qualitative interviews. Note that family members will 
participate in the virtual support group as part of routine care available to them – the support group is 
not a study-specific intervention, nor will any research team members be involved in the 
administration of the virtual support group. The scope of the research study related to the virtual 
support group is to a) inform the 200 bereaved family participants about the support group, so that they 
may seek out this care available to them and b) conduct qualitative interviews with 20 participants who 
attended the virtual support group. As such, while we will obtain consent for conducting the qualitative 
interviews, consent will not be obtained for participation in the virtual support groups.  
 
Phase 1: Retrospective chart review  
 
We will abstract clinical information from the medical records of all patients who died in an acute care 
hospital in Ottawa from November 1st, 2019 to August 31st, 2020.  
 
Data Collection  
A trained and experienced research assistant will abstract clinical data related to the patient’s 
admission, including admitting service, sex, gender, admitting source, diagnosis, comorbidities, 
resuscitative measures, presence of family at or soon before the time of death, comfort medications 

 
 
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ordered/used, and the involvement of the palliative care consultation team. De-identified data will be 
entered into the secure OHRI Electronic Data Capture System (EDCS) platform to allow consolidated 
data collection across all participating sites. Data transferred from each site into the EDCS will be 
limited to non-identifying information, with the exception of age, sex, gender, date of hospital 
admission (to calculate length of time in hospital), date of death (to calculate hospital length of stay 
and to establish the amount of time from patient death to when the Phase 2 questionnaires – see below 
–are completed by family members), and medical history. These variables are required for sub-group 
data analysis and for inclusion in regression models.  
 
Each site will additionally have a local participant Master File which includes the study ID, patient 
name, medical record number (MRN), date of birth, and a column indicating whether or not the 
participant’s chart abstraction has been completed and data entered into the online data collection 
platform (EDCS). Patient name and MRN are needed for data verification and to facilitate accurate 
chart review. Date of birth is required to calculate age. 
 
Performance Measurement, Health Records, or Decision Support departments at each site willy be 
consulted as needed to assist in data collection and for decedent cohort (i.e.study sample) 
identification. 
 
Phase 2: Prospective Bereavement Data Collection  
 
We will offer enrolment to the FM contacts indicated in the medical record of each patient who were 
identified in the retrospective chart review, beginning at minimum 6 months after the death of the 
patient. A list of FM contact names, phone number, and relationship to the deceased patient will be 
generated to all research assistants to contact FMs and offer study enrollment. For FMs who agree to 
enroll (our previous study found a 40-50% enrolment rate)10, we will collect basic demographic, 
mental health, and spirituality data similar to our previous work, as well as focused assessments of 
grief and relationships: 
• The Brief Family Relationship Scale (BFRS)27 to determine closeness of FM to the deceased  
• The Inventory for Complicated Grief-revised (ICG-r)28 to determine the severity of their grief 
symptoms. Those who enrol will complete the ICG-r at baseline (upon enrollment) and again 
6-months later. A recent meta-analysis of psychological interventions for grief suggestd that 
the ICG-r is superior to other grief measurement tools for measuring the effect of bereavement 
interventions.29 
 
Phase 3: Virtual Support Groups  
 
FMs who participate in the prospective bereavement data collection (i.e. Phase 2) will be invited to 
attend a virtual support group (VSG) led by Bereaved Families of Ontario- Ottawa (BFO). In pre-
COVID 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). The sessions were put on hold in March by the pandemic, but 

 
 
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BFO plans to begin holding these Closed Groups by videoconference (these will be the VSGs) again in 
September 2020.  
 
All participants in the prospective bereavement data collection component of this study will be invited 
to participate in the VSGs (see approved Virtual Support Group Information Sheet), regardless of the 
severity of their symptoms. Those with severe symptoms (indicated by an ICG-r score >25)29 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.29 
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 FM. Family members will participate in the virtual support group 
as part of routine care available to them by BFO. The support group is not a study-specific 
intervention, nor will any research team members be involved in the administration of the virtual 
support group, and no data will be collected from the virtual support group online sessions. The scope 
of the research study related to the virtual support group is to a) inform the 200 bereaved family 
participants about the support group, so that they may seek out this care available to them and b) 
conduct qualitative interviews with 20 participants who attended the virtual support group (see Phase 4 
below). As such, while we will obtain consent for conducting the Phase 2 questionnaires and the Phase 
4 qualitative interviews, consent will not be obtained for participation in the virtual support groups.  
Any participant who expresses suicidal ideation or intention, or other concerning features of severe 
grief reaction, will be referred for urgent assessment and professional support through their family 
physician or the emergency department, as per usual practice with BFO. 
 
Phase 1-3: Quantitative Data Analysis 
To address research objectives #1 and #2, we will divide the patients (and FMs) into three groups: 
a. Pre-COVID: Deaths that occurred in an acute care hospital before the impact of the pandemic 
was first felt in Ottawa (November 1st, 2019-February 29th, 2020): approximately 160 patients. 
b. COVID: Deaths that occurred in an acute care hospital due to COVID-19 (March 1st – August 
31st, 2020). Approximately 250 COVID-19 deaths have been reported between January and June 
2019 in Ottawa by Ottawa Public Health, of which preliminary data suggestapproximately 80 
patients died in acute care. 
c. Non-COVID: Deaths that occurred in an acute care hospital between March 1st – August 31st, 
2020 but were not COVID-19 related: approximately 160 patients. 
 
To assess the overall impact of the pandemic, we will perform statistical comparisons of clinical and 
end-of-life care metrics for the Pre-COVID vs. COVID and Non-COVID groups combined. Patients 
will be matched based on their health and demographic profiles in a 2:1:2 ratio (2 decdenets in pre-
COVID period: 1 decedent during the pandemic who died of COVID-19: 2 decedents who died during 
the pandemic of non-COVID-19 causes). We will compare the COVID vs. Non-COVID groups to 
determine how much of the impact was specifically associated with COVID infection as opposed to 
the pandemic in general. Pairwise comparisons will be performed using an unpaired t-test or Mann-
Whitney test as appropriate for the distribution of the data. We will then also use logistic regression 
analysis to identify factors associated with an ICG score >25 (i.e. severe scores).  
 
To address research objective #3, we will compare the changes in ICG scores between baseline and 6-
months post-baseline for FMs who did versus did not participate in the VSGs (i.e. the difference in 
differences). This comparison is important since grief symptoms typically improve over time even 
without intervention. In addition, group allocation is not random and so our analysis may be 

 
 
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confounded by the possibility that people who choose to participate in support groups have more 
severe symptoms.22 We will therefore perform an adjusted analysis similar to Newsom et al. in their 
naturalistic controlled trial of community-based bereavement support.18 We will estimate an average 
score for the outcome variable at each time point for the support-group and no-support-group (control) 
conditions. Where baseline differences in clinical, demographic or loss‐related variables exist, these 
variables will be added as covariates. Assumptions of linearity, multicollinearity, homoscedasticity, 
and normality of residuals will be tested prior to analysis.  
 
Phase 4: Family Member Interviews  
 
To addess research objectives #1 and #3, FMs who participated in a VSG will be invited to participate 
in semi-structured interviews to determine how the FM perceived their loved one’s end-of-life 
experience, their own bereavement experience, the usefulness of the VSG, and successes and 
challenges of the intervention. Approximately 20 interviews will be conducted, or until thematic 
saturation is reached. We will use maximum variation sampling based on grief severity (ICG scores), 
participant demographics, and whether or not the participants loved one died of COVID-19 versus 
other causes.  
 
Semi-structured interviews will also be conducted with bereaved family members who did not attend 
any VSGs. This will be done to better understand their loved one’s end-of-life experience, their own 
bereavement experience, their experiences of facilitators or barriers to attending VSGs, their reasons 
for not attending the VSG, and how they coped overall with their loss (e.g., the use of other coping 
strategies).  
 
Qualitative Data Analysis 
Qualitative interviews will be transcribed verbatim. Using an iterative thematic analysis,30 a qualitative 
researcher will apply open coding (facilitated by ATLAS.TI software) to inductively find emerging 
themes and group them together based on labels relevant to the interviews or bereavement literature. 
The team will then discuss the emerging themes and interpret the qualitative findings for analysis with 
the retrospective and quantitative findings. Themes related to the VSGs will be fed back to the BFO 
facilitators as a formative evaluation to guide revisions to the conduct of the VSGs.      
 
RECRUITEMENT & CONSENT 
 
Recruitment will be necessary for the prospective portion of the study that involves family members 
participation. Family members will  be asked to provide verbal consent to provide basic demographic 
information and complete questionnaires over the phone or secure online platform. Each participant 
who provides verbal consent will be invited to participate in a virtual support group that is provided by 
BFO-Ottawa outside of this research study. Family members who participated in the VSG will be 
invited to participate in a qualitative interview about their experience of the VSG – a separate, 
additional informed consent form will be provided to these participants. In addition, family members 
who did not participate in any VSGs will be invited to participate in a qualitative interview enquiring 
about their reasons for not attending – participants will be reconsented if they choose to take part in 
these interviews. 
 
We will offer enrolment to the contacts of each patient who were identified in the retrospective chart 
review. Only family members of patients deceased between November 1st, 2019 to August 31st, 2020 
from the three participating sites will be eligible to participate in the study. Contact information (name, 

 
 
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relationship, and phone number) of potential participants will be taken from the FM contacts listed on 
the deceased patient’s medical record. A research staff member will call the bereaved family members 
to explain the project. Family members will be asked to verbally consent to the first phase of the study 
which includes the demographic and grief questionnaires.  
 
Following the completion of the questionnaires, participants who are interested in being involved in 
the subsequent phases of the study will provide phone/video consent to participate in a qualitative 
interview, and will also provide their address so the research team member can mail the copy of the 
consent form to the participant. 
 
 
KNOWLEDGE TRANSLATION AND DISSEMINATION PLAN 
 
Feasibility and scalability are key factors for future knowledge translation (KT) and dissemination. 
Partnering with BFO-Ottawa for their VSGs will allow for rapid implementation of the intervention, 
with potential scalability of the approach to other BFO chapters across Ontario and partner 
organizations across Canada. We will also be working with Canadian Virtual Hospice (CVH), which is 
world-renowned for their web-based end-of-life and bereavement support tools, such as mygrief.ca. 
Building on the findings from this study, our team plans to collaborate with the Ontario Centre for 
Learning, Research and Innovation in Long-Term Care at Bruyère (CLRI), which has a strong 
presence in Long-Term Care and works to implement effective interventions to improve quality of care 
and quality of life. As >80% of COVID deaths have taken place in LTC residents, CLRI will help to 
ensure engagement of the bereaved from these as we believe it is important to work alongside of them 
to ensure that proper bereavement support resources can be accessed by residents who have lost 
friends in LTC homes and their families. CLRI will be important in the dissemination of the virtual 
support program in future to long-term care homes that have been particularly hit by COVID-19. Our 
team will also work with Champlain Hospice Palliative Care Program that works across LTC, hospice, 
hospital and community to coordinate a full and cohesive response to palliative care and bereavement.  
 
 
 

 
 
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TIMELINE 
 
 
2020 
2021 
Month 
S O 
N 
D 
J 
F 
M 
A 
M 
J 
J 
A 
S 
O 
Ethics Approval 
(September-November 
2020) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase I: Retrospective 
chart review 
(Quantitative- October 
2020 – February 2021) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase II: Prospective 
Bereavement Data 
Collection 
(Quantitative- 
October-December 
2020, April-June 2021) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase III: Virtual 
Support Groups 
(October 2020 – 
March 2021) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Quantitative Data 
Analysis (June – 
August 2021) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Phase IV:FM 
Interviews (November 
2020 – June 2021) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Qualitative Data 
Analysis (January  - 
August 2021)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Knowledge 
Translation and 
Dissemination (August 
-October 2021) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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