Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588415
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2020-10-08
Brief Title:
Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientFM 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
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 patientFM 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None