Death Clinical Trial
Official title:
Dying During the Pandemic: Preserving Compassionate End-of-Life Care
NCT number | NCT04602520 |
Other study ID # | 3WPC19 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 16, 2020 |
Est. completion date | August 1, 2021 |
Verified date | March 2023 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Compassionate and humanistic care for patients dying in the hospital has been especially challenging during the pandemic. Family presence is restricted, maximal barrier precautions are advised, and personal protective equipment must be preserved. This research examines the impact of adaptations to compassionate approaches to end of life care in a single center. The 3 Wishes Project (3WP) was created to promote the connections between patients, family members, and clinicians that are foundational to empathic end-of-life care. It provides a scaffold for discussions about preferences and values at the end of life and leads to acts of compassion that arise from soliciting and implementing wishes that honour the dying patient. It is partnered with the Footprints Project, which is an initiative encouraging staff to learn more about each patient. In a previous multi-center evaluation, the authors reported how the 3 Wishes Project is valuable, transferable, affordable and sustainable. During the pandemic, end of life care, facilitated by the 3 Wishes Project and Footprints Project, will be adapted to accommodate reduced family visiting and requirements to preserve PPE. The objective of this study is to evaluate whether the adapted 3 Wishes Project continues to be feasible and valuable during the pandemic, and determine how it influences the experiences of clinicians caring for patients dying during the pandemic.
Status | Completed |
Enrollment | 118 |
Est. completion date | August 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria (Patients): - >18 years of age; - >95% of dying during the hospital stay as judged by the attending physician; or - a decision has been made to withdraw or withhold life support in anticipation of death. Inclusion Criteria (Family Member): - Family member or friend of dying patient Exclusion Criteria (Patients and Family): - Prohibitive logistical barriers (e.g., patient admitted for <24 hours); - Patient or family declines. N.B. A patient who has "no family" (even very broadly defined as friends and neighbours, or community members and case workers for homeless persons) would not be excluded from the wish elicitation and implementation component of the project. |
Country | Name | City | State |
---|---|---|---|
Canada | St Joseph's Healthcare Hamilton | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR) |
Canada,
Cook DJ, Takaoka A, Hoad N, Swinton M, Clarke FJ, Rudkowski JC, Heels-Ansdell D, Boyle A, Toledo F, Dennis BB, Fiest K, Vanstone M. Clinician Perspectives on Caring for Dying Patients During the Pandemic : A Mixed-Methods Study. Ann Intern Med. 2021 Apr;1 — View Citation
Dennis B, Vanstone M, Swinton M, Brandt Vegas D, Dionne JC, Cheung A, Clarke FJ, Hoad N, Boyle A, Huynh J, Toledo F, Soth M, Neville TH, Fiest K, Cook DJ. Sacrifice and solidarity: a qualitative study of family experiences of death and bereavement in crit — View Citation
Elma A, Cook D, Howard M, Takaoka A, Hoad N, Swinton M, Clarke F, Rudkowski J, Boyle A, Dennis B, Vegas DB, Vanstone M. Use of Video Technology in End-of-Life Care for Hospitalized Patients During the COVID-19 Pandemic. Am J Crit Care. 2022 May 1;31(3):24 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceptions and beliefs about value of the program | Given the nascent knowledge of how the adaptations forced by the Covid-19 pandemic are perceived and experienced, it is important to understand clinician experiences of caring for dying patients during this time, and how adaptations are made to existing clinical programs designed to humanize end-of-life care. Accordingly, in this study investigators will solicit open-ended, qualitative perceptions of the value of the program. This information will be analyzed inductively to generate domains of value. Inductive analysis involves generation of categories and domains directly from the data, without pre-conceived notions of what these categories or domains might be. By generating understanding of the types of value clinicians see in this program, investigators will be able to devise ways to further refine the approach to end of life care and to measure this value in future research. | Through study completion, an average of 1 year | |
Primary | Feasibility of Enrolment as indicated by enrollment of 45 patients and successful adaptation of this approach to end of life care for all patients | Enrolment will be deemed feasible when 45 patients have been enrolled and cared for with this personalized end of life care program. | Through study completion, an average of 1 year | |
Primary | Wish Implementation | > 3 wishes per patient are implemented; Higher proportion implemented by research and clinical staff collaboration than in pre-pandemic times. | Through study completion for each patient, from enrollment to 1 month postmortem | |
Primary | Wish Cost of less than $5/wish | The $5/wish figure was established by this program in pre-pandemic times. It does not refer to patient compensation. Instead, it refers to the cost of running the intervention for each enrolled patient. Given the individually-adapted nature of this intervention, the costs will vary per participant. Affordability of the program to the unit running the program is an essential part of information collected in this program evaluation.
Affordability will be informed by mean cost per wish and per patient at each center and overall. Also, investigators will perform a cost description of the project including both direct and indirect costs. |
Through study completion for each patient, from enrollment to 1 month postmortem | |
Primary | Family visiting as proportion of patients who had a family member present at the end of life | For patients who have family or friends who desire and are able to visit, what proportion visited either physically or virtually. | Through enrollment to death for each patient. |
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