Clinical trial NCT04602520: Preserving Compassionate End of Life Care in the Pandemic
Official title: Dying During the Pandemic: Preserving Compassionate End-of-Life Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Communication, Multidisciplinary
Empathy
Compassion
Family Members
Bereavement
Empowerment
Patient Engagement
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-10-26
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must be admitted into the Intensive Care Unit, the Medical Step-Down unit or the Covid-19 unit who are seriously ill and have a poor outcome (\>95% probability of dying during the admission). When death looms, people invariably interpret life through a lens of meaning - existential, spiritual, and relational. Through this lens, the 3 Wishes Project clearly facilitates holistic care, beyond the physical, to honor and celebrate a life. Staff are empowered and encouraged to sensitively elicit and then implementing at least 3 wishes from patients, family members, and/or clinicians caring for dying patients.

Brief summary: 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.

Detailed description: This is a mixed-methods formative program evaluation of the adaptations necessitated by the pandemic to the 3 Wishes Project. The adaptations will be studied as implemented in 3 acute care units at St. Joseph's Healthcare Hamilton (medical stepdown unit, medical-surgical ICU and the COVID-19 unit) during the 2020 SARS-CoV-2 pandemic. End-of-life care for patients dying in hospital is profoundly changed during the SARS-CoV-2 pandemic, affecting the experience of everyone involved.

At this institution, end-of-life care includes 2 interventions designed to humanize the experience for patients and families (the 3 Wishes Project and Footprints Project). Both of these programs encourage clinicians to learn more about the patient as an individual and to find ways to honor them. The 3 Wishes Project is a long-running clinical program at St. Joseph's Healthcare Hamilton and has become the usual approach to end of life care, partnered with the Footprints Project which involves sharing personal information about patients with the clinical staff. In this study, to learn more about each patient, the clinical staff will telephone family members to collate personal information about patients to share with staff via a whiteboard in the patients' room, and in the patient's electronic medical record, reassuring families about interest in their loved one as a person. Building on this information about 'what matters most' and respecting and recognizing each dying patient, staff will elicit and implement terminal wishes from dying patients (if able), family members, and clinicians. During the SARS-CoV-2 pandemic, these programs will be adapted to accommodate infection prevention and control restrictions and bridge the gap when family presence is limited due to visiting restrictions.

Population: In this single-center mixed-methods formative evaluation study the researchers will enroll up to 45 patients in these 3 units, along with 45 corresponding families and 45 clinicians who cared for these patients (acknowledging that some will care for more than one dying patient). N=135 three wards in a single hospital (St. Joseph's Healthcare Hamilton)

Data: Data will be both quantitative and qualitative. Quantitative data will include patient characteristics, family visits and presence at the time of death, the number, type, and cost of terminal wishes implemented. Qualitative data will be from interviews and focus groups with clinicians and family members if not prohibited by complex grief provoked by losing a loved one during the pandemic.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceptions and beliefs about value of the program
timeFrame: Through study completion, an average of 1 year
measure: Feasibility of Enrolment as indicated by enrollment of 45 patients and successful adaptation of this approach to end of life care for all patients
timeFrame: Through study completion, an average of 1 year
measure: Wish Implementation
timeFrame: Through study completion for each patient, from enrollment to 1 month postmortem
measure: Wish Cost of less than $5/wish
timeFrame: Through study completion for each patient, from enrollment to 1 month postmortem
measure: Family visiting as proportion of patients who had a family member present at the end of life
timeFrame: Through enrollment to death for each patient.
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Deborah Cook, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
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 critical care settings during the pandemic. BMJ Open. 2022 Jan 19;12(1):e058768. doi: 10.1136/bmjopen-2021-058768.
citation: 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;174(4):493-500. doi: 10.7326/M20-6943. Epub 2020 Dec 8.
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):240-248. doi: 10.4037/ajcc2022722.