DeathNCT04602520
Preserving Compassionate End of Life Care in the Pandemic
An observational study of Death and Communication, Multidisciplinary, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Communication, Multidisciplinary, Empathy
- What is being tested?
- 3 Wishes Project
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 16 Mar 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- >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.
- Family member or friend of dying patient
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dying During the Pandemic: Preserving Compassionate End-of-Life Care
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.
Read the 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.
- Conditions
- Death, Communication, Multidisciplinary, Empathy, Compassion, Family Members, Bereavement
- Being tested
- 3 Wishes Project
- Medical subject headings
- Death, Communication, Empowerment, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Wishes ProjectBehavioural
Behavioral: Focused conversations at end-of-life to promote the connections between patients, family members, and clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Dying patients | Behavioral: Focused end of life conversations to promote connections among patients, family members and clinicians.
All eligible dying patients and families in the 3 participating acute care wards are invited to participate in wish elicitation and implementation. For clinician interviews, criterion sampling will be used, based on involvement in the care of enrolled dying patients. We will use qualitative and quantitative methods to collect and analyze data. Quantitative data will include characteristics of patients, families and clinicians. Qualitative data will be based on interviews. Pending the pandemic burden, and the status of their grief, family members of deceased patients may be invited for an interview later months after the death of their loved one. Receives: Behavioral: 3 Wishes Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Wish Implementation
> 3 wishes per patient are implemented; Higher proportion implemented by research and clinical staff collaboration than in pre-pandemic times.
Measured: Through study completion for each patient, from enrollment to 1 month postmortem
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.
Measured: Through study completion for each patient, from enrollment to 1 month postmortem
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.
Measured: Through enrollment to death for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start16 Mar 2020
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Deborah Cook, MD MSc, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602520
- Sponsor's protocol ID
- 3WPC19
- Status last verified
- Mar 2023
- First submitted
- 20 Oct 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants will not be asked to consent to data sharing (qualitative or quantitative) outside the institution; further, in some instances, this would be identifying. Aggregate data will be fully reported. Feel free to contact the investigators for further information.
Publications
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.
PubMed 35046010Cook 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.
PubMed 33284683Elma 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.
PubMed 35118491
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dying During the Pandemic: Preserving Compassionate End-of-Life Care
- ClinicalTrials.gov ID
- NCT04602520
- Acronym / sponsor ID
- 3WPC19
- Conditions
- Death, Communication, Multidisciplinary, Empathy, Compassion, Family Members, Bereavement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dying patients | – | Behavioral: 3 Wishes ProjectBehavioral: Focused end of life conversations to promote connections among patients, family members and clinicians. All eligible dying patients and families in the 3 participating acute care wards are invited to participate in wish elicitation and implementation. For clinician interviews, criterion sampling will be used, based on involvement in the care of enrolled dying patients. We will use qualitative and quantitative methods to collect and analyze data. Quantitative data will include characteristics of patients, families and clinicians. Qualitative data will be based on interviews. Pending the pandemic burden, and the status of their grief, family members of deceased patients may be invited for an interview later months after the death of their loved one. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- >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.
- Family member or friend of dying patient
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 Wishes ProjectBehavioral: Focused conversations at end-of-life to promote the connections between patients, family members, and clinicians. | Behavioural | Dying patients |
Primary outcome
Perceptions and beliefs about value of the program
Time frame: Through study completion, an average of 1 year
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.
Feasibility of Enrolment as indicated by enrollment of 45 patients and successful adaptation of this approach to end of life care for all patients
Time frame: Through study completion, an average of 1 year
Enrolment will be deemed feasible when 45 patients have been enrolled and cared for with this personalized end of life care program.
Wish Implementation
Time frame: Through study completion for each patient, from enrollment to 1 month postmortem
> 3 wishes per patient are implemented; Higher proportion implemented by research and clinical staff collaboration than in pre-pandemic times.
Wish Cost of less than $5/wish
Time frame: Through study completion for each patient, from enrollment to 1 month postmortem
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.
Family visiting as proportion of patients who had a family member present at the end of life
Time frame: Through enrollment to death for each patient.
For patients who have family or friends who desire and are able to visit, what proportion visited either physically or virtually.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Results publication: PubMed 35046010Dennis 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.
- Results publication: PubMed 33284683Cook 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.
- Results publication: PubMed 35118491Elma 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.
- Individual participant dataSharing planned: No. Participants will not be asked to consent to data sharing (qualitative or quantitative) outside the institution; further, in some instances, this would be identifying. Aggregate data will be fully reported. Feel free to contact the investigators for further information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Cook, MD MSc principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death and Communication, Multidisciplinary, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions and beliefs about value of the program (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602520, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.