Death3WPNCT04147169
A Multicenter Implementation Study of the 3 Wishes Project
An observational study of Death and Communication, Multidisciplinary, run by McMaster University at 1 site in Canada.
Trial summary
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… 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?
- Focused end-of-life conversations to promote connections among patients, family members and clinicians.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 730 participants
- Where
- 1 siteCanada
- Study dates
- 27 Apr 2016to 12 Apr 2019
- 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, who are critically ill and have a poor outcome (likely to die during the ICU admission). When death looms in the ICU, 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 honour 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.
Patient Inclusion Criteria:
- Patient is >18 years of age (a subgroup analysis will be conducted on those >65 years of age);
- Patient has a >95% of dying during the ICU stay as judged by the ICU attending physician; or
- a decision has been made to withdraw or withhold advanced life support in anticipation of death.
Patient/Family Exclusion Criteria:
- Prohibitive communication challenges (e.g., serious psychological or psychiatric illness in the patient and/or family, inability of patient and/or family to communicate reasonably well in English or other language for which an interpreter exists - professional staff or otherwise);
- Prohibitive logistics (e.g., patient admitted to the ICU for <24 hours, or anticipated to die within 24 hours of screening)
- Patient or family declines. (Note that 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: Compassionate End of Life Care in the ICU: Evaluating the Value, Transferability, Affordability, and Sustainability and Value of the 3 Wishes Project
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. In a single center, investigators previously reported how the 3 Wishes Project forges interpersonal connections among patients, family members and clinicians, eases family grief, and offers experiential end of life education for clinicians-in-training.
The objective of this study was to evaluate whether the 3 Wishes Project could enhance compassionate care for dying patients and their families when implemented as a multicenter program. Given the importance of empowering frontline staff to adapt the 3WP to their own practice patterns, investigators did not protocolize this approach to personalizing end-of-life care. Investigators conceptualized this study as a formative evaluation of 3WP to examine its 1) Value: as experienced by family members, frontline clinicians, ICU managers and hospital administrators; 2) Transferability: successful implementation beyond the original ICU by a different mix of clinicians; 3) Affordability: cost of wishes being less than $50/patient; 4) Sustainability: project continuation beyond the first year of evaluation.
Read the detailed description
This is a mixed-methods formative program evaluation of the 3 Wishes Project implemented in ICUs in Toronto, Vancouver, Los Angeles, and the original center in Hamilton.
Implementation of the 3WP was aligned with the interests and cultural norms at each center, adapted by local clinicians with the resources available, assisted by close contact and informational guidance from the original site. Each center implemented the 3WP as both a clinical program and research project. Participating ICUs were all located in academic tertiary care centers with some differing features.
Design: This is a multi-center mixed-methods implementation and formative evaluation study. Data collection will be quantitative and qualitative (interviews and focus groups). Investigators will take a systems-level approach to produce information on how to implement the 3 Wishes Project in different settings, each with its own social microcosm, affordances and constraints.
Specific Aims are: 1) For patients, to provide compassionate end of life care consistent with their values and preferences; 2) For family members, to evaluate the project's impact on family views on end of life care; 3) For clinicians, to explore the project's impact on compassion, resilience, moral distress, and views on end of life care; 4) For ICU managers, to learn of any barriers to implementation and strategies for facilitation; and 5) For hospital administrators, to understand perceived costs and institutional benefits such as alignment with priorities for end of life care.
Investigators will use a case study approach examining particularities of the 'eco-system' of each ICU to examine how the 3 Wishes Project operates in each setting. This examination will include the constraints, affordances, and impacts available from the staffing model, organizational culture, end of life policies and administrative structure. An understanding of each ICU will be developed, with comparisons made to illuminate broader findings and suggest strategies for expanding the project elsewhere.
- Conditions
- Death, Communication, Multidisciplinary, Empathy, Compassion, Family Members, Bereavement
- Being tested
- Focused end-of-life conversations to promote connections among patients, family members and clinicians.
- Keywords
- Compassionate, End-of-Life Care, Interpersonal connections
- 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.
Focused end-of-life conversations to promote connections among patients, family members and clinicians.Behavioural
All eligible patients and families who were invited to participate in wish elicitation and implementation. For family interviews, criterion sampling was used. For the clinician focus groups, criterion sampling was used, based on involvement in the care of a 3WP patient. For the manager/hospital administrator interviews, purposive sampling was used, based on relevant leadership positions. Investigators employed qualitative and quantitative methods to collect and analyze data. Quantitative data include characteristics of patients, families and clinicians, questionnaire responses from families who agree to interviews, and clinicians who agree to focus groups, respectively, types of wishes elicited and implemented, and their cost. Qualitative data was obtained through individual family interviews, inter-professional clinician focus groups, project team field notes, additional ideas about the costs and benefits of the project from manager interviews, and analysis of project documents.
| Study group | Role | What they receive |
|---|---|---|
| Dying patients | Dying patients admitted to the Intensive Care Unit who are approaching end-of-life. Receives: Behavioral: Focused end-of-life conversations to promote connections among patients, family members and clinicians. |
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 experiences and perceptions of value, it is important that investigators first understand which program elements family members and clinicians appreciate, and what their experiences of these elements are. In future research, investigators will then measure achievement in those domains. Accordingly, in this study investigators will solicit open-ended, qualitative perceptions of value of the program from family members, clinicians, and ICU managers and hospital administrators. This information will be analyzed inductively to generate domains of value which may be measured in future research. 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 family members, clinicians and managers see in this program, investigators will be able to devise ways to measure this value in future research.
Measured: Through study completion, an average of 1 year.
Transferability as indicated by successful establishment in 3 new ICU settings
Successful implementation beyond the original ICU by a different mix of clinicians.
Measured: Through study completion, an average of 1 year.
Affordability: cost of wishes being less than $50/patient.
The $50/patient figure quoted 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 ICU 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, an average of 1 year
Sustainability of the intervention after the research study has been completed.
Sustainability will be affirmed if the project remains operational in each ICU in July 2019.
Measured: 6 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start27 Apr 2016
- Primary completion31 Dec 2018
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- 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
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Greenwall Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147169
- Sponsor's protocol ID
- 3WP_Multicenter
- Acronym
- 3WP
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants did not agree to data sharing (qualitative or quantitative). Also, in some instances, this would be identifying. Feel free to contact us for further information.
Publications
Vanstone M, Neville TH, Swinton ME, Sadik M, Clarke FJ, LeBlanc A, Tam B, Takaoka A, Hoad N, Hancock J, McMullen S, Reeve B, Dechert W, Smith OM, Sandhu G, Lockington J, Cook DJ. Expanding the 3 Wishes Project for compassionate end-of-life care: a qualitative evaluation of local adaptations. BMC Palliat Care. 2020 Jun 30;19(1):93. doi: 10.1186/s12904-020-00601-5.
PubMed 32605623Vanstone M, Neville TH, Clarke FJ, Swinton M, Sadik M, Takaoka A, Smith O, Baker AJ, LeBlanc A, Foster D, Dhingra V, Phung P, Xu XS, Kao Y, Heels-Ansdell D, Tam B, Toledo F, Boyle A, Cook DJ. Compassionate End-of-Life Care: Mixed-Methods Multisite Evaluation of the 3 Wishes Project. Ann Intern Med. 2020 Jan 7;172(1):1-11. doi: 10.7326/M19-2438. Epub 2019 Nov 12.
PubMed 31711111
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate End of Life Care in the ICU: Evaluating the Value, Transferability, Affordability, and Sustainability and Value of the 3 Wishes Project
- ClinicalTrials.gov ID
- NCT04147169
- Acronym / sponsor ID
- 3WP / 3WP_Multicenter
- Conditions
- Death, Communication, Multidisciplinary, Empathy, Compassion, Family Members, Bereavement
- Keywords
- Compassionate, End-of-Life Care, Interpersonal connections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Greenwall Foundation
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 31 Oct 2019 (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.
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. In a single center, investigators previously reported how the 3 Wishes Project forges interpersonal connections among patients, family members and clinicians, eases family grief, and offers experiential end of life education for clinicians-in-training.
The objective of this study was to evaluate whether the 3 Wishes Project could enhance compassionate care for dying patients and their families when implemented as a multicenter program. Given the importance of empowering frontline staff to adapt the 3WP to their own practice patterns, investigators did not protocolize this approach to personalizing end-of-life care. Investigators conceptualized this study as a formative evaluation of 3WP to examine its 1) Value: as experienced by family members, frontline clinicians, ICU managers and hospital administrators; 2) Transferability: successful implementation beyond the original ICU by a different mix of clinicians; 3) Affordability: cost of wishes being less than $50/patient; 4) Sustainability: project continuation beyond the first year of evaluation.
Detailed description
This is a mixed-methods formative program evaluation of the 3 Wishes Project implemented in ICUs in Toronto, Vancouver, Los Angeles, and the original center in Hamilton.
Implementation of the 3WP was aligned with the interests and cultural norms at each center, adapted by local clinicians with the resources available, assisted by close contact and informational guidance from the original site. Each center implemented the 3WP as both a clinical program and research project. Participating ICUs were all located in academic tertiary care centers with some differing features.
Design: This is a multi-center mixed-methods implementation and formative evaluation study. Data collection will be quantitative and qualitative (interviews and focus groups). Investigators will take a systems-level approach to produce information on how to implement the 3 Wishes Project in different settings, each with its own social microcosm, affordances and constraints.
Specific Aims are: 1) For patients, to provide compassionate end of life care consistent with their values and preferences; 2) For family members, to evaluate the project's impact on family views on end of life care; 3) For clinicians, to explore the project's impact on compassion, resilience, moral distress, and views on end of life care; 4) For ICU managers, to learn of any barriers to implementation and strategies for facilitation; and 5) For hospital administrators, to understand perceived costs and institutional benefits such as alignment with priorities for end of life care.
Investigators will use a case study approach examining particularities of the 'eco-system' of each ICU to examine how the 3 Wishes Project operates in each setting. This examination will include the constraints, affordances, and impacts available from the staffing model, organizational culture, end of life policies and administrative structure. An understanding of each ICU will be developed, with comparisons made to illuminate broader findings and suggest strategies for expanding the project elsewhere.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dying patients | – | Behavioral: Focused end-of-life conversations to promote connections among patients, family members and clinicians.Dying patients admitted to the Intensive Care Unit who are approaching end-of-life. |
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, who are critically ill and have a poor outcome (likely to die during the ICU admission). When death looms in the ICU, 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 honour 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.
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 |
|---|---|---|
| Focused end-of-life conversations to promote connections among patients, family members and clinicians.All eligible patients and families who were invited to participate in wish elicitation and implementation. For family interviews, criterion sampling was used. For the clinician focus groups, criterion sampling was used, based on involvement in the care of a 3WP patient. For the manager/hospital administrator interviews, purposive sampling was used, based on relevant leadership positions. Investigators employed qualitative and quantitative methods to collect and analyze data. Quantitative data include characteristics of patients, families and clinicians, questionnaire responses from families who agree to interviews, and clinicians who agree to focus groups, respectively, types of wishes elicited and implemented, and their cost. Qualitative data was obtained through individual family interviews, inter-professional clinician focus groups, project team field notes, additional ideas about the costs and benefits of the project from manager interviews, and analysis of project documents. | 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 experiences and perceptions of value, it is important that investigators first understand which program elements family members and clinicians appreciate, and what their experiences of these elements are. In future research, investigators will then measure achievement in those domains. Accordingly, in this study investigators will solicit open-ended, qualitative perceptions of value of the program from family members, clinicians, and ICU managers and hospital administrators. This information will be analyzed inductively to generate domains of value which may be measured in future research. 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 family members, clinicians and managers see in this program, investigators will be able to devise ways to measure this value in future research.
Transferability as indicated by successful establishment in 3 new ICU settings
Time frame: Through study completion, an average of 1 year.
Successful implementation beyond the original ICU by a different mix of clinicians.
Affordability: cost of wishes being less than $50/patient.
Time frame: Through study completion, an average of 1 year
The $50/patient figure quoted 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 ICU 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.
Sustainability of the intervention after the research study has been completed.
Time frame: 6 months after study completion
Sustainability will be affirmed if the project remains operational in each ICU in July 2019.
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 4 Nov 2019.
- Derived from this study: PubMed 32605623Vanstone M, Neville TH, Swinton ME, Sadik M, Clarke FJ, LeBlanc A, Tam B, Takaoka A, Hoad N, Hancock J, McMullen S, Reeve B, Dechert W, Smith OM, Sandhu G, Lockington J, Cook DJ. Expanding the 3 Wishes Project for compassionate end-of-life care: a qualitative evaluation of local adaptations. BMC Palliat Care. 2020 Jun 30;19(1):93. doi: 10.1186/s12904-020-00601-5.
- Derived from this study: PubMed 31711111Vanstone M, Neville TH, Clarke FJ, Swinton M, Sadik M, Takaoka A, Smith O, Baker AJ, LeBlanc A, Foster D, Dhingra V, Phung P, Xu XS, Kao Y, Heels-Ansdell D, Tam B, Toledo F, Boyle A, Cook DJ. Compassionate End-of-Life Care: Mixed-Methods Multisite Evaluation of the 3 Wishes Project. Ann Intern Med. 2020 Jan 7;172(1):1-11. doi: 10.7326/M19-2438. Epub 2019 Nov 12.
- Individual participant dataSharing planned: No. Participants did not agree to data sharing (qualitative or quantitative). Also, in some instances, this would be identifying. Feel free to contact us 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.
The record lists no contact. Use the official record to reach the sponsor.
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?
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 4 Nov 2019. 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 4 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 NCT04147169, which also lists 2 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 4 Nov 2019.