Advance Care PlanningNCT02797444
Advance Care Planning for Critical Care - A Prelude to Breaking Barriers
An observational study of Advance Care Planning and End of Life Care, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Advance Care Planning (ACP) is a process of 'reflection and communication, in which a person with decision-making capacity makes decisions regarding their future health and/or personal care in the event that they become incapable of consenting to or refusing treatment' Most Canadians have not planned for end-of-life… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning, End of Life Care
- What is being tested?
- semi-structured interviews
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2015to Jun 2017
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy lay persons living at home in London, ON.
Who may be able to join
- Members from the community who are i) > 55 yrs of age, ii) living in London Middlesex community, iii) not housebound, iv) in apparent good health and iv) have the ability to make independent decisions for themselves
Who cannot join
- Factors that preclude a meaningful interview (such as cognitive impairment, aphasia, profound hearing impairment, language barriers) or anticipated emotional burden with the proposed topic.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dr. Ravi Taneja
London, Ontario, N6A 5A5
London Health Sciences Centre
London, Ontario, N6A 5A5
About this study
Advance Care Planning (ACP) is a process of 'reflection and communication, in which a person with decision-making capacity makes decisions regarding their future health and/or personal care in the event that they become incapable of consenting to or refusing treatment' Most Canadians have not planned for end-of-life Care and are at risk of aggressive medical care that may not be compatible with their wishes. This study aims to systematically evaluate local barriers to making personal choices with regards to life support interventions that can be provided in the contemporary Intensive Care Unit.
Read the detailed description
HYPOTHESIS: The overarching hypothesis is that the average layperson lacks sufficient knowledge about the aggressive life support measures used routinely in contemporary Critical Care to make informed decisions for themselves and their loved ones. Considering that most Canadians have not even heard of the term Advance Care Planning, it is likely that there is a gap in their knowledge and expectations of Critical Care. Such a gap can be bridged through education - the only caveat being that the individual should be in full possession of their faculties and can make informed decisions. This point is critical.
Thus this study uses a mixed methods (qualitative and quantitative) research design to address the following questions: 1) What is the state of knowledge about Critical Care interventions among healthy elderly laypersons in London, Ontario? 2) What are the barriers to formulating ACPs? 3) What opportunities exist for increasing ACP in the healthy elderly population? The primary objective of this proposal is to assess public knowledge of Critical Care interventions (and their outcomes) from the perspective of making Advance Care Plans. Secondary Objectives are 1) To evaluate local barriers to Advance Care Planning 2) To determine effective modes of education for Advance Care Planning that could be used for the community and in our hospital setting.
- Conditions
- Advance Care Planning, End of Life Care
- Being tested
- semi-structured interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured interviewsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Lay person perception and knowledge of various Critical Care interventions
This is a qualitative study. The primary objective of this proposal is to assess public knowledge of Critical Care interventions (and their outcomes) from the perspective of making Advance Care Plans. Examples of such interventions include but are not limited to Cardiopulmonary resuscitation, mechanical ventilation, dialysis and artificial feeding. Outcomes involve lay person knowledge, beliefs and perceptions of Critical care from the perspective of making Advance Care Plans.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionJun 2017
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 Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Taneja, MBBS, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797444
- Sponsor's protocol ID
- 106476
- Status last verified
- Feb 2016
- First submitted
- 31 Mar 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Teixeira AA, Hanvey L, Tayler C, Barwich D, Baxter S, Heyland DK; Canadian Researchers at End of Life Network (CARENET). What do Canadians think of advanced care planning? Findings from an online opinion poll. BMJ Support Palliat Care. 2015 Mar;5(1):40-7. doi: 10.1136/bmjspcare-2013-000473. Epub 2013 Oct 4.
PubMed 24644188Taneja R, Faden LY, Schulz V, Rawal A, Miller K, Bishop KA, Lingard L. Advance care planning in community dwellers: A constructivist grounded theory study of values, preferences and conflicts. Palliat Med. 2019 Jan;33(1):66-73. doi: 10.1177/0269216318803487. Epub 2018 Oct 4. No abstract available.
PubMed 30284950
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Care Planning for Critical Care - A Prelude to Breaking Barriers
- ClinicalTrials.gov ID
- NCT02797444
- Acronym / sponsor ID
- 106476
- Conditions
- Advance Care Planning, End of Life Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
Advance Care Planning (ACP) is a process of 'reflection and communication, in which a person with decision-making capacity makes decisions regarding their future health and/or personal care in the event that they become incapable of consenting to or refusing treatment' Most Canadians have not planned for end-of-life Care and are at risk of aggressive medical care that may not be compatible with their wishes. This study aims to systematically evaluate local barriers to making personal choices with regards to life support interventions that can be provided in the contemporary Intensive Care Unit.
Detailed description
HYPOTHESIS: The overarching hypothesis is that the average layperson lacks sufficient knowledge about the aggressive life support measures used routinely in contemporary Critical Care to make informed decisions for themselves and their loved ones. Considering that most Canadians have not even heard of the term Advance Care Planning, it is likely that there is a gap in their knowledge and expectations of Critical Care. Such a gap can be bridged through education - the only caveat being that the individual should be in full possession of their faculties and can make informed decisions. This point is critical.
Thus this study uses a mixed methods (qualitative and quantitative) research design to address the following questions: 1) What is the state of knowledge about Critical Care interventions among healthy elderly laypersons in London, Ontario? 2) What are the barriers to formulating ACPs? 3) What opportunities exist for increasing ACP in the healthy elderly population? The primary objective of this proposal is to assess public knowledge of Critical Care interventions (and their outcomes) from the perspective of making Advance Care Plans. Secondary Objectives are 1) To evaluate local barriers to Advance Care Planning 2) To determine effective modes of education for Advance Care Planning that could be used for the community and in our hospital setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy lay persons living at home in London, ON.
Key inclusion criteria (1 listed)
- Members from the community who are i) > 55 yrs of age, ii) living in London Middlesex community, iii) not housebound, iv) in apparent good health and iv) have the ability to make independent decisions for themselves
Key exclusion criteria (1 listed)
- Factors that preclude a meaningful interview (such as cognitive impairment, aphasia, profound hearing impairment, language barriers) or anticipated emotional burden with the proposed topic.
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 |
|---|---|---|
| semi-structured interviews | Other | – |
Primary outcome
Lay person perception and knowledge of various Critical Care interventions
Time frame: 1 year
This is a qualitative study. The primary objective of this proposal is to assess public knowledge of Critical Care interventions (and their outcomes) from the perspective of making Advance Care Plans. Examples of such interventions include but are not limited to Cardiopulmonary resuscitation, mechanical ventilation, dialysis and artificial feeding. Outcomes involve lay person knowledge, beliefs and perceptions of Critical care from the perspective of making Advance Care Plans.
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 28 Sep 2017.
- Background: PubMed 24644188Teixeira AA, Hanvey L, Tayler C, Barwich D, Baxter S, Heyland DK; Canadian Researchers at End of Life Network (CARENET). What do Canadians think of advanced care planning? Findings from an online opinion poll. BMJ Support Palliat Care. 2015 Mar;5(1):40-7. doi: 10.1136/bmjspcare-2013-000473. Epub 2013 Oct 4.
- Derived from this study: PubMed 30284950Taneja R, Faden LY, Schulz V, Rawal A, Miller K, Bishop KA, Lingard L. Advance care planning in community dwellers: A constructivist grounded theory study of values, preferences and conflicts. Palliat Med. 2019 Jan;33(1):66-73. doi: 10.1177/0269216318803487. Epub 2018 Oct 4. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Advance Care Planning
Active, not recruiting
ACP Video Intervention for Patients With Life-Limiting Illness
Health Care Utilization, End Stage Disease
Recruiting
Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
Heart Failure, Older Adults (65 Years and Older)
Not yet recruiting
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
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.
Ravi Taneja, MBBS principal investigator
London Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advance Care Planning and End of Life Care, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites 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 1 inclusion and 1 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 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Lay person perception and knowledge of various Critical Care interventions (time frame: 1 year). 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 NCT02797444, 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 28 Sep 2017.