Terminal DiseasesNCT02428504
Decision Making in End of Life as Individual Preferences
An observational study of Terminal Diseases, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
It is not universal that terminally ill patients choose surrogate in the event of disagreement between the treating physician and the surrogate at the end of their lives. There are several factors that influence the terminally ill patient's decision to choose a decision maker at the end of his / life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Diseases
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2015
- 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 from Oncology, Pulmonary and Heart Failure.
Who may be able to join
- Non-resectable malignancy undergoing palliative care treatment
- Severe end stage COPD with FEV1 < 30% and receiving home O2 for > six months
- End stage cardiomyopathy NYHA class III/IV, not candidate for heart transplantation.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospital Center
New York, New York, 10019
About this study
Official title: Decision Making in End of Life: Individual Preferences
It is not universal that terminally ill patients choose surrogate in the event of disagreement between the treating physician and the surrogate at the end of their lives. There are several factors that influence the terminally ill patient's decision to choose a decision maker at the end of his / life.
Read the detailed description
The right of the patient to exercise autonomy, whether to accept the recommendation of physician is not lost when the patient is unable to make health related decision. This is the basis of substituted judgment. Without written advance directives, a surrogate has to be assigned using relevant state relationship hierarchy, and usually a family member serves as a surrogate when the patient no longer has capacity to make medical decisions. Several studies showed that surrogates do not predict the patients preference accurately when both are asked to respond to hypothetical questions. Patient designated hierarchy predicted the patient treatment preferences with 69% accuracy whereas legally assigned proxy was accurate in 68%. Even the prior discussion of the treatment preferences did not seem to improve the surrogate accuracy. Surrogates make errors predicting patient's preferences in different directions, as was found in several studies. Three studies have found that surrogates err by providing intervention that patients do not want, while others found no specific trends. Other studies showed physicians to be less accurate than surrogates in predicting the patient's wishes.
Some studies have shown that patients want their surrogates to make decision for them when there is disagreement between the patient's wishes and his or her surrogate. No studies have looked at patients preferences when there is conflict between the surrogate and the physician.
To choose the right surrogate is a paramount. One way to do this is to analyze the patient's trends as to 'how' and 'why' patients choose his or her surrogates. Little is known about what factors influence the patients' decisions to choose the surrogate and what would be their decision in the event of disagreement between the treating physician and the surrogate. Factors such as patient's culture, ethnic or religious background may play an important role in patients' preferences at the end of their lives.
The investigators aim to assess terminally ill patients' decision making preferences at the end of life and identify specific factors that determine their preferences.
- Conditions
- Terminal Diseases
- Keywords
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| End of life decision | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
DECISION MAKING IN END OF LIFE: INDIVIDUALS PREFERENCES
Individual Preferences
Measured: 1 year
Secondary outcomes (1)
DECISION MAKING IN END OF LIFE: INDIVIDUALS PREFERENCES
Risk factors influencing individual preferences
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 posted28 Apr 2015 (estimated)
- Study startJun 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Terminal DiseasesStudies 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
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Khouli, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428504
- Sponsor's protocol ID
- 08-150
- Status last verified
- Mar 2016
- First submitted
- 15 Oct 2012
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making in End of Life: Individual Preferences
- ClinicalTrials.gov ID
- NCT02428504
- Acronym / sponsor ID
- 08-150
- Conditions
- Terminal Diseases
- Keywords
- Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Apr 2015 (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.
It is not universal that terminally ill patients choose surrogate in the event of disagreement between the treating physician and the surrogate at the end of their lives. There are several factors that influence the terminally ill patient's decision to choose a decision maker at the end of his / life.
Detailed description
The right of the patient to exercise autonomy, whether to accept the recommendation of physician is not lost when the patient is unable to make health related decision. This is the basis of substituted judgment. Without written advance directives, a surrogate has to be assigned using relevant state relationship hierarchy, and usually a family member serves as a surrogate when the patient no longer has capacity to make medical decisions. Several studies showed that surrogates do not predict the patients preference accurately when both are asked to respond to hypothetical questions. Patient designated hierarchy predicted the patient treatment preferences with 69% accuracy whereas legally assigned proxy was accurate in 68%. Even the prior discussion of the treatment preferences did not seem to improve the surrogate accuracy. Surrogates make errors predicting patient's preferences in different directions, as was found in several studies. Three studies have found that surrogates err by providing intervention that patients do not want, while others found no specific trends. Other studies showed physicians to be less accurate than surrogates in predicting the patient's wishes.
Some studies have shown that patients want their surrogates to make decision for them when there is disagreement between the patient's wishes and his or her surrogate. No studies have looked at patients preferences when there is conflict between the surrogate and the physician.
To choose the right surrogate is a paramount. One way to do this is to analyze the patient's trends as to 'how' and 'why' patients choose his or her surrogates. Little is known about what factors influence the patients' decisions to choose the surrogate and what would be their decision in the event of disagreement between the treating physician and the surrogate. Factors such as patient's culture, ethnic or religious background may play an important role in patients' preferences at the end of their lives.
The investigators aim to assess terminally ill patients' decision making preferences at the end of life and identify specific factors that determine their preferences.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End of life decision | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Oncology, Pulmonary and Heart Failure.
Key inclusion criteria (3 listed)
- Non-resectable malignancy undergoing palliative care treatment
- Severe end stage COPD with FEV1 < 30% and receiving home O2 for > six months
- End stage cardiomyopathy NYHA class III/IV, not candidate for heart transplantation.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DECISION MAKING IN END OF LIFE: INDIVIDUALS PREFERENCES
Time frame: 1 year
Individual Preferences
1 secondary outcome
DECISION MAKING IN END OF LIFE: INDIVIDUALS PREFERENCES
Time frame: 1 year
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 9 Mar 2016.
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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.
Hassan Khouli, MD principal investigator
St. Luke's-Roosevelt Hospital Center
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 Terminal Diseases, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 3 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 9 Mar 2016. 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 United States. 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?
DECISION MAKING IN END OF LIFE: INDIVIDUALS PREFERENCES (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2016.