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Decision Making in End of Life as Individual Preferences

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ClinicalTrials.gov Identifier: NCT02428504
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Tracking Information
First Submitted Date October 15, 2012
First Posted Date April 28, 2015
Last Update Posted Date March 9, 2016
Study Start Date June 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2015)
DECISION MAKING IN END OF LIFE: INDIVIDUALS PREFERENCES [ Time Frame: 1 year ]
Individual Preferences
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02428504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 27, 2015)
DECISION MAKING IN END OF LIFE: INDIVIDUALS PREFERENCES [ Time Frame: 1 year ]
Risk factors influencing individual preferences
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Decision Making in End of Life as Individual Preferences
Official Title Decision Making in End of Life: Individual Preferences
Brief 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.
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients from Oncology, Pulmonary and Heart Failure.
Condition Terminal Diseases
Intervention Not Provided
Study Groups/Cohorts End of life decision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 8, 2016)
148
Original Estimated Enrollment
 (submitted: April 27, 2015)
300
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Non-resectable malignancy undergoing palliative care treatment
  2. Severe end stage COPD with FEV1 < 30% and receiving home O2 for > six months
  3. End stage cardiomyopathy NYHA class III/IV, not candidate for heart transplantation.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02428504
Other Study ID Numbers 08-150
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party St. Luke's-Roosevelt Hospital Center
Study Sponsor St. Luke's-Roosevelt Hospital Center
Collaborators Not Provided
Investigators
Principal Investigator: Hassan Khouli, MD St. Luke's-Roosevelt Hospital Center
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date March 2016