Patient Understanding of End of Life Care
Primary Purpose
Advance Directives, Resuscitation Orders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized explanation
Sponsored by
About this trial
This is an interventional health services research trial for Advance Directives
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Admitted to regular nursing floor
Exclusion Criteria:
- altered mental status
- admitted in ICU
- positive screening for depression
- terminal illness defined as life expectancy< 100 days
- inability to consent
Sites / Locations
- Saint Vincent Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Questionnaire
Standardized explanation followed by questionnaire
Outcomes
Primary Outcome Measures
Composite score of correct responses
Patients in both arms were administered a questionnaire, that assessed demographics, subjective questions as well as a set of objective questions designed to assess patient understanding of code status. The responses to the objective questions were scored and the composite score of correct responses was used as a marker of patient understanding. Patients in the control arm were administered the questionnaire alone. Patients in the intervention arm first received our standard explanation, and were then administered the questionnaire
Secondary Outcome Measures
Compare differences in demographic, medical, social and associated factors on patient choice of code status
Full Information
NCT ID
NCT01683097
First Posted
July 25, 2012
Last Updated
September 7, 2012
Sponsor
Partners in Internal Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01683097
Brief Title
Patient Understanding of End of Life Care
Official Title
Assessing Patient Understanding and Factors That Govern Advanced Directives and End of Life Discussion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Partners in Internal Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims at assessing factors that affect patient choices for end of life care. 300 patients would be assigned either to a control arm (questionnaire alone) or intervention arm (standardized explanation+ questionnaire). Our intervention is a standardized explanation which explains what code status, advance directive and end of life care mean. Based on patient responses, factors that affect choices of code status would be analyzed. We will also evaluate if a standardized explanation improves patient understanding of end of life issues. This would be determined by generating a composite score of correct responses to a subset of objective questions in the questionnaire
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Directives, Resuscitation Orders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Questionnaire
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Standardized explanation followed by questionnaire
Intervention Type
Other
Intervention Name(s)
Standardized explanation
Intervention Description
Standardized explanation provided on code status, advance directives and end of life care
Primary Outcome Measure Information:
Title
Composite score of correct responses
Description
Patients in both arms were administered a questionnaire, that assessed demographics, subjective questions as well as a set of objective questions designed to assess patient understanding of code status. The responses to the objective questions were scored and the composite score of correct responses was used as a marker of patient understanding. Patients in the control arm were administered the questionnaire alone. Patients in the intervention arm first received our standard explanation, and were then administered the questionnaire
Time Frame
Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
Secondary Outcome Measure Information:
Title
Compare differences in demographic, medical, social and associated factors on patient choice of code status
Time Frame
Patients interviewed within 48 hours of admission, questionnaire adminsitered at the time of interview
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Admitted to regular nursing floor
Exclusion Criteria:
altered mental status
admitted in ICU
positive screening for depression
terminal illness defined as life expectancy< 100 days
inability to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Abraham, MD
Organizational Affiliation
Saint Vincent Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kriti Mittal, MD
Organizational Affiliation
Saint Vincent Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Vincent Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Patient Understanding of End of Life Care
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