An Intervention to Improve End of Life Decision Making Among Homeless Persons
Primary Purpose
End of Life Decision Making, Advance Care Planning
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided intervention
Sponsored by
About this trial
This is an interventional health services research trial for End of Life Decision Making
Eligibility Criteria
Inclusion Criteria:
- Homeless in last six months
- Speak English
- Age 18-65
Exclusion Criteria:
- Intoxicated
- Minor
Sites / Locations
- Listening House
Outcomes
Primary Outcome Measures
Completion of an advance directive
Secondary Outcome Measures
Knowledge, attitude, and behavioral measures
Full Information
NCT ID
NCT00471016
First Posted
May 4, 2007
Last Updated
May 4, 2007
Sponsor
University of Minnesota
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00471016
Brief Title
An Intervention to Improve End of Life Decision Making Among Homeless Persons
Official Title
An Intervention to Improve End of Life Decision Making Among Homeless Persons
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project is a prospective, randomized controlled trial to improve the end of life experience for homeless persons by facilitating the expression of their wishes and enhancement of their dignity when facing serious illness, death, or the prospect of dying. Our main hypothesis is that homeless persons will engage in this intervention and increase rates of advance directive completion.
Detailed Description
This project is a prospective, randomized controlled trial to improve the end of life experience for homeless persons by facilitating the expression of their wishes and enhancement of their dignity when facing serious illness, death, or the prospect of dying. Our main hypothesis is that homeless persons will engage in this intervention and increase rates of advance directive completion.
Participants were recruited from Listening House, a drop-in center for homeless individuals located in St. Paul, Minnesota and represent a convenience sample. Participants were required to speak English, not be overtly intoxicated, and have been homeless during the previous six months. The study was reviewed and approved by the institutional review board of the University of Minnesota. All participants who entered the study gave written and oral consent for randomization and data measurement and screening.
After recruitment and consent, participants were randomized into two intervention arms, minimal intervention (MI) and guided intervention (GI). All participants received educational materials about advance directives and advance care planning, pre-intervention surveys, and an advance care planning document, designated HELP, specifically designed for marginalized populations to preserve autonomy and elicit preferences of EOL care.
All participants completed a baseline written pre-test and survey. For this, they received compensation of $5. Those randomized to the minimal intervention were provided the opportunity to complete a HELP document if they so desired. Participants randomized to the GI group were provided with the written instructions and tools and asked to return to meet with investigators for one-on-one counseling and assistance in completion of the HELP document on one of several days later during the week of enrollment. Three months after enrollment, post-intervention evaluations were sought from both MI and GI subjects. There was no financial incentive offered for completion of the HELP form.
Measurement The primary outcome of interest was the completion of a legally valid advance directive, the HELP document, which was measured by inspection of HELP documents as well as self-report. Secondary outcomes include knowledge, attitude, and behavior variables measured through a questionnaire administered at baseline and at follow-up. Demographic information, including education and living situations, was also collected at baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life Decision Making, Advance Care Planning
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Guided intervention
Primary Outcome Measure Information:
Title
Completion of an advance directive
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Knowledge, attitude, and behavioral measures
Time Frame
Three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Homeless in last six months
Speak English
Age 18-65
Exclusion Criteria:
Intoxicated
Minor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Y Song, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Listening House
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
12. IPD Sharing Statement
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An Intervention to Improve End of Life Decision Making Among Homeless Persons
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