An Intervention to Improve End of Life Decision Making Among Homeless Persons

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00471016
First received: May 4, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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.


Condition Intervention
End of Life Decision Making
Advance Care Planning
Behavioral: Guided intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: An Intervention to Improve End of Life Decision Making Among Homeless Persons

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Completion of an advance directive [ Time Frame: Three months ]

Secondary Outcome Measures:
  • Knowledge, attitude, and behavioral measures [ Time Frame: Three months ]

Enrollment: 59
Study Start Date: June 2006
Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Homeless in last six months
  • Speak English
  • Age 18-65

Exclusion Criteria:

  • Intoxicated
  • Minor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471016

Locations
United States, Minnesota
Listening House
St. Paul, Minnesota, United States, 55102
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: John Y Song, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00471016     History of Changes
Other Study ID Numbers: 0210S34223
Study First Received: May 4, 2007
Last Updated: May 4, 2007
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014