Clinical trial NCT00471016: 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
Overall status: COMPLETED
Phase: NA
Conditions: End of Life Decision Making
Advance Care Planning
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2007-05-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Intoxicated
* Minor

Primary outcomes:
measure: Completion of an advance directive
timeFrame: Three months
Secondary outcomes:
measure: Knowledge, attitude, and behavioral measures
timeFrame: Three months
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Listening House
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: John Y Song, MD
role: PRINCIPAL_INVESTIGATOR
References: