Advance Care Planning Clinical Trial
Official title:
An Intervention to Improve End of Life Decision Making Among Homeless Persons
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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