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

NCT ID: NCT00471016

Last Updated: 2007-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End of Life Decision Making Advance Care Planning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Guided intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Intoxicated
* Minor
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Y Song, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Listening House

Saint Paul, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0210S34223

Identifier Type: -

Identifier Source: org_study_id