Intervention to Improve Expression of End of Life Preferences for Homeless Persons

Healthy Clinical Trial

— SELPH  

Official title:

Intervention to Improve Expression of End of Life Preferences for Homeless Persons

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00546884
• Other study ID #: 0704S06282
• Secondary ID: RO1 NR009815-01A
• Status: Active, not recruiting
• Phase: N/A
• First received: October 17, 2007
• Last updated: February 24, 2009
• Start date: November 2007
• Est. completion date: November 2010

Study information

• Verified date: February 2009
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether homeless individuals will complete a living will and whether guidance enhances rates of completion and to see whether filling out a living will has any impact on the care given at the end of life.

Description:

Much research and effort have been directed towards improving end-of-life (EOL) care in the US. However, there is consensus that large gaps in knowledge remain regarding quality EOL care, most notably because previous research has focused on narrowly defined populations. There is little known about individuals who are from different ethnic, cultural, and socioeconomic backgrounds. There is some evidence that these individuals may desire and experience EOL care differently and may encounter barriers to obtaining this care. What is not known is what interventions are effective in these populations. This study addresses EOL care for homeless people, the most extreme examples of these overlooked populations. They have the greatest risk of death in the US, have unique perspectives of good EOL care, encounter significant barriers to care, and lack the resources and relationships assumed necessary for good EOL care. Despite this, there are no interventional studies determining whether EOL care can be improved in this population. Encouraging individuals to document preferences for EOL care through Advance Directives (ADs), has been central to efforts to improve EOL care. ADs, however, have been subject to conceptual and empirical criticism, particularly that they may not ultimately affect EOL care received. However, these shortcomings have been mainly demonstrated in specific and similar populations, and has not been addressed in underserved populations. There are reasons to believe that ADs and advance care planning have different utility and efficacy for homeless persons and are much desired in this population. This proposal builds upon four years of research, including an NIH/NINR-funded investigation, regarding EOL care, dying, and death. This research is some of the first work defining the concerns of homeless persons regarding EOL care and confirmed the relevance and potential of ADs in this population to impact EOL care positively. We seek to test an intervention to improve EOL care for homeless persons: 300 participants will be randomized into two arms, guided intervention (GI) and minimal intervention (MI). The GI condition will expose participants to education, guidance and counseling, and an AD tool, designated HELP (Appendix A), specifically designed for underserved and estranged populations to enhance autonomy and elicit preferences of EOL care. The MI condition will expose participants to the provision of HELP and instructions, mimicking community standards and the requirements of the federal PSDA.

Primary Aim 1: To determine whether homeless individuals will complete an AD and whether guidance enhances rates of completion. Hypothesis 1: We hypothesize that the MI will result in greater completion rate in this population than most others studied, and that the GI will result in a significantly greater rate than the MI - we anticipate a 20% completion rate in the MI condition and a 50% rate in the GI condition. Primary Aim 2: To determine whether completion of ADs by homeless individuals lead to their use during county hospital care encounters over 18 months after the intervention. Hypothesis 2: We hypothesize that when completed ADs exist, they will be used or documented as part of clinical care at least 70% of the time during county health care encounters.

It is important to test appropriate, reproducible interventions in underserved populations, and insights from this project will be significant in several ways: they will help address the EOL concerns of homeless persons, and provide the basis to address the needs of others who are disenfranchised from loved ones and/or receive fragmented, episodic care, such as the rural and urban poor, homebound persons, or undocumented persons.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Homeless in the previous 6 months as defined by the federal McKinney Act

• At least 18 years old

• Speak English

• Able to give valid informed consent

Exclusion Criteria:

• Actively intoxicated

• Cognitive deficiencies using BLESSED tool

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• MI condition
Individuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it.
• GI
The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	VA Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of advance directive		21 months	No
Primary	Change in clinical care given		21 months	No
Secondary	Psychosocial outcomes		3 months	No
Secondary	Autonomy preserving behaviors		3 months	No