An interventional study of MI condition and GI in Healthy, sponsored by University of Minnesota. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-13.
Sponsored by University of Minnesota · Not applicable, Interventional, and Health services research
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.
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.
572 studies on the registry are indexed under Death; 111 are open to participants now.
This study's enrollment of 262 is above the median of 133 across 260 interventional studies indexed under Death.
Browse Death studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The MI condition will expose participants to the provision of an advance directive and written instructions, roughly mimicking community standards and the requirements of the federal Patient Self Determination Act.
Behavioral: MI condition
Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care
Behavioral: GI
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.
The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.
Completion of Advance Directive
Completing an advance directive for the individuals health care when they are not able to direct it themselves
Time frame: 21 months
| Milestone | Minimal Intervention | Guided Intervention |
|---|---|---|
| Started | 145 | 117 |
| Completed | 145 | 117 |
| Not completed | 0 | 0 |
Completing an advance directive for the individuals health care when they are not able to direct it themselves
| Participants | Minimal Intervention | Guided Intervention |
|---|---|---|
| Completion of Advance Directive | 15 | 55 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Minimal Intervention | — | 0/145 (0%) | 0/145 (0%) |
| Guided Intervention | — | 0/117 (0%) | 0/117 (0%) |
| Age, Categorical(Participants) | Minimal Intervention | Guided Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 123 | 94 | 217 |
| >=65 years | 22 | 23 | 45 |
| Age, Continuous(years) | Minimal Intervention | Guided Intervention | Total |
|---|---|---|---|
| Mean | 43.3 (19 to 68) | 43.1 (21 to 70) | 43.1 (19 to 70) |
| Sex: Female, Male(Participants) | Minimal Intervention | Guided Intervention | Total |
|---|---|---|---|
| Female | 34 | 35 | 69 |
| Male | 111 | 82 | 193 |
| Race (NIH/OMB)(Participants) | Minimal Intervention | Guided Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 7 | 11 | 18 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 81 | 60 | 141 |
| White | 48 | 35 | 83 |
| More than one race | 8 | 10 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Minimal Intervention | Guided Intervention | Total |
|---|---|---|---|
| United States | 145 | 117 | 262 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Minnesota