HealthySELPHNCT00546884
Intervention to Improve Expression of End of Life Preferences for Homeless Persons
A study testing MI condition and GI in people with Healthy, run by University of Minnesota at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MI condition and GI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Actively intoxicated
- Cognitive deficiencies using BLESSED tool
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
VA Medical Center
Minneapolis, Minnesota, 55417
About this study
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- MI condition, GI
- Keywords
- End of Life, Advance Directives, Randomized controlled trial, End of life care, End of life advance care planning
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI conditionBehavioural
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.
GIBehavioural
The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.
| Study group | Role | What they receive |
|---|---|---|
| MI | Placebo comparator | 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. Receives: Behavioral: MI condition |
| GI | Active comparator | Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care Receives: Behavioral: GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Advance Directive
Completing an advance directive for the individuals health care when they are not able to direct it themselves
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2008
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- John Y Song, MD, MPH, MAT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546884
- Sponsor's protocol ID
- 0704S06282
- Other IDs
- NR/NINR NIH, R01NR009815
- Acronym
- SELPH
- Status last verified
- Jun 2017
- First submitted
- 17 Oct 2007
- Last updated
- 13 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Song J, Ratner ER, Wall MM, Bartels DM, Ulvestad N, Petroskas D, West M, Weber-Main AM, Grengs L, Gelberg L. Effect of an End-of-Life Planning Intervention on the completion of advance directives in homeless persons: a randomized trial. Ann Intern Med. 2010 Jul 20;153(2):76-84. doi: 10.7326/0003-4819-153-2-201007200-00003.
PubMed 20643989
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Expression of End of Life Preferences for Homeless Persons
- ClinicalTrials.gov ID
- NCT00546884
- Acronym / sponsor ID
- SELPH / 0704S06282
- Conditions
- Healthy
- Keywords
- End of Life, Advance Directives, Randomized controlled trial, End of life care, End of life advance care planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Posted 14 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MI | Placebo comparator | Behavioral: MI conditionThe 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. |
| GI | Active comparator | Behavioral: GISubjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Actively intoxicated
- Cognitive deficiencies using BLESSED tool
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI conditionIndividuals randomized to this condition will be provided with written end of life educational materials an advance directive form, along with instructions to complete it. | Behavioural | MI |
| GIThe GI condition will expose participants to education, guidance and counseling, and an advance directive tool. | Behavioural | GI |
Primary outcome
Completion of Advance Directive
Time frame: 21 months
Completing an advance directive for the individuals health care when they are not able to direct it themselves
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20643989Song J, Ratner ER, Wall MM, Bartels DM, Ulvestad N, Petroskas D, West M, Weber-Main AM, Grengs L, Gelberg L. Effect of an End-of-Life Planning Intervention on the completion of advance directives in homeless persons: a randomized trial. Ann Intern Med. 2010 Jul 20;153(2):76-84. doi: 10.7326/0003-4819-153-2-201007200-00003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Y Song, MD, MPH, MAT principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI condition and GI in people with Healthy, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Advance Directive (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00546884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.