NCT00546884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

March 14, 2017

Completed
Last Updated

July 13, 2017

Status Verified

June 1, 2017

Enrollment Period

9 months

First QC Date

October 17, 2007

Results QC Date

June 27, 2016

Last Update Submit

June 16, 2017

Conditions

Healthy

Keywords

End of LifeAdvance DirectivesRandomized controlled trialEnd of life careEnd of life advance care planning

Outcome Measures

Primary Outcomes (1)

  • Completion of Advance Directive

    Completing an advance directive for the individuals health care when they are not able to direct it themselves

    21 months

Study Arms (2)

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.

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

Behavioral: GI

Interventions

MI conditionBEHAVIORAL

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.

MI
GIBEHAVIORAL

The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.

GI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Actively intoxicated
  • Cognitive deficiencies using BLESSED tool

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

  • 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.

    PMID: 20643989DERIVED

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
John Song MD MPH MAT
Organization
University of Minnesota
songx006@umn.edu
612-624-8936

Study Officials

  • John Y Song, MD, MPH, MAT

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

November 1, 2007

Primary Completion

August 1, 2008

Study Completion

July 1, 2010

Last Updated

July 13, 2017

Results First Posted

March 14, 2017

Record last verified: 2017-06

Locations

US(2)