Trial Outcomes & Findings for Intervention to Improve Expression of End of Life Preferences for Homeless Persons (NCT NCT00546884)

NCT ID: NCT00546884

Last Updated: 2017-07-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 262 participants
• Primary outcome timeframe: 21 months
• Results posted on: 2017-07-13

Participant Flow

Participant milestones

Measure	Minimal Intervention 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. 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.	Guided Intervention Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.
Overall Study STARTED	145	117
Overall Study COMPLETED	145	117
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Minimal Intervention n=145 Participants 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. 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.	Guided Intervention n=117 Participants Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.	Total n=262 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	123 Participants n=5 Participants	94 Participants n=7 Participants	217 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Age, Continuous	43.3 years n=5 Participants	43.1 years n=7 Participants	43.1 years n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	111 Participants n=5 Participants	82 Participants n=7 Participants	193 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	81 Participants n=5 Participants	60 Participants n=7 Participants	141 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	35 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	145 participants n=5 Participants	117 participants n=7 Participants	262 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 months

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

Outcome measures

Measure	Minimal Intervention n=117 Participants 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. 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.	Guided Intervention n=145 Participants Subjects randomized to the GI group will be invited to meet individually with a health care professional specializing in EOL care GI: The GI condition will expose participants to education, guidance and counseling, and an advance directive tool.
Completion of Advance Directive	15 Participants	55 Participants

Adverse Events

Minimal Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Guided Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Song MD MPH MAT

University of Minnesota

Phone: 612-624-8936

Email: songx006@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place