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Intervention to Improve Expression of End of Life Preferences for Homeless Persons (SELPH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00546884
First Posted: October 19, 2007
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
Results First Submitted: June 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Healthy
Interventions: Behavioral: MI condition
Behavioral: GI

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Minimal Intervention   Guided Intervention
STARTED   145   117 
COMPLETED   145   117 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Minimal Intervention   Guided Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   117   262 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      123  84.8%      94  80.3%      217  82.8% 
>=65 years      22  15.2%      23  19.7%      45  17.2% 
Age 
[Units: Years]
Mean (Full Range)
 43.3 
 (19 to 68) 
 43.1 
 (21 to 70) 
 43.1 
 (19 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      34  23.4%      35  29.9%      69  26.3% 
Male      111  76.6%      82  70.1%      193  73.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      7   4.8%      11   9.4%      18   6.9% 
Asian      1   0.7%      1   0.9%      2   0.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      81  55.9%      60  51.3%      141  53.8% 
White      48  33.1%      35  29.9%      83  31.7% 
More than one race      8   5.5%      10   8.5%      18   6.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   145   117   262 


  Outcome Measures

1.  Primary:   Completion of Advance Directive   [ Time Frame: 21 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John Song MD MPH MAT
Organization: University of Minnesota
phone: 612-624-8936
e-mail: songx006@umn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00546884     History of Changes
Other Study ID Numbers: 0704S06282
NR/NINR NIH ( Other Identifier: NINR )
R01NR009815 ( U.S. NIH Grant/Contract )
First Submitted: October 17, 2007
First Posted: October 19, 2007
Results First Submitted: June 27, 2016
Results First Posted: March 14, 2017
Last Update Posted: July 13, 2017