We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aligning Resources to Care for Homeless Veterans (ARCH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01550757
First Posted: March 12, 2012
Last Update Posted: October 11, 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.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: May 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Health Services Research
Conditions: Homeless Persons
Primary Health Care
Intervention: Behavioral: Embedded Peer Mentor

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Normal PACT Clinical Care Normal Patient Aligned Care Team Clinical Care
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor

Normal PACT Clinical Care + Embedded Peer Mentor

Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.

Arm 3: Normal Homeless Oriented PACT Clinical Care Normal Homeless Oriented Patient Aligned Care Team Clinical Care
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded

Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor

Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.


Participant Flow:   Overall Study
    Arm 1: Normal PACT Clinical Care   Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor   Arm 3: Normal Homeless Oriented PACT Clinical Care   Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded
STARTED   56   52   130   144 
COMPLETED   33   38   85   90 
NOT COMPLETED   23   14   45   54 
Lost to Follow-up                21                14                42                53 
Withdrawal by Subject                2                0                3                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Arm 1: Normal PACT Clinical Care Normal Patient Aligned Care Team Clinical Care
Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor

Normal PACT Clinical Care + Embedded Peer Mentor

Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.

Arm 3: Normal Homeless Oriented PACT Clinical Care Normal Homeless Oriented Patient Aligned Care Team Clinical Care
Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded

Normal Homeless Oriented PACT Clinical Care + Embedded Peer Mentor

Embedded Peer Mentor: This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.

Total Total of all reporting groups

Baseline Measures
   Arm 1: Normal PACT Clinical Care   Arm 2: Normal PACT Clinical Care + Embedded Peer Mentor   Arm 3: Normal Homeless Oriented PACT Clinical Care   Arm 4: Normal Homeless Oriented PACT Clinical Care + Embedded   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   52   130   144   382 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      52  92.9%      49  94.2%      120  92.3%      130  90.3%      351  91.9% 
>=65 years      4   7.1%      3   5.8%      10   7.7%      14   9.7%      31   8.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.5  (8.8)   50.3  (10.0)   51.2  (9.5)   52.6  (9.4)   52.2  (1.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      7  12.5%      1   1.9%      2   1.5%      6   4.2%      16   4.2% 
Male      49  87.5%      51  98.1%      128  98.5%      138  95.8%      366  95.8% 
Region of Enrollment 
[Units: Participants]
         
United States   49   51   128   138   366 


  Outcome Measures

1.  Primary:   A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.   [ Time Frame: Two years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
All AE and SAE monitoring was discussed with and approved by all regulatory authorities (IRB, DSMB, and research compliance officer).


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas O'Toole, MD
Organization: US Department of Veterans Affairs
phone: (401) 273-7100 ext 6359
e-mail: thomas.otoole@va.gov


Publications of Results:
Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01550757     History of Changes
Other Study ID Numbers: SDR 11-230
First Submitted: September 13, 2011
First Posted: March 12, 2012
Results First Submitted: May 16, 2017
Results First Posted: October 11, 2017
Last Update Posted: October 11, 2017