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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01346514
Other study ID # SDR 11-231
Secondary ID
Status Completed
Phase N/A
First received April 29, 2011
Last updated August 9, 2016
Start date October 2011
Est. completion date May 2016

Study information

Verified date August 2016
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The study examined intensive case management for homeless Veterans in addiction treatment by integrating addiction/housing case managers (AHCM), operating from a Life Skills Training perspective, into an addiction specialty program. The primary aim was to determine whether the AHCM intervention increases number of days housed during the year following treatment entry. Secondary aims were to compare costs and cost-effectiveness of AHCM vs. time and attention control, determine if AHCM improves addiction outcomes and functional status, and examine treatment process variables associated with improved outcomes.


Description:

Background: Homelessness, substance use, and co-occurring psychiatric disorders form a mutually perpetuating, downwardly spiraling triad that maintains a state of homelessness, increases morbidity and mortality and thereby escalates health care utilization and costs. Addiction treatment is one portal of health care entry accessed by many Veterans with this devastating triad, yet addiction treatment fails to address homelessness directly. Homeless Veterans entering addiction treatment have worse treatment outcomes and incur more costs than housed Veterans entering such treatment. Further, many homeless Veterans never obtain housing after treatment entry and substantial proportion of those who do may subsequently return to homelessness. Assertive community treatment / intensive case management shows promise in improving housing status, as well as substance use and mental health outcomes in this population. Life Skills Training, which has been shown to improve the likelihood of maintaining housing, may increase the effectiveness of this method of treatment. An approach to homelessness incorporating assertive community treatment / intensive case management and Life Skills Training has never previously been integrated into VA addiction specialty care.

Objectives: The proposed study will examine intensive case management for homeless Veterans in addiction treatment by integrating addiction/housing case managers (AHCM), operating from a Life Skills Training perspective, into an addiction specialty program. The primary aim is to determine whether the AHCM intervention increases number of days housed during the year following treatment entry. Secondary aims are to compare costs and cost-effectiveness of AHCM vs. time and attention control, determine if AHCM improves addiction outcomes and functional status, and examine treatment process variables associated with improved outcomes.

Methods: The proposed study is a, parallel design, intention to treat, randomized clinical trial comparing the AHCM intervention to a time and attention control (weekly housing group) among homeless Veterans (N=400) newly entering addiction treatment. Following baseline assessment, Veterans will be randomly assigned, stratified by gender and primary substance problem, to one of the two treatment conditions and followed for 12 months. All Veterans will receive addiction treatment as usual. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals. Veterans assigned to the control condition will attend a weekly housing group where housing options are discussed. Participants will complete research assessments every 3 months through one year and then every 6 months for up to 2 years post-randomization to assess housing status and other outcomes. The Northwest Regional Data Warehouse and Decision Support System data sources will be used to determine outpatient and inpatient VA health care services and costs for the 1 year before and 2 years after study enrollment.

Impact: If the AHCM model interrupts the mutually perpetuating triad of homelessness, substance use, and co-occurring psychiatric disorders by increasing days stably housed, reducing costs and excessive health care utilization, and improving functional status, the model could be feasibly and rapidly replicated in VA addiction programs nationwide thereby decreasing homelessness among Veterans and preserving precious health care resources.


Recruitment information / eligibility

Status Completed
Enrollment 181
Est. completion date May 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Veterans newly presenting or returning to specialty treatment for substance dependence at VA Puget Sound Seattle Division who, after an initial evaluation, are scheduled for a treatment appointment in the Addiction Treatment Center

- Currently homeless (unsheltered, staying in temporary emergency shelter, or doubled up with friends/family)

Exclusion Criteria:

- Not planning to stay in the Puget Sound area during the next 12 months

- Unable to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Intervention

Behavioral:
LifeSkills Training/Intensive Case Management
Assertive community treatment / intensive case management. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
Time and attention control
Veterans assigned to the control condition will attend a weekly housing group where housing options are discussed.

Locations

Country Name City State
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of days housed during the year following treatment entry in AHCM vs. time and attention control The primary aim is to determine whether the Addiction/Housing Case Management intervention increases number of days housed during the year following treatment entry. 12 months (18 to 24 month outcomes examined in secondary analyses) No
Secondary Secondary aims are to compare costs and cost-effectiveness of AHCM vs. time and attention control, Secondary aims are to compare costs and cost-effectiveness of AHCM vs. time and attention control, determine if AHCM improves addiction outcomes and functional status, and examine treatment process variables associated with improved outcomes. 12 months No
Secondary Functional, addiction, and mental health status in AHCM vs. time and attention control Determine if Addiction/Housing Case Management compared to time and attention control significantly improves functional status, addiction, and mental health outcomes among homeless Veterans entering addiction specialty care over the 12-month study course. 12 months (18 and 24 outcomes examined in secondary analyses) No
Secondary Treatment process measures (number of treatment sessions, type of housing placement, and change in Life Skills) Analyses will explore whether treatment process variables mediate differences in outcomes between Addiction/Housing Case Management and time and attention conditions. 12 months (18 and 24 outcomes examined in secondary analyses) No
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