HomelessnessAHCMNCT01346514
Addiction Housing Case Management for Homeless Veterans
A study testing Intensive Addiction/Housing Case Management and Housing Support Group in people with Homelessness and Substance Abuse Disorders, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homelessness, Substance Abuse Disorders, Mental Disorders
- What is being tested?
- Intensive Addiction/Housing Case Management and Housing Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Not planning to stay in the Puget Sound area during the next 12 months
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Addiction Housing Case Management for Homeless Veterans Enrolled in Addictions Treatment
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.
Read the detailed 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.
- Conditions
- Homelessness, Substance Abuse Disorders, Mental Disorders
- Being tested
- Intensive Addiction/Housing Case Management, Housing Support Group
- Keywords
- Homeless Persons, Housing, Case Management, Veterans, Substance Related Disorders, Mental Disorders, Social Adjustment
- Medical subject headings
- Mental Disorders, Substance-Related Disorders, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Addiction/Housing Case ManagementBehavioural
Also called AHCM
AHCM provided: 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
Housing Support GroupBehavioural
Also called HSG
The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Addiction/Housing Case Management(AHCM) | Experimental | The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues who may be unable to take advantage of housing opportunities available in the VA due to difficulty navigating multiple services and maintaining stability with respect to SUD and co-occurring mental health conditions. Receives: Behavioral: Intensive Addiction/Housing Case Management |
| Arm 2: Housing Support Group(HSG) | Active comparator | The HSG condition involved a weekly drop-in housing support group. Receives: Behavioral: Housing Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Days Housed in AHCM vs. HSG, Baseline to 12 Months.
The primary aim is to determine whether the Addiction/Housing Case Management intervention increases percent days in long-term housing (permanent or long-term transitional) during the year following treatment entry relative to a Housing Support Group.
Measured: 12 months (18 to 24 month outcomes examined in secondary analyses)
Secondary outcomes (6)
Costs and Cost-effectiveness of AHCM vs. HSG, Baseline to 12 Months
Costs and cost-effectiveness of Addiction/Housing Case Management to the Housing Support Group condition.
Measured: Baseline to 12 months
Change in Functional Status in AHCM vs. HSG From Baseline to 12 Months
Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved functional status outcomes among homeless Veterans entering addiction specialty care over the 12-month study course. Functional status was measured by Medical, Employment, Family/Social, and Legal Composite Scores (range 0 to 1 with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Physical Component Summary (PCS, range 0 to 100 with lower scores indicating greater severity) on the SF-36. Negative change on the ASI measures indicates improvement. Positive change on the SF-36 PCS indicates improvement.
Measured: Baseline to 12 months
Change in Alcohol and Drug Outcomes in AHCM vs. HSG From Baseline to 12 Months
Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved alcohol and drug outcomes, as measured by Alcohol and Drug Composite Scores (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI), among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI measures indicates improvement.
Measured: Baseline to 12 months
Change in Percent of Participants Abstinent From Baseline to 12 Month Follow-up
Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly increase the percent of participants abstinent from alcohol and drugs over the past 30 days among homeless Veterans entering addiction specialty care over the 12-month study course. Positive change indicates improvement.
Measured: Baseline to 12 months
Change in Mental Health Status in AHCM vs. HSG From Baseline to 12 Months
Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved mental health outcomes, as measured by the Psychiatric Composite Score (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Mental Component Summary (MCS, range 0 to 100 with lower scores indicating greater severity) of the SF-36, among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI Psychiatric Composite Score indicates improvement. Positive change on the SF-36 MCS indicates improvement.
Measured: Baseline to 12 months
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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HomelessnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Andrew J. Saxon, MD, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346514
- Sponsor's protocol ID
- SDR 11-231
- Acronym
- AHCM
- Status last verified
- Jan 2017
- First submitted
- 29 Apr 2011
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Malte CA, Cox K, Saxon AJ. Providing intensive addiction/housing case management to homeless veterans enrolled in addictions treatment: A randomized controlled trial. Psychol Addict Behav. 2017 May;31(3):231-241. doi: 10.1037/adb0000273.
PubMed 28481614Cox KB, Malte CA, Saxon AJ. Characteristics and service utilization of homeless veterans entering VA substance use treatment. Psychol Serv. 2017 May;14(2):208-213. doi: 10.1037/ser0000133.
PubMed 28481606
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction Housing Case Management for Homeless Veterans Enrolled in Addictions Treatment
- ClinicalTrials.gov ID
- NCT01346514
- Acronym / sponsor ID
- AHCM / SDR 11-231
- Conditions
- Homelessness, Substance Abuse Disorders, Mental Disorders
- Keywords
- Homeless Persons, Housing, Case Management, Veterans, Substance Related Disorders, Mental Disorders, Social Adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 May 2011 (estimated)
- Results
- Posted 28 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Addiction/Housing Case Management(AHCM) | Experimental | Behavioral: Intensive Addiction/Housing Case ManagementThe AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues who may be unable to take advantage of housing opportunities available in the VA due to difficulty navigating multiple services and maintaining stability with respect to SUD and co-occurring mental health conditions. |
| Arm 2: Housing Support Group(HSG) | Active comparator | Behavioral: Housing Support GroupThe HSG condition involved a weekly drop-in housing support group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Not planning to stay in the Puget Sound area during the next 12 months
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Addiction/Housing Case ManagementAlso: AHCMAHCM provided: 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation). | Behavioural | Arm 1: Addiction/Housing Case Management(AHCM) |
| Housing Support GroupAlso: HSGThe HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues. | Behavioural | Arm 2: Housing Support Group(HSG) |
Primary outcome
Percent Days Housed in AHCM vs. HSG, Baseline to 12 Months.
Time frame: 12 months (18 to 24 month outcomes examined in secondary analyses)
The primary aim is to determine whether the Addiction/Housing Case Management intervention increases percent days in long-term housing (permanent or long-term transitional) during the year following treatment entry relative to a Housing Support Group.
6 secondary outcomes
Costs and Cost-effectiveness of AHCM vs. HSG, Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Functional Status in AHCM vs. HSG From Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Alcohol and Drug Outcomes in AHCM vs. HSG From Baseline to 12 Months
Time frame: Baseline to 12 months
Change in Percent of Participants Abstinent From Baseline to 12 Month Follow-up
Time frame: Baseline to 12 months
Change in Mental Health Status in AHCM vs. HSG From Baseline to 12 Months
Time frame: Baseline to 12 months
Treatment Process Measures (Number of Treatment Sessions, Type of Housing Placement, and Change in Life Skills)
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28481614Malte CA, Cox K, Saxon AJ. Providing intensive addiction/housing case management to homeless veterans enrolled in addictions treatment: A randomized controlled trial. Psychol Addict Behav. 2017 May;31(3):231-241. doi: 10.1037/adb0000273.
- Derived from this study: PubMed 28481606Cox KB, Malte CA, Saxon AJ. Characteristics and service utilization of homeless veterans entering VA substance use treatment. Psychol Serv. 2017 May;14(2):208-213. doi: 10.1037/ser0000133.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J. Saxon, MD principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Addiction/Housing Case Management and Housing Support Group in people with Homelessness and Substance Abuse Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Days Housed in AHCM vs. HSG, Baseline to 12 Months. (time frame: 12 months (18 to 24 month outcomes examined in secondary analyses)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.