Dual DiagnosisPhase 2NCT00012727
Matching, Outcomes and Costs in Substance Abuse/Psychiatric Treatment
A Phase 2 study testing Matching Symptom Severity to Service Intensity in people with Dual Diagnosis, run by US Department of Veterans Affairs at 6 sites in United States.
Trial summary
This project�s goal is to improve the quality of care and reduce treatment costs for veterans with substance abuse and psychiatric problems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dual Diagnosis
- What is being tested?
- Matching Symptom Severity to Service Intensity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento Aug 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be entering a VA inpatient substance abuse or psychiatric treatment program and be clinically judged as appropriate for inpatient or community residential care.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Hampton VA Medical Center, Hampton, VA
Hampton, Virginia, 23667
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, 73104
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1873
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
This project�s goal is to improve the quality of care and reduce treatment costs for veterans with substance abuse and psychiatric problems.
Read the detailed description
Background:
This project�s goal is to improve the quality of care and reduce treatment costs for veterans with substance abuse and psychiatric problems.
Objectives:
This project is evaluating a patient-treatment matching strategy to improve residential treatment for substance abuse patients with psychiatric disorders. Its immediate objective is to examine whether the matching strategy results in more effective and cost-effective treatment in VA programs. We hypothesize that patients with severe clinical problems will have better outcomes when they are matched to service-intensive programs; patients with moderate problems will have better outcomes when they are matched to programs having a lower intensity of services. For both patient groups, community treatment should prove to be more cost-effective than hospital treatment.
Methods:
The project utilized a stratified randomized design. We paired each of three VA hospital programs that treat dual diagnosis patients and are high on intensity with a nearby high-intensity community residential facility (CRF) that contracts with the VA. We also paired four VA hospital and four CRFs that are low on intensity. Veterans who applied for substance abuse treatment at VA facilities were randomly assigned to either the VA hospital or CRF. Patient assessments have been conducted at intake (N=230), discharge, and a 4-month follow-up. Primary outcomes are patients� severity of substance abuse and psychiatric problems. Secondary outcomes are patients� functional status and their VA and non-VA health care utilization and its costs.
Status:
Completed.
- Conditions
- Dual Diagnosis
- Being tested
- Matching Symptom Severity to Service Intensity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matching Symptom Severity to Service IntensityProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Procedure: Matching Symptom Severity to Service Intensity |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dual DiagnosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Christine Timko, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012727
- Sponsor's protocol ID
- IIR 95-011
- Status last verified
- Jul 2005
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Timko C, Sempel JM, Moos RH. Models of standard and intensive outpatient care in substance abuse and psychiatric treatment. Adm Policy Ment Health. 2003 May;30(5):417-36. doi: 10.1023/a:1024693614501.
PubMed 12940684Timko C, Sempel JM. Short-term outcomes of matching dual diagnosis patients' symptom severity to treatment intensity. J Subst Abuse Treat. 2004 Apr;26(3):209-18. doi: 10.1016/S0740-5472(04)00002-9.
PubMed 15063915Timko C, Lesar M, Calvi NJ, Moos RH. Trends in acute mental health care: comparing psychiatric and substance abuse treatment programs. J Behav Health Serv Res. 2003 Apr-Jun;30(2):145-60. doi: 10.1007/BF02289804.
PubMed 12710369Timko C, Lesar M, Engelbrekt M, Moos RH. Changes in services and structure in community residential treatment facilities for substance abuse patients. Psychiatr Serv. 2000 Apr;51(4):494-8. doi: 10.1176/appi.ps.51.4.494.
PubMed 10737825Timko C, Sempel JM. Intensity of acute services, self-help attendance and one-year outcomes among dual diagnosis patients. J Stud Alcohol. 2004 Mar;65(2):274-82. doi: 10.15288/jsa.2004.65.274.
PubMed 15151360Chen S, Barnett PG, Sempel JM, Timko C. Outcomes and costs of matching the intensity of dual-diagnosis treatment to patients' symptom severity. J Subst Abuse Treat. 2006 Jul;31(1):95-105. doi: 10.1016/j.jsat.2006.03.015.
PubMed 16814015Timko C, Yu K, Moos RH. Demand characteristics of residential substance abuse treatment programs. J Subst Abuse. 2000;12(4):387-403. doi: 10.1016/s0899-3289(01)00056-6.
PubMed 11452841
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matching, Outcomes and Costs in Substance Abuse/Psychiatric Treatment
- ClinicalTrials.gov ID
- NCT00012727
- Acronym / sponsor ID
- IIR 95-011
- Conditions
- Dual Diagnosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Aug 2001 (actual)
- First posted
- 16 Mar 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project�s goal is to improve the quality of care and reduce treatment costs for veterans with substance abuse and psychiatric problems.
Detailed description
Background:
This project�s goal is to improve the quality of care and reduce treatment costs for veterans with substance abuse and psychiatric problems.
Objectives:
This project is evaluating a patient-treatment matching strategy to improve residential treatment for substance abuse patients with psychiatric disorders. Its immediate objective is to examine whether the matching strategy results in more effective and cost-effective treatment in VA programs. We hypothesize that patients with severe clinical problems will have better outcomes when they are matched to service-intensive programs; patients with moderate problems will have better outcomes when they are matched to programs having a lower intensity of services. For both patient groups, community treatment should prove to be more cost-effective than hospital treatment.
Methods:
The project utilized a stratified randomized design. We paired each of three VA hospital programs that treat dual diagnosis patients and are high on intensity with a nearby high-intensity community residential facility (CRF) that contracts with the VA. We also paired four VA hospital and four CRFs that are low on intensity. Veterans who applied for substance abuse treatment at VA facilities were randomly assigned to either the VA hospital or CRF. Patient assessments have been conducted at intake (N=230), discharge, and a 4-month follow-up. Primary outcomes are patients� severity of substance abuse and psychiatric problems. Secondary outcomes are patients� functional status and their VA and non-VA health care utilization and its costs.
Status:
Completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Matching Symptom Severity to Service Intensity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be entering a VA inpatient substance abuse or psychiatric treatment program and be clinically judged as appropriate for inpatient or community residential care.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Matching Symptom Severity to Service Intensity | Procedure or surgery | Arm 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Results publication: PubMed 12940684Timko C, Sempel JM, Moos RH. Models of standard and intensive outpatient care in substance abuse and psychiatric treatment. Adm Policy Ment Health. 2003 May;30(5):417-36. doi: 10.1023/a:1024693614501.
- Results publication: PubMed 15063915Timko C, Sempel JM. Short-term outcomes of matching dual diagnosis patients' symptom severity to treatment intensity. J Subst Abuse Treat. 2004 Apr;26(3):209-18. doi: 10.1016/S0740-5472(04)00002-9.
- Results publication: PubMed 12710369Timko C, Lesar M, Calvi NJ, Moos RH. Trends in acute mental health care: comparing psychiatric and substance abuse treatment programs. J Behav Health Serv Res. 2003 Apr-Jun;30(2):145-60. doi: 10.1007/BF02289804.
- Results publication: PubMed 10737825Timko C, Lesar M, Engelbrekt M, Moos RH. Changes in services and structure in community residential treatment facilities for substance abuse patients. Psychiatr Serv. 2000 Apr;51(4):494-8. doi: 10.1176/appi.ps.51.4.494.
- Results publication: PubMed 15151360Timko C, Sempel JM. Intensity of acute services, self-help attendance and one-year outcomes among dual diagnosis patients. J Stud Alcohol. 2004 Mar;65(2):274-82. doi: 10.15288/jsa.2004.65.274.
- Results publication: PubMed 16814015Chen S, Barnett PG, Sempel JM, Timko C. Outcomes and costs of matching the intensity of dual-diagnosis treatment to patients' symptom severity. J Subst Abuse Treat. 2006 Jul;31(1):95-105. doi: 10.1016/j.jsat.2006.03.015.
- Results publication: PubMed 11452841Timko C, Yu K, Moos RH. Demand characteristics of residential substance abuse treatment programs. J Subst Abuse. 2000;12(4):387-403. doi: 10.1016/s0899-3289(01)00056-6.
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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.
Christine Timko, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Matching Symptom Severity to Service Intensity in people with Dual Diagnosis, run by US Department of Veterans Affairs at 6 sites 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 1 inclusion and 0 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 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00012727, which also lists 7 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 7 Apr 2015.