Alcohol Dependence Clinical Trial
Official title:
Improving Longterm SUD Outcomes With Telephone Case Monitoring
NCT number | NCT00265512 |
Other study ID # | IIR 05-021 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2006 |
Est. completion date | January 2010 |
Verified date | July 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The prevalence of substance use disorders (SUD) in the VA is rising, making SUD(s) among the most commonly diagnosed disorders in the VA. A substantial body of data attests to the effectiveness of substance use disorder treatment; further the predictor most consistently associated with positive addiction treatment outcomes is duration. Despite the body of evidence supporting length of treatment as one of the stronger predictors of long-term SUD outcomes, only 36% of SUD treatment programs in the VA are meeting the continuing care performance criterion specified by the Office of Quality Performance. This randomized clinical trial investigates whether substance use disorder patients assigned to telephone case monitoring (TCM) for continuing care will do better than those attending face-to-face continuing care as usual (CCAU)(standard outpatient care).
Status | Completed |
Enrollment | 667 |
Est. completion date | January 2010 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Participants will be recruited from all patients who complete at least 14 days of intensive outpatient (IOP) substance use disorder treatment over an 18-month period in 2 VA IOP SUD programs. Exclusion Criteria: Completion of less than 14 days of IOP treatment. |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
United States | St. Louis VA Medical Center John Cochran Division, St. Louis, MO | Saint Louis | Missouri |
United States | VA Eastern Kansas Health Care System Colmery-O'Neil VA Medical Center, Topeka, KS | Topeka | Kansas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Austin J, McKellar JD, Moos R. The influence of co-occurring axis I disorders on treatment utilization and outcome in homeless patients with substance use disorders. Addict Behav. 2011 Sep;36(9):941-4. doi: 10.1016/j.addbeh.2011.05.001. Epub 2011 May 7. — View Citation
Barbosa PV, Thomas IC, Srinivas S, Buyyounouski MK, Chung BI, Chertow GM, Asch SM, Wagner TH, Brooks JD, Leppert JT. Overall Survival in Patients with Localized Prostate Cancer in the US Veterans Health Administration: Is PIVOT Generalizable? Eur Urol. 20 — View Citation
Gidwani R, Joyce N, Kinosian B, Faricy-Anderson K, Levy C, Miller SC, Ersek M, Wagner T, Mor V. Gap between Recommendations and Practice of Palliative Care and Hospice in Cancer Patients. J Palliat Med. 2016 Sep;19(9):957-63. doi: 10.1089/jpm.2015.0514. E — View Citation
McKellar J, Wagner T, Harris A, Oehlert M, Buckley S, Moos R. One-year outcomes of telephone case monitoring for patients with substance use disorder. Addict Behav. 2012 Oct;37(10):1069-74. doi: 10.1016/j.addbeh.2012.03.009. Epub 2012 Mar 13. — View Citation
Oser M, Cucciare M, McKellar J, Weingardt K. Correlates of hazardous drinking among Veterans with and without hepatitis C. J Behav Med. 2012 Dec;35(6):634-41. doi: 10.1007/s10865-011-9394-9. Epub 2012 Jan 11. — View Citation
Oser ML, McKellar J, Moos BS, Moos RH. Changes in ambivalence mediate the relation between entering treatment and change in alcohol use and problems. Addict Behav. 2010 Apr;35(4):367-9. doi: 10.1016/j.addbeh.2009.10.024. Epub 2009 Oct 30. — View Citation
Wagner TH, Burstin H, Frakt AB, Krein SL, Lorenz K, Maciejewski ML, Pizer SD, Weiner M, Yoon J, Zulman DM, Asch SM. Opportunities to Enhance Value-Related Research in the U.S. Department of Veterans Affairs. J Gen Intern Med. 2016 Apr;31 Suppl 1:78-83. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rates of Substance Use | Percentage of days abstinent from alcohol use. Each person is followed for 3 months. For each person, we then calculate the number of days they were abstinent and the percentage of days abstinent (days abstinent/ all days in 3 months). | Rates of substance use measured at 3 months | |
Secondary | Psychiatric Symptoms | 3 month, 6 month and 12 month measures of psychiatric symptoms, as measured by the Brief Symptom Inventory (BSI). Minimum observed score was 22; maximum observed score was 110. Higher score is worse. Minimum score possible is 22. Maximum score possible is 110. | Psychiatric symptoms measured at 3 months, 6 months, 12 months post randomization | |
Secondary | Health Related Quality of Life | Physical and mental health subscales from the 12-item Medical Outcomes Study Short-form Health Survey, adapted for Veterans (VR-12). Observed scores on the MCS ranged from 2.89 to 70.39. Scores on the PCS ranged from 13.26 to 70.10. Higher scores denote better health. The minimum and maximum scores possible are 0 and 100, respectively. | 3 months, 6 months and 12 months after randomization |
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