BACKGROUND/RATIONALE:
The present project was developed in response to a request for proposals issued under VA’s new QUERI initiative (RFP title: Service-directed research regarding best practices in VA opiate substitution programs). Clinical practice guidelines for methadone maintenance recommend that patients be dosed in the 60-100mg range, and that a variety of psychosocial services be available to patients. Even though both of these guidelines have been supported in well-controlled randomized clinical trials, many VA and non-VA methadone clinics do not follow them.

OBJECTIVE(S):
The purpose of the present study is to evaluate: 1) how patient outcomes are affected when methadone clinics more closely adhere to clinical practice guidelines; 2) the cost-effectiveness and health care cost-offset by more closely following practice guidelines for methadone maintenance; and 3) the barriers to more closely following clinical practice guidelines, and how these barriers could be surmounted.

METHODS:
This multi-site study enrolled patients from VA opioid substitution treatment clinics at 8 sites across the country. Patients were interviewed at treatment intake, and followed at 6 and 12 months. The interviews consisted of the Addiction Severity Index, the SF-36, a high-risk injection practices inventory, a survey of non-VA health care utilization, and a treatment satisfaction questionnaire. These provided information to allow for key case mix-adjusted outcomes to be evaluated, including overall physical health, overall mental health, employment, mortality, HIV risk behavior, heroin use, cocaine use, criminal behavior, and treatment satisfaction. Analysis of Phase I data focuses on the clinical benefits to VA patients following treatment at clinics with high versus low adherence to clinical practice guidelines for opioid substitution treatment. For Phase II of the study, VA and non-VA health care utilization and cost data is being gathered to supplement the information on patient outcomes gathered in Phase I. Data analysis will focus on whether the cost of guideline concordant treatment practices can be justified either through superior patient outcomes (i.e., cost-effectiveness) and/or through reduced long-term health care costs (i.e., cost-offset). Finally, Phase III is investigating barriers and facilitators to providing practice guideline concordant opioid substitution treatment in the VA.

FINDINGS/RESULTS:
Overall, Opioid Substitution Treatment at the VA was associated with reductions in drug use, criminal behavior and needle use. Patients attending sites with high adherence to clinical practice guidelines achieved greater reductions in drug use, using less heroin at 6 and 12 month follow-up and less cocaine at 12 month follow-up than patients at low guideline adherent sites. Patients at high guideline adherent sites reported better health-related quality of life and greater treatment satisfaction than patients at low guideline adherent sites at 6 months; this difference between the clinics decreased by 12 months. Cost-effectiveness data is not yet available.

Clinic directors who are more research-savvy are more likely to report clinical guideline concordant treatment beliefs and practices. Clinic directors’ decision to offer opioid substitution treatment to their patients is related to their belief in clinical trial results and not their belief in clinical practice guidelines.

IMPACT:
The cost study of human subjects procedures provided a recommendation that all VA multi-site studies undergo national review as do co-op studies instead of independent review by every single site. If implemented, VA research would be easier to conduct and less costly, with no loss of protection for human subjects.

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External Links for this Project

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PUBLICATIONS:

Journal Articles

1. Trafton JA, Humphreys K, Harris AH, Oliva E. Consistent adherence to guidelines improves opioid dependent patients' first year outcomes. The journal of behavioral health services & research. 2007 Jul 1; 34(3):260-71. [view]
2. Trafton JA, Minkel J, Humphreys K. Determining effective methadone doses for individual opioid-dependent patients. PLoS Medicine. 2006 Mar 1; 3(3):e80. [view]
3. Trafton JA, Tracy SW, Oliva EM, Humphreys K. Different components of opioid-substitution treatment predict outcomes of patients with and without a parent with substance-use problems. Journal of Studies On Alcohol. 2007 Mar 1; 68(2):165-72. [view]
4. Humphreys K, Trafton JA, Oliva EM. Does following research-derived practice guidelines improve opiate-dependent patients' outcomes under everyday practice conditions? Results of the Multisite Opiate Substitution Treatment study. Journal of substance abuse treatment. 2008 Mar 1; 34(2):173-9. [view]
5. Trafton J, Barnett P, Finney J, Moos RH, Willenbring M, Humphreys K. Effective Treatment of Opioid Dependence. VA Practice Matters. 2001 Jun 1; 6:1-6. [view]
6. Trafton JA, Minkel J, Humphreys K. Opioid substitution treatment reduces substance use equivalently in patients with and without posttraumatic stress disorder. Journal of Studies On Alcohol. 2006 Mar 1; 67(2):228-35. [view]
7. Villafranca SW, McKellar JD, Trafton JA, Humphreys K. Predictors of retention in methadone programs: a signal detection analysis. Drug and Alcohol Dependence. 2006 Jul 27; 83(3):218-24. [view]
8. Ilgen MA, Trafton JA, Humphreys K. Response to methadone maintenance treatment of opiate dependent patients with and without significant pain. Drug and Alcohol Dependence. 2006 May 20; 82(3):187-93. [view]
9. Barnett PG, Trafton JA, Humphreys K. The cost of concordance with opiate substitution treatment guidelines. Journal of substance abuse treatment. 2010 Sep 1; 39(2):141-9. [view]
10. Humphreys K, Trafton J, Wagner TH. The cost of institutional review board procedures in multicenter observational research. Annals of internal medicine. 2003 Jul 1; 139(1):77. [view]
11. Barnett PG, Hui SS. The cost-effectiveness of methadone maintenance. The Mount Sinai Journal of Medicine, New York. 2000 Oct 1; 67(5-6):365-74. [view]
12. Trafton JA, Oliva EM, Horst DA, Minkel JD, Humphreys K. Treatment needs associated with pain in substance use disorder patients: implications for concurrent treatment. Drug and Alcohol Dependence. 2004 Jan 7; 73(1):23-31. [view]

Book Chapters

1. Oliva E, Horst D, Trafton J, Humphreys K. Pilot study of racial and geographic HIV risk among methadone patients. In: Proceedings of the XIV International AIDS Conference, Barcelona 2002. Bologna, Italy: Monduzzi Editore; 2002. 279-282 p. [view]

Reports

1. Ayyangar L, Trafton J, Barnett P. Comparison of the National VA Outpatient Database to Electronic Medical Records. 2003 Dec 1. Report No.: HERC Technical Report #8. [view]

Conference Presentations

1. Trafton J, Oliva E, Horst DA, Minkel JD, Humphreys KN. Clinical practices and outcomes in opioid substitution programs: 6-month outcomes. Meeting the changing needs of veterans: the quality/cost equation. Paper presented at: VA HSR&D National Meeting; 2004 Mar 2; Washington, DC. [view]
2. Humphreys K, Trafton JA, Oliva E. Does following practice guidelines matter in the real world of heroin dependence treatment: Multisite Opioid Substitution Treatment Study. Paper presented at: VA HSR&D National Meeting; 2005 Jun 26; Boston, MA. [view]
3. Trafton JA, Minkel JD, Humphreys K. Posttraumatic stress disorder does not impair substance use disorder outcomes in opioid substitution treatment. Paper presented at: VA HSR&D National Meeting; 2005 Jun 26; Boston, MA. [view]

DRA: Health Systems Science, Substance Use Disorders
DRE: none
Keywords: Clinical practice guidelines, Cost, Patient outcomes
MeSH Terms: none