Clinical Practices and Outcomes in VA Methadone Maintenance Programs
Keith N. Humphreys PhD
VA Palo Alto Health Care System (152MPD)
Palo Alto, CA
Funding Period: July 2000 - June 2004

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.

PUBLICATIONS:

Journal Articles

1. 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; 68(2): 165-72.
2. Villafranca SW, McKellar JD, Trafton JA, Humphreys K. Predictors of retention in methadone programs: a signal detection analysis. Drug and Alcohol Dependence. 2006; 83(3): 218-24.
3. 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; 82(3): 187-93.
4. 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; 67(2): 228-35.
5. 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; 73(1): 23-31.
6. Trafton J, Barnett P, Finney J, Moos RH, Willenbring M, Humphreys K. Effective Treatment of Opioid Dependence. VA Practice Matters. 2001; 6: 1-6.
7. Barnett PG, Hui SS. The cost-effectiveness of methadone maintenance. The Mount Sinai Journal of Medicine, New York. 2000; 67(5-6): 365-74.

DRA: Health Services and Systems, Substance Abuse, Addictive Disorders
DRE: Communication and Decision Making, Quality of Care
Keywords: Clinical practice guidelines, Cost, Patient outcomes
MeSH Terms: none