This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Challenge Topic, 05-DA-105: Comparing Episodic and Continuous Care for Drug Abuse Treatment. Our treatment system continues to rely primarily on relatively short, isolated episodes of care, despite mounting evidence of the chronic nature of substance use disorders, at least for those who enter the formal treatment system (McLellan et al., 2000). Therefore, although treatment for drug use disorders can lead to substantial reductions in substance use, a significant percentage of patients drop out relatively quickly, rates of relapse are high, and continuing care is often inadequate or unavailable. Continuing care interventions have been developed in an attempt to extend the positive effects of treatment, and some have been shown to be efficacious (McKay, 2009). However, the potential impact of existing continuing care models is limited by the following: ? Early treatment dropouts are usually excluded from participation in continuing care studies ? Retention rates in continuing care are often low ? Heterogeneity of response to continuing care interventions is high, both within and between individuals To have high impact, a continuing care model of treatment must address these three limitations. First, all patients should be enrolled in the intervention, not just the better prognosis patients who complete an initial phase of care. Second, methods to increase rates of sustained participation need to be included. Finally, modifications to the intervention must be available when patients do not exhibit an adequate response initially, or deteriorate at a later point. In prior NIDA and NIAAA funded studies, we have developed an extended continuing care protocol that has generated better cocaine and alcohol use outcomes than treatment as usual over periods as long as two years (McKay et al., 2005, 2008, 2009). This protocol is referred to as """"""""Telephone Monitoring and Adaptive Counseling"""""""" (TMAC). The protocol features telephone-based monitoring and brief counseling, which incorporates elements of motivational interviewing (MI) and cognitive-behavioral therapy (CBT) designed to increase recognition of high risk situations and improve coping abilities. In addition, the protocol includes an adaptive algorithm, which makes use of data obtained in a brief progress assessment done at the beginning of each call to determine whether changes in treatment intensity and modality are needed to improve response. Importantly, however, TMAC has been evaluated only in patients who have completed at least two weeks of treatment. Therefore, it is not clear whether patients who are early treatment dropouts-who may be in the greatest need of a continuous model of addiction treatment-can be successfully engaged and retained in the intervention. The purpose of this challenge grant is to conduct an initial test of a new, enhanced version of this protocol (TMAC-E), which has been modified to address the three limitations discussed above. In this new study, we will recruit 150 cocaine dependent patients in publicly funded, community-based intensive outpatient programs (IOPs) and randomize them to treatment as usual or the new continuing care protocol. We will recruit these individuals at entrance to treatment, to make sure that all patients have access to the intervention. The new protocol will contain all the elements of our existing continuing care intervention (e.g., telephone monitoring and brief counseling, adaptive stepped care, and low level incentives for participation). Additional new features and components which have been included to increase rates of sustained participation are: (a) provision of low level incentives for participation;(b) allowing patients to choose the modality of continuing care sessions (i.e., telephone or in person);(c) provision of cell phones to those who need them;(d) modules to strengthen social support and linkage to community resources for recovery;(e) greater emphasis on positive recovery factors;and (f) more systematic and aggressive outreach following dropout. These features were identified through reviews of the literature, our prior research findings, and discussions with patients and counselors regarding factors that contribute to continuing care dropout. All participants will be enrolled in the first year of the project, and provided with one year of the continuing care intervention. Data on alcohol and drug use, treatment utilization, and other multi-dimensional outcomes will be obtained at baseline, and 3, 6, 9, and 12 month follow-ups. Analyses will compare TMAC-E to TAU on rates of total abstinence in each 3-month period of the follow-up and frequency of drug use in those periods. Secondary outcomes include drug use related negative consequences, HIV risk behaviors, and use of expensive, acute care substance use treatment interventions during the follow-up period. The magnitude of the effects in these tests will also be compared to the magnitude of effect sizes generated in earlier studies of the TMAC intervention. Mediation analyses will explore mechanisms of action within TMAC-E. Rates of engagement and participation in TMAC-E will be examined between 6 and 12 months to determine if further methods to increase retention are needed prior to the recruitment of more participants. Preparation work being done now with existing staff and funding will enable us to begin recruitment within a month of challenge grant funding. This grant will create or preserve 15 jobs. Treatment for drug use disorders generally consists of relatively brief episodes of care that do not properly address the chronic, relapsing nature of these disorders. In prior work, we have developed a telephone-based adaptive continuing care model that provides extended care and has proved efficacious in several carefully controlled studies. The proposed supplement will determine whether a new 12 month version of this adaptive continuing care protocol that incorporates stepped care algorithms, patient choice, incentives for participation, and several other improvements designed to increase sustained participation rates will be more effective than standard care and yield larger effect sizes than our prior version of the protocol.
Treatment for drug use disorders generally consists of relatively brief episodes of care that do not properly address the chronic, relapsing nature of these disorders. In prior work, we have developed a telephone-based adaptive continuing care model that provides extended care and has proved efficacious in several carefully controlled studies. The proposed supplement will determine whether a new 12 month version of this adaptive continuing care protocol that incorporates stepped care algorithms, patient choice, incentives for participation, and several other improvements designed to increase sustained participation rates will be more effective than standard care and yield larger effect sizes than our prior version of the protocol.
