Research Findings - Services Research
Comparative Effectiveness Trial of 5 Smoking Cessation Pharmacotherapies in Primary Care Clinics
Randomized efficacy clinical trials conducted in research settings may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical settings. Effectiveness trials (e.g., in primary care settings) are needed to estimate the benefits of cessation treatments in real-world use. To perform this comparative effectiveness trial a total of 1346 adult primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics in the mid-west United States. Patients were randomly assigned to 5 active pharmacotherapies: 3 monotherapies (nicotine patch, nicotine lozenge, and bupropion hydrochloride sustained release [SR]) and 2 combination therapies (patch + lozenge and bupropion SR + lozenge). Patients were referred to a telephone quit line for cessation counseling. Primary outcomes included 7-day point prevalence abstinence at 1 week, 8 weeks, and 6 months after quitting and number of days to relapse. The researchers found that among 7128 eligible smokers (> or =10 cigarettes per day) attending routine primary care appointments, 1346 (18.9%) were enrolled in the study. Six-month abstinence rates for the 5 active pharmacotherapies were the following: bupropion SR, 16.8%; lozenge, 19.9%; patch, 17.7%; patch + lozenge, 26.9%; and bupropion SR + lozenge, 29.9%. Bupropion SR + lozenge was superior to all of the monotherapies (odds ratio, 0.46-0.56); patch + lozenge was superior to patch and bupropion monotherapies (odds ratio, 0.56 and 0.54, respectively). This study showed that one in 5 smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence-based counseling and medication. In this comparative effectiveness study of 5 tobacco dependence treatments, combination pharmacotherapy significantly increased abstinence compared with monotherapies. Provision of free cessation medications plus quit line counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit. Smith S, McCarthy D, Japuntich S, Christiansen B, Piper M, Jorenby D, Fraser D, Fiore M, Baker T, Jackson T. Comparative effectiveness of 5 smoking cessation pharmacotherapies in primary care clinics. Arch Intern Med. 2009; 169(22): 2148-2155.
Opioid Prescriptions for Chronic Pain and Association to Overdose: A Cohort Study
Long-term opioid therapy for chronic non-cancer pain is becoming increasingly common in community practice. Concomitant with this change in practice, rates of fatal opioid overdose have increased. The extent to which overdose risks are elevated among patients receiving medically prescribed long-term opioid therapy is unknown. The objective of this study is to estimate rates of opioid overdose and their association with an average prescribed daily opioid dose among patients receiving medically prescribed, long-term opioid therapy. Data from 9940 persons enrolled in a large HMO in the Pacific north-west who received 3 or more opioid prescriptions within 90 days for chronic non-cancer pain between 1997 and 2005 were included in the study. Cox proportional hazards models were used to estimate overdose risk as a function of average daily opioid dose (morphine equivalents) received at the time of overdose. Average daily opioid dose over the previous 90 days was obtained from automated pharmacy data. Primary outcomes were: nonfatal and fatal overdoses--were identified through diagnostic codes from inpatient and outpatient care and death certificates and were confirmed by medical record review. The authors found 51 opioid-related overdoses, including 6 deaths. Compared with patients receiving 1 to 20 mg/d of opioids (0.2% annual overdose rate), patients receiving 50 to 99 mg/d had a 3.7-fold increase in overdose risk (95% CI, 1.5 to 9.5) and a 0.7% annual overdose rate. Patients receiving 100 mg/d or more had an 8.9-fold increase in overdose risk (CI, 4.0 to 19.7) and a 1.8% annual overdose rate. Limitations in this study are: that increased overdose risk among patients receiving higher dose regimens may be due to confounding by patient differences and by use of opioids in ways not intended by prescribing physicians. The small number of overdoses in the study cohort is also a limitation. In this study patients receiving higher doses of prescribed opioids are at increased risk for overdose, which underscores the need for close supervision of these patients. Dunn K, Saunders K, Rutter C, Banta-Green C, Merrill J, Sullivan M, Weisner C, Silverberg M, Campbell C, Psaty B, Von Korff M. Opioid prescriptions for chronic pain and association to overdose: a cohort study. Ann Intern Med. 2010; 152(2): 85-92.
Interim Methadone Reduced Heroin Use in Six New Clinics
Evidence in the US and Canada is mounting that interim methadone, providing the drug without psychosocial services for up to 120 days, reduces opiate use and increases enrollment in full treatment. Previous research at a single Baltimore clinic found interim methadone patients were more likely to enroll in treatment than those on waitlists without interim maintenance. This study evaluated expansion of interim maintenance to six new Baltimore area clinics. These results expand evidence of effectiveness. Of the 1000 patients enrolled in interim maintenance, 76% enrolled in full methadone treatment at 120 days. The sample was 56% male with an average age of 41. Seventy-one percent were African American, 29% were Caucasian. The average educational level was 11th grade, and the average days of heroin use at admission was 25. At the time of entering full treatment, positive tests for the presence of opiate metabolite dropped from 90% to 38%. The study also divided the sample into two groups; one charged a $10 weekly fee, and one charged nothing. Comparative results indicated the fee had no significant impact on enrollment rates or heroin use. Results show that expansion of interim maintenance is possible. In fact, four of the six clinics continued interim maintenance at their own expense after study support ended. One factor should be noted, implementation was delayed over six months due to the requirement to obtain special permission from local (1), state (2), and federal (1) agencies, which could be a disincentive for future expansion. Schwartz RP, Jaffe JH, O'Grady KE, Das B, Highfield DA, Wilson ME. Scaling-up interim methadone maintenance: treatment for 1,000 heroin-addicted individuals. J Subst Abuse Treat. 2009; 37: 362-367.
Methadone Patients Drop Out of Treatment Mainly Because of Program-Related Inflexibility and Incarceration
Methadone treatment was designed and implemented to be an extended program of opiate agonist maintenance. Methadone, though addicting, restores patient cognitive-emotional functioning, and abates craving and withdrawal symptoms so patients may hold steady employment, establish a fixed residence, and begin to rebuild their lives. Unfortunately, dropout rates within the first year of treatment exceed 50%. This study interviewed 42 methadone treatment dropouts in the Baltimore Maryland area to learn why they left. The average age of the sample was 40, and average time in treatment was 138 days. Sixty-four percent were African American and 60% were males. Individual interviews were conducted using a flexibly-structured interview. Four primary factors were identified through analysis of patient remarks: Program-Related factors (40%), methadone-related concerns (12%), life events/logistics (10%), and incarceration (38%). Program factors focused on program inability to adapt to the evolving needs of patients struggling to restore their lives, usually exhibited as rule inflexibility or unwillingness to help patients transition to a different program or counselor. Methadone-related issues emphasized concerns about methadone withdrawal issues, and concern that methadone left patients still opiate-addicted. Life-event issues included relocation of partner, and getting a job too far from the clinic. Incarceration topics emphasized problems with patients not being detoxified by jailers, putting some through agonizing withdrawal episodes. Results suggest that methadone service reengineering is warranted, especially with respect to interface with the criminal justice system. Schacht Reiseinger H, Schwartz RP, Schwartz RPS, Peterson JA, Kelly SM, O'Grady KE, Marrari EA, Brown BS, Agard MH. Premature discharge from methadone treatment: patient perspectives. J Psychoactive Drugs. 2009; 41(3): 285-296.
Program-related Factors Associated with Methadone Treatment Drop-out
Longer retention in drug abuse treatment is associated with better patient outcomes, and research indicates the first 12 months of methadone treatment are critical to patient success. Nevertheless, large-scale multisite longitudinal studies over the past three decades indicate that the majority of patients drop out during the first year of methadone treatment. Through an examination of 42 qualitative interviews with patients prematurely discharged from six methadone treatment programs in Baltimore, this study highlights factors patients describe as contributing to their reasons for being discharged within the first 12 months of the treatment. The mean age of patients was 40.4 years, 25 (59.5%) were men, 31 (73.8%) reported injecting heroin, and the sample had a mean of 2.8 lifetime drug abuse treatment episodes. The length of treatment prior to discharge of the total sample ranged from two days to 363 days, with an average treatment length of 138 days. Of the interviewed participants, 27 (64.3%) were African American and 15 (35.7%) were Caucasian. The two most consistent themes on reasons for discharge were program-related factors and incarceration. Program-related reasons for discharge included a disagreement over program rules, conflict with counselor, and schedule conflicts. The factors are richly described through patients' words and underscore the ways in which patients' perceptions of control exerted by the program and by the medication and misunderstandings of program structure can lead to premature discharge. Patients' reasons for discharge were compared to counselors' reasons as indicated in discharge summary forms. An analysis of the patterns of agreement and disagreement are presented. Possible approaches to deal with program-related reasons for discharge include having rules clearly communicated to the patients at admission and throughout treatment, having a clearly described and fairly implemented system of appeal, which includes a patient advocate and appeal to an outside authority (such as the funder), and the ability to switch counselors when conflicts are insurmountable. It might also be useful to consider separating the counseling function from the rule enforcement function to try to improve rapport with counselors and improve patient satisfaction. Another alternative would be to have a discharge team of clinical experts to review each case prior to discharge and to make alternative treatment recommendations or transfer to another program when discharge is determined to be the best course. Additional patient-centered program and policy implications are discussed. Reisinger H, Schwartz R, Mitchell S, Peterson J, Kelly S, O 'Grady K, Marrari E, Brown B, Agar M. Premature discharge from methadone treatment: patient perspectives. J Psychoactive Drugs. 2009; 41(3): 285-296.
Diverted Methadone and Buprenorphine Among Opiate-addicted Individuals
This study examined the uses of diverted methadone and buprenorphine among opiate-addicted individuals recruited from new admissions to methadone programs and from out-of-treatment individuals recruited from the streets. Self-report data regarding diversion were obtained from surveys and semi-structured qualitative interviews. Approximately 16% (n = 84) of the total sample (N = 515) reported using diverted (street) methadone two-three times per week for six months or more, and for an average of 7.8 days (SD = 10.3) within the past month. The group reporting lifetime use of diverted methadone as compared to the group that did not report such use was less likely to use heroin and cocaine in the 30 days prior to admission (ps <.01) and had lower ASI Drug Composite scores (p <.05). Participants in the qualitative sub-sample (n = 22) indicated that street methadone was more widely used than street buprenorphine and that both drugs were largely used as self-medication for detoxification and withdrawal symptoms. Participants reported using low dosages and no injection of either medication was reported. Gwin Mitchell S, Kelly S, Brown B, Schacht Reisinger H, Peterson J, Ruhf A, Agar M, O 'Grady K, Schwartz R. Uses of diverted methadone and buprenorphine by opioid-addicted individuals in Baltimore, Maryland. Am J Addict. 2009; 18(5): 346-355.
Ethnographic Investigation of Opioid Withdrawal Experiences During Incarceration
Both heroin-addicted individuals and methadone maintenance patients are likely to face untreated opioid withdrawal while incarcerated. Limited research exists concerning the withdrawal experiences of addicted inmates and their impact on individuals' attitudes and plans concerning drug abuse treatment. In the present study, 53 opioid dependent adults (32 in methadone treatment and 21 out of treatment) were interviewed in an ethnographic investigation of withdrawal experiences during incarceration. The 53 participants who discussed incarceration had a mean age of 41 years; 70% were male, 70% were African American, 62% were either divorced or had never been married, and most had completed less than 12 years of formal education. When treatment for opioid withdrawal was unavailable, detoxification experiences were usually described as negative and were often associated with a variety of unhealthy behaviors designed to relieve withdrawal symptoms. Negative methadone withdrawal experiences also negatively influenced participants' receptivity to seeking methadone treatment upon release. A minority of participants took a positive view of their withdrawal experience and saw it as an opportunity to detox from heroin or discontinue methadone. Findings support the importance of providing appropriate opioid detoxification and/or maintenance therapy to opioid-dependent inmates. Correctional institutions present a useful venue for providing, encouraging and facilitating access to substance abuse treatment. Mitchell S, Kelly S, Brown B, Reisinger H, Peterson J, Ruhf A, Agar M, Schwartz R. Incarceration and opioid withdrawal: the experiences of methadone patients and out-of-treatment heroin users. J Psychoactive Drugs. 2009; 41(2): 145-152.
Integrating Employee Assistance Programs and Managed Behavioral Health Care Plans May Increase Access to Addiction Treatment
Claims data on 286,750 enrollees in Managed Health Network (MHN), a large national managed behavioral health care organization (MBHO) were used to explore whether or not participation in a plan that integrated the employee assistance program (EAP) benefits and MBHO benefits resulted in increased access to addiction services compared with participation in a plan where EAP and MBHO benefits and services were not integrated. The integrated plans analyzed here provided a single toll-free number for employees to access care for either EAP or managed behavioral healthcare services, allowed employees to use the EAP portion of the benefit first, if appropriate, and allowed them to remain with the same network provider once EAP benefits had been exhausted. Most, but not all, of those in the non-integrated plans had separate EAP benefits. Weighted logistic regression using exact matching (on gender, age group, census region, and spouse/dependent status) was used to estimate the relationship. The analysis revealed that participation in an integrated plan was associated with higher odds of accessing addiction services (OR = 1.23, CI 1.04-1.46, P <0.01). These results suggest that the way benefits are organized may have significant implications for the appropriate use of services although further research focused on those with addiction (as opposed to general population analyses) and using designs that can account for patient diagnoses and support causal inferences are needed to bolster that conclusion. Levy Merrick E, Hodgkin D, Horgan C, Hiatt D, McCann B, Azzone V, Zolotusky G, Ritter G, Reif S, McGuire T. Integrated employee assistance program/managed behavioral health care benefits: relationship with access and client characteristics. Adm Policy Ment Health. 2009; 36(6): 416-423.
New Process-Oriented Measure of Addiction Counselor Performance
Until now, the job of addiction counselor has not been mapped and modeled in any way that permits quantitative research. This study applied the Critical Incident Technique (CIT) commonly used in performance research by industrial/organizational (I/O) psychologists to a) develop descriptions of what counselors do, b) develop conceptual domains for building a generic performance model, and then c) build a questionnaire to validate the model. CIT sessions (14) were held at various times over an 8-month period involving 116 staff. Incidents (998) addressed those between clients and counselors and counselors and their peers, managers, and funding agencies. Respondents were 47% white, 28% African American, and 25% Hispanic, and evenly split on gender. Incidents were q-sorted by three groups of one clinical and two I/O psychologists into macro-domains (providing clinical services, actions that facilitate clinical performance (e.g. scheduling appointments), managerial behaviors, and employee citizenship behaviors. Redundant CIs were eliminating and then sorted into one of 15 quality of care-related dimensions. CIs were converted into brief descriptive item stems for rating on a five-point Likert-type scale addressing frequency of engaging in the behavior. The resulting items were administered in mailed questionnaires to 997 counselors in 51 agencies in California (39) and Maryland (12) with a 62% response rate (n=618). Respondents were 66% female; 53% were white, 31% African American, and 21% were Hispanic or Asian; and 94% had at least a GED/HS diploma with the remainder having at least some college education. Scales were validated against job satisfaction, turnover intent, and relative agency performance levels. Using classic test theory, 32 items were eliminated to yield a final instrument of 68 items with alpha reliabilities of .80 or higher. The 68-item, 15 scale version was found to have the best fit in confirmatory factor analysis with a CFI of .90, RMSEA of .05, and a significant Chi-square of 5,241.76 (p<.01, df=2,105). Interclass correlations for within-agency agreement were all significant at the p<.05 level; and validities between the 15 scales and the three outcome measures were all significant at the p<.01 level. Managerial scale scores had the strongest relationship to outcome measures with most exceeding r=.40. Results suggest that this new counselor performance measure is suitable for future health services delivery research into quality of care. Mael FA, O'Shea PG, Smith MA, Burling AS, Carman KL, Haas A, Rogers KS. Development of a model and measure of process-oriented quality of care for substance abuse treatment. J Behav Health Serv Res. 2010; 37(1): 4-24.
Clinic Directors Experiencing Burn Out and Intention to Quit Position
A national sample of 410 addiction treatment clinic directors were surveyed (66% response rate) to determine their experienced levels of emotional exhaustion and intent to quit their jobs. The sample was evenly split for gender, with 67% holding masters degrees, and average levels of tenure in their position of 9.6 years. Using structural equation modeling, the degree of emotional exhaustion reported by respondents on the Maslach burnout inventory was found to be positively and directly related to turnover intention. Those in organizations emphasizing centralized (as opposed to more participative) decision-making reported higher intention to quit, but it did not affect burnout levels. Respondents who engaged in more long-range planning were less likely to report emotional exhaustion, as well as turnover intent, thereby demonstrating that planning had a moderating effect on turnover intention. Likewise, those with less autonomy and freedom for innovative decision-making were more likely to want to quit. All correlations between these variables were significant (p<.01). Knudsen HK, Ducharme LJ, Roman PM. Adapting the Job Demands-Resources Model to leaders of addiction treatment organizations. J Occupational Health Psy. 2009; 14(1): 84-95.
Organizational Adaptations May Undermine Essential Elements of Therapeutic Communities
Traditional therapeutic communities (TCs) are characterized by confrontational group therapy, treatment phases, a tenure-based resident hierarchy, and long-term residential care. In recent years, many TCs have modified the structure and intensity of the traditional model, tailored services for specific patient populations, and hired more professionally trained staff. Using data obtained from interviews with directors of a nationally representative sample of 380 TCs, this study examined the extent to which these recent modifications affect the underlying core technology of the TC modality. Results from a structural equation model indicate that TCs offering services for specific populations and professionalization of staff has had limited impact on six core TC elements as defined by the TC Survey of Essential Elements Questionnaire (SEEQ). Modifications to structure and intensity of TC programming evidenced the strongest effect. Outpatient-only TCs showed significantly lower adherence to five of the six elements. Short-term residential programs showed a similar negative trend. These findings are important because organizations implement changes in response to consumer demand and resource constraints (i.e., shortened intensity and duration of treatment); such changes have the potential to alter the core technology of treatment modalities. Research is needed to determine whether these adaptations have deleterious effects on patient outcomes. Dye MH, Ducharme LJ, Johnson JA, Knudsen HK, Roman PM. Modified Therapeutic Communities and adherence to traditional elements. J Psychoactive Drugs. 2009; 41(3): 275-283.
Therapist Behavior in Multi-systemic Therapy as a Predictor of Black and White Caregiver Responsiveness
The present study addressed two gaps in the emerging literature on the mechanisms of evidence-based family therapies. The first pertains to the need to examine what the multi-systemic therapy (MST) therapist does in therapy sessions to propel change, and how caregivers respond to those therapist behaviors. Consistent with family systems theory, the MST model of change emphasizes the role of family transactions in maintaining adolescent problem behavior. Therefore, as in many family treatments, therapeutic interventions typically attempt to change family patterns of interaction. The second gap in the literature pertains to the lack of therapy process research focusing specifically on minority populations. Although evidence-based family therapies have been used successfully with minority samples, little research has examined whether different therapist skills are required to engage caregivers from different racial backgrounds in treatment. This study examined the relationship between observed therapist behaviors and positive in-session caregiver responses and engagement using audiotapes from a randomized clinical trial of the effectiveness of integrating MST into juvenile drug court. In that study families in two MST conditions (drug court with MST, and drug court with MST enhanced with contingency management) showed significantly better substance use outcomes than in other conditions. Eighty-nine families who had participated in MST conditions (including some pilot families) were included in the present study. For 67% of these families, caregivers self-identified as Black and the rest as White. This study examined whether (a) therapist behaviors thought to enhance family treatment predicted caregiver in-session responses, and (b) caregiver race, racial match between caregiver and therapist, and family financial hardship moderated the relationships between therapist and caregiver behavior. Observers coded caregiver and therapist behavior during one session of MST for substance abusing adolescents. Therapist teaching, focusing on strengths, making reinforcing statements, problem solving, and dealing with practical family needs predicted caregiver engagement and/or positive response, regardless of race, racial match, or financial hardship. Caregiver race, financial hardship, and therapist-caregiver racial match occasionally moderated the relationship between other therapist and caregiver behaviors. Findings suggest both commonalities and differences in how therapist behavior may function to engage caregivers in family treatment, depending on diversity-related factors. Foster S, Cunningham P, Warner S, McCoy D, Barr T, Henggeler S. Therapist behavior as a predictor of black and white caregiver responsiveness in multisystemic therapy. J Fam Psychol. 2009; 23(5): 626-635.