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Can the Outcomes Research Literature Inform the Search for Quality Indicators in Substance Abuse Treatment?

A. Thomas McLellan, Mark Belding, James R. McKay, David Zanis, and Arthur I. Alterman

Penn-Veterans Affairs Center for Studies of Addiction, Philadelphia

Over the past 20 years, treatment researchers within the field of substance abuse have focused on questions of whether treatment is effective and which type of substance abuse treatment is most effective (Bale, 1979; Gerstein et al., 1994; Hubbard and Marsden, 1986; McLellan et al., 1992, 1994; Sells and Simpson, 1980). The data on these questions have been quite consistent, with well-substantiated evidence available from both controlled clinical trials and field studies, suggesting four important conclusions.

  1. Many of the traditional forms of substance abuse treatment (e.g., methadone maintenance, therapeutic communities, outpatient drug-free treatment) have been evaluated multiple times and have been shown to be effective (Ball and Ross, 1991; Gerstein et al., 1994; Hubbard and Marsden, 1986; IOM, 1990a, b; McLellan et al., 1980; Simpson and Sells, 1982).

  2. The benefits obtained from these treatments typically extend beyond the reduction of substance use to areas that are important to society, such as reduced crime, reduced risk of infectious diseases, and improved social function (Ball and Ross, 1991; Gerstein et al., 1994; IOM 1990a, b; McLellan et al., 1980).

  3. Individuals who complete treatment or receive more days of treatment typically show more improvements than those who leave care prematurely (DeLeon, 1984; Gerstein et al., 1994; Hubbard et al., 1989; Sells and Simpson, 1980).

  4. The costs associated with the provision of substance abuse treatment provide three- to sevenfold returns to employers, the health insurers, and society within



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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH B Can the Outcomes Research Literature Inform the Search for Quality Indicators in Substance Abuse Treatment? A. Thomas McLellan, Mark Belding, James R. McKay, David Zanis, and Arthur I. Alterman Penn-Veterans Affairs Center for Studies of Addiction, Philadelphia Over the past 20 years, treatment researchers within the field of substance abuse have focused on questions of whether treatment is effective and which type of substance abuse treatment is most effective (Bale, 1979; Gerstein et al., 1994; Hubbard and Marsden, 1986; McLellan et al., 1992, 1994; Sells and Simpson, 1980). The data on these questions have been quite consistent, with well-substantiated evidence available from both controlled clinical trials and field studies, suggesting four important conclusions. Many of the traditional forms of substance abuse treatment (e.g., methadone maintenance, therapeutic communities, outpatient drug-free treatment) have been evaluated multiple times and have been shown to be effective (Ball and Ross, 1991; Gerstein et al., 1994; Hubbard and Marsden, 1986; IOM, 1990a, b; McLellan et al., 1980; Simpson and Sells, 1982). The benefits obtained from these treatments typically extend beyond the reduction of substance use to areas that are important to society, such as reduced crime, reduced risk of infectious diseases, and improved social function (Ball and Ross, 1991; Gerstein et al., 1994; IOM 1990a, b; McLellan et al., 1980). Individuals who complete treatment or receive more days of treatment typically show more improvements than those who leave care prematurely (DeLeon, 1984; Gerstein et al., 1994; Hubbard et al., 1989; Sells and Simpson, 1980). The costs associated with the provision of substance abuse treatment provide three- to sevenfold returns to employers, the health insurers, and society within

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH 3 years following treatment (French et al., 1991; Gerstein et al., 1994; Holder and Blose, 1992). HOW DO THESE RESULTS TRANSLATE INTO RECOMMENDATIONS FOR PROVIDING QUALITY TREATMENT? Although the conclusions from this line of research are important and gratifying, they are not adequate to inform important clinical, economic, or health and social policy questions regarding the delivery of substance abuse treatment services. Knowledge that some of these treatments can work and that better outcomes are associated with longer treatment does not help to determine (1) which of the multiple elements in these multicomponent treatments are causally related to the favorable outcomes (i.e., the so-called active ingredients of treatment), (2) how long or at what level of intensity these ingredients should be delivered, or (3) the point at which the additional provision of these ingredients is no longer associated with increased benefits. If the field of substance abuse treatment research is to help guide and inform the search for better, faster, less expensive treatments, it will be necessary to develop better, faster, less expensive means of evaluating the specific effects of substance abuse treatments. To respond to this need, the treatment field has begun to look for markers of or proxies for true outcomes that can be easily measured during the course of treatment (ideally as part of a management information system) and that have been associated with favorable outcomes following treatment. These early indicators of subsequent favorable outcomes have been called “quality indicators.” Until now, these indicators have typically been developed by groups of clinicians and administrators who have simply selected indicators that have a clear, “face-valid” or intuitive link with longer-term outcomes. This common sense approach has had great appeal because the results have been measures that can be collected, analyzed, and reported rapidly and inexpensively, with the results being clear to patients, clinicians, and administrators alike. Furthermore, because these indicators could be measured for individual patients and during the early course of an individual's treatment, they have the potential for use as early warning signs to correct inappropriate treatments. Because of their potential clinical and administrative value, systems of quality indicators have already been widely adopted by treatment providers, and there is a widespread effort to build the reporting of these measures into existing clinical or management information systems. The existing and proposed quality indicators for the substance abuse field (e.g., American Managed Behavioral Healthcare Association and the National Committee for Quality Assurance) have been useful in identifying obvious problems in the conduct of treatment, in bringing the consumer perspective into the treatment setting, and in stimulating the treatment field toward greater self-

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH examination and self-evaluation. At the same time, there is some concern that these initial indicators may only identify extremely poor outcomes, bordering on malpractice (e.g., prescribing antipsychotic medications to patients without psychosis diagnoses). Furthermore, although the indicators have been developed to encourage improved clinical practices, some of them can be made to show apparent improvement through administrative action without actually changing treatment practices (e.g., an administrative decision not to readmit discharged patients within 1 month posttreatment to give the impression of a low 1-month relapse rate). Thus, the current indicators may be insufficient to differentiate subtler levels of treatment quality or to offer guidance for providers searching for more effective treatment methods. WHAT QUALITIES ARE NECESSARY FOR AN IDEAL QUALITY INDICATOR? Some of the problems with the existing quality indicators result from the lack of a clear rationale or conceptual basis for what would and would not constitute an indicator that is valid and useful. In our view, such an indicator would be a measure of a treatment process or a patient characteristic that can be recorded easily during treatment and that has been clearly associated with a favorable outcome. It is important to examine the rationale for and subtleties of each of the components of this definition of an ideal quality indicator. First, the definition includes both treatment process factors and patient changes during treatment. Although the majority of current quality indicators focus on treatment practices, policies, and processes, it is potentially more practical and more informative to focus upon interim patient changes brought about during the course of treatment. The distinctions between these two types of potential indicators are important and are discussed at the end of this paper. The definition also suggests that the measures that will ultimately serve as these indicators must be easily, inexpensively, and reliably made during the course of treatment at the individual patient level. Ease of measurement is essential if these indicators are to be used widely in standard clinical settings. Furthermore, these measures should be recorded at the individual patient level because early indications of favorable or unfavorable treatment progress could be extremely useful for clinical management of individual patients, again increasing the likelihood that they will be adopted and used regularly in the clinical setting. Moreover, indicators that are recorded at the individual patient level can always be aggregated through sampling to permit reporting at the program level. However, indicators that are based on the aggregate data from a treatment program can rarely be reduced to provide clinically significant information at the individual patient level. Finally and most importantly, the true value of potential quality indicators rests ultimately upon the relationship of those indicators to treatment outcomes.

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH Although this may seem apparent, there has been, in fact, a lack of agreement about how to define and measure outcomes, which in turn makes it difficult to identify useful indicators. One way to approach this issue is to identify two separate and distinct stages of substance abuse treatment: detoxification-stabilization and rehabilitation. Each of these stages has distinct therapeutic goals, different treatment processes, and markedly different expectations with regard to outcome. Thus, this paper will review the available outcomes research for the detoxification-stabilization stage and the rehabilitation stage of treatment. Each section will include a description of processes and therapeutic goals for the treatment stage, define outcomes on the basis of these therapeutic goals, discuss a strategy for reviewing the literature based on the outcomes definitions, and finally, present research findings pertinent to the identification of quality indicators within that stage of treatment. The review includes only data from clinical trials, treatment matching program studies, or health services studies where the patients were adults who were clearly alcohol or drug (excluding tobacco) dependent by contemporary criteria, where the treatment provided was a conventional form of either detoxification or rehabilitation (any setting or modality), and where there were measures of either treatment processes or patient change during the course of treatment as well as posttreatment measures of outcome as defined later in the paper. THE DETOXIFICATION OR ACUTE STABILIZATION STAGE Before the advent of managed care strategies in the United States, the acute stage of substance dependence treatment was synonymous with hospitalization, regardless of whether the focus of the treatment was the medical detoxification of a true withdrawal syndrome (i.e., neuroadaptation, withdrawal symptoms, etc.) or simply the stabilization of physiological and emotional symptoms associated with the cessation of drug use that might not produce a bona fide withdrawal syndrome. Currently, detoxification from alcohol, opiate, barbiturate, or benzodiazepine use is generally the only type of treatment for which hospital admission may be warranted, and even the majority of these “true detoxifications ” now occur in outpatient or nonmedical settings. However, this review includes both true detoxification as well as initial stabilization from the acute effects of drugs in which tolerance and withdrawal are less clearly documented (e.g., phencyclidine, LSD, marijuana, and even cocaine). The therapeutic settings, procedures, and goals are quite similar for both forms of these acute treatments, which seek to stabilize the patient medically and psychologically and to develop an effective discharge plan that includes continued rehabilitative care, almost always in an outpatient setting. The acute stage of treatment is associated with lasting improvements only when there is continued rehabilitative treatment (IOM, 1990a, b). This associa-

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH tion is quite important in the development of indicators of treatment effectiveness and quality for this stage of treatment. Goals of Detoxification and Stabilization Patients and Treatment Settings The detoxification and stabilization phase of treatment is designed for patients who have been actively abusing alcohol or street drugs, or both, and who are suffering physiological or emotional instability, or both. In cases of severe withdrawal potential or extreme physiological or emotional instability, detoxification-stabilization helps to prevent serious medical consequences of abrupt withdrawal, to reduce the physiological and emotional signs of instability, and to motivate necessary behavioral change strategies that will be the focus of rehabilitation. This stage of treatment may take place in inpatient settings, either a hospital or a nonhospital, residential setting, or in outpatient settings, such as in a hospital-based clinic or a residential or social setting. Treatment Elements and Methods Medications are available for both physiological withdrawal signs and for the temporary relief of acute medical problems associated with physiological instability (e.g., sleep medications, antidiarrheal medications, vitamins, and nutritional supplements). Motivational counseling is widely used to address shame and ambivalence, as well as to increase adherence with recommendations for continued rehabilitation. Duration Regardless of the setting, stabilization of acute problems is typically completed within 2 to 10 days, with the average being 3 to 5 days (Fleming and Barry, 1992). True detoxification is necessary only for cases of severe alcohol, opiate, benzodiazepine, or barbiturate use, although many cocaine-dependent and other drug-dependent patients suffer from significant physiological and emotional instability that precludes immediate participation in rehabilitation. The duration of the detoxification-stabilization process depends on the presence and severity of the patient's dependence symptoms as well as concurrent medical and psychiatric problems. Stays longer than 5 days are unusual and typically are due to conjoint medical or psychiatric problems or physiological dependence upon some forms of sedatives (e.g., alprazolam).

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH Key Findings for Detoxification and Stabilization Treatment This section reviews research on treatment processes or patient changes during the course of detoxification and stabilization that have been associated with sustained reductions in physiological and emotional instability and, particularly, with continued engagement in the rehabilitation stage of treatment. As suggested earlier, there are recognized tolerance and withdrawal syndromes following the heavy use of alcohol, opiates, benzodiazepines, and barbiturates. The standard detoxification strategy for barbiturate withdrawal was described more than a decade ago by Robinson and colleagues (Robinson et al., 1981). The majority of published work on detoxification strategies for alcohol and opiates has been reviewed in two former Institute of Medicine publications (IOM, 1990a, b). Much less has been written regarding detoxification procedures for benzodiazepine dependence, perhaps because dependence upon this group of drugs is much less prevalent. Although cocaine “withdrawal” has been recognized in the Diagnostic and Statistical Manual, Fourth Edition (DSM IV), there is continued debate regarding the treatment and even the existence of a bona fide withdrawal syndrome following cocaine use (Satel et al., 1991; Weddington, 1992). At the same time, there is clear agreement that patients who have used cocaine or crack continuously over sustained periods, suffer two to five day periods of measurable physiological and psychiatric instability (Gawin and Ellinwood, 1988; Gawin and Kleber, 1986). For this reason, stabilization is included along with detoxification in this treatment category and was included with detoxification in the few available studies that have investigated factors associated with the acute stabilization of cocaine cessation. Setting of Care: Medical or Nonmedical and Inpatient or Outpatient Debate regarding the appropriate setting of care in which to detoxify alcohol-dependent patients has been substantial. Since the mid-1970s, medical settings such as residential treatment facilities or even outpatient treatment centers have conducted detoxification or stabilization treatments for alcohol, opiates, and more recently, cocaine. Although studies have not systematically compared social settings with medical settings for detoxification from alcohol dependence, there are reports of favorable outcomes in both (Naranjo et al., 1983; Whitfield et al., 1978). In the presence of significant physiological signs of alcohol, opiate, benzodiazepine, or barbiturate withdrawal, however, the standard treatment includes medical supervision in either a hospital or an outpatient medical clinic (Fleming and Barry, 1992; IOM, 1990b). Although research is not extensive, medical settings are generally viewed as being more appropriate for detoxifications involving medical problems (particularly those with a history of seizures) and psychiatric problems (particularly for individuals with depression and at risk of suicide) and also when patients

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH have concurrent cocaine dependence. This last group of patients now makes up the majority of many clinical populations (DATOS, 1992; ONDCP, 1995). Alcohol Detoxification. Within the framework of medically supervised alcohol detoxification, the relative effectiveness and costs of inpatient versus outpatient alcohol detoxification have been examined (Hayashida et al., 1989; Stockwell et al., 1986). In a study by Hayashida et al. (1989), chronic alcohol-dependent patients without histories of serious psychiatric or medical complications were randomly assigned to receive medically supervised alcohol withdrawal in either an inpatient or a day-hospital setting. On two of the outcome domains considered important for detoxification treatments (safe elimination of withdrawal signs and engagement in ongoing rehabilitation), the inpatient group showed significantly better performance, but the readdiction rates were less than 12 percent for both groups. Despite this statistically significant advantage for the inpatient setting, it was 10 times more costly than outpatient detoxification in an outpatient setting. There may be some advantage to inpatient detoxification when a patient does not have the social or personal supports necessary to comply with the outpatient attendance requirements. However, despite somewhat lower retention rates for outpatient than for inpatient alcohol detoxification (Hayashida et al., 1989; Stockwell et al., 1991), outpatient detoxification may be more acceptable to a wider range of drinkers who wish to avoid the stigma of treatment in a designated detoxification (Stockwell et al., 1990). Opiate Detoxification. Available evidence suggests that opiate detoxification with methadone can generally be accomplished in an outpatient setting under medical supervision with gradually reduced doses of methadone (Cushman and Dole, 1973; IOM, 1995a). However, completion rates for treatment of opioid dependence may be higher in inpatient than in outpatient detoxification programs (Gossop et al., 1986; Lipton and Maranda, 1983). Cocaine and Crack Detoxiflcation. Few studies have examined the appropriate setting for the stabilization of physiological and psychiatric signs and symptoms associated with extended cocaine or crack use. The prevailing practice has been to attempt to stabilize all but the most severely affected patients through outpatient care (Higgins et al., 1994). Patients who are in the acute stages of cocaine cessation and who are more severely affected (medically or psychiatrically) are placed into a hospital if they have significant cardiac problems or significant psychiatric symptomatology or are at least placed in inpatient social settings for the first 3 to 5 days of treatment (Fleming and Barry, 1992). The available literature is replete with accounts of early dropouts during the first 2 to 3 weeks of outpatient cocaine treatment (Alterman et al., 1994; Carroll et al., 1994; Higgins et al., 1993; Kang et al., 1991), with attrition rates ranging

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH from a low of 27 percent to a high of 47 percent in the first few weeks of care. As discussed below, it is reasonable to conclude that the patients with the most severe medical and psychiatric problems are most susceptible to drop out of treatment early. Length of Stay and Criterion for Completion Alcohol and Opiates. Several detoxification studies (Cushman and Dole, 1973; Hayashida et al., 1989; Senay et al., 1981) have measured detoxification as 3 consecutive days of abstinence from observable withdrawal signs or symptoms (opiate or alcohol), using standardized inventories of these physical measures. Lengths of stay for alcohol detoxifications vary from about 3 days to as long as 1 month. However, the great majority of detoxifications can be accomplished in 3 to 5 days (Fleming and Barry, 1992), and there is no evidence of greater effectiveness from extended stays. In an early study by Cushman and Dole (1973), only 3 percent of 525 opiate-dependent patients who failed to provide an opiate-negative urine specimen following the outpatient detoxification (signifying at least 3 days of abstinence) were able to engage in the suggested abstinence-oriented rehabilitation program following detoxification. One hundred percent of these patients were readdicted to opiates at the 6-month follow-up. Cocaine. A recent study of cocaine-dependent patients entering outpatient rehabilitation also offers some relevant information on the clinical importance of developing a criterion of successful completion. In a study of cocaine-dependent veterans, Alterman et al. (1996) found that the single best predictor of engagement in the rehabilitation process, and ultimately program completion (elimination of cocaine use verified by urinalysis), was the presence or absence of cocaine metabolites in the urine sample submitted upon admission to the program, signifying recent cocaine use. Of those patients without cocaine metabolites present in their urine on admission, 79 percent engaged in and completed the outpatient treatment, whereas only 39 percent of those with a positive urine sample on admission engaged and completed the outpatient treatment. Potential Quality Indicators for Detoxification and Stabilization The therapeutic goals of detoxification and stabilization are focused primarily on the amelioration and stabilization of the acute medical, psychiatric, or substance use symptoms that were out of control and thus responsible for preventing the patient from entering directly into rehabilitation. Thus, the goal of detoxification-stabilization is removal of the physiological and emotional instability that has impeded direct entry to rehabilitative treatment. Readiness for the rehabilitation stage of treatment should be assessed separately.

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH Patient-Level Indicators Detoxification can be said to have succeeded if shortly after discharge (i.e., 1 week to 1 month) the patient has: shown significant reductions in physiological and emotional instability (at least to levels appropriate for rehabilitation entry), has not had serious medical or psychiatric complications, and has been integrated into and engaged in an appropriate rehabilitation program. Program-Level Indicators As summarized above, serious consequences can result from not addressing medical complications from alcohol detoxification, such as seizure history. Thus, a potential indicator for nonmedical or social detoxification settings could be the number of patients admitted with a history of medical complications, such as seizures or cardiac arrhythmias. Given that alcohol-dependent and perhaps cocaine-dependent patients may not have the requisite personal or social resources to comply with the daily attendance requirements associated with outpatient detoxification regimens, one potential negative indicator could be the number of individuals in outpatient treatment who are homeless or who have previously failed outpatient detoxification. Evidence suggests that it may be possible to set measurable thresholds for determining whether the detoxification has at least reduced the physiological and emotional symptoms that were the foci of treatment. This threshold may be importantly related to subsequent performance in rehabilitation treatment, at least for outpatient rehabilitation. Thus, a potential positive indicator of detoxification performance could be the number of patients who are discharged or transferred from acute care (detoxification or stabilization) who have had 3 consecutive days without withdrawal signs or symptoms. This might be measured by standard inventories of symptoms and signs or at least by breathalyzer and urinalysis measures. REHABILITATION Goals of Rehabilitation Patients and Treatment Settings Rehabilitation is appropriate for patients who are no longer suffering from the acute physiological or emotional effects of recent substance use and who need behavioral change strategies to regain control of their urges to use substances.

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH Rehabilitation can take place in inpatient settings, such as a hospital (which is very rare) or a residential setting (which is increasingly rare). More frequently, however, rehabilitation takes place in a hospital-based clinic or a residential or social setting. Treatment Elements and Methods The purposes of this stage of treatment are to prevent a return to active substance use that would require detoxification-stabilization; to assist the patient in developing control over urges to use alcohol or drugs, or both, usually through sustaining total abstinence from all drugs and alcohol; and to assist the patient in regaining or attaining improved personal health and social function, both as a secondary part of the rehabilitation function and because these improvements in lifestyle are important for maintaining sustained control over substance use. Professional opinions vary widely regarding the underlying reasons for the loss of control over alcohol and drug abuse, for example, genetic predispositions, acquired metabolic abnormalities, learned, negative behavioral patterns, deeply ingrained feelings of low self-worth, self-medication of underlying psychiatric or physical medical problems, character flaws, and lack of family and community support for positive function. Thus, there is an equally wide range of treatment strategies and treatments that can be used to correct or ameliorate these underlying problems and to provide continuing support for the targeted patient changes. Strategies have included such diverse elements as psychotropic medications to relieve “underlying psychiatric problems”; medications to relieve alcohol and drug cravings; acupuncture to correct acquired metabolic imbalances; educational seminars, films, and group sessions to correct false impressions about alcohol and drug use; group and individual counseling and therapy sessions to provide insight, guidance, and support for behavioral changes; and peer help groups (e.g., Alcoholics Anonymous [AA] and Narcotics Anonymous [NA]) to provide continued support for the behavioral changes thought to be important for sustaining improvement. Duration Typically, inpatient hospital-based forms of treatment last 7 to 11 days (ONDCP, 1995; White Paper, 1995). Nonhospital forms of residential rehabilitation are typically longer, ranging from 30 to 90 days; therapeutic community modalities typically range from 6 months to 2 years in. Outpatient forms of treatment (at least abstinence-oriented treatments) range from 30 to 120 days (ONDCP, 1995; White Paper, 1995). Many of the more intensive forms of outpatient treatment (intensive outpatient and day hospital) begin with full or half-day sessions five or more times per week for approximately 1 month. As the rehabilitation progresses, the intensity of the treatment reduces to shorter-duration sessions of 1 to 2 hours delivered twice

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH weekly to semimonthly. The final part of outpatient treatment is typically called “continuing care” or “aftercare,” with biweekly to monthly group support meetings continuing (in association with parallel activities in self-help groups) for as long as 2 years. Maintenance forms of treatment are designed with an indeterminate length, with some intended to continue throughout the patient's life. Maintenance Medications Although the majority of rehabilitation treatment programs in the United States are abstinence oriented, a significant number of rehabilitation programs maintain patients on a medication that is designed to either block the effects of the abusable drugs (e.g., disulfiram and naltrexone) or, in the case of opiates and nicotine, a medication that is designed to override the effects of the abusable drugs through the development of tolerance to a safer, more potent, and longer-acting form of the drug (nicotine patch, methadone, buprenorphine, levo-alpha-acetylmethadol [LAAM]). These maintenance approaches are quite similar to current strategies for ameliorating the physiological or emotional problems in individuals with other chronic medical conditions, such as long-term maintenance on antidepressant, antipsychotic, or other psychotropic medications for psychiatric patients; maintenance on beta-blockers and other normotensive agents for patients with hypertension; antiasthmatics for asthma sufferers; and insulin for diabetics. The use of medications in general and maintenance medications in particular has been controversial because this general medical approach has often conflicted with the broader view that it is important to teach substance-dependent patients to live without a reliance on any type of medication. At the same time, a substantial amount of research has shown that these medications can be very effective in the rehabilitation of several forms of addiction (IOM, 1995a; O'Malley et al., 1992; Transdermal Nicotine Study Group, 1991; Volpicelli et al., 1992). Among the most widely and thoroughly studied medications in the pharmacopoeia is methadone. Despite this fact, methadone, at least as a maintenance medication in the rehabilitation of opiate dependence, remains a controversial medication (IOM, 1995a). Compared with the medications used to treat other types of addiction, the medication is among the most tightly controlled and regulated, the chronicity and the severity of the patients' treatment problems are different from those of patients addicted to other drugs, and maintenance on methadone is often for 10 or more years, compared with 1 to 3 months maintenance for any other form of addiction medication. This review, however, includes methadone maintenance, as well as maintenance with its long-acting form, LAAM, as part of the general category of rehabilitation treatments, because the psychosocial elements of methadone treatment and the overall rehabilitative goals of methadone treatment are quite similar to those for other forms of rehabilitation. Many of the same patient and treatment

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH ciated with the initial cessation of substance use and the motivation and engagement of the patient into continued rehabilitation. Treatment characteristics that were most closely associated with these outcomes were the inpatient setting of care (at least for patients likely to drop out prematurely) and treatment to the criterion of 3 consecutive days without withdrawal signs or symptoms. For rehabilitative treatment to have an opportunity to succeed, the outcomes from the detoxification-stabilization stage would have to be achieved. An outcome from rehabilitative treatment should be lasting improvements in those problems that led to the treatment admission and that were important to the patient and to society. Three outcomes domains have been measured at least 6 months following treatment discharge: reduction in substance use, improvement in personal health and social function, and reduction in public health and safety problems. Patient variables that had been reliably associated with better outcomes from rehabilitation included (1) low severity of dependence and psychiatric symptoms at admission, (2) “readiness for change” beyond the precontemplation stage of change, (3) being employed or self supporting, and (4) having family and social supports for sobriety. Treatment variables that have been reliably associated with better outcomes in rehabilitation included (1) staying longer in treatment and being more compliant with treatment recommendations, (2) having an individual counselor or therapist (particularly an effective one), (3) receiving proper medications, (4) participating in voucher-based, behavioral reinforcement interventions, (5) participating in AA or NA following treatment, and (6) having specialized services provided for adjunctive medical, psychiatric, or family problems. Although none of these patient or treatment variables showed a completely unambiguous record of prediction outcomes, the findings have been replicated across more than one type of primary drug problem (alcohol, cocaine, or opiates) and in more than one evaluation. However, although some of the predictors identified (e.g., longer lengths of stay and greater adherence) are quite robust, there is no clear understanding of the basis for the predictive relationship. No single rehabilitation modality or therapeutic process has yet been reliably associated with superior outcomes across all populations of patients. Furthermore, it was surprising that some of the treatment elements that are most widely provided in substance abuse treatment (e.g., group therapy) have not been associated with outcomes. Clearly, more research is needed to identify the “active ingredients” of treatment and the “minimal effective dose” of these ingredients. The ability to identify potentially useful quality indicators relies on a clear understanding of the ways in which these indicators will ultimately be used. Quality indicators can be used in two ways: (1) at the individual patient level to provide clinicians with early warning signs for poor outcome and thus allow for modification of the treatment plan, and (2) in the aggregate, to provide evaluators and regulators with rapid, easily collected, and face-valid indications of treat-

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH ment program performance, ultimately for purposes of interprogram comparisons and possibly for report cards. Because a primary purpose for these indicators will be clinical decision support, they need to be measured at the individual patient level and to be collectable as early as possible in the course of treatment, using nonintrusive and rapid methods of data collection. These features are essential for the information to be relevant to clinical decision-making and, in turn, worthwhile for the clinicians who will ultimately be charged with recording these measures. Not all variables identified as predictors of outcome will be useful in clinical decision-making, because many (e.g., gender and socioeconomic strata) cannot be modified in the course of treatment. At the same time, because a second purpose of these quality indicators will be to compare aggregated mean values between two treatment programs or among several patient subgroups, it will be important to have access to all variables that affect the outcomes of treatment independent of the treatment process. These “case mix adjusters” are important in any comparative study of outcomes or quality indicators to adjust the groups on variables that could have an independent effect on outcome, thus helping to provide a level playing field when the comparative evaluations are performed. Before any of the prospective quality indicators can be used in a comparative fashion, however, much more research comparing different case mix adjustment strategies and different combinations of predictor variables is needed. Although both treatment process and patient change variables can serve as quality indicators, patient change variables are conceptually and practically much better. Only two types of measures meet the practical and conceptual needs of the clinical, management, and regulatory groups that are interested in identifying quality indicators. The first of these are treatment elements, processes and practices: interventions or services that are done to or for the patient during treatment. The second of these are interim changes in patient status: aspects of the patient's affect, knowledge, motivation, and behavior that are presumed to be problematic in the patient at the start of treatment and are thus the direct focus of the treatment elements within rehabilitation. The great majority of the quality indicators used thus far in the evaluation of substance abuse and mental health treatments have been treatment process indicators (counseling provided to urge smokers to quit, referral to outpatient care following inpatient discharge, etc.). Typically, they have been measured by staff notations in treatment charts. There is justification for using these process measures. First, because costs or charges are typically associated with the provision of treatment processes, these measures are generally available and accessible in clinical management information systems. Second, and more importantly, there are

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH clear indications from the outcomes literature that certain treatment processes and treatment elements are reliably related to outcomes. This review has referred to these treatment process measures as secondary indicators of treatment quality for two reasons. The first reason is practical and based on the quality of available evidence. The simple notation in a chart that an activity, labeled as the appropriate or intended process, has been provided at some level of intensity, by someone with an unknown ability or training level, with no indication of its immediate effects, is not, by itself, the type of evidence that inspires confidence in the quality of that treatment. The second reason for referring to even those treatment practices or treatment elements that have been reliably associated with outcomes as secondary indicators of quality relates to the level of inference that is available from such an association. No treatment element, service, or procedure produces a lasting outcome directly but, rather, produces an outcome through the production of at least one interim change in a patient's attitude, affect, knowledge, motivation, cognition, or behavior. For example, patients who attend rehabilitation following detoxification have better posttreatment outcomes than those who stop treatment following detoxification. Thus, it can be said that the treatment process or the treatment practice of referring a patient to outpatient treatment is associated with a better posttreatment outcome. However, this association is only true when the referral has actually resulted in the patient 's attendance and participation in the rehabilitation. Actually, it is this interim change in the patient's behavior (attendance) rather than the process of referral that is most directly associated with the ultimate outcome, and the treatment practice is only associated with that outcome through its ability to produce that interim result. There is another reason to use measures of interim changes in patient status (symptoms, signs, behaviors, etc.) instead of treatment process measures as quality indicators. The majority of patient status measures can be measured in a more valid, unbiased, and verifiable way than most treatment process measures. Thus, although it would be possible to check a patient chart for a note indicating the current dose of methadone (a secondary indicator of treatment quality), greater confidence would come from primary indicators, such as interim results in the form of reductions in observed withdrawal signs and negative urine screens. Although these measures of interim change in patient status may be slightly more difficult to collect, most are not burdensome and are, again, directly associated with the focus of the treatment elements or interventions being applied. Specifically, given a patient status variable that has been reliably associated with treatment outcome (e.g., a high-severity psychiatric problem at admission) and a treatment process variable that has also been reliably related to outcome (e.g., provision of professional psychotherapy), the responsible clinician and clinical regulator will be better informed regarding the quality of the care provided to the patient by measuring changes in psychiatric symptomatology over the course of

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MANAGING MANAGED CARE: QUALITY IMPROVEMENT IN BEHAVIORAL HEALTH treatment (e.g., a weekly change in Beck Depression Inventory) rather than measuring the number of therapy sessions provided during the course of treatment. NEED FOR FURTHER RESEARCH A new line of research is needed to address at least two central questions of effective and efficient treatment delivery. What types of interim changes in patients should be effected during treatment to provide the highest probability of lasting gains following treatment? Not all of the changes in patients' attitudes, affects, motivation, knowledge, and behavior that are the interim goals of substance abuse treatments are important for attaining favorable posttreatment outcomes. An important role for future treatment research will be to identify those interim patient changes that are reliably predictive of lasting benefits following treatment. These ultimately will be the quality indicators that the field is searching for. Which treatment settings, modalities, and services provide the most potent and rapid ways of effecting the during-treatment changes that have been shown to be important predictors of lasting outcomes, and at what costs? Not all of the treatment elements, services, or activities that are provided to patients in treatment will be appropriate or adequate to produce the interim patient changes that are desired. An important role for future treatment research will be to identify the active ingredients and the minimum effective dose of those ingredients that can effect the important interim changes in patients during the course of treatment. Combinations of active ingredients will ultimately be translated into empirically derived clinical pathways and treatment guidelines. Because these combinations of proven effective treatment ingredients are compared for potency and duration of action as well as on the basis of their costs of delivery for both the provider and the patient, real estimates of the value and efficiency of treatments can be developed. REFERENCES Allison M, Hubbard RL. 1982. Drug Abuse Treatment Process: A Review of the Literature. TOPS Research Monograph. Raleigh, NC: Research Triangle Press. Alterman AI, McLellan AT, O'Brien CP, August DS, Snider EC, Cornish JC, Droba M, Hall CP, Raphaelson A, Schrade F. 1994. Effectiveness and costs of inpatient versus day hospital cocaine rehabilitation. Journal of Nervous and Mental Diseases 182:157-163.

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