1. Introduction: why a new definition of effectiveness and why now
The treatment of addiction to alcohol, illicit and/or pharmaceutical drugs has been segregated from the rest of health care, conceptually (debate on whether addiction is an illness), organizationally (separate government agencies provide most licensing and regulatory control), and most importantly — financially. Addiction treatment has been funded predominantly through federal block grant dollars and many other state and federal mechanisms — with limited funding through federal or private health care insurance.
Not surprisingly, the nature of contemporary addiction treatment is quite different from the treatment of most other serious and widespread chronic illnesses. Addiction care is provided by “treatment programs” offering standard sets of services (predominantly counseling) in acute care-oriented, time-limited settings. In parallel, there has also been expansion of medication-assisted treatment (MAT) using methadone, buprenorphine and naltrexone for opioid dependent patients. This care has also been delivered by specialized programs or practices that are largely segregated from the rest of healthcare.
This segregation of addiction treatment is changing with implementation of multiple health care reforms within the federal, state and private sectors. Most prominently and far-reaching are the Affordable Care Act (ACA) and the Mental Health Parity and Addiction Equity Act (Parity Act) (
Barry and Huskamp, 2011
, Dentzer, 2011
). The historic provisions of these acts require health insurers to cover, and health care organizations to provide, prevention, screening, brief interventions and treatment for the full spectrum of substance use disorders (SUDs) — “harmful use” through “addiction.” Together these two pieces of legislation require that care for SUDs has the same type, duration, range of services and patient financial burden as the care currently available to patients with comparably serious physical illnesses. The illnesses considered to be “comparable” to addiction are acquired, chronic illnesses such as hypertension and particularly Type 2 diabetes (McLellan et al., 2000
). Importantly, this legislation has mandated care delivery within mainstream health care settings including primary care.These are not simply mechanistic changes in financing and regulations. These mandates signal remarkable changes in how SUDs are to be conceptualized and managed as well as how they are evaluated for effectiveness and value. It is likely that within the next decade SUDs will be treated like other serious, chronic illnesses, increasingly by the same multidisciplinary treatment teams now practicing general health care, and using the same continuing management and monitoring approaches to achieve the goals of long term “disease control” and “patient self-management.” In addition, the currently separated and distinct addiction treatment programs may serve as part of an overall approach to care management, much as cardiology or endocrinology serves as specialty services in the care of patients with coronary artery disease or diabetes. What is missing in addiction care is the long-term continuity and monitoring generally provided in primary care for other chronic diseases.
There is much to be optimistic about in the prospects for integration of addiction care into mainstream chronic care management. Buprenorphine treatment already shows some success as a model for integrating addiction services into general medicine. This has increased access to care for previously untreated opioid addicted patients. The majority of wavered physicians who prescribe buprenorphine are not practicing in traditional specialty addiction or opioid treatment programs. Yet, as this integration proceeds to include additional services, there are important conceptual and methodological issues on which the addiction field must reach consensus. For example, in other areas of chronic illness management there is consensus on when treatment is necessary (and when services will be paid for), almost always based upon one or more objective biological markers signifying disease status (e.g., blood pressure readings, HgA1c results, weight, etc.). As treatment progresses, these markers are repeatedly monitored as part of the ongoing evaluation of the effectiveness of the care delivered to that point; and used to guide modifications to care (e.g., reduce or increase medication dose, add or reduce supportive services, etc.). When the biological markers monitored reach sustained normal levels and there is return to function in the activities of daily life, the illness is considered to be “under control” and at that point the number, frequency and intensity of care supports and monitoring are reduced (in conjunction with increases in patient and family education and training). This does not mean that the patient is not provided any care or monitoring, nor does it mean that no action is required by the patient who has achieved this status. Instead, it means that the patient is doing the things necessary to maintain this positive health status. The most favorable health outcomes that can be expected are “disease control” (reduction in symptoms to normal levels concomitant with good functional status) under “patient self-management.” For instance typical care of patients with Type 2 diabetes includes routine self-management by patient and quarterly office visits to a physician to perform a physical exam, to review tests (e.g. hemoglobin A1C levels and blood glucose), and to provide counseling. Coordination of care with other specialties (e.g. ophthalmology) if needed is also conducted. Such a model for monitoring and coordination with specialty services could be used in addiction care management.
Compared to other chronic illness management strategies addiction treatment shares the ultimate objective of patient self-management of their illness; but addiction treatment has fewer medications and more social and behavioral services to offer patients during the course of treatment. Furthermore, the very limited training in addictions in medical professions and the resulting stigma among medical professionals represent significant barriers to full integration into mainstream medical care. Yet, the addiction field has one solid biological marker signifying the presence of a primary symptom of the “disease state”: substance use, detectable through biological specimen testing (e.g., urine, oral fluids, hair, sweat, etc.). Thus, a central conceptual question for the addiction field as it joins the rest of chronic illness management is what is the acceptability of drug testing during treatment to monitor treatment efficacy; and, in combination with other measures of general health and function, as a long-term measure of treatment effectiveness. This paper advocates a consensus method of measuring and managing addiction services; and for judging effectiveness and value of addiction services based on the goal of five year recovery.
2. Disease control in addiction treatment: what, why and how
Three factors have the potential to reshape the management and the measurement of the effectiveness of SUD treatment. The first is the severity, complexity and chronicity of SUDs among persons in treatment for these conditions. The prevalence of substance use problems in the general population is variable, but chronic, severe substance use as well as significant medical comorbidity is not common. In contrast, marked severity, chronicity and complexity are common among those people who meet diagnostic criteria for addiction — and virtually universal among the still smaller proportion of addicted individuals referred for treatment. People with SUDs rarely acknowledge that they have a disorder and usually do not want treatment, typically rejecting referral. Even among those who enter specialty treatment, many drop out before completion (
Brorson et al., 2013
, Dakof et al., 2001
, McHugh et al., 2013
, Samuel et al., 2011
). Not surprisingly, relapse to substance use following treatment discharge is a common outcome among the severely affected population. Advances in brain imaging and genetic studies have provided a biological understanding of this typical treatment trajectory. There are now well-documented progressive, drug-related changes in brain circuits associated with reward, motivation, and cognition associated with virtually every substance with addictive liability (Koob and Volkow, 2010
).The second important factor reshaping clinical management in this field is the recognition that SUDs are seldom the result of the use of a single drug. Most people with SUDs have problems with many substances including alcohol and tobacco. Combined with increasing scientific evidence of long-lasting changes in motivation and reward salience that accompany addictions, it is understandable that most contemporary strategies for treatment-seeking patients who generally have severe substance use disorders do not attempt to engender “controlled substance use” advocating instead for complete abstinence from alcohol and other potentially addictive substances (with the exception that tobacco abstinence has been inconsistently encouraged).
The third factor reshaping addiction care is the rapid organizational and management changes generally occurring in health care — particularly health care for serious chronic illnesses such as asthma and diabetes (
Coleman et al., 2009
). Contemporary chronic care is now proactive and individualized, relying upon regular monitoring of patient symptoms, function and risk factors combined with sophisticated and individualized combinations of medications, social services and patient/family education to detect incipient relapse and intervene rapidly to prevent escalation of illness, morbidity and health costs. In this new model of health care, chronic conditions are carefully managed by monitoring patients pro-actively over many years to prevent and intervene early with relapses.These three changes provide a contextual framework for a fresh look at clinical management and measuring the effectiveness within addiction treatment. It is important here, to note that we are specifically referring not to the broad group of individuals with risky substance use or mild/moderate substance use disorder, but instead to those with severe substance use disorder referred for treatment (i.e. generally those with complicated multi-substance use issues that are so typical of treatment samples). Key to this context is a change in clinical focus away from reactive, time-limited episodes of care administered in isolated silos. The move now is toward long-term management of all substance use, including alcohol and tobacco. Further, many treatment providers believe that the primary route to achieving the shared goals of improved functioning and health is through sustained abstinence from the use of all addictive substances because any use of substances that produce intense brain reward is likely to trigger a relapse and thereby risk significant morbidity and mortality. This goal of abstinence is not universally accepted by professionals in the treatment of addiction but it is well-established for tobacco, where even the use of a single cigarette is considered to threaten long-term abstinence.
This reorientation brings new meaning and rationale for an old and well-established target in the treatment of addictions, “recovery.” While the definition of recovery has been controversial, it has been defined as “a voluntarily maintained lifestyle characterized by sobriety, personal health, and citizenship” (
Betty Ford Institute Consensus Panel, 2007
), “a process of sustained action that addresses the biological, psychological, social, and spiritual disturbances inherent in addiction” (American Society of Addiction Medicine, 1982
) and “a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential” (Substance Abuse and Mental Health Services Administration, 2012
). Consider the logic of this conclusion. Science and clinical experience show that addiction is best understood as a chronic, complex illness typically manifest by substance-related, perhaps genetically-mediated changes in brain structure and function leading to impaired ability to control substance use. What makes an illness “chronic” is that it cannot be cured. Instead it can be medically controlled and managed toward the ultimate goal of patient self-management. Further, in our view, patients using medications in their treatment, including methadone, buprenorphine and naltrexone should be considered to be in recovery if they are using the medicines as prescribed and abstaining from using alcohol and other addictive drugs. Recovery can be supported by these medications, which are intended to support the patient’s normalizing their social-emotional functioning and minimizing intoxication.With this reorientation comes the availability of a clear, objective, biological measure of “disease control” — drug screening of urine or other biological matrices (hair, blood, oral fluid, and sweat). Drug screening measures have many of the same clinical advantages as comparable measures of disease control now used in the monitoring and management of other chronic illnesses — e.g. blood pressure, weight, HgA1c, etc. These measures can be easily and inexpensively collected and interpreted. Recurrent biological screening for alcohol and other drugs within clinical settings serves the joint purposes of determining effectiveness of care delivered to that point; and guidance for how to adjust ongoing treatment that has not yet achieved the goal of complete and sustained abstinence.
3. A model of “chronic disease management” that consistently produces positive long-term outcomes for SUDs
To continue the argument that addiction can be conceived and managed like the other chronic illnesses, the proposed reorientation suggests an ambitious, but achievable, longer-term outcome goal for the treatment of addiction — Five Year Recovery (
Institute for Behavior and Health, Inc, 2014a
). Based on a new paradigm for care management of SUDs, this model has demonstrated that long-term abstinence and recovery can be the expected outcome of addiction care, particularly for patients with severe substance use disorders.During the past four decades the U.S. Physician Health Programs (PHPs) have developed a unique state-based system of care management for addictions (and other behavioral disorders) with the goal of producing the best long-term outcomes, that is, “recovery.” These programs, commonly working in cooperation with state licensing boards, do not provide any treatment or monitoring themselves. Instead, they manage the care of participating physicians for five years or longer. Physicians referred to their state PHP begin with a detailed, formal medical evaluation. Those who are diagnosed with substance use disorders are offered a contract in which the PHP provides a safe harbor for the physicians by verifying their abstinence from any use of alcohol or other drugs and their continued compliance with the recommendations of the PHP (
DuPont et al., 2009
). The diagnosed physicians are then referred to treatment programs that have demonstrated to the PHPs the excellence of their work (Talbott and Wright, 1987
). Physicians typically enter either 30 to 90 days of residential treatment or three months or more of intensive outpatient treatment. Comorbid conditions and other problems are identified and addressed.Physicians are monitored for any alcohol or drug use through frequent random drug and alcohol testing. Each day they must check to see if they are required to be tested that day. Typically the initial random testing frequency is once or twice a week. After long demonstration of abstinence, the frequency is gradually reduced to once a month. Any positive test or any missed test is considered a serious violation of the program rules and typically leads to the physician being taken out of practice for an extensive reevaluation. The physicians are encouraged to participate in community support groups, usually Alcoholics Anonymous (AA) and Narcotics Anonymous (NA), and generally participate in 12-Step meetings specifically limited to health care professionals (often called “Caduceus meetings”). The long-term recovery outcomes from this care management are remarkable (
Skipper et al., 2009
). For example, a study of 16 PHPs showed that over the course of five years of monitoring, 78% of physicians never had a single positive test for alcohol or drug use, and of those who tested positive, two-thirds only had a single positive test result (McLellan et al., 2008
).Evidence from two criminal justice programs, HOPE Probation and South Dakota’s 24/7 Sobriety Project, with comparable intensive monitoring procedures, suggests that similar rates of abstinence and improved quality of life can be achieved in criminal offender populations with substance use problems (
DuPont and Humphreys, 2011
). Caron Treatment Centers has developed a program based on the care management of PHPs, called My First Year of Recovery. Similar experiences with dramatically different populations suggest that this model of care management can be widely applied, at least when there is significant leverage to make monitoring failures consequential (Institute for Behavior and Health, Inc, 2014b
).We recognize that health care generally lacks the leverage that characterizes both the PHP model and the programs in the criminal justice system. Addicted physicians can lose their licenses for continued drug and alcohol use and offenders under supervision in the criminal justice system can be jailed for continued alcohol or other drug use. We cite these examples because of the extended duration of their random monitoring and care management which deserves consideration for implementation in health care settings. Nevertheless, a key issue differentiates addiction from these other chronic conditions: typically negative responses to ongoing drug use. Unlike diabetes or hypertension care, in addiction care, there can be severe social (including legal) consequences for positive urine drug screens or missed appointments. This is a complexity with which all clinicians and clinical researchers grapple. Of course, an approach to consider which mimics other chronic diseases is to use continued drug use (or other behavioral manifestations of potential relapse) as reasons to change and possibly intensify treatment until improvement is seen. The goal is clinical improvement, not punishment, which is the same goal that characterizes the PHP programs and the two criminal justice programs cited here, HOPE Probation and 24/7 Sobriety.
One key way to take such a long-term, recursive approach is within primary care and health care systems themselves. Unlike isolated and often time-limited specialty treatment programs, the overall health care system has long-term (sometimes even lifetime) relations with patients and families permitting even longer-term monitoring and management than these programs provide. Within health care, the consequences of continued alcohol and other drug use should not lead to punitive intervention but to new or intensified care, just as in the model used for promoting healthy behavior for other chronic disorders such as diabetes and coronary artery disease. Health care providers may manage the process using outside organizations providing the specialty care that is required. This model of long-sustained care management is available to medical care organizations, permitting them to take advantage of the expertise of community resources while maintaining continuing responsibility for the care of these patients within the general health care (or primary care) setting.
4. The standard of five-year recovery
The precise need for “five years” is modeled not only after the PHP standard but also after the well-known long-term cancer survival model. In cancer, this model has come under criticism because some cancers have a much more rapid recurrence and a shorter duration of remission would indicate “cure” while for other cancers, “cure” may not be certain until even more years have passed. Despite these shortcomings, the concept of extended abstinence predicting markedly improved outcomes is clear. The work of
Dennis et al., 2007
on the long-term trajectories of persons entering drug treatment suggests approximately three years of abstinence as indicating high likelihood of a stable recovery. Vaillant, 2012
, in his landmark study of alcoholism, supports the use of five years of abstinence as a standard indicating that the risk of relapse is no longer greater than that of the general population. While the precise duration of abstinence needed to define a stable recovery isn’t fully established, our goal is to move toward a system of care for SUDs that encourages long-term recovery.Adoption of five-year recovery as a standard treatment outcome measure does not replace other measures of effectiveness, including in-treatment assessments and functional outcomes (e.g. employment), but rather it adds to those measures and should support their achievement. It ensures that a standard measure of treatment success is long-term recovery. This encourages addiction treatment programs and clinicians to work to make recovery, not relapse, the expected outcome of treatment (
Institute for Behavior and Health, Inc, 2014b
).In this regard, we have to question the all-too-common research paradigm to evaluate the effectiveness of a new medication or behavioral therapy — typically a 12-week randomized clinical trial; usually lacking any continuing care; and often evaluated 6 or 12 months "post-treatment." Consistent with disease management models currently used in other illnesses, these typical trials do evaluate “during treatment” reductions in symptoms (substance use) and function (social and health) thereby providing early indicators of benefit. They can be considered interim outcomes for acute episodes. However, unlike the management of other illnesses; and unlike the management model used by PHPs, very few of these trials provide any form of continuing care that is embedded into a robust long-term care management system. Also, while abstinence and symptom reduction may be the most likely pathway to recovery, further thinking about how best to measure long-term functional improvements will be needed to improve this long-term approach to patient outcomes.
Using sustained five-year abstinence and recovery as a primary measure of outcomes can reshape both treatment outcome research as well as clinical practice. It can increase the quality of treatment, spawn a new generation of monitoring and care management and deliver more consistently the outcome widely sought but seldom achieved: a sustained healthy lifestyle. Having a five-year recovery standard for all systems of care will provide useful information for patients, families and funding sources. It will also create a goal toward which programs strive.
A commitment to routine, long-term monitoring of patient behavior and compliance to improve five-year outcomes as part of patient-centered medical care with long-term monitoring and frequent assessment holds great promise for the management of SUDs. With this model, clinicians are encouraged to monitor patients with SUDs routinely to maintain recovery. The successful management of SUDs includes conducting random tests (sometimes frequently, especially early in care) for the use of alcohol and other drugs to monitor compliance, similar to the sustained monitoring for diabetes and hypertension. This model of integrated long-term monitoring and care management is now being more widely adopted throughout medicine. It requires incorporating many elements of the PHP model into routine health care for every patient suffering from a substance use disorder. Yet, a key challenge in caring for patients with addictions will be to assure that the response to a test that indicates substance use is proactive and supportive. The goal is to encourage behavior change through a positive treatment environment, not to drive patients further into the shadows. Thus, implementing these new approaches will require careful assessment.
Clinicians need to recognize their important role in medically managing addictions and that they also need to identify long-term recovery as the ultimate objective of their care. With further research, it may turn out that abstinence is not the only route to such healthy outcomes, especially for those with milder or sub-threshold substance use disorders, but at the present time, abstinence is the most supported approach to achieving meaningful recovery for treatment-seeking patients (
National Institute on Drug Abuse, 2015
). In the model we are proposing, this means articulating the abstinence objective to patients and their families and then monitoring for its achievement as a means of supporting recovery. In addition, the five-year recovery standard for assessing treatment outcomes encourages treatment programs to look beyond the time of formal episodes of care of their patients. Acceptance of the five-year recovery rate permits all addiction treatment programs to compete on a level playing field.5. Conclusions
The discussion of strategies for monitoring and measuring treatment response five years after entering treatment is built on the evaluations that have been conducted on the physician health programs and the initial effort of the committee convened by the Betty Ford Institute to define “recovery” including an important review of the instruments now available to assess recovery in individual patients (
Betty Ford Institute Consensus Panel, 2007
). Today there is an obvious need to create new instruments and cost-effective, practical strategies to assess interim and long-term treatment outcomes for SUDs.Rather than lay out the specifics of the proposed strategies we encourage a fresh look at treatment evaluation using the standard of five-year recovery. Our focus is on how this new goal can shift the way treatment is assessed to create incentives for substantially improving treatment outcomes. Our goal is to make recovery, not relapse, the expected outcome of substance use disorder treatment.
The confluence of forces in medicine today encourages a new look at evaluating the effectiveness of treatment for SUDs, expanding the focus from one drug to all addictive drugs, including alcohol and tobacco, as well as both during and after treatment. The five-year recovery standard offers a model that can be applied to various populations by identifying an intake sample and following them for five years following admission to treatment.
The identification of five-year recovery rates for treatment programs will give a level playing field for comparing a wide range of treatment programs and it will encourage all treatment programs to focus their attention on long-term patient outcomes. This will in turn facilitate innovation in addiction treatment and reward programs and treatment modalities that are better able to achieve long-term recovery with resulting functional and health improvements.
Finally, there are significant implications of using five-year recovery as the outcome for research. We see five-year recovery as a useful conceptual standard to inspire both practice and research. Yet, few “evidence-based practices” have been tested against this standard; most are primarily examined for their short-term impact. These current studies can provide key treatment resources that can be part of the care management envisioned using the five-year outcomes. How evidence based treatments can be incorporated into a recursive model of continuing care is just beginning to be studied (
Dennis and Scott, 2012
). Even when it comes to addiction medications, there is controversy about whether these are best for early stabilization or for long-term maintenance care. Further, the very nature of most research funding with a maximum of five years of support, makes a five-year outcome a difficult goal for a single study. New research methods that take advantage of electronic health records for comparative effectiveness research present a possible solution. Recognizing these limitations, we encourage the research community to develop new approaches to study these essential long-term models of clinical and health outcomes.Acknowledgements
No external funding supported the writing of this manuscript.
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Article info
Publication history
Published online: August 01, 2015
Accepted:
June 26,
2015
Received in revised form:
June 24,
2015
Received:
May 24,
2015
Footnotes
☆Disclaimers: The findings and conclusions of this article are those of the authors and do not necessarily reflect the views of the National Institute on Drug Abuse, the National Institutes of Health or the U.S. Department of Health and Human Services.
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Published by Elsevier Inc.
