D.12 VA-DOD Clinical Practice Guideline for Substance Use Disorders.pdf

VA/DoD CLINICAL PRACTICE GUIDELINE FOR

THE MANAGEMENT OF SUBSTANCE USE

DISORDERS

Department of Veterans Affairs

Department of Defense

QUALIFYING STATEMENTS

The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one.

Neither should they be interpreted as prescribing an exclusive course of management.

This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation.

Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation.

These guidelines are not intended to represent TRICARE policy. Further, inclusion of recommendations for specific testing and/or therapeutic interventions within these guidelines does not guarantee coverage of civilian sector care. Additional information on current TRICARE benefits may be found at www.tricare.mil or by contacting your regional TRICARE Managed Care Support Contractor.

Version 3.0 – 2015

VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders

December 2015 Page 2 of 169

Prepared by:

The Management of Substance Use Disorders Work Group

With support from:

The Office of Quality, Safety and Value, VA, Washington, DC

Office of Evidence Based Practice, U.S. Army Medical Command

Version 3.0 – 2015

Based on evidence reviewed through January 2015

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Table of Contents

I. Introduction

II. Background

A. Description of Substance Use Disorders

B. Epidemiology and Impact

C. Factors Affecting Risk of Substance Use Disorders

D. Substance Use Disorders in the Department of Veterans Affairs and the Department of Defense

E. Working Toward Successful Substance Use Disorders Treatment

III. About this Clinical Practice Guideline

A. Methods

a. Grading Recommendations

b. Reconciling 2009 Clinical Practice Guideline Recommendations

c. Peer Review Process

B. Conflict of Interest

C. Scope of this Clinical Practice Guideline

D. Highlighted Features of this Clinical Practice Guideline

E. Patient-centered Care

F. Shared Decision Making

G. Engagement Strategies

H. Addiction-focused Medical Management

I. Accreditation Standards

J. Management of Substance Use Disorders in Department of Defense Healthcare Settings

K. Substance Use Disorders and Co-occurring Conditions

a. Substance Use Disorder and Tobacco Use

b. Patients with Multiple Substance Use Disorders

c. Substance Use Disorder and Other Co-occurring Conditions

L. Implementation

IV. Guideline Work Group

V. Algorithm

A. Module A: Screening and Treatment

B. Module B: Stabilization

VI. Recommendations

A. Screening

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B. Brief Alcohol Intervention

C. Determination of Treatment Setting

D. Treatment

a. Alcohol Use Disorder

b. Opioid Use Disorder

c. Cannabis Use Disorder

d. Stimulant Use Disorder

E. Promoting Group Mutual Help Involvement

F. Co-occurring Mental Health Conditions and Psychosocial Problems

G. Follow-up

H. Stabilization and Withdrawal

a. Assessment

b. Alcohol Use Disorder Stabilization and Withdrawal

c. Opioid Use Disorder Stabilization and Withdrawal

d. Sedative Hypnotic Use Disorder Stabilization and Withdrawal

VII. Knowledge Gaps and Recommended Research

A. Determination of Treatment Setting

B. Pharmacotherapy

a. Opioid Use Disorder

b. Stimulant Use Disorder

C. Psychosocial Interventions

a. Substance Use Disorders

b. Opioid Use Disorder

D. Follow-up

E. Stabilization and Withdrawal

F. Telehealth

Appendix A: Evidence Review Methodology

A. Developing the Scope and Key Questions

a. Population(s)

b. Interventions

c. Outcomes

B. Conducting the Systematic Review

a. Criteria for Study Inclusion/Exclusion

b. Literature Search Strategy

C. Convening the Face-to-face Meeting

D. Grading Recommendations

E. Recommendation Categorization

a. Recommendation Categories and Definitions

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b. Categorizing Recommendations with an Updated Review of the Evidence

c. Categorizing Recommendations without an Updated Review of the Evidence

F. Drafting and Submitting the Final Clinical Practice Guideline

Appendix B: Pharmacotherapy for Alcohol Use Disorder and Opioid Use Disorder

Appendix C: Psychosocial Interventions

A. Behavioral Couples Therapy

B. Cognitive-Behavioral Coping Skills Therapy

C. Community Reinforcement Approach

D. Contingency Management for Substance Use Disorders Treatment

E. Individual Drug Counseling

F. Motivational Enhancement Therapy

G. 12-Step Facilitation

Appendix D: Evidence Table

Appendix E: 2009 Recommendation Categorization Table

Appendix F: Participant List

Appendix G: Conflict of Interest Disclosures Based on Financial Relationships with Industry

Appendix H: Literature Review Search Terms and Strategy

A. Topic-specific Search Terms

B. Search Strategies

Appendix I. Acronym List

References

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I. Introduction

The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations.[1] This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with substance use disorders (SUD), thereby leading to improved clinical outcomes.

In 2009, the VA and DoD published a CPG for the Management of Substance Use Disorders (2009 SUD CPG), which was based on evidence reviewed through 2007. Since the release of that guideline, a growing body of research has expanded the general knowledge and understanding of SUD. Improved recognition of the complex nature of these conditions has led to the adoption of new strategies to manage and treat patients with SUD, including new developments related to pharmacotherapy and other treatment options.

Consequently, a recommendation to update the 2009 SUD CPG was initiated in 2014. The updated CPG includes objective, evidence-based information on the management of SUD. It is intended to assist healthcare providers in all aspects of patient care, including, but not limited to, diagnosis, treatment, and follow-up. The system-wide goal of evidence-based guidelines is to improve the patient’s health and wellbeing by guiding health providers who are taking care of patients with SUD along the management pathways that are supported by evidence. The expected outcome of successful implementation of this guideline is to:

Assess the patient’s condition and determine in collaboration with the patient the best treatment method

Optimize each individual’s recovery to decrease or eliminate consumption, improve health and wellness, live a self-directed life, and strive to reach his or her full potential [2]

Minimize preventable complications and morbidity

Emphasize the use of patient-centered care

II. Background

A. Description of Substance Use Disorders SUD can develop in individuals who use alcohol or other addicting drugs in harmful quantities. About 9% of Americans over age 18 have a non-tobacco SUD, and about one in every four Americans will develop a non-tobacco SUD over the course of a lifetime.[3,4] According to the Centers for Disease Control and Prevention (CDC), excessive alcohol use costs the United States (U.S.) over $223.5 billion annually.[5] According to the U.S. Department of Justice, the estimated cost of illicit drug use in the U.S. was more than $193 billion (in 2007).[6] This reflects direct and indirect public costs related to crime ($61.4 billion), health ($11.4 billion), and lost productivity ($120.3 billion).[6] Excessive alcohol use itself leads to about 88,000 premature deaths each year from acute (e.g., alcohol poisoning, motor vehicle accidents) and chronic causes (e.g., liver disease, hypertension, heart disease, stroke, pancreatitis). SUDs including tobacco

December 2015 Page 7 of 169 represent the leading actual cause of death in the U.S.[7] While the costs to our nation’s health are high, healthcare professionals are in a unique position to positively impact the health and wellbeing of the Service Members and Veterans they treat by implementing effective SUD prevention and treatment strategies.

As termed in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), a “substance use disorder describes a problematic pattern of using alcohol or another substance that results in impairment in daily life or noticeable distress.”[8] This use can lead to a change in the way the brain functions and can cause other long-term health problems such as cardiovascular disease, stroke, and lung disease.[9] It can also limit a person’s ability to fulfill roles in his or her professional or personal life and can have other legal, social, or physical ramifications.[10,11]

In the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (and in International Classification of Diseases, Tenth Revision), SUD consists of two distinct conditions, abuse and dependence, as they relate to substances such as tobacco, alcohol, opioids, cannabis, and seven others. Field trials of the DSM-IV criteria showed that the substance dependence syndrome was both reliable and valid as a definition, but that the abuse syndrome based on a theoretical and hierarchical relationship between abuse (less severe) and dependence (more severe) was not valid. Some symptoms of “abuse” (e.g., failure to fulfill major role obligations) indicated severe SUD, while about half of the “abuse” definitions were based only on a single criterion, most often “hazardous use.”[12] Factor analysis supports a single SUD syndrome. Thus, DSM-5 now defines SUD using 11 diagnostic criteria and defines mild, moderate, and severe sub-classifications.[8] Presence of at least two symptoms indicates a disorder. Severity is defined as mild, moderate, and severe, with the presence of two to three, four to five, and six or more symptoms, respectively.[8,12]

Addictive substances disrupt the functioning of brain circuits that mediate a complex array of functions (e.g., motivation, decision making, memory) involved in obtaining the natural rewards such as food and water that are essential for survival. Addicting substances act by either mimicking the brain’s natural chemicals or by interfering with the brain’s regulation of its chemicals, or both.[13] This activity changes the reward system in patients with SUD. When functioning normally, the mesolimbic dopamine pathway allows a person to experience pleasure in response to stimuli such as food and social interactions, and therefore encourages and motivates an individual to seek out these stimuli. Connections between mesolimbic dopamine and memory circuits enable a person to remember the people, places, and things associated with the reward. Addicting substances activate mesolimbic dopamine pathways more powerfully than natural rewards. With sufficient repeated use of addicting substances, one can develop an SUD. In patients with SUD, the mesolimbic pathway responds to cues that addictive substances are available, while its response to the drug itself and to natural rewards diminishes. Simultaneously, repeated substance use impairs the ability to exert inhibitory control. Over time, substance-related cues become more salient, drug craving becomes more compelling, and the individual is less able to inhibit impulses to use substances even as the “high” experienced is diminished.[14] This leads to impairment in substance-related decision making that leads to many of the DSM-5 symptoms of an SUD.

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B. Epidemiology and Impact In 2014, an estimated 8.1% of the population indicated they were affected by SUD within the past year. An estimated 6.4% were affected by alcohol use disorder (AUD), while 2.7% were affected by an illicit drug use disorder.[15] The leading causes of death in 2000 were tobacco (435,000 deaths; 18.1% of total U.S.

deaths), poor diet and physical inactivity (365,000 deaths; 15.2%), and alcohol consumption (85,000 deaths; 3.5%). Other causes of death were microbial agents (75,000), toxic agents (55,000), motor vehicle crashes (43,000), incidents involving firearms (29,000), sexual behaviors (20,000), and illicit use of drugs (17,000).[7] From 1990-2010, the highest disability-adjusted life years, which accounted for years of life lost due to premature mortality as well as years lived with disability, were associated with risk factors including dietary risks, tobacco smoking, high body mass index, high blood pressure, high fasting plasma glucose, physical inactivity, and alcohol use.[16] Since the early 1990s, there has been an increase in marijuana and prescription drug use disorders.[17] During a similar time period (1999-2008), overall opioid related death rates also increased. [18] Deaths from opioid overdose more than tripled between 1999 and 2012.[19] Following the rise in prescription opioid use, heroin use increased from 2002 to 2013, and deaths resulting from heroin overdose also concurrently increased.[20]

Despite the increases in both use of many of these substances and associated mortality, alcohol and drug use disorders continue to be undertreated.[17,21] From the 2012-2013 National Epidemiologic Survey on Alcohol and Related Conditions III (NESARC-III), only 19.8% of respondents with lifetime AUD were ever treated for AUD.[21] Many individuals who are untreated identify stigma as a major barrier.[22,23]

For treatment of alcohol or illicit drug use in 2013, the most common locations of treatment were outpatient rehabilitation facilities or mutual help groups.[24,25] Among Gulf War, Afghanistan, and Iraq War era Veterans, Veterans who were deployed were found to be at increased risk of AUD compared to Veterans who were not deployed.[26]

C. Factors Affecting Risk of Substance Use Disorders The risk of a person developing SUD is affected by a number of factors. One factor is biology, including genetic make-up, gender, ethnicity, and the presence of other comorbidities. For instance, rates of alcohol and drug use disorders in males are nearly double that in females.[27] In 2012-2013, 12-month and lifetime prevalence of AUD were higher for people who identified as white and Native American.[21] There is an increased risk for developing substance and other mental health disorders if a relative is affected by SUD.[27] Other factors that may affect development of the disease are social environment and age or stage of development. As adolescents’ brains are still developing, including areas governing decision making and self-control, they may be more susceptible to taking risks such as using alcohol or drugs. The prevalence of alcohol and drug use disorders peaks in late adolescence and early adulthood, and starts to decrease after age 26.[27] In addition, those who were affected by substance use earlier in their lives are more likely to be affected by SUD in adulthood.[28] Socioeconomic status, SUD in family and friends, and quality of life can also influence risk.[29]

D. Substance Use Disorders in the Department of Veterans Affairs and the Department of Defense

SUD commonly co-occurs with and complicates other conditions or issues. These conditions or issues may be health-related, such as other mental health conditions, or may be societal, such as homelessness, December 2015 Page 9 of 169 criminal justice involvement, or unemployment. For instance, among Veterans with posttraumatic stress disorder (PTSD), co-occurring SUD was common and found to be associated with an increase in mortality.

The association was especially pronounced for young Veterans, including those who served in Iraq and Afghanistan.[30] Furthermore, it was found that roughly 33% and 22% of homeless Veterans had spent money on alcohol and drugs, respectively, in the past month; however, there was no significant association found between the source of income (e.g., VA disability compensation) and the amount spent on alcohol and drugs.[31] Among Iraq or Afghanistan Veterans who were first-time users of VA healthcare between October 15, 2001 and September 30, 2009 and followed through January 1, 2010, SUD diagnoses were associated with being male, less than 25 years of age, and exposed to combat.[32] Of those with an SUD diagnosis, 55-75% also received diagnoses for PTSD or depression.[32]

E. Working Toward Successful Substance Use Disorders Treatment It is common for a person to relapse, even if his or her condition is being managed, and he or she is amenable to treatment. Relapse does not indicate that treatment has failed, but only signals that it needs to be adjusted, reinstated, or changed in order to move toward recovery.[33]

III. About this Clinical Practice Guideline

This guideline represents a significant step toward improving the treatment and management of patients with SUD in the VA and DoD. As with other CPGs, however, challenges remain, including evidence gaps, the need to develop effective strategies for guideline implementation and to evaluate the effect of guideline adherence on clinical outcomes. This guideline is intended for VA and DoD healthcare practitioners including physicians, nurse practitioners, physician assistants, psychologists, social workers, nurses, pharmacists, chaplains, addiction counselors, and others involved in the care of Service Members or Veterans who have a suspected or diagnosed SUD.

As elaborated in the qualifying statement on page one, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on information available by January 2015 and is intended to provide a general guide to best practices. The guideline can assist care providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.

A. Methods The current document is an update to the 2009 VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders. The methodology used in developing the 2015 CPG follows the Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (Champions) and other subject matter experts from within the VA and DoD, known as the Work Group, and ultimately, the development and submission of a new or updated SUD CPG.

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The Champions and Work Group for this CPG were charged with developing evidence-based clinical practice recommendations and writing and publishing a guideline document to be used by providers within the VA/DoD healthcare systems. Specifically, the Champions and Work Group members for this guideline were responsible for identifying the key questions (KQs) of the most clinical relevance, importance, and interest for the management of patients with SUD. The Champions and the Work Group also provided direction on inclusion and exclusion criteria for the evidence review and assessed the level and quality of the evidence. The amount of new scientific evidence that had accumulated since the previous version of the CPG was also taken into consideration in the identification of the KQs. In addition, the Champions assisted in:

Identifying appropriate disciplines of individuals to be included as part of the Work Group

Directing and coordinating the Work Group

Participating throughout the guideline development and review processes

The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S.

Army Medical Command, the proponent for CPGs for the DoD, identified three clinical leaders, Karen Drexler, MD and Daniel Kivlahan, PhD from the VA and Lieutenant Colonel Christopher Perry, MD from the DoD, as Champions for the 2015 CPG.

The Lewin Team, including The Lewin Group, Duty First Consulting, ECRI Institute, and Sigma Health Consulting, LLC, was contracted by the VA and DoD to support the development of this CPG and conduct the evidence review. The first conference call was held in October 2014, with participation from the contracting officer’s representative (COR), leaders from the VA Office of Quality, Safety and Value and the DoD Office of Evidence Based Practice, and the Champions. During this call, participants discussed the scope of the guideline initiative, the roles and responsibilities of the Champions, the project timeline, and the approach for developing and prioritizing specific research questions on which to base a systematic review (SR) about the management of SUD. The group also identified a list of clinical specialties and areas of expertise that are important and relevant to the management of SUD, from which Work Group members were recruited. The specialties and clinical areas of interest included: psychiatry, psychology, nursing, pharmacy, social work, primary care, family medicine, religious and spiritual services, bioethics, dietetics, pain, addiction psychiatry, addiction medicine, and substance use specialties.

The guideline development process for the 2015 CPG update consisted of the following steps:

1. Formulating and prioritizing evidence questions (KQs)

2. Conducting the SR

3. Convening a face-to-face meeting with the CPG Champions and Work Group members

4. Drafting and submitting a final CPG about the management of SUD to the VA/DoD EBPWG

Appendix A provides a detailed description of each of these tasks.

a. Grading Recommendations The Champions and Work Group used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to assess the quality of the evidence base and assign a grade for the strength

December 2015 Page 11 of 169 for each recommendation. The GRADE system uses the following four domains to assess the strength of each recommendation:[34]

Balance of desirable and undesirable outcomes

Confidence in the quality of the evidence

Patient or provider values and preferences

Other implications, as appropriate, e.g.,:

Resource use

Equity

Acceptability

Feasibility

Subgroup considerations

Using this system, the Champions and Work Group determined the relative strength of each recommendation (Strong or Weak). A strong recommendation indicates that the Work Group is highly confident that desirable outcomes outweigh undesirable outcomes. If the Work Group is less confident of the balance between desirable and undesirable outcomes, they give a weak recommendation.

They also determined the direction of each recommendation (For or Against). Similarly, a recommendation for a therapy or preventive measure indicates that the desirable consequences outweigh the undesirable consequences. A recommendation against a therapy or preventive measure indicates that the undesirable consequences outweigh the desirable consequences.

Using these elements, the grade of each recommendation is presented as part of a continuum:

Strong For (or “We recommend offering this option …”)

Weak For (or “We suggest offering this option …”)

Weak Against (or “We suggest not offering this option …”)

Strong Against (or “We recommend against offering this option …”)

The grade of each recommendation made in the 2015 CPG can be found in the section on Recommendations. Additional information regarding the use of the GRADE system can be found in Appendix A.

b. Reconciling 2009 Clinical Practice Guideline Recommendations Evidence-based CPGs should be current, which typically requires revisions of previous guidelines based on new evidence, or as scheduled, subject to time-based expirations.[35] For example, the U.S. Preventive Services Task Force (USPSTF) has a process for refining or otherwise updating its recommendations pertaining to preventive services.[36] Further, the inclusion criteria for the National Guideline Clearinghouse specify that a guideline must have been developed, reviewed, or revised within the past five years.

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The SUD Guideline Work Group focused largely on developing new and updated recommendations based on the evidence review conducted for the priority areas addressed by the KQs. In addition to those new and updated recommendations, the Guideline Work Group considered, without complete review of the relevant evidence, the current applicability of other recommendations that were included in the previous 2009 SUD CPG, subject to evolving practice in today’s environment.

A set of recommendation categories was adapted from those used by the National Institute for Health and Care Excellence (NICE).[37,38] These categories, along with their corresponding definitions, were used to account for the various ways in which older recommendations could have been updated. In brief, the categories took into account whether or not the evidence that related to a recommendation was systematically reviewed, the degree to which the recommendation was modified, and the degree to which a recommendation is relevant in the current patient care environment and inside the scope of the CPG.

Additional information regarding these categories and their definitions can be found in Appendix A. The categories for the recommendations included in the 2015 version of the guideline can be found in the section on Recommendations. The categories for the recommendations from the 2009 SUD CPG are noted in Appendix E.

The CPG Work Group recognized the need to accommodate the transition in evidence rating systems from the 2009 SUD CPG to the current CPG. In order to report the strength of all recommendations using a consistent format (i.e., the GRADE system) the CPG Work Group converted the USPSTF strengths of the recommendation accompanying the carryover recommendations from the 2009 guideline to the GRADE system. As such, the CPG Work Group considered the strength of the evidence cited for each recommendation in the 2009 SUD CPG as well as harms and benefits, values and preferences, and other implications, where possible. The CPG Work Group referred to the available evidence as summarized in the body of the 2009 SUD CPG and did not re-assess the evidence systematically. In some instances, peer-reviewed literature published since the 2009 SUD CPG was considered along with the evidence base used for that CPG.

Where such newer literature was considered when converting the strength of the recommendation from the USPSTF to the GRADE system, it is referenced in the discussion that follows the corresponding recommendation, as well as in Appendix D.

The CPG Work Group recognizes that, while there are practical reasons for incorporating findings from a previous SR, previous recommendations,[39] or recent peer-reviewed publications into an updated CPG, doing so does not involve an original, comprehensive SR and, therefore, may introduce bias.

c. Peer Review Process The CPG was developed through an iterative process in which the Work Group produced multiple drafts of the CPG. The process for developing the initial draft is described in more detail in Drafting and Submitting the Final Clinical Practice Guideline.

Once a near-final draft of the guideline was agreed upon by the Champions and Work Group members, the draft was sent out for peer review and comment. The draft was posted on a wiki website for a period of 14 business days. The peer reviewers comprised individuals working within the VA and DoD health systems as well as experts from relevant outside organizations designated by the Work Group members.

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Organizations designated by the Work Group who were contacted to participate in the peer review included the following:

American Psychiatric Nurses Association, Addictions Council

International Nurses Society on Addictions

Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment

The VA and DoD Leadership reached out to both the internal and external peer reviewers to solicit their feedback on the CPG. Reviewers were provided a hyperlink to the wiki website where the draft CPG was posted. All reviewer feedback was posted in tabular form on the wiki site, along with the name of the reviewer, for transparency. All feedback from the peer reviewers was discussed and considered by the Work Group. Modifications made throughout the CPG development process were made in accordance with the evidence.

B. Conflict of Interest At the start of this guideline development process and at other key points throughout, the project team was required to submit disclosure statements to reveal any areas of potential conflict of interest (COI) in the past 12 months. Verbal affirmations of no COI were used as necessary during meetings throughout the guideline development process. The project team was also subject to random web-based surveillance (e.g., ProPublica). Disclosed industry related COIs are listed in Appendix G.

If a project team member reported a COI (actual or potential), then it was reported to the Office of Evidence Based Practice. It was also discussed with the SUD CPG Work Group in tandem with their review of the evidence and development of recommendations. The Office of Evidence Based Practice and the SUD CPG Work Group determined whether or not action, such as restricting participation and/or voting on sections related to the conflict or removal from the Work Group, was necessary. If it was deemed necessary, action was taken by the co-chairs and Office of Evidence Based Practice, based on the level and extent of involvement, to mitigate the COI.

Several Work Group members disclosed relationships and/or affiliations which had the potential to introduce bias into the guideline. Based on the level and extent of involvement, no individuals were removed from the Work Group. In order to mitigate the risk of bias while maximizing the contributions of those with expertise in a specific area of SUD treatment, co-chairs asked Work Group members to disclose relevant relationships during related guideline development discussions. Members with potential COIs contributed to the discussions related to their particular areas of expertise as well as the overarching guideline document in order to ensure differing viewpoints and experiences were adequately represented.

C. Scope of this Clinical Practice Guideline Regardless of setting, any patient in the healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances.

Guideline recommendations are intended to be patient-centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient is essential and should be supported by evidence-based information tailored to the

December 2015 Page 14 of 169 patient’s needs. Use of an empathetic and non-judgmental (versus a confrontational) approach facilitates discussions sensitive to gender, culture, and ethnic differences. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate.

This CPG is designed to assist providers in managing or co-managing patients with SUD. Moreover, the patient population of interest for this CPG is adults who are eligible for care in the VA and DoD healthcare delivery systems. It includes Veterans as well as deployed and non-deployed Active Duty Service Members.

This CPG does not provide recommendations for the management of SUD in children or adolescents.

The literature review encompassed interventional studies (primarily randomized controlled trials [RCTs]) published between November 2007 and January 2015, and targeted 12 KQs focusing on the means by which the delivery of healthcare could be optimized for patients with SUD. The selected KQs were prioritized from many possible KQs. Due to resource constraints, a review of the evidence in all important aspects of care for patients with SUD was not feasible for the update to this CPG.

D. Highlighted Features of this Clinical Practice Guideline The 2015 edition of the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders is the second update to the original CPG. It provides practice recommendations for the care of populations with SUD with any level of severity. While screening for and addressing co-occurring mental disorders is considered good clinical practice, specific guidance on management of co-occurring mental health conditions and SUD is beyond the scope of this CPG. Interested readers are referred to related VA- DoD CPGs (see Substance Use Disorders and Co-occurring Conditions). A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with SUD.

The framework for recommendations in this CPG considered factors beyond the strength of the evidence, including balancing desired outcomes with potential harms of treatment, equity of resource availability, and the potential for variation in patient values and preferences. Applicability of the evidence to VA/DoD populations was also taken into consideration. A structured algorithm accompanies the guideline to provide an overview of the recommendations in the context of the flow of patient care and clinician decision making and to assist with training providers. The algorithm may be used to help facilitate translation of guideline recommendations into effective practice.

E. Patient-centered Care VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is individualized based on patient capabilities, needs, goals, prior treatment experience and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, PCC may decrease patient anxiety, increase trust in clinicians,[40] and improve treatment adherence.[41] Improved patient-clinician communication through PCC can be used to convey openness to discuss any future concerns.

As part of the PCC approach, clinicians should review the outcomes of previous self-change efforts, past treatment experiences, and outcomes (including reasons for treatment drop-out) with the patient. They

December 2015 Page 15 of 169 should ask the patient about willingness to accept a referral to an addiction specialist. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care.

F. Shared Decision Making Throughout this VA/DoD CPG, the authors encourage clinicians to focus on shared decision making (SDM).

The SDM model was introduced in Crossing the Quality Chasm, an Institute of Medicine report, in 2001.[42] It is readily apparent that patients with SUD, together with their clinicians, make decisions regarding which care they choose to engage in; however, these patients require sufficient information to be able to make informed decisions. Clinicians must be adept at presenting information to their patients regarding both individual treatments and levels and locations of care. For instance, for a patient who is not interested in specialty referral, the clinician should briefly explore the patient’s rationale, present relevant and individualized information about how specialty care might better meet the patient’s needs, identify reasons a specialty referral might be recommended for his or her specific case, and provide information regarding the abilities and the limitations of the primary care or general mental health clinic. If the patient continues to decline specialty referral despite counseling, the primary care clinician should respect this decision by providing as much care as possible for the patient. Unfortunately, SDM can be complicated as the patients’ ability to make decisions may be impaired by the SUD itself.[43]

G. Engagement Strategies A fundamental goal of this VA/DoD CPG is to promote early engagement and retention of patients with substance use conditions who can benefit from addiction-focused treatment. Many patients may initially decline voluntary referral,[44] or at least express ambivalence, but provider encouragement and support may improve patient willingness to pursue further involvement if they see it as consistent with their other priorities. There is considerable evidence from psychotherapy research that general factors such as therapist skill, the strength of the therapeutic alliance, and the structure provided by regular clinical contact can have as powerful an effect on engagement as the specific content or conceptual approach of specialized interventions.[45] Therefore, attention to these general therapeutic factors is at least as important as the specific treatment approach selected.

The following principles are fundamental to the engagement/re-engagement process for patients with SUD:

1. Indicate to the patient and significant others that treatment is more effective than no treatment (i.e., “Treatment works”).

2. Consider the patient’s prior treatment experience and respect patient preference for the initial intervention approach(es), since no single intervention approach has emerged as the treatment of choice.

3. Regardless of the particular psychosocial intervention chosen, use motivational interviewing (MI) style during therapeutic encounters with patients [46-48] and emphasize the common elements of effective interventions including: improving self-efficacy for change, promoting a therapeutic relationship, strengthening coping skills, changing reinforcement contingencies for recovery, and enhancing social support for recovery.

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4. Emphasize that the most consistent predictors of successful outcome are retention in formal treatment and/or active involvement with community support for recovery.

5. Use strategies demonstrated to be efficacious to promote active involvement in available mutual help programs (e.g., Alcoholics Anonymous [AA], Narcotics Anonymous [NA]).

6. Coordinate addiction-focused psychosocial interventions with evidence-based intervention(s) for other biopsychosocial problems to address identified concurrent problems consistent with patient priorities.

7. Provide intervention in the least restrictive setting necessary to promote access to care, safety and effectiveness.

8. If a patient drops out of treatment, the treatment team should make efforts to contact the patient and re-engage him/her in treatment.

9. If the patient remains unwilling to engage in any addiction-focused care, maintain MI style of interactions. Emphasize that options remain available in the future and determine whether treatment for medical and psychiatric problems can be effectively and safely provided while looking for windows of opportunity to engage the patient in addiction treatment.

Even when patients refuse referral or are unable to participate in specialized addiction treatment, many are accepting of general medical or mental health care. The chronic illness approach is consistent with management approaches for many other disorders treated in medical and psychiatric settings.[33,49]

H. Addiction-focused Medical Management Addiction-focused Medical Management is a manualized psychosocial intervention designed to be delivered by a medical professional (e.g., physician, nurse, physician assistant) in a primary care setting.[50] The treatment provides strategies to increase medication adherence and monitoring of substance use and consequences, as well as supporting abstinence through education and referral to support groups.

While variably defined, addiction-focused Medical Management typically includes:[51-55]

1. Monitoring self-reported use, laboratory markers, and consequences

2. Monitoring adherence, response to treatment, and adverse effects

3. Education about AUD and/or OUD consequences and treatments

4. Encouragement to abstain from non-prescribed opioids and other addictive substances

5. Encouragement to attend community supports for recovery (e.g., mutual help groups) and to make lifestyle changes that support recovery

Session structure varies according to the patient’s substance use status and treatment compliance. An initial session (40-60 minutes) may involve discussion of the specific findings and diagnosis, negative consequences from substance use, a recommendation to abstain, medication information, strategies to enhance medication adherence, and referral to support groups. In the subsequent monitoring visits, the clinician assesses the patient’s substance use. The assessment includes monitoring lab or physiologic measures and assessing overall functioning, medication adherence, and any medication side effects.

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Follow-up sessions are typically 15-20 minutes initially twice weekly tapering to weekly then biweekly for up to 12 weeks. When the patient does not adhere to the medication regimen, the clinician evaluates the reasons and helps the patient devise plans to address the problem(s). Clinicians offer common sense recommendations, such as avoiding specific situations like going to bars. If the patient suffers from medication side effects, the clinician specifies procedures for using concomitant medication to ameliorate them or reduces the dosage of medication, resuming medications if side effects remit. If a patient discontinues medication because he or she cannot tolerate it, the clinician schedules a monthly 15- to 25-minute “medical attention” meeting, during which the clinician employs a similar approach that focuses on the patient’s substance use and overall health, omitting the medication adherence component.

I. Accreditation Standards This VA/DoD CPG was developed with a focus on evidence-based practices to help improve patient outcomes. Although they are not explicitly evidence-based, attention should be given to standards provided by various accrediting agencies, most notably The Joint Commission (TJC) and the Commission on Accreditation of Rehabilitation Facilities (CARF). TJC standards can be found at:

http://www.jointcommission.org/standards_information/standards.aspx. CARF standards can be found at:

http://www.carf.org/home/.

TJC accreditation requirements address important functions relating to the care, treatment, or services of individuals and the management of behavioral health care organizations. They provide a framework to help manage risk and enhance the quality and safety of care, treatment, and services. For many providers and organizations, including VA and DoD, these requirements are considered to be the standard of care.

The mission of CARF is to promote the quality, value, and optimal outcomes of services through a consultative accreditation process and continuous improvement services that center on enhancing the lives of persons served.

Among the accreditation standards, clinicians are expected to obtain a comprehensive biopsychosocial assessment with a diagnostic formulation that synthesizes the various assessments and, using the results from the assessment, to develop an individualized treatment plan in accordance with TJC or CARF standards.

J. Management of Substance Use Disorders in Department of Defense Healthcare Settings

As specified by the DoD, “Substance abuse1 by military personnel is inconsistent with the Department of Defense’s Values, the Warrior Ethos, and the standards of performance, discipline, and readiness necessary to accomplish the DoD’s mission.”[56] On 28 September 1971, Public Law (PL) 92-129, mandated that the Secretary of Defense develop programs for the identification, treatment, and

1 Although the terminology “substance abuse” is not a diagnostic term and is not used elsewhere in the CPG, it is the language used in DoD policy and is thus used in this section.

December 2015 Page 18 of 169 rehabilitation of alcohol or other substance dependent persons in the Armed Forces.[57] In turn, the Secretary of Defense requires each of the Services to develop alcohol and other substance abuse prevention and control programs in accordance with Department of Defense Directive (DODD) 1010.4.[58] In response to these directives, the DoD conducts a comprehensive program to prevent and control the abuse of alcohol and other substances. The service specific programs are designed to strengthen the overall fitness and effectiveness of the DoD workforce, conserve manpower, enhance combat readiness, and increase individual fitness and overall unit readiness.

The DoD substance abuse programs are command and medical programs that emphasize readiness and personal responsibility. These programs are designed to provide services which are proactive and responsive to the needs of the DoD workforce by emphasizing alcohol and other substance abuse deterrence, prevention, education, and rehabilitation. The implementation of alcohol and other substance risk reduction and prevention strategies are designed to provide effective alcohol and other substance abuse prevention and education at all levels of command, and encourage commanders to provide alcohol and drug-free leisure activities. The ultimate goal of DoD substance use programs is to improve readiness and to restore to duty those substance-impaired Service Members who have the potential for continued military service.

In the DoD, Active Duty Service Members who are involved in the abuse of alcohol or use of illicit substances are encouraged to voluntarily refer themselves for care and treatment to a substance use program. However, if a Service Member screens positive for the use of illicit drugs during a mandatory unit urinalysis, regulations require that the Service Member enroll into a substance abuse program and be processed for possible separation from the military. The Service Member’s commander intervenes early for all personnel assigned to his/her command suspected of being alcohol and/or substance abusers.

Service Members, who fail to participate adequately in substance use programs or to respond successfully to rehabilitation, may be faced with administrative separation from the military.

After enrollment into substance abuse programs, all Active Duty Service Members will have a treatment team convene with the patient, clinician, and command representative to review the treatment plan and goals. Recognizing the importance of medical readiness, the Health Insurance Portability and Accountability Act (HIPAA) specifically exempts some communication between clinicians and commanders.

Regulations require that Active Duty personnel enrolled in rehabilitation and referral services have an individualized aftercare plan designed to identify the continued support of the patient with monthly monitoring (minimally) during the first year after inpatient treatment. The following regulations guide the rehabilitation programs in the various services: Army Regulation 600-85, The Army Substance Abuse Program dated 28 Dec 2012;[56] OPNAVINST 5350.4D, Navy Alcohol and Drug Abuse Prevention and Control dated 04 Jun 2009;[59] Air Force Instruction 44-121, Alcohol and Drug Abuse Prevention and Treatment (ADAPT) dated 08 July 2014.[60]

Care of Veterans and Service Members in transition between facilities, services, or from the DoD healthcare system to the VA healthcare system should include a transition plan that ensures continuity of care and coordination among providers. Healthcare teams should work jointly to provide assessment and services to patients within this transitioning population. Management should be reviewed throughout the transition process, and there should be clarity about who is the lead clinician to ensure continuity of care.

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If a clear transition process is lacking, then an effort should be made to construct a functional transition process that supports PCC.

K. Substance Use Disorders and Co-occurring Conditions

a. Substance Use Disorder and Tobacco Use

In Combatting Tobacco Use in Military and Veteran Populations, the Institute of Medicine (2009) notes that great progress has been made in decreasing the rate of smoking of Active Duty and Veterans from 51% in 1980 to 32% in 2005, but that about 22% of Veterans enrolled in VA healthcare continue to smoke.[61] In its discussion about tobacco use disorder treatment during SUD treatment the Substance Abuse and Mental Health Services Administration (SAMHSA) (2011) notes an early study on the morbidity and mortality among people seeking treatment for addictions.[62] Among the 845 participants in that study, 51% died as a result of…