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Abstract: There is an urgent need within the substance-use-disorders (SUD) treatment field to develop and implement consensus-based common core data elements (CDEs) with standardized vocabularies relevant to drug addiction treatment that could be incorporated and widely adopted into harmonized electronic medical record systems (EMRs). This will benefit patients by improving the quality of care and will assist in integration of specialty addiction treatment into disciplines of mainstream medicine. To achieve these aims, the NIDA Clinical Trials Network (CTN) has collected and collated dozens of treatment-form-related information and standardized instruments to develop a treatment-relevant set of CDEs. These CDEs were refined following a consensus-based meeting of federal, state, and community-based treatment stakeholders and providers. This poster describes the collaborative “Mind Map” used for developing and implementing core questions as CDEs for EMRs on SUD in primary care and SUD specialty treatment settings. Current progress in developing EMR core questions as CDEs for use in those settings is also provided, as well as implications of this project for the future of drug abuse treatment. NIDA is especially interested in input from College on Problems of Drug Dependence (CPDD) members on data collection hierarchy and core data elements and on the overall strategy in regards to other sources of input, other stakeholders who should be consulted, and other “next steps” as this project moves forward.

Abstract:

This is the outcomes article for CTN-0062-Ot.

Guidelines recommend that adult patients receive screening for alcohol and drug use during primary care visits, but the adoption of screening in routine practice remains low. Clinics frequently struggle to choose a screening approach that is best suited to their resources, workflows, and patient populations.

The purpose of this study was to evaluate how to best implement electronic health record (EHR)-integrated screening for substance use by comparing commonly used screening methods and examining their association with implementation outcomes. This article presents the outcomes of phases 3 and 4 of a 4-phase quality improvement, implementation feasibility study (CTN-0062-Ot) in which researchers worked with stakeholders at 6 primary care clinics in 2 large urban academic health care systems to define and implement their optimal screening approach. Site A was located in New York City and comprised 2 clinics, and Site B was located in Boston, MA, and comprised 4 clinics.

Clinics integrated validated screening questions and a brief counseling script into the EHR, with implementation supported by the use of clinical champions (i.e., clinicians who advocate for change, motivate others, and use their expertise to facilitate the adoption of an intervention) and the training of clinic staff. Clinics varied in their screening approaches, including the type of visit targeted for screening (any visit vs. annual examinations only), the mode of administration (staff-administered vs. self-administered by the patient), and the extent to which they used practice facilitation and EHR usability testing.

Data from the EHRs were extracted quarterly for 12 months to
measure implementation outcomes. The primary outcome was screening rate for alcohol and drug use. Secondary outcomes were the prevalence of unhealthy alcohol and drug use detected via screening, and clinician adoption of a brief counseling script.

Patients of the 6 clinics had a mean (SD) age ranging from 28.9 (17.3) years at clinic B2 to 59.1 (16.7) years at clinic B3, were predominantly female (52.4% at A1 to 64.6% at A2), and were English-speaking. Racial diversity varied by location. Of the 93,114 patients with primary care visits, 71.8% received screening for alcohol use and 70.5% received screening for drug use. Screening at any visit (implemented at site A) in comparison with screening at annual examination only (implemented at site B) was associated with higher screening rates for alcohol use (90.3%-94.7% vs. 24.2%-72%, respectively) and drug use (89.6%-93.9% vs. 24.6%-69.8%). The 5 clinics that used a self-administered screening approach had a higher detection rate for moderate- to high-risk alcohol use (14.7%-36.6%) compared with the 1 clinic that used a staff-administered screening approach (1.6%). The detection of moderate- to high-risk drug use was low across all clinics (0.5%-1%). Clinics with more robust practice facilitation and EHR usability testing had somewhat greater adoption of the counseling script for patients with moderate-high risk alcohol or drug use (1.4%-12.5% vs. 0.1%-1.1%).

Conclusions: In this quality improvement study, EHR-integrated screening was feasible to implement in all clinics and unhealthy alcohol use was detected more frequently when self-administered screening was used at any primary care clinic visit. The detection of drug use was low at all clinics, as was clinician adoption of counseling. These findings can be used to inform the decision-making of health care systems that are seeking to implement screening for substance use.

Related protocols: CTN-0062-Ot

Abstract:

Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S. and screening for alcohol and drug use in primary care is recommended. However, such screening has not become part of routine health care, and substance use information is not systematically collected in electronic health records. This presentation describes the objectives, methods, and outcomes of CTN-0062-Ot, a phased feasibility and proof-of-concept study seeking to incorporate addiction-specific screening and assessment common data elements into a widely used EHR.

Related protocols: CTN-0062-Ot

Abstract:

Chronic diseases are prevalent and the leading causes of mortality. Comorbidity of substance use disorders (SUDs) and chronic diseases is understudied to inform behavioral healthcare integration.

This study, part of CTN-0057-Ot, leveraged electronic health record (EHR) data of 211,880 adults from a large health system to examine prevalence and correlates of comorbidity of SUDs and nine chronic disease groups and to determine their association with hospitalization.

Logistic regression analyses were conducted to estimate associations between chronic diseases and SUDs. To control for severity of diagnosis, analyses of associations between SUD and hospitalization were stratified by the number of chronic conditions.

In the sample, 48.3% had =1 chronic condition (hypertension 33.7%, arthritis 16.2%, diabetes 13.7%, chronic kidney disease 9.9%, asthma 9.1%, chronic obstructive pulmonary disease 8.9%, ischemic heart disease 8.3%, cancer 4.6%, and hepatitis 1.3%). Prevalence of SUD (overall 13.3%) among patients increased with multiple chronic conditions (14.3% having SUD among patients with one condition; 21.2% having SUD among patients with two to three conditions; and 32.5% having SUD among patients with 4-9 conditions). Chronic conditions were associated with increased odds of SUDs. For all SUD groups, hospitalization was more prevalent among patients with SUD than those without it; prevalence of hospitalization increased with the number of comorbid chronic conditions.

Conclusions: Findings reveal a striking pattern of multicomorbidity of SUD and chronic diseases and its positive association with hospitalization. Behavioral healthcare integration should consider efforts to assess and treat comorbid SUD and chronic diseases, especially among adults with multiple chronic conditions.

Related protocols: CTN-0057-Ot

Abstract:

Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S., but screening for alcohol and drug use is not part of routine health care and substance use information is not systematically collected in electronic health records.

This presentation described two protocols in the CTN that aimed to address this issue: CTN-0059, in which the TAPS Tool for screening and brief assessment was developed and validated, and CTN-0062, a feasibility and proof-of-concept study to assess incorporating the NIDA CTN Common Data Elements into electronic health records in large primary care settings.

Related protocols: CTN-0059, CTN-0062-Ot

Abstract:

There are limited data about the extent of DSM-5 substance use disorders (SUDs) among primary care patients. This study analyzed data from a multisite validation study of a substance use screening instrument conducted in a diverse sample of 2,000 adults aged 18 or older recruited from five primary care practices in four states, NIDA Clinical Trials Network protocol CTN-0059, the TAPS Tool study. Prevalence and correlates of 12-month DSM-5 SUDs were examined. Results found that overall, 75.5% of the sample used any substance, including alcohol (62%), tobacco (44.1%), or illicit drugs/nonmedical medications (27.9%) in the past 12 months (marijuana 20.8%, cocaine 7.3%, opioids 4.8%, sedatives 4.1%, heroin 3.9%). The prevalence of any 12-month SUD was 36% (mild disorder 14.2%, moderate/severe disorder 21.8%): tobacco 25.3% (mild 11.5%, moderate/severe 13.8%); alcohol 13.9% (mild 6.9%, moderate/severe 7%); and any illicit/nonmedical drug 14% (mild 4%, moderate/severe 10%). Among past 12-month users, a high proportion of tobacco and drug users met criteria for a disorder: tobacco use disorder 57.4% (26.1% mild, 31.3% moderate/severe) and any drug use disorder 50.2% (14.3% mild, 35.8% moderate/severe); a lower proportion of alcohol users (22.4%) met criteria for alcohol use disorder (11.1% mild, 11.3% moderate/severe). Over 80% of adults with opioid/heroin use disorder met criteria for a moderate/severe disorder. Younger ages, male sex, and low education were associated with increased odds of having SUD.

Conclusions: Given the national movement toward the integration of primary care and SUD treatment, these findings have implications for clinical practice. Twelve-month SUDs were prevalent among primary care patients in this sample, which highlights a need to improve primary care providers’ training and willingness to provide screening and treatment for SUD. To improve that integration, research is needed to inform primary care physicians’ willingness to use validated tools for screening substance misuse, identify effective approaches for addressing SUDs in medical settings, and engage patients into SUD treatment.

Related protocols: CTN-0059

Abstract:

This is the primary outcomes article for CTN-0059.

Substance use, a leading cause of illness and death, is under-identified in medical practice. The Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) tool was developed to address the need for a brief screening and assessment instrument that includes all commonly used substances and fits into clinical workflows. The goal of this multisite study conducted within the NIDA Clinical Trials Network, CTN-0059, was to assess the performance of the TAPS tool in primary care patients by comparing it with a reference standard measure, the modified World Mental Health Composite International Diagnostic Interview (CIDI), which measures problem use and substance use disorder (SUD).

The study was conducted at 5 adult primary care clinics with 2000 adult patients consecutively recruited from clinic waiting areas. Results found that interviewer- and self-administered versions of the TAPS tool had similar diagnostic characteristics. For identifying problem use (at a cutoff of 1+), the TAPS tool had a sensitivity of 0.93 (95%CI, 0.90 to 0.95) and specificity of 0.87 (CI, 0.85 to 0.89) for tobacco and a sensitivity of 0.74 (CI, 0.70 to 0.78) and specificity of 0.79 (CI, 0.76 to 0.81) for alcohol. For problem use of illicit and prescription drugs, sensitivity ranged from 0.82 (CI, 0.76 to 0.87) for marijuana to 0.63 (CI, 0.47 to 0.78) for sedatives; specificity was 0.93 or higher. For identifying any SUD (at a cutoff of 2+), sensitivity was lower.

Limitations of this study included the low prevalence of some drug classes, leading to poor precision in some estimates. Also, research assistants were not blinded to participants’ TAPS tool responses when they administered the CIDI.

Conclusions: Having information about a patient’s substance use is essential for ensuring the quality and safety of medical care. This study supports the use of the TAPS tool (at a cutoff of 1+) in screening diverse populations of adult primary care patients for problem substance use. Although it may detect tobacco, alcohol, and marijuana use disorders, further refinement is needed before it can be recommended broadly for SUD screening. Because it asks a limited number of questions to identify problem use of all commonly used substances and has the flexibility to be either self-administered or completed as an interview, the TAPS tool has the potential to ease barriers to incorporating substance use screening into busy clinical environments.

Related protocols: CTN-0059

Abstract:

Substance use and its associated use disorders are under-detected and under-treated in primary care. There is a need for a clinically useful brief screening and assessment instrument to identify primary care patients with substance use, sub-threshold substance use disorder (SUD), and SUD to facilitate brief intervention and treatment. This article describes the design of the recently completed NIDA Clinical Trials Network’s “Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool” validation study (CTN-0059). Study aims included to:

develop a 2-stage screening and brief assessment tool (TAPS Tool) to detect substance use, problem use, and SUD among adult primary care patients

examine the validity of both the screen component and the TAPS Tool by comparing them to reference standard screening and assessment measures of no use, problem use, and SUD; and

determine the feasibility and acceptability of the self-administration and interviewer-administration of the tool.

The design included a pilot testing phase (n=30) and the main study of 2,000 adult primary care participants who were randomly assigned in counter-balanced order to have the interviewer-administration or the self-administration of the TAPS Tool followed by the other administration format. Participants’ views of feasibility, acceptability and preference for format of self-administration versus interviewer-administration of the TAPS Tool were assessed. Criterion measures of use and DSM-5 SUDs were administered.

The TAPS Tool study builds on prior work to develop a 2-stage clinical tool for facilitating the adoption of screening, brief assessment and treatment for SUDs in primary care. The Tool is poised to make a unique contribution to the field in multiple ways, and addresses a timely need to develop a quick screen for early identification of substance use disorders and an assessment tool for detection of risk levels of substance use to inform optimal clinical management among adults in primary care settings.

Related protocols: CTN-0059

Abstract:

Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and post-traumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on “superiority” designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment.

This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses as a case example one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN). The paper concludes with implications of this secondary analytic approach to improve addiction researchers’ ability to identify best practices for community-based treatment of these disorders.

Conclusions: Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Given the continuing gap between research and practice, appropriately executed secondary analytic studies are an important step in addressing questions that have real-world value to community clinicians. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal consideration and care to the primary outcome analysis.

Abstract:

Comorbid physical and mental health problems are associated with poorer substance abuse treatment outcomes; however, little is known about these conditions among stimulant abusers at treatment entry. This study compared racial and ethnic groups on baseline measures of drug use patterns, comorbid physical and mental health disorders, quality of life, and daily functioning among cocaine and stimulant abusing/dependent patients. Baseline data from a multi-site, randomized clinical trial of vigorous exercise as a treatment strategy for a diverse population of stimulant abusers (N=290) were analyzed (National Drug Abuse Treatment Clinical Trials Network protocol CTN-0037).

Significant differences between groups were found on drug use characteristics, stimulant use disorders, and comorbid mental and physical health conditions. White, Black, and Hispanic participants reported varied demographic characteristics, substance use patterns and diagnoses, and comorbid mental and physical health conditions. Blacks were more likely to use alcohol and to be diagnosed with a cocaine use disorder only, whereas Whites were more likely to use methamphetamines and a variety of other illicit drugs and to be diagnosed with both a cocaine and other stimulant use disorder or other stimulant use disorder only. Hispanics, similar to Blacks, were more likely to use alcohol, but their rates of methamphetamine use and diagnoses for cocaine and other stimulant use disorder or other stimulant use disorder only fell in between Whites and Blacks. Additionally, Blacks in this study reported fewer psychiatric disorders and symptoms of depression, and better mental health status and well-being than Whites or Hispanics; however, they also reported more comorbid medical conditions, poorer health status, and lower physical and cognitive functioning than other groups. This may be related to barriers to quality medical services for Blacks.

Conclusions: These findings offer implications for stimulant use treatment. They highlight the usefulness of integrating mental and physical health services into substance abuse treatment programs serving racially and ethnically diverse patients. Receipt of primary medical care is associated with lower addiction severity and suggests that efforts to link treatment-seeking substance abusers to primary medical care services should be considered. Integrating mental and physical health care into substance use disorder treatment while paying attention to differences in racial and ethnic groups could have a substantial impact on treatment outcomes.

Related protocols: CTN-0037

Abstract:

The Patient Protection and Affordable Care Act (2010) and the Mental Health Parity and Addiction Equity Act (2008) expand substance use disorder (SUD) care services in the USA into general medical settings. Care offered in these settings will engage substance-using patients in an integrated and patient-centered environment that addresses physical and mental health comorbidities and follows a chronic care model.

This expansion of SUD services presents a great need for evidence-based practices useful in general medical settings, and reveals several research gaps to be addressed.

The National Drug Abuse Treatment Clinical Trials Network (CTN) of the National Institute on Drug Abuse can serve an important role in this endeavor. This commentary highlights high-priority research gaps, and suggests that, to meet the challenge of filling those gaps, the SUD clinical research community and, in particular, the NIDA CTN, should: expand clinical research infrastructures to include practice-based research networks in general medical settings; develop the “learning health care system” model for conducting practical trials and comparative effectiveness research; identify and evaluate feasible chronic care models for the treatment of SUDs and co-occurring conditions; and leverage modern health information technology, including electronic health records, as new resources for data collection and data sharing.

These foundational steps should help to ensure that new models for mainstreamed, integrative SUD care can be built upon a sturdy base of research evidence.

Abstract:

Undertreated or untreated substance use disorders (SUD) remain a pervasive, medically-harmful public health problem in the United States, particularly in medically underserved and low-income populations lacking access to appropriate treatment. The need for greater access to SUD treatment was expressed as policy in the Final Rule on standards related to essential health benefits, required to be covered through the 2010 Affordable Care Act (ACA) health insurance exchanges. SUD treatment services have been included as an essential health benefit, in a manner that complies with the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008. Consequently, with the ACA, a vast expansion of SUD-care services in primary care is looming.

NIDA’s Center for the Clinical Trials Network, along with other partners, is supporting the development, validity and reliability testing, and electronic specification of a standardized and science-based composite clinical quality measure/performance measure that would be used for combined screening and intervention for substance abuse. This commentary discusses additional challenges and other opportunities under the ACA for equipping health care professionals with appropriate workforce training, infrastructure, and resources to support and guide science-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for SUD in primary care.

Abstract:

Addiction is a chronic brain disease with consequences that remain problematic years after discontinuation of use. Despite this, treatment models focus on acute interventions and are carved out from the main health care system. The Patient Protection and Affordable Care Act (2010) brings the opportunity to change the way substance use disorder (SUD) is treated in the United States. The treatment of SUD must adapt to a chronic care model offered in an integrated care system that screens for at-risk patients and includes services needed to prevent relapses. The partnering of the health care system with substance abuse treatment programs could dramatically expand the benefits of prevention and treatment of SUD. Screening, Brief Intervention, and Referral to Treatment (SBIRT), the subject of National Drug Abuse Treatment Clinical Trials Network protocols CTN-0047 (SMART-ED) and CTN-0057-Ot (SBIRT-PC), is cited as an effective strategy in identifying and intervening drug problems in emergency departments and primary care and improving health outcomes. Expanding roles of health information technology and nonphysician workforces, such as social workers, are essential to the success of a chronic care model.

This article by the Director of the Center for the Clinical Trials Network (CCTN, Dr. Tai) and the Director of the National Institute on Drug Abuse (NIDA, Dr. Volkow) is part of a special issue of the journal Social Work in Public Health about “The Role of Social Work in the Prevention and Treatment of Substance Use Disorders” that includes a number of articles about the National Drug Abuse Treatment Clinical Trials Network (CTN). See [*URL*] for more information about the issue.

Related protocols: CTN-0047, CTN-0057-Ot

Abstract:

Electronic health records (EHR) are essential in improving quality and enhancing efficiency of health-care delivery. By 2015, medical care receiving service reimbursement from US Centers for Medicare and Medicaid Services (CMS) must show “meaningful use” of EHRs. Substance use disorders (SUD) are grossly under-detected and under-treated in current US medical care settings. Hence, an urgent need exists for improved identification of and clinical intervention for SUD in medical settings. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) has leveraged its infrastructure and expertise and brought relevant stakeholders together to develop consensus on brief screening and initial assessment tools for SUD in general medical settings, with the objective of incorporation into US EHRs. Stakeholders were identified and queried for input and consensus on validated screening and assessment for SUD in general medical settings to develop common data elements to serve as shared resources for EHRs on screening, brief intervention, and referral to treatment (SBIRT), with the intent of supporting interoperability and data exchange in a developing Nationwide Health Information Network. Through consensus of input from stakeholders, a validated screening and brief assessment instrument, supported by Clinical Decision Support tools, was chosen to be used at out-patient and general medical settings. The screening instrument consists of a single question, “How many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons?” (developed and validated by Smith et al, Arch Intern Med 2010:170:1155-60), and the 10-item version of the Drug Abuse Screening Test (DAST) serves as the assessment tool for those who screen positive for potential SUD.

Conclusions: The creation and adoption of a core set of validated common data elements and the inclusion of such consensus-based data elements for general medical settings will enable the integration of SUD treatment within mainstream health care, and support the adoption and “meaningful use” of the US Office of the National Coordinator for Health Information Technology (ONC)-certified EHRs, as well as CMS reimbursement.

Abstract:

While substance use problems are considered to be common in medical settings, they are not systematically assessed and diagnosed for treatment management. Research data suggest that the majority of individuals with a substance use disorder do not use treatment or delay treatment-seeking for over a decade. The separation of substance abuse services from mainstream medical care and a lack of preventive services for substance abuse in primary care can contribute to under-detection of substance use problems. When fully enacted in 2014, the Patient Protection and Affordable Care Act 2010 will address these barriers by supporting preventive services for substance abuse (screening, counseling) and integration of substance abuse care with primary care. One key factor that can help to achieve this goal is to incorporate the standardized screeners or common data elements for substance use and related disorders into the electronic health records (EHR) system in the health care setting. NIDA has asked its Clinical Trials Network (CTN) to lead the effort to develop a set of such data elements for drug abuse research that could also be used in EHRs for patient care.

This commentary focuses on recent evidence about routine screening and intervention for alcohol/drug use and related disorders in primary care. Federal efforts in developing common data elements for use as screeners for substance use and related disorders are described. A pressing need for empirical data on screening, brief intervention, and referral to treatment (SBIRT) for drug-related disorders to inform SBIRT and related EHR efforts is highlighted.

Supported by the Duke Clinical Research Institute (CTN DSC 1).