Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients

Tobacco and alcohol use are among the leading causes of preventable death in the United States (1, 2), and illicit substance use is a significant contributor to the HIV and opioid overdose epidemics (3, 4). Health care settings offer an opportunity to identify substance use and related problems, provide timely interventions, and guide patients to treatment. Tobacco screening and treatment are core clinical quality measures for primary care (5), and screening followed by a brief intervention for unhealthy alcohol use is recommended by the U.S. Preventive Services Task Force (69). Although the efficacy of brief interventions in reducing drug use has not been clearly established (1013), screening for substance use in medical settings may be clinically justified by the effects of substance use on the prevention and treatment of other medical conditions (1416), as well as the potential for drugmedication interactions (17, 18) and overdose (19). Primary care settings require a screening and assessment approach that is efficient and accurate, and informs clinical care (2023). Although very brief screening tools have been developed to efficiently identify alcohol and drug use (2427), they do not provide enough information about the specific substances used, or the patient's risk level, to guide clinical actions. A structured substance use assessment may provide this information, but current options either are too lengthy (28) or do not provide sufficient detail (29, 30) to meet the needs of medical providers. We developed the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool as a better instrument for substance use screening in primary care settings. This tool consists of a 4-item screen for tobacco, alcohol, illicit drugs, and nonmedical use of prescription medications, followed by a substance-specific assessment of risk level for individuals with positive screening results. The TAPS tool is flexible enough to be administered face to face or self-administered with a tablet computer, so it can accommodate various clinical workflows. This article presents the results from a large multisite study conducted within the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network to assess the performance of the TAPS tool compared with a reference standard measure in adult primary care patients. Supplement. Study Protocol Methods Participants and Recruitment Participants were recruited from 5 primary care clinics in Baltimore, Maryland; New York, New York; Richmond, Virginia; and 2 sites in Kannapolis, North Carolina. Clinics were selected to provide a geographically diverse sample of urban and suburban participants, in whom substance use patterns would be expected to vary. A sample size of 2000 was set before recruitment began, and sites enrolled competitively from August 2014 to April 2015 until that number was reached. Sample size was determined by using computer simulations to calculate the precision of the estimates of sensitivity and specificity as a function of the number of participants and the prevalence of substance use. We determined that a sample size of 2000 would allow us to estimate sensitivity with a precision (defined as the 95th percentile of the half-width of the 95% CI) of 12.5% for substances with a prevalence of 5% and up to 2.5% for those with a prevalence of 50%. Eligibility Criteria Adults aged 18 years or older who were in a clinic for a medical visit and could provide informed consent were eligible to participate. Persons were excluded if they could not comprehend spoken English, were physically unable to complete the self-administered TAPS tool, or were enrolled in this study previously. Recruitment Research assistants (RAs) consecutively approached each patient in the waiting area. Interested patients were screened for eligibility and provided verbal consent. They were given the option of having the study visit before their appointment if the wait time was longer than 1 hour; otherwise, the study encounter occurred after the medical visit. Study Procedures Study visits were completed in a private room. Participants were assigned a unique identifier and were told that responses were confidential and would not be shared with anyone in the clinic. The electronic data capture system randomly assigned half of the participants to begin with the self-administered TAPS tool and half to begin with the interviewer-administered version. After completing the TAPS tool in the first format (for example, self-administered), the participants completed it in the other version (for example, interviewer-administered). The self-administered version was delivered on a tablet computer (iPad, Apple), which gave participants the option of hearing the questions and response options read verbatim by a recorded female voice. For the interviewer version, the RAs read all the questions and response options aloud to the participants. After both versions were completed, the RA administered a questionnaire about the feasibility and acceptability of the TAPS tool; then, additional substance use measures were collected for comparison purposes. The RAs were not blinded to participant responses on the interviewer-administered TAPS tool when they administered the reference standard measure: the modified World Health Organization World Mental Health Composite International Diagnostic Interview (www.hcp.med.harvard.edu/wmhcidi/index.php) here referred to as CIDI. After completing self-reported assessments, all participants were asked to provide verbal consent to participate in oral fluid testing for drugs. Participants received $20 for the main study and an additional $10 for oral fluid testing. All study procedures were approved by local institutional review boards (Duke University Health System, Friends Research Institute, New York University School of Medicine, and Virginia Commonwealth University). Measures Experimental Instrument: TAPS Tool The TAPS tool was developed as a 2-step screening and brief assessment approach from instruments that had not been validated. The screening component, TAPS-1, was adapted from NIDA Quick Screen V1.0 (31), whereas the brief assessment component, TAPS-2, is a modified version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)-Lite (32). A prototype of the TAPS tool was evaluated through cognitive interviews (3335) with 30 adult primary care patients from 3 of the study sites. On the basis of these interviews, the wording of TAPS tool items was modified slightly before the instrument was finalized for use in this study. The tool is shown in Figure 1. The TAPS-1 component asked how frequently in the previous 12 months the participant used tobacco, alcohol (above guideline-recommended daily limits: 5 or more drinks per day for men; 4 or more drinks per day for women [36]), illicit drugs, or prescription medications (sedatives, opioids, and stimulants) for nonmedical purposes. Respondents chose from 5 options ranging from never to daily or almost daily. In TAPS-2, participants answered yes or no to questions regarding use of tobacco, alcohol, 6 classes of illicit drugs, and other drugs in the past 3 months. If a participant answered yes to any question, he or she received 2 or 3 follow-up items specific to that substance class. Figure 1. TAPS tool parts 1 and 2, showing items, skip pattern, and scoring system. ADHD = attention deficithyperactivity disorder; GHB = -hydroxybutyrate; LSD = lysergic acid diethylamide; MDMA = 3,4-methylenedioxymethamphetamine; TAPS = Tobacco, Alcohol, Prescription medication, and other Substance use. * Percocet is a trademark for a combination of acetominophen and oxycodone, manufactured by Endo Pharmaceuticals. Vicodin is a trademark for a combination of acetominophen and hydrocodone, manufactured by AbbVie. Xanax is a trademark for alprazolam, manufactured by Pfizer. Ativan is a trademark for lorazepam, manufactured by Wyeth. Klonopin is a trademark for clonazepam, manufactured by Genentech. Adderall is a trademark for mixed salts of a single-entity amphetamine product, manufactured by Shire. ** Ritalin is a trademark for methylphenidate hydrochloride, manufactured by Novartis. For TAPS-1, any response other than never constituted a positive result; participants with positive TAPS-1 results completed the corresponding items on TAPS-2, and their responses were summed within each substance class to generate a substance-specific risk score. The scores have a potential range of 0 to 3 for tobacco and other drugs and 0 to 4 for alcohol. In clinical practice, TAPS-2 would be administered only to participants with a positive result on TAPS-1; however, for the purposes of the study, participants completed all of TAPS-2 regardless of TAPS-1 responses. Reference Measures The CIDI was used as the gold standard reference measure. Prior versions of the CIDI have been used widely in epidemiologic and clinical research to assess substance use disorder (SUD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-4) (3741). As in our previous research (42), we used the existing CIDI items that mapped onto the DSM-5 SUD classifications (by omitting the item on legal problems and including the one on craving). Problem use was defined as past-year use with endorsement of 1 or more items on the CIDI. This approach was taken in previous screening tool studies to identify clinically important substance use that may not be severe enough to meet the criteria for an SUD (42, 43). The definition of an SUD was based on the standard diagnostic threshold of meeting 2 or more DSM criteria on the CIDI. Oral Fluid Testing The Intercept immunoassay (OraSure Technologies) objectively measured point prevalence for the following drug classes: marijuana, cocaine, phencyclidine, opiates, amphetamines, benzodiazepines, and barbiturates. It has a window of detection of up to 3 days for mos