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Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.

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.We describe the design of the recently completed National Drug Abuse Treatment Clinical Trials Network's tobacco, alcohol, prescription medications, and substance use/misuse screen and brief assessment tool validation study. 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 2000 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.

SUBMITTER: Wu LT

PROVIDER: S-EPMC5035619 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.

Wu Li-Tzy LT McNeely Jennifer J Subramaniam Geetha A GA Sharma Gaurav G VanVeldhuisen Paul P Schwartz Robert P RP

Contemporary clinical trials 20160719

<h4>Background</h4>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.<h4>Methods</h4>We describe the design of the recently completed National Drug Abuse Treatment Clinical Trials Network's tobacco, alcohol, prescr ...[more]

PMID: 27444426

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Project description:BackgroundSubstance use, a leading cause of illness and death, is underidentified in medical practice.ObjectiveThe 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 study was to assess the performance of the TAPS tool in primary care patients.DesignMultisite study, conducted within the National Drug Abuse Treatment Clinical Trials Network, comparing the TAPS tool with a reference standard measure. (ClinicalTrials.gov: NCT02110693).Setting5 adult primary care clinics.Participants2000 adult patients consecutively recruited from clinic waiting areas.MeasurementsInterviewer- and self-administered versions of the TAPS tool were compared with a reference standard, the modified World Mental Health Composite International Diagnostic Interview (CIDI), which measures problem use and substance use disorder (SUD).ResultsInterviewer- 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.LimitationsThe low prevalence of some drug classes led to poor precision in some estimates. Research assistants were not blinded to participants' TAPS tool responses when they administered the CIDI.ConclusionIn a diverse population of adult primary care patients, the TAPS tool detected clinically relevant problem substance use. Although it also may detect tobacco, alcohol, and marijuana use disorders, further refinement is needed before it can be recommended broadly for SUD screening.Primary funding sourceNational Institute on Drug Abuse.

Project description:BACKGROUND:The TAPS Tool is a substance use screening and brief assessment instrument that was developed for use in primary care medical settings. It is one of the first screening instruments to provide rapid assessment of all commonly used substance classes, including illicit and prescription opioids, and is one of the only available screeners designed and validated in an electronic self-administered format (myTAPS). This secondary analysis of data from the TAPS Tool validation study describes the feasibility and acceptability of the myTAPS among primary care patients. METHODS:Adult patients (N?=?2000) from five primary care clinics completed the TAPS Tool on a tablet computer (myTAPS), and in an interviewer-administered format. Requests for assistance and time required were tracked, and participants completed a survey on ease of use, utilization of audio guidance, and format preference. Logistic regression was used to examine outcomes in defined subpopulations, including groups that may have greater difficulty completing an electronic screener, and those that may prefer an electronic self-administered approach. RESULTS:Almost all participants (98.3%) reported that the myTAPS was easy to use. The median time to complete myTAPS screening was 4.0 min (mean 4.48, standard deviation 2.57). More time was required by participants who were older, Hispanic, Black, or reported non-medical prescription drug use, while less time was required by women. Assistance was requested by 25% of participants, and was more frequently requested by those who with lower education (OR?=?2.08, 95% CI 1.62-2.67) or age?>?65 years (OR?=?2.79, 95% CI 1.98-3.93). Audio guidance was utilized by 18.3%, and was more frequently utilized by participants with lower education (OR?=?2.01, 95% CI 1.54-2.63), age?>?65 years (OR?=?1.79, 95% CI 1.22-2.61), or Black race (OR?=?1.30, 95% 1.01-1.68). The myTAPS format was preferred by women (OR?=?1.29, 95% CI 1.00-1.66) and individuals with drug use (OR?=?1.43, 95% CI 1.09-1.88), while participants with lower education preferred the interviewer-administered format (OR?=?2.75, 95% CI 2.00-3.78). CONCLUSIONS:Overall, myTAPS screening was feasible and well accepted by adult primary care patients. Clinics adopting electronic screening should be prepared to offer assistance to some patients, particularly those who are older or less educated, and should have the capacity to use an interviewer-administered approach when required.

Project description:BackgroundThe Tobacco, Alcohol, Prescription Medication, and Other Substance use (TAPS) tool is a combined two-part screening and brief assessment developed for adult primary care patients. The tool's first-stage screening component (TAPS-1) consists of four items asking about past 12-month use for four substance categories, with response options of never, less than monthly, monthly, weekly, and daily or almost daily.ObjectiveTo validate the TAPS-1 in primary care patients.DesignParticipants completed the TAPS tool in self- and interviewer-administered formats, in random order. In this secondary analysis, the TAPS-1 was evaluated against DSM-5 substance use disorder (SUD) criteria to determine optimal cut-points for identifying unhealthy substance use at three severity levels (problem use, mild SUD, and moderate-to-severe SUD).ParticipantsTwo thousand adult patients at five primary care sites.Main measuresDSM-5 SUD criteria were determined via the modified Composite International Diagnostic Interview. Oral fluid was used as a biomarker of recent drug use.Key resultsOptimal frequency-of-use cut-points on the self-administered TAPS-1 for identifying SUDs were ≥ monthly use for tobacco and alcohol (sensitivity = 0.92 and 0.71, specificity = 0.80 and 0.85, AUC = 0.86 and 0.78, respectively) and any reported use for illicit drugs and prescription medication misuse (sensitivity = 0.93 and 0.89, specificity = 0.85 and 0.91, AUC = 0.89 and 0.90, respectively). The performance of the interviewer-administered format was similar. When administered first, the self-administered format yielded higher disclosure rates for past 12-month alcohol use, illicit drug use, and prescription medication misuse. Frequency of use alone did not provide sufficient information to discriminate between gradations of substance use problem severity. Among those who denied drug use on the TAPS-1, less than 4% had a drug-positive biomarker.ConclusionsThe TAPS-1 can identify unhealthy substance use in primary care patients with a high level of accuracy, and may have utility in primary care for rapid triage.

Project description:IntroductionAlcohol and substance misuse are a public health priority. The World Health Organisation (WHO) estimates that harmful alcohol use accounts for 5.1% of the global burden of disease and that 35.6 million people worldwide are affected by substance misuse. The Coronavirus Disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has disrupted delivery of face-to-face alcohol and substance misuse interventions and has forced the development of alternative remote interventions or adaptation to existing ones. Although existing research on remote interventions suggests they might be as effective as face-to-face delivery, there has been a lack of systematic exploration of their content, the experience of service users, and their effectiveness for behavioural outcomes. This review will provide a narrative synthesis of the behaviour change techniques (BCT) contained in interventions for alcohol and/or substance misuse and their association with effectiveness.Methods and analysisSystematic searches will be conducted in MEDLINE, Scopus, PsycINFO (ProQuest), and the Cochrane Library. Included studies will be those reporting remote interventions focusing on alcohol and/or substance misuse among adults living in the community and which have a primary behaviour change outcome (i.e., alcohol levels consumed). Data extraction will be conducted by one author and moderated by a second, and risk of bias and behaviour change technique (BCT) coding will be conducted by two authors independently. A narrative synthesis will be undertaken focussing upon the association of BCTs with intervention effectiveness using promise ratios.Patient and public involvement (ppi)The Public Involvement in Research Group (PIRG), part of the NIHR-funded PHIRST, will be involved in refining the review questions, eligibility criteria, data synthesis and dissemination.DisseminationDissemination will be through an academic peer reviewed publication, alongside other outputs to be shared with non-academic policy, professional, and public audiences, including local authorities, service users and community organisations.

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Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.

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Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.

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