Contemporary Clinical Trials 2016;50:90-97. [doi: 10.1016/j.cct.2016.07.013]
Li-Tzy Wu, ScD (Duke University, MS Node), Jennifer McNeely, MD, MS (New York University School of Medicine, GNY Node), Geetha A. Subramaniam, MD (NIDA Center for the Clinical Trials Network), Gaurav Sharma, PhD (CTN Data & Statistics Center, EMMES), Paul C. VanVeldhuisen, PhD (CTN Data & Statistics Center, EMMES), Robert P. Schwartz, MD (Friends Research Institute, MA Node).
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. (Article (Peer-Reviewed), PDF, English, 2016)
Keywords: Alcohol | CTN protocol development | Integrated medical and behavioral health care | Prescription-type opiates | Primary care | Screening and assessment instruments | Smoking | Contemporary Clinical Trials (journal)
Document No: 1216, PMID: 27444426, PMCID: PMC5035619.
Submitted by CTN Dissemination Librarians, 7/25/2016.