Clinical trial NCT03879785: TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform
Official title: TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use
Keywords: Tobacco
Alcohol
Prescription Drug
Illicit Substance Use
Screening
Spanish
Hispanic
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This Phase 1 STTR project will develop a technology platform for delivering the TAPS Tool to a Spanish-speaking, health disparity population in a community health center. This will involve the adaptation of the TAPS into Spanish, its deployment on a self-administered mobile/tablet technology platform, and an empirical study of its preliminary validity, feasibility, and acceptability in a Spanish-speaking primary care sample. The investigators refer to this novel adaptation of the TAPS Tool as the TAPS-Electronic Spanish Platform, or TAPS-ESP.

Detailed description: Linguistically Accurate Screening and Assessment is Critical for Quality Patient Care. Accurate screening, diagnosis and treatment are entirely dependent on a linguistically-accurate and culturally-relevant assessment, especially for sensitive topics such as substance use. Language accessibility is essential to quality healthcare, the lack of which is an independent predictor of poor control of chronic disease and a significant contributor to health disparities, lack of patient satisfaction with healthcare, and poor quality patient education and understanding of their disorder. Hispanics experience a disproportionate burden of disability associated with mental disorders because of these disparities.

Primary care settings often are the gateway to identifying undiagnosed or untreated behavioral health disorders through effective screening. Thus, primary care settings can play a critical role in reducing behavioral health disparities by identifying individuals at risk of substance use problems. As the first steps in ensuring access to appropriate intervention or linkage to treatment services, screening and assessment are essential ingredients in quality care. It is widely believed that substance use problems are over represented in primary care settings, but providers lack the tools to effectively screen. Most of the patients seen in primary care are unlikely to seek treatment in the specialty behavioral health service system. Moreover, failure to identify unhealthy alcohol and other drug use can produce harmful medication interactions, resulting in significant clinical complications.

The "Tobacco, Alcohol, Prescription medication, and illicit Substance use screening Tool (or TAPS Tool), is a two-stage screening and brief assessment tool that first screens the four broad substance abuse categories (tobacco, alcohol, prescription drug misuse, and illicit substance use). In the second stage, the patient is assessed for more specific risks related to an expanded array of substances (tobacco, alcohol, cannabis, cocaine, methamphetamines, prescription stimulants, heroin, prescription opioids, sedatives, and other substances). The 4-item screener triggers brief assessment on these substance categories, and each substance yields a score of 0-3 (except alcohol, which is scored on a 0-4 range), which conveys to providers whether an intervention is indicated (a score of 1 suggests sub-diagnostic problem use; a score of 2 suggests substance use disorder). The TAPS Tool was validated against established diagnostic assessments in both interviewer-administered and self-administered iPad formats in a large, multi-site study (described in Preliminary Studies, below). However, only 11.7% of the original TAPS study sample reported Hispanic ethnicity, and the TAPS Tool currently exists only in an English language version.

The Proposed Study: TAPS-Electronic Spanish Platform (TAPS-ESP). The current study proposes to develop a technology platform for delivering the TAPS Tool to a Spanish-speaking, health disparity population in community health centers. This Phase 1 STTR project will involve: the adaptation of the TAPS into Spanish, its development on a self-administered mobile/tablet technology platform, and an empirical study of its preliminary validity, feasibility, and acceptability in a Spanish-speaking primary care sample. The investigators refer to this novel adaptation of the TAPS Tool as the TAPS-Electronic Spanish Platform, or TAPS-ESP.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* A patient at the established clinic site
* Spanish-language dominant (with ability to read Spanish)

Exclusion Criteria:

* Unable to provide informed consent (e.g., due to acute impairment or psychosis)
* Inability to comprehend or read Spanish
* Inability to self-administer the iPad tool due to physical limitations
* Previously enrolled in the study

Primary outcomes:
measure: Translation of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool (TAPS Tool)
timeFrame: Estimated 4 Month
measure: Preliminary Examination of the translated Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)
timeFrame: Estimated 4 Month
measure: Feasibility and Acceptability of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)
timeFrame: Estimated 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Research Institiute
state: Texas
Study officials:
References:
citation: Sanchez K, Gryczynski J, Carswell SB, Schwartz RP. Development and Feasibility of a Spanish Language Version of the Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use (TAPS) Tool. J Addict Med. 2021 Jan-Feb 01;15(1):61-67. doi: 10.1097/ADM.0000000000000699.