TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform

Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Clinical Trial

— TASP-ESP  

Official title:

TAPS-ESP: Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use Electronic Spanish Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879785
• Other study ID #: 018-596
• Status: Completed
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use

Intervention

Other:
• Screening
Screening and validation of assessment tool translated into Spanish

Locations

Country	Name	City	State
United States	Baylor Scott & White Research Institiute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Translation of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool (TAPS Tool)	To conduct a research-driven translation and adaptation of the TAPS Tool into a Spanish-language, self-administered mobile/tablet platform (TAPS-ESP), informed by cognitive interviews with 10 Spanish-speaking primary care patients.	Estimated 4 Month
Primary	Preliminary Examination of the translated Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)	To conduct a preliminary examination of the validity of the TAPS-ESP with 100 Spanish-speaking primary care patients, compared to established Spanish-language reference standard measures	Estimated 4 Month
Primary	Feasibility and Acceptability of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP)	To determine the (a) feasibility and (b) acceptability of the TAPS-ESP (including patient perspectives and preferences regarding TAPS-ESP integration with electronic health records) among Spanish-speaking adult primary care patients, using a brief survey with the 100 participants in the validation study.	Estimated 4 Months