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Tobacco, Alcohol, Prescription Drug, and Illicit Substance UseTASP-ESPNCT03879785

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

A study testing Screening in people with Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
14 Mar 2019to 30 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Baylor Scott & White Research Institiute

    Dallas, Texas, 75204

Other trials in United States

About this study

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.

Read the 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.

Being tested
Screening
Keywords
Tobacco, Alcohol, Prescription Drug, Illicit Substance Use, Screening, Spanish, Hispanic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ScreeningOther

    Screening and validation of assessment tool translated into Spanish

Study groups in NCT03879785
Study groupRoleWhat they receive
Self-Administration followed by Interviewer-AdministeredActive comparatorNot described
Receives: Other: Screening
Interviewer-Administered followed by Self-AdministrationActive comparatorNot described
Receives: Other: Screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Estimated 4 Month

  2. 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

    Measured: Estimated 4 Month

  3. 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.

    Measured: Estimated 4 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start14 Mar 2019
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879785
Sponsor's protocol ID
018-596
Acronym
TASP-ESP
Status last verified
Aug 2019
First submitted
12 Mar 2019
Last updated
21 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32657958

Questions about this trial

What is this clinical trial studying?

A study testing Screening in people with Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use, run by Baylor Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Translation of the Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool (TAPS Tool) (time frame: Estimated 4 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879785, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.

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