TAU vs m-SBIRT in Primary Care

NCT06250153 | Withdrawn

• 1 other identifier: Pro00133783
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this research is to leverage technology in primary care clinics to improve screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and treatment attendance by comparing

1. 1.a text message-based screening, phone-based brief intervention, and referral to treatment by a remote care coordinator (m-SBIRT; intervention arm), versus
2. 2.evidence-based, in-person Screening, Brief Intervention, and Referral to Treatment (SBIRT; Treatment As Usual (TAU); control arm).

Conditions

Substance Use Disorders

Keywords

Substance Use Disorders; Social Determinants of Health; Screening, Brief Intervention, Referral to Treatment (SBIRT); Telehealth; Mobile SBIRT (m-SBIRT); Primary Care

Outcome Measures

Primary Outcomes (2)

• Positive screens for substance use

  A positive screen is defined as positive endorsement of substance use (alcohol, drugs, tobacco, etc) within the questionnaire. We will compare rates of positive screens for substance use in individuals assigned to m-SBIRT compared to TAU.

  Immediately following screening.

• Change in treatment attendance

  Treatment attendance is defined as attending one or more visits to address substance use concerns within one month of referral. We will compare rates of treatment attendance of individuals assigned to m-SBIRT compared to TAU.

  Within one month of referral to treatment.

Study Arms (2)

Treatment as Usual

NO INTERVENTION

This group will receive routine substance use screening questions during their in-person primary care visit as part of standard of care.

m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)

EXPERIMENTAL

This group will receive a mobile phone text message based substance use screening (questions used in standard of care) with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to substance use disorder (SUD) treatment.

Behavioral: m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)

Interventions

m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment) BEHAVIORAL

M-SBIRT is a mobile phone-based program designed to enhance delivery of Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based approach for mental health and substance use screening and treatment. The program utilizes mobile phone text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to substance use disorder treatment services.

m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Attended a primary care visit at the MUSC Family Medicine clinic on Bee St
• English fluency
• Owner of a cell phone with SMS text-message based capability
• Access to WIFI
• A device to allow audio and video teleconferencing if completing informed consent remotely
• Able to provide informed consent.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Constance Guille, MD

  Professor-Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 8, 2024
• Study Start: January 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02