TAU vs m-SBIRT in Primary Care

In-Person Versus Text/Telephone Screening, Brief Intervention and Referral to Treatment in Primary Care

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

Primary Aim is to compare the efficacy of m-SBIRT to TAU in positive screens for substance use. Secondary Aim is to compare m-SBIRT to TAU on Substance Use Treatment Attendance.

Study Overview

• Status: Withdrawn
• Conditions: Substance Use Disorders
• Intervention / Treatment: Behavioral: m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment)

Detailed Description

This research study is looking at the use of technology in primary care clinics and seeing if it improves screening, brief intervention and referral to Substance Use Disorder (SUD) treatment, and attendance to treatment. To do so the study, Investigators will be comparing a text message based substance use screening and treatment program, called Mobile Screening, Brief intervention, and Referral to Treatment (m-SBIRT) to standard of care Screening, Brief Intervention and Referral Treatment which traditionally takes place in-person. Patients at the MUSC Bee Street Primary Care Clinic between the ages of 18-75 may be eligible.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as Usual; This group will receive routine substance use screening questions during their in-person primary care visit as part of standard of care.
Experimental: m-SBIRT (mobile-Screening, Brief Intervention, and Referral to Treatment); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Constance Guille, MD, Professor-Faculty

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: January 27, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Primary Care; Telehealth; Social Determinants of Health; Substance Use Disorders; Screening, Brief Intervention, Referral to Treatment (SBIRT); Mobile SBIRT (m-SBIRT)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: Pro00133783

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No