Pilot Randomized Controlled Trial (RCT): Remote SBIRT Vs. In-Person SBIRT

NCT04630249 | Completed Results DMC

• 1 other identifier: 00103742
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim 1: Conduct a pilot, small-scale randomized controlled trial to examine feasibility and preliminary efficacy of LTW, compared to TAU. Outcomes related to feasibility include percentage of eligible patients recruited, study attrition, study retention, and mental health and substance use treatment appointment attendance. Outcomes related to preliminary efficacy will include participation in screening, referral and treatment at baseline, compared to TAU. Specific Aim 2: Conduct a randomized controlled trial to examine the effectiveness of LTW, compared to TAU. Outcomes related to effectiveness include screening, screening positive, referred to and attendance to treatment at baseline, compared to TAU.

Conditions

Pregnancy; Substance Use; Depression; Anxiety

Keywords

Pregnancy; Depression; Substance Use; Anxiety

Outcome Measures

Primary Outcomes (4)

• Completion of SBIRT (Specific Aim 1)

  We will compare the proportion of participants that complete a screen for mental health and substance use among those assigned to LTWP, compared to TAU.

  Baseline

• Screened Positive (Specific Aim 1)

  We will compare the proportion of those screening positive that are referred to treatment among those assigned to LTWP, compared to TAU.

  Baseline

• Referred to Treatment (Specific Aim 1)

  We will compare the proportion of participants referred to treatment that had at least one mental health and/or substance use disorder treatment appointment among those assigned to LTWP, compared to TAU.

  Baseline

• Treatment Attendance (Specific Aim 1)

  Treatment attendance (defined as attending at least 1 or more visits with a mental health and/or substance use disorder (SUD) treatment provider during pregnancy and the postpartum year)

  Baseline

Secondary Outcomes (3)

• Screened Positive (Specific Aim 2)

  Baseline

• Referred to Treatment (Specific Aim 2)

  Baseline

• Treatment Attendance (Specific Aim 2)

  Baseline

Study Arms (2)

Listening to Women and Pregnant and Postpartum People

EXPERIMENTAL

Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services. The text screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.

Behavioral: Listening to Women and Pregnant and Postpartum People

Usual Care

NO INTERVENTION

This group will receive in-person screening and referral to treatment by a nurse or physician per usual prenatal care. The in person screenings contain the SBIRT which is a survey with 9 questions related to depression, anxiety, substance abuse (alcohol, cigarettes, other drugs including prescription medication), and domestic violence.

Interventions

Listening to Women and Pregnant and Postpartum People BEHAVIORAL

Participants are enrolled in text message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, referral to telemedicine mental health and substance use disorder treatment services.

Listening to Women and Pregnant and Postpartum People

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) age 18-41; 2) currently pregnant or postpartum; 3) if pregnant, receiving prenatal care; 4) English fluency; 5) owner of a cell phone with short message service (SMS) text-message based capability; 6) access to Wireless Fidelity (WIFI) and a device to allow audio and video teleconferencing; 7) able to provide informed consent.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Depression; Anxiety Disorders

Interventions

Gravidity

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Pregnancy; Reproduction; Reproductive History; Epidemiologic Factors; Public Health; Environment and Public Health

Limitations and Caveats

Limited data capture of primary outcomes in EHR, particularly for treatment attendance. Treatment may have occurred in other settings not captured by EHR. It is possible that participants in TAU were screened and referred but findings were not recorded in the EHR. The study took place within a single health system and findings may not be generalizable. It is unknown whether the screening completion rates within LTWP would differ in settings where staff do not enroll patients into LTWP.

Results Point of Contact

• Title: Constance Guille
• Organization: The Medical University of South Carolina

guille@musc.edu

843-792-6489

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 16, 2020
• Study Start: December 15, 2020
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: October 18, 2024
• Results First Posted: October 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)