Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
NCT ID: NCT05910580
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2025-07-03
2027-05-31
Brief Summary
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The main questions it aims to answer are:
* Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing?
* Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity?
* Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)?
Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months.
Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.
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Detailed Description
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Family planning (FP) clinics are uniquely well-suited but entirely untapped sites for implementing and scaling integrated alcohol/substance use services. Largely community-based health centers that are publicly funded and/or serve Medicaid enrollees, FP clinics are a trusted care source and primary access point for reproductive aged women, and a safety net for the most socially disadvantaged groups. Yet few, if any, studies have rigorously evaluated interventions or implementation strategies to accelerate the uptake of alcohol/substance services in FP contexts. In obstetrics and HIV, widespread adoption of evidence-based SBIRT (screening, brief intervention, and referral to treatment) is precluded by multi-level barriers; data on specific challenges faced by FP providers are lacking. Virtually nothing is known about telemedicine, which has been rolled out for contraception and other routine visits during the pandemic, as a technological infrastructure for SBIRT. Whether and how the promising strategy of Implementation and Sustainment Facilitation (ISF) can bridge systems barriers and support scale up in FP settings is unknown.
The researchers of this study propose an explanatory, sequential, mixed methods study of alcohol and drug SBIRT in an expansive FP clinic network - a novel and highly impactful setting with a national reach of a diverse and largely structurally disadvantaged population of reproductive-aged women at greatest risk for AUDs/SUDs. The researchers will conduct a randomized Type 1 Hybrid Effectiveness-Implementation Trial within a large Northeastern regional affiliate and its four clinics of a national SRH care organization.
Results will inform an evidence-based, innovative, stakeholder-driven FP SBIRT model in response to the high-level calls for integrated women's health care. With concrete guidance for scaling alcohol/ drug services in SRH settings nationally, findings will promote women's health equity across the U.S.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Patients at study clinics who are randomized to receive the Screening, Brief Intervention, and Referral to Treatment (SBIRT) intervention, which is delivered in-person and through telemedicine.
Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based approach supported by national healthcare organizations, including the Preventative Services Task Force and the American College of Obstetrics and Gynecologists. Validated tools will efficiently screen an individual's substance use risk. Patients who screen in the risky/harmful range then receive a brief motivational interviewing-based intervention adapted from the evidence-based Brief Negotiated Interview, lasting 5-10 minutes, which provides feedback, helps explore health risks, and motivates change. Individuals who screen in the severe category, indicating a likely AUD/SUD, also receive a brief intervention, aimed at increasing motivation to accept a referral to treatment, and requiring a more intensive approach will also receive a warm-hand off referral to specialty addiction treatment. Procedures for SBIRT delivery will be adapted to the flow of telemedicine visits.
Usual Care
Patients at study clinics who are randomized to receive usual care. None of the clinic sites have implemented standardized screening, brief intervention, or referral to treatment components. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.
No interventions assigned to this group
Interventions
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Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based approach supported by national healthcare organizations, including the Preventative Services Task Force and the American College of Obstetrics and Gynecologists. Validated tools will efficiently screen an individual's substance use risk. Patients who screen in the risky/harmful range then receive a brief motivational interviewing-based intervention adapted from the evidence-based Brief Negotiated Interview, lasting 5-10 minutes, which provides feedback, helps explore health risks, and motivates change. Individuals who screen in the severe category, indicating a likely AUD/SUD, also receive a brief intervention, aimed at increasing motivation to accept a referral to treatment, and requiring a more intensive approach will also receive a warm-hand off referral to specialty addiction treatment. Procedures for SBIRT delivery will be adapted to the flow of telemedicine visits.
Eligibility Criteria
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Inclusion Criteria
* U.S. residing
* Have internet access (own a computer or smart phone)
* Screen positive to one or more risky alcohol and substance use behaviors as determined by our standardized abbreviated instruments
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Stanford University
OTHER
Planned Parenthood League of Massachusetts
OTHER
Emory University
OTHER
Responsible Party
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Justine Welsh
Associate Professor
Principal Investigators
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Kelli S Hall, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Justine Welsh, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Greater Boston Health Center
Boston, Massachusetts, United States
Metro West Health Center
Marlborough, Massachusetts, United States
Western Massachusetts Health Center
Springfield, Massachusetts, United States
Central Massachusetts Health Center
Worcester, Massachusetts, United States
Countries
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Central Contacts
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References
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National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Examination of the Integration of Opioid and Infectious Disease Prevention Efforts in Select Programs. Opportunities to Improve Opioid Use Disorder and Infectious Disease Services: Integrating Responses to a Dual Epidemic. Washington (DC): National Academies Press (US); 2020 Jan 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK555809/
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Other Identifiers
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STUDY00005766
Identifier Type: -
Identifier Source: org_study_id
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