Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

Official title

Improving Alcohol and Substance Use Care Access, Outcomes, and Equity During the Reproductive Years: A Type 1 Hybrid Trial in Family Planning Clinics

Overview

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. 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.

Detailed description

Risky alcohol and drug use are associated with severe, negative, and long-term health outcomes and disparities, including sexual and reproductive health (SRH), among reproductive aged people in the United States. High rates and sequelae of alcohol and drug use disproportionately experienced by structurally marginalized groups shape lifelong health inequities for people of racial/ethnic minority, living in poverty, and residing in under-resourced and under-served communities. Among populations at risk of pregnancy-related sequelae (predominantly those self-identifying as women and thus this study's primary focus), harmful alcohol and substance use and alcohol use disorders (AUDs)/substance use disorders (SUDs) contribute to condom and contraceptive nonuse among those not intending pregnancy, sex while intoxicated, non-consensual sex, violence/rape, sexually transmitted infections, unintended pregnancy, and maternal and infant morbidity and mortality.

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.

Interventions

• Behavioral 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, las

Primary outcome measures

• Average Number of Drinks Per Drinking Day [Time frame: Baseline, Day 30, Month 3]
• Number of Days of Drug Use [Time frame: Baseline, Day 30, Month 3]
• Incidence of sex under influence of alcohol/drugs [Time frame: Baseline, Day 30, Month 3]
• Number of events of sex under influence of alcohol/drugs [Time frame: Baseline, Day 30, Month 3]
• Patient Health Questionnaire (PHQ-9) [Time frame: Baseline, Day 30, Month 3]
• Number of Clinic Patients Receiving a Brief Intervention During Implementation Phase [Time frame: During the 12-month implementation phase]
• Number of Clinic Patients Receiving a Brief Intervention During Sustainment Phase [Time frame: During the 12-month sustainment phase]
• Number of Providers Using SBIRT During Implementation Phase [Time frame: During the 12-month implementation phase]
• Number of Clinics Using SBIRT During Sustainment Phase [Time frame: During the 12-month sustainment phase]
• Number of Providers Using SBIRT During Sustainment Phase [Time frame: During the 12-month sustainment phase]

Secondary outcome measures (12)

• Number of Days of Alcohol Use [Time frame: Baseline, Day 30, Month 3]
• Number of Days of Binge Drinking [Time frame: Baseline, Day 30, Month 3]
• Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Score [Time frame: Baseline, Day 30, Month 3]
• Drug Abuse Screening Test (DAST-10) Score [Time frame: Baseline, Day 30, Month 3]
• Incidence of condom nonuse [Time frame: Baseline, Day 30, Month 3]
• Number of events of condom nonuse [Time frame: Baseline, Day 30, Month 3]
• Incidence of contraceptive nonuse [Time frame: Baseline, Day 30, Month 3]
• Number of events of contraceptive nonuse [Time frame: Baseline, Day 30, Month 3]
• Incidence of regretted/nonconsensual sex and sexual violence [Time frame: Baseline, Day 30, Month 3]
• Number of events of regretted/nonconsensual sex and sexual violence [Time frame: Baseline, Day 30, Month 3]
• Unintended pregnancy [Time frame: Baseline, Day 30, Month 3]
• Generalized Anxiety Disorder 7-item (GAD-7) Scale Score [Time frame: Baseline, Day 30, Month 3]

Eligibility criteria

Inclusion criteria

• Over the age of 18 years
• 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

• Not capable of communicating (reading, speaking, writing) in English or Spanish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Greater Boston Health Center — Boston
• Metro West Health Center — Marlborough
• Western Massachusetts Health Center — Springfield
• Central Massachusetts Health Center — Worcester

Publications

• Tan CH, Denny CH, Cheal NE, Sniezek JE, Kanny D. Alcohol use and binge drinking among women of childbearing age - United States, 2011-2013. MMWR Morb Mortal Wkly Rep. 2015 Sep 25;64(37):1042-6. doi: 10.15585/mmwr.mm6437a3. PMID 26401713
• Naimi TS, Lipscomb LE, Brewer RD, Gilbert BC. Binge drinking in the preconception period and the risk of unintended pregnancy: implications for women and their children. Pediatrics. 2003 May;111(5 Pt 2):1136-41. PMID 12728126
• Thomas AG, Brodine SK, Shaffer R, Shafer MA, Boyer CB, Putnam S, Schachter J. Chlamydial infection and unplanned pregnancy in women with ready access to health care. Obstet Gynecol. 2001 Dec;98(6):1117-23. PMID 11755563
• Kesmodel U, Wisborg K, Olsen SF, Henriksen TB, Secher NJ. Moderate alcohol intake in pregnancy and the risk of spontaneous abortion. Alcohol Alcohol. 2002 Jan-Feb;37(1):87-92. doi: 10.1093/alcalc/37.1.87. PMID 11825863
• Iyasu S, Randall LL, Welty TK, Hsia J, Kinney HC, Mandell F, McClain M, Randall B, Habbe D, Wilson H, Willinger M. Risk factors for sudden infant death syndrome among northern plains Indians. JAMA. 2002 Dec 4;288(21):2717-23. doi: 10.1001/jama.288.21.2717. PMID 12460095
• Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30. PMID 21036512
• Ko JY, Wolicki S, Barfield WD, Patrick SW, Broussard CS, Yonkers KA, Naimon R, Iskander J. CDC Grand Rounds: Public Health Strategies to Prevent Neonatal Abstinence Syndrome. MMWR Morb Mortal Wkly Rep. 2017 Mar 10;66(9):242-245. doi: 10.15585/mmwr.mm6609a2. PMID 28278146
• 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): PMID 32293827

Identifiers

NCT: NCT05910580 · STUDY00005766 · R01AA030529

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗