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

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA), Emory University, Stanford University, Planned Parenthood League of Massachusetts

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 SBIRT, 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.

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 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.

Alcohol-Related Disorders, Substance-Related Disorders, Mental Health, Reproductive Health, Sexual Health, Sexually Transmitted Diseases, Contraception, Maternal Health, Pregnancy, Women's Health

Implementation Science, Mass Screening, Motivational Interviewing, Referral and Consultation, Quality of Health Care, Early Medical Intervention, Family Planning Services, Primary Health Care, Reproductive Health Services, Telemedicine, Preconception Care, Young Adult

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 (AUDIT-C and NIDA ASSIST) 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.

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.

Score on the depression scale from the Patient Health Questionnaire (PHQ-9), which measures depression severity in past 14 days. Scores can range from 0 to 27, with scores of 0-4 classified as minimal depression, 5-9 as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression, and ≥ 20 as severe depression). Each item on the scale can be scored from 0 (not at all) to 3 (nearly everyday).

Score on the depression scale from the Patient Health Questionnaire (PHQ-9), which measures depression severity in past 14 days. Scores can range from 0 to 27, with scores of 0-4 classified as minimal depression, 5-9 as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression, and ≥ 20 as severe depression). Each item on the scale can be scored from 0 (not at all) to 3 (nearly everyday).

Score on the depression scale from the Patient Health Questionnaire (PHQ-9), which measures depression severity in past 14 days. Scores can range from 0 to 27, with scores of 0-4 classified as minimal depression, 5-9 as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression, and ≥ 20 as severe depression). Each item on the scale can be scored from 0 (not at all) to 3 (nearly everyday).

Mean score on the first 10 items of the Brief Intervention Observation Sheet (BIOS) per provider from a sample of audio recorded brief interventions (BI). Scores can range from 0-10, with higher scores indicating better performance.

Mean score on the 11th item of the Brief Intervention Observation Sheet (BIOS) per provider from a sample of audio recorded brief interventions (BI). The 11th item reflects how well the provider use a motivational style. Scores can range from 1-7, with higher scores indicating better performance.

Number of audio recordings needed to achieve competency as rated by SBIRT trainers using the Brief Intervention Observation Sheet (BIOS)

Percent of patients in each clinic out of all who screen positive, who receive a brief intervention during the implementation phase (IP)

Score on screening measure for risky drinking; adjusted to past 30 days. The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument. The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally, the higher the score, the more likely it is that a person's drinking is affecting his or her safety.

Score on screening measure for risky drinking; adjusted to past 30 days. The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument. The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally, the higher the score, the more likely it is that a person's drinking is affecting his or her safety.

Score on screening measure for risky drinking; adjusted to past 30 days. The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument. The AUDIT-C has 3 questions and is scored on a scale of 0-12. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Generally, the higher the score, the more likely it is that a person's drinking is affecting his or her safety.

Score on the Generalized Anxiety Disorder 7-item (GAD-7) scale, which measures anxiety severity. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating higher levels of anxiety based on past 14 days. A score of 0-4 is classified as minimal anxiety, 5-9 as mild anxiety, 10-14 as moderate anxiety, and as 15-21 severe anxiety.

Score on the Generalized Anxiety Disorder 7-item (GAD-7) scale, which measures anxiety severity. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating higher levels of anxiety based on past 14 days. A score of 0-4 is classified as minimal anxiety, 5-9 as mild anxiety, 10-14 as moderate anxiety, and as 15-21 severe anxiety.

Score on the Generalized Anxiety Disorder 7-item (GAD-7) scale, which measures anxiety severity. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), with higher scores indicating higher levels of anxiety based on past 14 days. A score of 0-4 is classified as minimal anxiety, 5-9 as mild anxiety, 10-14 as moderate anxiety, and as 15-21 severe anxiety.

Each provider's score on the first 10 items of the Brief Intervention Observation Sheet (BIOS) on the last observation conducted during provider training. Scores can range from 0-10, with higher scores indicating better performance.

Each provider's score on the 11th item of the Brief Intervention Observation Sheet (BIOS) on the last observation conducted during provider training. Scores can range from 1-7, with higher scores indicating better performance.

Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days

Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days

Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days

Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days

Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days

Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days

Score on the National Institute of Drug Addiction-Modified Alcohol, Smoking and Substance Involvement Screening Test (NIDA-Modified ASSIST) screening measure for risky drinking; adjusted to past 30 days. Scores range from 0 to 390, with higher scores indicating greater risk. A score of 0-3 is considered lower risk, 4-26 is considered moderate risk, and 27 and over is considered high risk.

Score on the National Institute of Drug Addiction-Modified Alcohol, Smoking and Substance Involvement Screening Test (NIDA-Modified ASSIST) screening measure for risky drinking; adjusted to past 30 days. Scores range from 0 to 390, with higher scores indicating greater risk. A score of 0-3 is considered lower risk, 4-26 is considered moderate risk, and 27 and over is considered high risk.

Score on the National Institute of Drug Addiction-Modified Alcohol, Smoking and Substance Involvement Screening Test (NIDA-Modified ASSIST) screening measure for risky drinking; adjusted to past 30 days. Scores range from 0 to 390, with higher scores indicating greater risk. A score of 0-3 is considered lower risk, 4-26 is considered moderate risk, and 27 and over is considered high risk.

Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days

Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days

Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days

Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days

Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days

Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days

Percent of patients who screen at a severe level of alcohol use, who receive a referral during the implementation phase (IP)

Percent of patients who screen at a severe level of alcohol use, who receive a referral during the sustainment phase (SP)

Score on the 12-Item Short Form Health Survey, which measures physical and mental health functioning in past 30 days. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Score on the 12-Item Short Form Health Survey, which measures physical and mental health functioning in past 30 days. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Score on the 12-Item Short Form Health Survey, which measures physical and mental health functioning in past 30 days. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Score on University of Missouri-Kansas City Screening & Brief Intervention Knowledge Assessment. Will b be completed by providers undergoing training in SBIRT. Scores range from 0-20, with higher scores indicating more knowledge of SBIRT.

Score on the World Health Organization-Five Well-Being Index (WHO-5), a five-item scale that measures subjective psychological well-being in past 14 days. Scores range from 0-5, with 0 representing the worst possible and 25 representing the best possible quality of life.

Score on the World Health Organization-Five Well-Being Index (WHO-5), a five-item scale that measures subjective psychological well-being in past 14 days. Scores range from 0-5, with 0 representing the worst possible and 25 representing the best possible quality of life.

Score on the World Health Organization-Five Well-Being Index (WHO-5), a five-item scale that measures subjective psychological well-being in past 14 days. Scores range from 0-5, with 0 representing the worst possible and 25 representing the best possible quality of life.

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

Per the NIAAA Exemption Request Committee's determination electronic health records/administrative records data components will not be shared. Quantitative survey data will be shared.

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