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

Study Overview
=================
Brief Summary
-----------------
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.

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 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.

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

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

Intervention / Treatment
-----------------
* Behavioral: Screening, Brief Intervention, and Referral to Treatment (SBIRT)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBIRT<br>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. | Behavioral: Screening, Brief Intervention, and Referral to Treatment (SBIRT)<br>* See SBIRT arm description.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average drinks per drinking day (T0) | Average number of drinks consumed on days where individual consumed alcohol (past 30 days) | Baseline | 
| Average drinks per drinking day (T1) | Average number of drinks consumed on days where individual consumed alcohol (past 30 days) | 30 days | 
| Average drinks per drinking day (T2) | Average number of drinks consumed on days where individual consumed alcohol (past 30 days) | 3 months | 
| Depression score (T0) | 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). | Baseline | 
| Depression score (T1) | 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). | 30 days | 
| Depression score (T2) | 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). | 3 months | 
| Fidelity - BIOS score for audio recordings (1) | 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. | During the 12-month implementation phase | 
| Fidelity - BIOS score for audio recordings (2) | 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. | During the 12-month implementation phase | 
| Incidence of sex under influence of alcohol/drugs (T0) | Any incidence of sex under influence of alcohol/drugs in past 30 days | Baseline | 
| Incidence of sex under influence of alcohol/drugs (T1) | Any incidence of sex under influence of alcohol/drugs in past 30 days | 30 days | 
| Incidence of sex under influence of alcohol/drugs (T2) | Any incidence of sex under influence of alcohol/drugs in past 30 days | 3 months | 
| Number of days of drug use (T0) | Number of days of drug use in past 30 days | Baseline | 
| Number of days of drug use (T1) | Number of days of drug use in past 30 days | 30 days | 
| Number of days of drug use (T2) | Number of days of drug use in past 30 days | 3 months | 
| Number of events of sex under influence of alcohol/drugs (T0) | Number of events of sex under influence of alcohol/drugs in past 30 days | Baseline | 
| Number of events of sex under influence of alcohol/drugs (T1) | Number of events of sex under influence of alcohol/drugs in past 30 days | 30 days | 
| Number of events of sex under influence of alcohol/drugs (T2) | Number of events of sex under influence of alcohol/drugs in past 30 days | 3 months | 
| Number of recordings to achieve competency | Number of audio recordings needed to achieve competency as rated by SBIRT trainers using the Brief Intervention Observation Sheet (BIOS) | During the 6-month preparation phase | 
| Patients receiving BI (IP) | Percent of patients in each clinic out of all who screen positive, who receive a brief intervention during the implementation phase (IP) | During the 12-month implementation phase | 
| Patients receiving BI (SP) | Patients receiving BI (SP) | During the 12-month sustainment phase | 
| SBIRT use (IP) | Number/proportion of providers in each clinic using SBIRT (implementation phase) | During the 12-month implementation phase | 
| SBIRT use (SP) | Number/proportion of clinics and of providers in each clinic using SBIRT (sustainment phase) | During the 12-month sustainment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUDIT-C score (T0) | 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. | Baseline | 
| AUDIT-C score (T1) | 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. | 30 days | 
| AUDIT-C score (T2) | 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. | 3 months | 
| Anxiety score (T0) | 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. | Baseline | 
| Anxiety score (T1) | 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. | 30 days | 
| Anxiety score (T2) | 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. | 3 months | 
| BIOS score (1) | 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. | During the 6-month preparation phase | 
| BIOS score (2) | 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. | During the 6-month preparation phase | 
| Days of alcohol use (T0) | Number of days of alcohol use in past 30 days | Baseline | 
| Days of alcohol use (T1) | Number of days of alcohol use in past 30 days | 30 days | 
| Days of alcohol use (T2) | Number of days of alcohol use in past 30 days | 3 months | 
| Days of binge drinking (T0) | Number of days of binge drinking (defined as 4 or more drinks) in past 30 days | Baseline | 
| Days of binge drinking (T1) | Number of days of binge drinking (defined as 4 or more drinks) in past 30 days | 30 days | 
| Days of binge drinking (T2) | Number of days of binge drinking (defined as 4 or more drinks) in past 30 days | 3 months | 
| General self-reported health (T0) | Likert rating of general self-reported health in past 30 days | Baseline | 
| General self-reported health (T1) | Likert rating of general self-reported health in past 30 days | 30 days | 
| General self-reported health (T2) | Likert rating of general self-reported health in past 30 days | 3 months | 
| Incidence of condom nonuse (T0) | Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | Baseline | 
| Incidence of condom nonuse (T1) | Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | 30 days | 
| Incidence of condom nonuse (T2) | Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | 3 months | 
| Incidence of contraceptive nonuse (T0) | Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | Baseline | 
| Incidence of contraceptive nonuse (T1) | Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | 30 days | 
| Incidence of contraceptive nonuse (T2) | Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | 3 months | 
| Incidence of regretted/nonconsensual sex and sexual violence (T0) | Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days | Baseline | 
| Incidence of regretted/nonconsensual sex and sexual violence (T1) | Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days | 30 days | 
| Incidence of regretted/nonconsensual sex and sexual violence (T2) | Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days | 3 months | 
| NIDA ASSIST score (T0) | 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. | Baseline | 
| NIDA ASSIST score (T1) | 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. | 30 days | 
| NIDA ASSIST score (T2) | 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. | 3 months | 
| Number of events of condom nonuse (T0) | Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | Baseline | 
| Number of events of condom nonuse (T1) | Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | 30 days | 
| Number of events of condom nonuse (T2) | Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | 3 months | 
| Number of events of contraceptive nonuse (T0) | Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | Baseline | 
| Number of events of contraceptive nonuse (T1) | Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | 30 days | 
| Number of events of contraceptive nonuse (T2) | Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | 3 months | 
| Number of events of regretted/nonconsensual sex and sexual violence (T0) | Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days | Baseline | 
| Number of events of regretted/nonconsensual sex and sexual violence (T1) | Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days | 30 days | 
| Number of events of regretted/nonconsensual sex and sexual violence (T2) | Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days | 3 months | 
| Patients receiving referral (IP) | Percent of patients who screen at a severe level of alcohol use, who receive a referral during the implementation phase (IP) | During the 12-month implementation phase | 
| Patients receiving referral (SP) | Percent of patients who screen at a severe level of alcohol use, who receive a referral during the sustainment phase (SP) | During the 12-month sustainment phase | 
| Patients screened (IP) | Percent of patients out of all patients seen who are screened during the implementation phase (IP) | During the 12-month implementation phase | 
| Patients screened (SP) | Percent of patients out of all patients seen who are screened during the sustainment phase (SP) | During the 12-month sustainment phase | 
| Quality of life score (T0) | 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. | Baseline | 
| Quality of life score (T1) | 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. | 30 days | 
| Quality of life score (T2) | 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. | 3 months | 
| SBIRT knowledge | 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. | During the 6-month preparation phase | 
| STI incidence (T0) | Any incidence of a sexually transmitted infection (STI) in past 30 days | Baseline | 
| STI incidence (T1) | Any incidence of a sexually transmitted infection (STI) in past 30 days | 30 days | 
| STI incidence (T2) | Any incidence of a sexually transmitted infection (STI) in past 30 days | 3 months | 
| Unintended pregnancy (T0) | Any incidence of unintended pregnancy in past 30 days | Baseline | 
| Unintended pregnancy (T1) | Any incidence of unintended pregnancy in past 30 days | 30 days | 
| Unintended pregnancy (T2) | Any incidence of unintended pregnancy in past 30 days | 3 months | 
| Well-being score (T0) | 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. | Baseline | 
| Well-being score (T1) | 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. | 30 days | 
| Well-being score (T2) | 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. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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