Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
- Conditions
- Reproductive HealthSexual HealthPregnancyAlcohol-Related DisordersSubstance-Related DisordersMaternal HealthMental HealthContraceptionWomen's HealthSexually Transmitted Diseases
- Interventions
- Behavioral: Screening, Brief Intervention, and Referral to Treatment (SBIRT)
- Registration Number
- NCT05910580
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 600
- 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
- Not capable of communicating (reading, speaking, writing) in English or Spanish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Screening, Brief Intervention, and Referral to Treatment (SBIRT) 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.
- Primary Outcome Measures
Name Time Method Average drinks per drinking day (T2) 3 months Average number of drinks consumed on days where individual consumed alcohol (past 30 days)
Depression score (T0) Baseline 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).
Average drinks per drinking day (T0) Baseline Average number of drinks consumed on days where individual consumed alcohol (past 30 days)
Depression score (T1) 30 days 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).
Depression score (T2) 3 months 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).
Fidelity - BIOS score for audio recordings (2) During the 12-month implementation phase 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.
Fidelity - BIOS score for audio recordings (1) During the 12-month implementation phase 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.
Incidence of sex under influence of alcohol/drugs (T1) 30 days Any incidence of sex under influence of alcohol/drugs in past 30 days
Number of events of sex under influence of alcohol/drugs (T1) 30 days Number of events of sex under influence of alcohol/drugs in past 30 days
Number of events of sex under influence of alcohol/drugs (T2) 3 months Number of events of sex under influence of alcohol/drugs in past 30 days
Number of recordings to achieve competency During the 6-month preparation phase Number of audio recordings needed to achieve competency as rated by SBIRT trainers using the Brief Intervention Observation Sheet (BIOS)
Patients receiving BI (IP) During the 12-month implementation phase Percent of patients in each clinic out of all who screen positive, who receive a brief intervention during the implementation phase (IP)
Patients receiving BI (SP) During the 12-month sustainment phase Patients receiving BI (SP)
Average drinks per drinking day (T1) 30 days Average number of drinks consumed on days where individual consumed alcohol (past 30 days)
Incidence of sex under influence of alcohol/drugs (T0) Baseline Any incidence of sex under influence of alcohol/drugs in past 30 days
Incidence of sex under influence of alcohol/drugs (T2) 3 months Any incidence of sex under influence of alcohol/drugs in past 30 days
Number of days of drug use (T1) 30 days Number of days of drug use in past 30 days
Number of events of sex under influence of alcohol/drugs (T0) Baseline Number of events of sex under influence of alcohol/drugs in past 30 days
Number of days of drug use (T0) Baseline Number of days of drug use in past 30 days
Number of days of drug use (T2) 3 months Number of days of drug use in past 30 days
SBIRT use (IP) During the 12-month implementation phase Number/proportion of providers in each clinic using SBIRT (implementation phase)
SBIRT use (SP) During the 12-month sustainment phase Number/proportion of clinics and of providers in each clinic using SBIRT (sustainment phase)
- Secondary Outcome Measures
Name Time Method Number of events of regretted/nonconsensual sex and sexual violence (T2) 3 months Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days
AUDIT-C score (T1) 30 days 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.Anxiety score (T1) 30 days 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.
Days of binge drinking (T1) 30 days Number of days of binge drinking (defined as 4 or more drinks) in past 30 days
Days of binge drinking (T2) 3 months Number of days of binge drinking (defined as 4 or more drinks) in past 30 days
General self-reported health (T1) 30 days Likert rating of general self-reported health in past 30 days
AUDIT-C score (T0) Baseline 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.AUDIT-C score (T2) 3 months 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.BIOS score (1) During the 6-month preparation phase 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.
General self-reported health (T0) Baseline Likert rating of general self-reported health in past 30 days
General self-reported health (T2) 3 months Likert rating of general self-reported health in past 30 days
Incidence of contraceptive nonuse (T0) Baseline Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days
Number of events of condom nonuse (T1) 30 days Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days
Number of events of regretted/nonconsensual sex and sexual violence (T0) Baseline Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days
Anxiety score (T0) Baseline 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.
Anxiety score (T2) 3 months 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.
BIOS score (2) During the 6-month preparation phase 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.
Days of alcohol use (T0) Baseline Number of days of alcohol use in past 30 days
Days of alcohol use (T1) 30 days Number of days of alcohol use in past 30 days
Days of alcohol use (T2) 3 months Number of days of alcohol use in past 30 days
Incidence of contraceptive nonuse (T2) 3 months Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days
Number of events of contraceptive nonuse (T2) 3 months Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days
Days of binge drinking (T0) Baseline Number of days of binge drinking (defined as 4 or more drinks) in past 30 days
Incidence of condom nonuse (T0) Baseline Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days
Incidence of contraceptive nonuse (T1) 30 days Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days
DAST-10 score (T2) 3 months Score on the 10-item version of the Drug Abuse Screening Test (DAST-10); adjusted to 30 days.
The DAST-10 assesses drug use (not including alcohol and tobacco use) and yields a quantitative index of the degree of consequences related to drug abuse. A score of 0 is classified as no problems reported, 1-2 as a low level of problems related to drug abuse, 3-5 as moderate, 6-8 as substantial, and 9-10 as severe.Patients screened (IP) During the 12-month implementation phase Percent of patients out of all patients seen who are screened during the implementation phase (IP)
Well-being score (T0) Baseline 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.
Well-being score (T1) 30 days 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.
Past or current receipt of substance use treatment or services (T0) Baseline Number of days/times the participant received treatment or counseling for alcohol or drugs or attended a self-help/mutual support meeting in past 30 days
Incidence of condom nonuse (T1) 30 days Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days
Incidence of condom nonuse (T2) 3 months Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days
Incidence of regretted/nonconsensual sex and sexual violence (T0) Baseline Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days
Incidence of regretted/nonconsensual sex and sexual violence (T1) 30 days Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days
DAST-10 score (T1) 30 days Score on the 10-item version of the Drug Abuse Screening Test (DAST-10); adjusted to 30 days.
The DAST-10 assesses drug use (not including alcohol and tobacco use) and yields a quantitative index of the degree of consequences related to drug abuse. A score of 0 is classified as no problems reported, 1-2 as a low level of problems related to drug abuse, 3-5 as moderate, 6-8 as substantial, and 9-10 as severe.Incidence of regretted/nonconsensual sex and sexual violence (T2) 3 months Any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days
DAST-10 score (T0) Baseline Score on the 10-item version of the Drug Abuse Screening Test (DAST-10); adjusted to 30 days.
The DAST-10 assesses drug use (not including alcohol and tobacco use) and yields a quantitative index of the degree of consequences related to drug abuse. A score of 0 is classified as no problems reported, 1-2 as a low level of problems related to drug abuse, 3-5 as moderate, 6-8 as substantial, and 9-10 as severe.Number of events of condom nonuse (T0) Baseline Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days
Number of events of condom nonuse (T2) 3 months Number of events of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days
Number of events of contraceptive nonuse (T1) 30 days Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days
Number of events of regretted/nonconsensual sex and sexual violence (T1) 30 days Number of events of non-consensual sex, regretted sex, or sexual violence in past 30 days
Patients receiving referral (SP) During the 12-month sustainment phase Percent of patients who screen at a severe level of alcohol use, who receive a referral during the sustainment phase (SP)
Patients screened (SP) During the 12-month sustainment phase Percent of patients out of all patients seen who are screened during the sustainment phase (SP)
Quality of life score (T0) Baseline 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.
Number of events of contraceptive nonuse (T0) Baseline Number of events of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days
SBIRT knowledge During the 6-month preparation phase 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.
Patients receiving referral (IP) During the 12-month implementation phase Percent of patients who screen at a severe level of alcohol use, who receive a referral during the implementation phase (IP)
Quality of life score (T2) 3 months 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.
STI incidence (T2) 3 months Any incidence of a sexually transmitted infection (STI) in past 30 days
Unintended pregnancy (T2) 3 months Any incidence of unintended pregnancy in past 30 days
Quality of life score (T1) 30 days 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.
Unintended pregnancy (T0) Baseline Any incidence of unintended pregnancy in past 30 days
Unintended pregnancy (T1) 30 days Any incidence of unintended pregnancy in past 30 days
STI incidence (T0) Baseline Any incidence of a sexually transmitted infection (STI) in past 30 days
STI incidence (T1) 30 days Any incidence of a sexually transmitted infection (STI) in past 30 days
Well-being score (T2) 3 months 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.
Past or current receipt of substance use treatment or services (T1) 30 days Number of days/times the participant received treatment or counseling for alcohol or drugs or attended a self-help/mutual support meeting in past 30 days
Past or current receipt of substance use treatment or services (T2) 3 months Number of days/times the participant received treatment or counseling for alcohol or drugs or attended a self-help/mutual support meeting in past 30 days
Trial Locations
- Locations (4)
Central Massachusetts Health Center
🇺🇸Worcester, Massachusetts, United States
Greater Boston Health Center
🇺🇸Boston, Massachusetts, United States
Metro West Health Center
🇺🇸Marlborough, Massachusetts, United States
Western Massachusetts Health Center
🇺🇸Springfield, Massachusetts, United States