Improving Alcohol and Substance Use Care Access, Outcomes, and Equity During the Reproductive Years: A Type 1 Hybrid Trial in Family Planning Clinics
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol-Related Disorders
- Sponsor
- Emory University
- Enrollment
- 400
- Locations
- 4
- Primary Endpoint
- Average Number of Drinks Per Drinking Day
- Status
- Recruiting
- Last Updated
- 9 months ago
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 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.
Investigators
Justine Welsh
Associate Professor
Emory University
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
Outcomes
Primary Outcomes
Average Number of Drinks Per Drinking Day
Time Frame: Baseline, Day 30, Month 3
Participants are asked to self-report the number of drinks consumed on days when alcohol was consumed, during the past 30 days.
Number of Days of Drug Use
Time Frame: Baseline, Day 30, Month 3
Participants are asked to self-report the number of days of drug use in the past 30 days.
Incidence of sex under influence of alcohol/drugs
Time Frame: Baseline, Day 30, Month 3
Any incidence of sex under influence of alcohol/drugs in past 30 days.
Number of events of sex under influence of alcohol/drugs
Time Frame: Baseline, Day 30, Month 3
The number of events of sex while under influence of alcohol/drugs in past 30 days.
Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, Day 30, Month 3
The Patient Health Questionnaire (PHQ-9) is a 9-item instrument assessing symptoms of depression during the prior two weeks. Responses are given on a 4-point scale where 0 = not at all and 3 = nearly everyday. Total scores range from 0 to 27 where higher scores indicate greater feelings of depression. Scores of 0 to 4 indicate minimal depression, scores of 5 to 9 indicate mild depression, scores of 10 to 14 indicate moderate depression, scores of 15 to 19 indicate moderately severe depression, and scores of 20 or more indicate severe depression.
Number of Clinic Patients Receiving a Brief Intervention During Implementation Phase
Time Frame: During the 12-month implementation phase
The number of patients in each clinic who screen positive receiving a brief intervention during the implementation phase of the study.
Number of Clinic Patients Receiving a Brief Intervention During Sustainment Phase
Time Frame: During the 12-month sustainment phase
The number of patients in each clinic who screen positive who receive a brief intervention during the sustainment phase of the study.
Number of Providers Using SBIRT During Implementation Phase
Time Frame: During the 12-month implementation phase
The number of providers in each clinic using SBIRT during the implementation phase.
Number of Clinics Using SBIRT During Sustainment Phase
Time Frame: During the 12-month sustainment phase
The number of clinics using SBIRT during the sustainment phase.
Number of Providers Using SBIRT During Sustainment Phase
Time Frame: During the 12-month sustainment phase
The number of providers in each clinic using SBIRT during the sustainment phase.
Number of Completed BIOS Tracking Sheets to Achieve Competency
Time Frame: During the preparation phase
The number of completed Brief Intervention Observation Sheets (BIOS) needed to achieve competency will be examined.
Brief Intervention Observation Sheet (BIOS) Score
Time Frame: During the 12-month implementation phase
Fidelity to the intervention is assessed as the mean score on the first 10 items of the Brief Intervention Observation Sheet (BIOS). The score per provider is determined from a sample of audio recorded brief interventions. Responses to items are recorded as a "yes" or "no" assessment of whether the steps of the brief intervention were completed. The total score is the number of "yes" items and can range from 0 to 10, with higher scores indicating more steps completed.
Brief Intervention Observation Sheet (BIOS) Score - Motivational Style
Time Frame: During the 12-month implementation phase
Fidelity to the intervention is assessed as the mean score on the 11th item of the Brief Intervention Observation Sheet (BIOS). The score per provider is determined from a sample of audio recorded brief interventions. Item 11 assesses the overall motivational interviewing style used by the provider. Scores are rated on a 7-point scale where 1 = not at all and 7 = very effectively. Higher scores indicate greater motivational interviewing style.
Secondary Outcomes
- Number of Days of Alcohol Use(Baseline, Day 30, Month 3)
- Number of Days of Binge Drinking(Baseline, Day 30, Month 3)
- Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Score(Baseline, Day 30, Month 3)
- Drug Abuse Screening Test (DAST-10) Score(Baseline, Day 30, Month 3)
- Incidence of condom nonuse(Baseline, Day 30, Month 3)
- Number of events of condom nonuse(Baseline, Day 30, Month 3)
- Incidence of contraceptive nonuse(Baseline, Day 30, Month 3)
- Number of events of contraceptive nonuse(Baseline, Day 30, Month 3)
- Incidence of regretted/nonconsensual sex and sexual violence(Baseline, Day 30, Month 3)
- Number of events of regretted/nonconsensual sex and sexual violence(Baseline, Day 30, Month 3)
- Unintended pregnancy(Baseline, Day 30, Month 3)
- Generalized Anxiety Disorder 7-item (GAD-7) Scale Score(Baseline, Day 30, Month 3)
- World Health Organization-Five Well-Being Index (WHO-5) Score(Baseline, Day 30, Month 3)
- General Self-reported Health Score(Baseline, Day 30, Month 3)
- 12-Item Short Form (SF-12) Health Survey Score(Baseline, Day 30, Month 3)
- Number of Patients Screened During Implementation Phase(During the 12-month implementation phase)
- Number of Patients Screened During Sustainment Phase(During the 12-month sustainment phase)
- Number of Patients Receiving Referral During Implementation Phase(During the 12-month implementation phase)
- Number of Patients Receiving Referral During Sustainment Phase(During the 12-month sustainment phase)
- University of Missouri-Kansas City Screening & Brief Intervention Knowledge Assessment Score(During the implementation phase)
- Brief Intervention Observation Sheet (BIOS) Score During Preparation Phase(During the preparation and implementation phases)
- Brief Intervention Observation Sheet (BIOS) Score - Motivational Style(During the preparation and implementation phases)