Clinical trial NCT05910580: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol-Related Disorders
Substance-Related Disorders
Mental Health
Reproductive Health
Sexual Health
Sexually Transmitted Diseases
Contraception
Maternal Health
Pregnancy
Women's Health
Keywords: 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
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Stanford University
name: Planned Parenthood League of Massachusetts
First posted: 2023-06-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average Number of Drinks Per Drinking Day
timeFrame: Baseline, Day 30, Month 3
measure: Number of Days of Drug Use
timeFrame: Baseline, Day 30, Month 3
measure: Incidence of sex under influence of alcohol/drugs
timeFrame: Baseline, Day 30, Month 3
measure: Number of events of sex under influence of alcohol/drugs
timeFrame: Baseline, Day 30, Month 3
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, Day 30, Month 3
measure: Number of Clinic Patients Receiving a Brief Intervention During Implementation Phase
timeFrame: During the 12-month implementation phase
measure: Number of Clinic Patients Receiving a Brief Intervention During Sustainment Phase
timeFrame: During the 12-month sustainment phase
measure: Number of Providers Using SBIRT During Implementation Phase
timeFrame: During the 12-month implementation phase
measure: Number of Clinics Using SBIRT During Sustainment Phase
timeFrame: During the 12-month sustainment phase
measure: Number of Providers Using SBIRT During Sustainment Phase
timeFrame: During the 12-month sustainment phase
measure: Number of Completed BIOS Tracking Sheets to Achieve Competency
timeFrame: During the preparation phase
measure: Brief Intervention Observation Sheet (BIOS) Score
timeFrame: During the 12-month implementation phase
measure: Brief Intervention Observation Sheet (BIOS) Score - Motivational Style
timeFrame: During the 12-month implementation phase
Secondary outcomes:
measure: Number of Days of Alcohol Use
timeFrame: Baseline, Day 30, Month 3
measure: Number of Days of Binge Drinking
timeFrame: Baseline, Day 30, Month 3
measure: Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Score
timeFrame: Baseline, Day 30, Month 3
measure: Drug Abuse Screening Test (DAST-10) Score
timeFrame: Baseline, Day 30, Month 3
measure: Incidence of condom nonuse
timeFrame: Baseline, Day 30, Month 3
measure: Number of events of condom nonuse
timeFrame: Baseline, Day 30, Month 3
measure: Incidence of contraceptive nonuse
timeFrame: Baseline, Day 30, Month 3
measure: Number of events of contraceptive nonuse
timeFrame: Baseline, Day 30, Month 3
measure: Incidence of regretted/nonconsensual sex and sexual violence
timeFrame: Baseline, Day 30, Month 3
measure: Number of events of regretted/nonconsensual sex and sexual violence
timeFrame: Baseline, Day 30, Month 3
measure: Unintended pregnancy
timeFrame: Baseline, Day 30, Month 3
measure: Generalized Anxiety Disorder 7-item (GAD-7) Scale Score
timeFrame: Baseline, Day 30, Month 3
measure: World Health Organization-Five Well-Being Index (WHO-5) Score
timeFrame: Baseline, Day 30, Month 3
measure: General Self-reported Health Score
timeFrame: Baseline, Day 30, Month 3
measure: 12-Item Short Form (SF-12) Health Survey Score
timeFrame: Baseline, Day 30, Month 3
measure: Number of Patients Screened During Implementation Phase
timeFrame: During the 12-month implementation phase
measure: Number of Patients Screened During Sustainment Phase
timeFrame: During the 12-month sustainment phase
measure: Number of Patients Receiving Referral During Implementation Phase
timeFrame: During the 12-month implementation phase
measure: Number of Patients Receiving Referral During Sustainment Phase
timeFrame: During the 12-month sustainment phase
measure: University of Missouri-Kansas City Screening & Brief Intervention Knowledge Assessment Score
timeFrame: During the implementation phase
measure: Brief Intervention Observation Sheet (BIOS) Score During Preparation Phase
timeFrame: During the preparation and implementation phases
measure: Brief Intervention Observation Sheet (BIOS) Score - Motivational Style
timeFrame: During the preparation and implementation phases
Other outcomes:
measure: Number of Participants with STI Diagnosis
timeFrame: Baseline, Day 30, Month 3
measure: Past or current receipt of substance use treatment or services
timeFrame: Baseline, Day 30, Month 3
Locations:
city: Boston
country: United States
facility: Greater Boston Health Center
state: Massachusetts
city: Marlborough
country: United States
facility: Metro West Health Center
state: Massachusetts
city: Springfield
country: United States
facility: Western Massachusetts Health Center
state: Massachusetts
city: Worcester
country: United States
facility: Central Massachusetts Health Center
state: Massachusetts
Study officials:
affiliation: Columbia University
name: Kelli S Hall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Justine Welsh, MD
role: PRINCIPAL_INVESTIGATOR
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