Pregnancy Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 | Central Massachusetts Health Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Emory University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Planned Parenthood League of Massachusetts, Stanford University |
United States,
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Iyasu S, Randall LL, Welty TK, Hsia J, Kinney HC, Mandell F, McClain M, Randall B, Habbe D, Wilson H, Willinger M. Risk factors for sudden infant death syndrome among northern plains Indians. JAMA. 2002 Dec 4;288(21):2717-23. doi: 10.1001/jama.288.21.2717. Erratum In: JAMA. 2003 Jan 15;289(3):303. — View Citation
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Naimi TS, Lipscomb LE, Brewer RD, Gilbert BC. Binge drinking in the preconception period and the risk of unintended pregnancy: implications for women and their children. Pediatrics. 2003 May;111(5 Pt 2):1136-41. — View Citation
National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Examination of the Integration of Opioid and Infectious Disease Prevention Efforts in Select Programs. Opportunities to Improve Opioid Use Disorder and Infectious Disease Services: Integrating Responses to a Dual Epidemic. Washington (DC): National Academies Press (US); 2020 Jan 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK555809/ — View Citation
Pinedo M. Help seeking behaviors of Latinos with substance use disorders who perceive a need for treatment: Substance abuse versus mental health treatment services. J Subst Abuse Treat. 2020 Feb;109:41-45. doi: 10.1016/j.jsat.2019.11.006. Epub 2019 Nov 14. — View Citation
Rahm AK, Boggs JM, Martin C, Price DW, Beck A, Backer TE, Dearing JW. Facilitators and Barriers to Implementing Screening, Brief Intervention, and Referral to Treatment (SBIRT) in Primary Care in Integrated Health Care Settings. Subst Abus. 2015;36(3):281-8. doi: 10.1080/08897077.2014.951140. Epub 2014 Aug 15. — View Citation
Robbins C, Boulet SL, Morgan I, D'Angelo DV, Zapata LB, Morrow B, Sharma A, Kroelinger CD. Disparities in Preconception Health Indicators - Behavioral Risk Factor Surveillance System, 2013-2015, and Pregnancy Risk Assessment Monitoring System, 2013-2014. MMWR Surveill Summ. 2018 Jan 19;67(1):1-16. doi: 10.15585/mmwr.ss6701a1. Erratum In: MMWR Morb Mortal Wkly Rep. 2018 Apr 27;67(16):479. — View Citation
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Terplan M, Lawental M, Connah MB, Martin CE. Reproductive Health Needs Among Substance Use Disorder Treatment Clients. J Addict Med. 2016 Jan-Feb;10(1):20-5. doi: 10.1097/ADM.0000000000000175. — View Citation
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Wright TE, Terplan M, Ondersma SJ, Boyce C, Yonkers K, Chang G, Creanga AA. The role of screening, brief intervention, and referral to treatment in the perinatal period. Am J Obstet Gynecol. 2016 Nov;215(5):539-547. doi: 10.1016/j.ajog.2016.06.038. Epub 2016 Jul 1. — View Citation
* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average drinks per drinking day (T0) | Average number of drinks consumed on days where individual consumed alcohol (past 30 days) | Baseline | |
Primary | Average drinks per drinking day (T1) | Average number of drinks consumed on days where individual consumed alcohol (past 30 days) | 30 days | |
Primary | Average drinks per drinking day (T2) | Average number of drinks consumed on days where individual consumed alcohol (past 30 days) | 3 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Incidence of sex under influence of alcohol/drugs (T0) | Any incidence of sex under influence of alcohol/drugs in past 30 days | Baseline | |
Primary | Incidence of sex under influence of alcohol/drugs (T1) | Any incidence of sex under influence of alcohol/drugs in past 30 days | 30 days | |
Primary | Incidence of sex under influence of alcohol/drugs (T2) | Any incidence of sex under influence of alcohol/drugs in past 30 days | 3 months | |
Primary | Number of days of drug use (T0) | Number of days of drug use in past 30 days | Baseline | |
Primary | Number of days of drug use (T1) | Number of days of drug use in past 30 days | 30 days | |
Primary | Number of days of drug use (T2) | Number of days of drug use in past 30 days | 3 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Patients receiving BI (SP) | Patients receiving BI (SP) | During the 12-month sustainment phase | |
Primary | SBIRT use (IP) | Number/proportion of providers in each clinic using SBIRT (implementation phase) | During the 12-month implementation phase | |
Primary | SBIRT use (SP) | Number/proportion of clinics and of providers in each clinic using SBIRT (sustainment phase) | During the 12-month sustainment phase | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Days of alcohol use (T0) | Number of days of alcohol use in past 30 days | Baseline | |
Secondary | Days of alcohol use (T1) | Number of days of alcohol use in past 30 days | 30 days | |
Secondary | Days of alcohol use (T2) | Number of days of alcohol use in past 30 days | 3 months | |
Secondary | Days of binge drinking (T0) | Number of days of binge drinking (defined as 4 or more drinks) in past 30 days | Baseline | |
Secondary | Days of binge drinking (T1) | Number of days of binge drinking (defined as 4 or more drinks) in past 30 days | 30 days | |
Secondary | Days of binge drinking (T2) | Number of days of binge drinking (defined as 4 or more drinks) in past 30 days | 3 months | |
Secondary | General self-reported health (T0) | Likert rating of general self-reported health in past 30 days | Baseline | |
Secondary | General self-reported health (T1) | Likert rating of general self-reported health in past 30 days | 30 days | |
Secondary | General self-reported health (T2) | Likert rating of general self-reported health in past 30 days | 3 months | |
Secondary | Incidence of condom nonuse (T0) | Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | Baseline | |
Secondary | Incidence of condom nonuse (T1) | Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | 30 days | |
Secondary | Incidence of condom nonuse (T2) | Any incidence of condom nonuse monogamous encounters among women not intending pregnancy in past 30 days | 3 months | |
Secondary | Incidence of contraceptive nonuse (T0) | Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | Baseline | |
Secondary | Incidence of contraceptive nonuse (T1) | Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | 30 days | |
Secondary | Incidence of contraceptive nonuse (T2) | Any incidence of contraceptive nonuse monogamous encounters among women not intending pregnancy in past 30 days | 3 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | DAST-10 score (T0) | 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. |
Baseline | |
Secondary | DAST-10 score (T1) | 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. |
30 days | |
Secondary | DAST-10 score (T2) | 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. |
3 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | STI incidence (T0) | Any incidence of a sexually transmitted infection (STI) in past 30 days | Baseline | |
Secondary | STI incidence (T1) | Any incidence of a sexually transmitted infection (STI) in past 30 days | 30 days | |
Secondary | STI incidence (T2) | Any incidence of a sexually transmitted infection (STI) in past 30 days | 3 months | |
Secondary | Unintended pregnancy (T0) | Any incidence of unintended pregnancy in past 30 days | Baseline | |
Secondary | Unintended pregnancy (T1) | Any incidence of unintended pregnancy in past 30 days | 30 days | |
Secondary | Unintended pregnancy (T2) | Any incidence of unintended pregnancy in past 30 days | 3 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Past or current receipt of substance use treatment or services (T0) | 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 | Baseline | |
Secondary | Past or current receipt of substance use treatment or services (T1) | 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 | 30 days | |
Secondary | Past or current receipt of substance use treatment or services (T2) | 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 | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
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