Screening to Augment Referral to Treatment- Project START (ProjectSTART)

The investigators propose to use obstetric-gynecological clinics to conduct a randomized clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and Treatment), delivered either by a trained nurse or by computer, to usual care (a control condition). As part of this trial, the investigators will include outcomes that allow us to assess the cost effectiveness of these three conditions.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Tobacco Use Disorder; Marijuana Abuse; Alcohol Abuse
• Intervention / Treatment: Behavioral: Motivational Interview; Other: Treatment as Usual

Detailed Description

Aim 1: To assess whether SBIRT, based upon motivational interviewing and delivered either by computer or a trained nurse, leads to decreased use of a subject's primary drug of abuse.

Hypothesis #1a: Referrals based upon motivational principles and delivered by computer, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse.

Hypothesis #1b: Referrals based upon motivational principles and delivered by nurse, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse.

Aim 2: To determine whether SBIRT based upon motivational interviewing and delivered either by computer or by a nurse will promote substance abuse treatment utilization for the primary drug of abuse.

Hypothesis #2a: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the computer delivered brief intervention than if she receives usual care only.

Hypothesis #2b: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the nurse delivered brief intervention than if she receives usual care only.

Secondary Aim 3: To evaluate whether SBI leads to a decrease in HIV/AIDS risk

Hypothesis #3: Rates of sexually transmitted diseases, injection drug use and risky sexual behavior will be lower at follow up for subjects who receive either computer or a nurse delivered brief intervention than usual care subjects.

Secondary Aim 4: To compare the relative cost-effectiveness of the three interventions.

Hypothesis #4a: Screening and usual care will be the most cost-effective intervention method when the value of an additional unit of effect for the given individual's outcome is relatively low.

Hypotheses #4b: Screening, and a brief intervention delivered by computer, will be the most cost-effective treatment method when the value of an additional unit of effect is relatively high.

Hypotheses #4c: Screening, and a brief intervention delivered by a nurse, will be less cost-effective than a brief intervention delivered by computer.

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital- York St Campus
    • New Haven, Connecticut, United States, 06519
      • Yale-New Haven Hospital-Chapel St Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

In order to participate, women must meet the following criteria:

1. Are non-pregnant and meet ASSIST criteria for at least moderate risk for alcohol (≥11) or drug (≥4) abuse or dependence (tobacco or illicit drugs, including cocaine, opiates, methamphetamine, marijuana or a prescription drug used in a medically inappropriate manner).
2. Are pregnant and meet ASSIST criteria for at least mild to moderate risk for alcohol (≥6) or drug (≥4) abuse or dependence (alcohol, tobacco, an illicit drug, or a prescription drug in a medically inappropriate manner). We define pregnant women who use alcohol or drugs at least monthly in the last 90 days as eligible because alcohol and many of the other substances (eg. tobacco) are teratogens and use in pregnancy would be consistent with a diagnosis of abuse ("recurrent use in situations in which it is physically hazardous"). This level of use in pregnancy also indicates a greater likelihood of problematic substance use.
3. Have used their primary substance at least once within the prior 28 days.
4. Are aged 18 or more. We include participants who are aged 18 or older because parents may not be available at screening to provide consent for non-pregnant participants and subjects may not wish to disclose drug or alcohol abuse to a parent.

Exclusion Criteria:

Women are ineligible if they have any of the following criteria:

1. Are unable to speak English.
2. Are incarcerated or at risk of incarceration. The YNHH Women's Center provides care to incarcerated women. These individuals as well as those at risk of incarceration are excluded because incarceration precludes their ability to seek specialty drug or alcohol abuse treatment (a dependent measure).
3. Have a cognitive disorder that would impair their ability to provide informed consent or provide accurate information.
4. Require immediate hospitalization because of general medical needs or due to active suicidal or homicidal ideation or other behavioral health problems. We exclude individuals who are in need of immediate hospitalization because hospitalization will render it more difficult for them to immediately follow-up on a referral and because providers, rather than subjects, may be making the decision to initiate treatment. Hospitalization would also potentially force women who smoke to initiate treatment for tobacco addiction.
5. Are currently participating or have participated in drug abuse treatment, including self-help interventions (eg. 12 step facilitation, smoking cessation interventions), within the last 3 months prior to screening.
6. Are planning to relocate out of the area in the following 6 months. Women who relocate out of the area would be difficult to see for follow up assessments and it would be difficult to confirm treatment attendance in local treatment centers.
7. Have previously participated in this protocol or
8. Are unwilling to participate or accept randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interview; Motivational interview provided by a clinical research nurse or physician.	Behavioral: Motivational Interview; Motivational Interview provided by either a Nurse or Computer
Active Comparator: Motivational Interview-Electronic; Motivational Interview provided by an interactive computer program.	Behavioral: Motivational Interview; Motivational Interview provided by either a Nurse or Computer
Placebo Comparator: Treatment as Usual; No intervention- resource list provided.	Other: Treatment as Usual; Subjects given a brochure listing relevant recovery resources in the local area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days Per Month of Primary Substance Use	Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.	7 non-overlapping monthly intervals from baseline to month 6
Treatment Utilization	Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).	baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of STDs	rates of incident std's per patient's medical records	baseline to 6 months
Mean Cost for Each Intervention	The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs	6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Kimberly A Yonkers, MD, Yale School of Medicine; Principal Investigator: Steve Martino, PhD, Yale School of Medicine

Publications and helpful links

General Publications

• Forray A, Martino S, Gilstad-Hayden K, Kershaw T, Ondersma S, Olmstead T, Yonkers KA. Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic. Addict Behav. 2019 Sep;96:156-163. doi: 10.1016/j.addbeh.2019.05.007. Epub 2019 May 8.
• Loree AM, Yonkers KA, Ondersma SJ, Gilstad-Hayden K, Martino S. Comparing satisfaction, alliance and intervention components in electronically delivered and in-person brief interventions for substance use among childbearing-aged women. J Subst Abuse Treat. 2019 Apr;99:1-7. doi: 10.1016/j.jsat.2019.01.007. Epub 2019 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2011
• Primary Completion (Actual): January 28, 2015
• Study Completion (Actual): January 28, 2015

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): February 27, 2012

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Disease; Tobacco Use Disorder; Marijuana Abuse
• Other Study ID Numbers: 1005006785; R01DA027194 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will require data request with delineation of variables of interest. Only de-identified data will be released after evaluation of the request