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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT01539525
First received: August 3, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Tobacco Use Disorder
Marijuana Abuse
Substance-Related Disorders
Behavioral: Motivational Interview
Other: Resource brochure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Screening to Augment Referral to Treatment- Project START

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Substance use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Decrease in subject's primary drug of abuse

  • Treatment utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Increase in subjects' treatment utilization


Secondary Outcome Measures:
  • Rates of STDs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Decreased rates of sexually transmitted diseases

  • Improved cost-effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Incremental cost-effectiveness ratios (ICERs) will be calculated separately for the societal perspective and the payer's perspective. ICERs measure the incremental cost of using a given intervention, compared to the next-least-costly intervention, to produce an extra unit of effect for each of the patient outcomes (e.g., an additional patient initiating treatment, an additional week of abstinence).


Estimated Enrollment: 660
Study Start Date: September 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interview-Nurse
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-Computer
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: Resource brochure
Subjects given a brochure listing relevant recovery resources in the local area.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539525

Contacts
Contact: Heather B Howell, MSW 203 764 6615 heather.howell@yale.edu
Contact: Sarah J Saiano, MA 203 764 8123 sarah.saiano@yale.edu

Locations
United States, Connecticut
Yale-New Haven Hospital- York St Campus Recruiting
New Haven, Connecticut, United States, 06510
Contact: Kimberly A Yonkers, MD    203-764-6615    kimberly.yonkers@yale.edu   
Contact: Heather B Howell, MSW    203 764 6615    heather.howell@yale.edu   
Principal Investigator: Kimberly A Yonkers, MD         
Yale-New Haven Hospital-Chapel St Campus Recruiting
New Haven, Connecticut, United States, 06519
Contact: Kimberly A Yonkers, MD       kimberly.yonkers@yale.edu   
Contact: Heather B Howell, MSW    203 764 6615    heather.howell@yale.edu   
Principal Investigator: Kimberly A Yonkers, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kimberly A Yonkers, MD Yale School of Medicine
Principal Investigator: Steve Martino, PhD Yale School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Kimberly Yonkers, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01539525     History of Changes
Other Study ID Numbers: 1005006785, R01DA027194
Study First Received: August 3, 2011
Last Updated: August 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Substance-Related Disorders
Tobacco Use Disorder
Disease
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014