Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA027194 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interview | Experimental | Motivational interview provided by a clinical research nurse or physician. |
|
| Motivational Interview-Electronic | Active Comparator | Motivational Interview provided by an interactive computer program. |
|
| Treatment as Usual | Placebo Comparator | No intervention- resource list provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interview | Behavioral | Motivational Interview provided by either a Nurse or Computer |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
In order to participate, women must meet the following criteria:
Exclusion Criteria:
Women are ineligible if they have any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kimberly A Yonkers, MD | Yale University | Principal Investigator |
| Steve Martino, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital- York St Campus | New Haven | Connecticut | 06510 | United States | ||
| Yale-New Haven Hospital-Chapel St Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31100713 | Derived | 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. | |
| 30797381 | Derived | 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. |
Not provided
Not provided
We will require data request with delineation of variables of interest. Only de-identified data will be released after evaluation of the request
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were women (non-pregnant and pregnant) presenting for outpatient reproductive healthcare in an urban academic hospital-based clinic. Data collection occurred between April 20, 2011 and January 28, 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interview-Nurse | Motivational interview provided by a clinical research nurse or physician. Motivational Interview: Motivational Interview provided by either a Nurse or Computer |
| FG001 | Motivational Interview-Computer | Motivational Interview provided by an interactive computer program. Motivational Interview: Motivational Interview provided by either a Nurse or Computer |
| FG002 | Treatment as Usual | No intervention- resource list provided. Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interview | Motivational interview provided by a clinical research nurse or physician. Motivational Interview: Motivational Interview provided by either a Nurse or Computer |
| BG001 | Motivational Interview-Electronic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | days per month | 7 non-overlapping monthly intervals from baseline to month 6 |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Interview | Motivational interview provided by a clinical research nurse or physician. Motivational Interview: Motivational Interview provided by either a Nurse or Computer |
Not provided
Not provided
Results may not be generalizable to populations differing from population from which sample was drawn.
Outcomes relied upon self-report, although we did try to verify through lab results for substance use and medical records/ provider for treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly A Yonkers | Yale University School of Medicine | 203-764-6621 | kimberly.yonkers@yale.edu |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D014029 | Tobacco Use Disorder |
| D002189 | Marijuana Abuse |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants received a behavioral intervention that could not be masked. Outcome data were self report and urine tests rom the participants.
Not provided
| Treatment as Usual | Other | Subjects given a brochure listing relevant recovery resources in the local area. |
|
| 6 months |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Protocol Violation |
|
Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer
| BG002 | Treatment as Usual | No intervention- resource list provided. Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Marital Status | Number | participants |
|
| Pregnant | Number | participants |
|
| Education | Number | participants |
|
| Employment status | Number | participants |
|
| Primary Substance | Number | participants |
|
| Primary substance use | Mean | Standard Deviation | days per month |
|
| Any substance use | Mean | Standard Deviation | days per month |
|
| Substance Use Disorders | Number | participants |
|
| Alcohol, Smoking, and Substance Involvement Screening Test Score | Scores range from 0 to 39, with higher scores indicating greater need for more intensive intervention. Scores are for primary substance. | Mean | Standard Deviation | units on a scale |
|
| Fagerstrom Test for Nicotine Dependence Score | Scores range from 0 to 10, with higher scores indicating higher levels of nicotine dependence. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Treatment as Usual | No intervention- resource list provided. Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area. |
|
|
|
| Primary | 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). | Posted | Number | participants | baseline to 6 months |
|
|
|
|
| Secondary | Rates of STDs | rates of incident std's per patient's medical records | Posted | Number | participants | baseline to 6 months |
|
|
|
|
| Secondary | 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 | This outcome was restricted to participants who had a time stamp for their intervention (n=11 were missing) and had all 6 months of follow-up data. | Posted | Mean | Standard Deviation | dollars | 6 months | participants | participants |
|
|
|
| 0 |
| 145 |
| 0 |
| 145 |
| EG001 | Motivational Interview-Electronic | Motivational Interview provided by an interactive computer program. Motivational Interview: Motivational Interview provided by either a Nurse or Computer | 0 | 143 | 0 | 143 |
| EG002 | Treatment as Usual | No intervention- resource list provided. Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area. | 0 | 151 | 0 | 151 |
Not provided
Not provided
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Title | Measurements |
|---|---|
|
| Regression, Logistic |
adjusted for stratifying variables- primary substance and pregnancy status |
| 0.990 |
| Odds Ratio (OR) |
| 0.968 |
| 2-Sided |
| 95 |
| 0.579 |
| 1.617 |
Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Missing |
|
| Regression, Logistic |
| 0.490 |
| Odds Ratio (OR) |
| 0.749 |
| 2-Sided |
| 95 |
| 0.205 |
| 2.732 |
Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual |
| Superiority or Other |