Alcohol Abuse, Marijuana Abuse, Substance-Related Disorders, Tobacco Use Disorder
Conditions
Brief summary
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.
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.
Interventions
BEHAVIORALMotivational Interview
Motivational Interview provided by either a Nurse or Computer
OTHERTreatment as Usual
Subjects given a brochure listing relevant recovery resources in the local area.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants received a behavioral intervention that could not be masked. Outcome data were self report and urine tests rom the participants.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days Per Month of Primary Substance Use | 7 non-overlapping monthly intervals from baseline to month 6 | Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations. |
| Treatment Utilization | baseline to 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of STDs | baseline to 6 months | rates of incident std's per patient's medical records |
| Mean Cost for Each Intervention | 6 months | The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interview Motivational interview provided by a clinical research nurse or physician.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer | 145 |
| Motivational Interview-Electronic Motivational Interview provided by an interactive computer program.
Motivational Interview: Motivational Interview provided by either a Nurse or Computer | 143 |
| Treatment as Usual No intervention- resource list provided.
Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area. | 151 |
| Total | 439 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 12 | 11 |
| Overall Study | Protocol Violation | 1 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Motivational Interview | Treatment as Usual | Motivational Interview-Electronic |
|---|---|---|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 11.1 | 33.6 years STANDARD_DEVIATION 109 | 34.4 years STANDARD_DEVIATION 12 | 34.6 years STANDARD_DEVIATION 10.3 |
| Alcohol, Smoking, and Substance Involvement Screening Test Score | 22.5 units on a scale STANDARD_DEVIATION 7.9 | 22.5 units on a scale STANDARD_DEVIATION 8.1 | 22.2 units on a scale STANDARD_DEVIATION 8.1 | 22.8 units on a scale STANDARD_DEVIATION 8.5 |
| Any substance use | 25.7 days per month STANDARD_DEVIATION 5.9 | 26.0 days per month STANDARD_DEVIATION 5.5 | 25.7 days per month STANDARD_DEVIATION 6.1 | 25.4 days per month STANDARD_DEVIATION 6.2 |
| Education Beyond high school | 110 participants | 35 participants | 42 participants | 33 participants |
| Education High school graduate | 181 participants | 64 participants | 57 participants | 60 participants |
| Education missing | 2 participants | 0 participants | 0 participants | 2 participants |
| Education Some high school or less | 146 participants | 46 participants | 52 participants | 48 participants |
| Employment status Full-time | 66 participants | 18 participants | 20 participants | 28 participants |
| Employment status Not working | 291 participants | 103 participants | 99 participants | 89 participants |
| Employment status Part-time | 82 participants | 24 participants | 32 participants | 26 participants |
| Fagerstrom Test for Nicotine Dependence Score | 3.9 units on a scale STANDARD_DEVIATION 2.6 | 3.8 units on a scale STANDARD_DEVIATION 2.7 | 3.9 units on a scale STANDARD_DEVIATION 2.7 | 3.6 units on a scale STANDARD_DEVIATION 2.8 |
| Marital Status Married/living with partner | 197 participants | 70 participants | 73 participants | 54 participants |
| Marital Status Other living situation | 242 participants | 75 participants | 78 participants | 89 participants |
| Pregnant Not pregnant | 359 participants | 118 participants | 122 participants | 119 participants |
| Pregnant Pregnant | 80 participants | 27 participants | 29 participants | 24 participants |
| Primary Substance Alcohol | 51 participants | 15 participants | 13 participants | 23 participants |
| Primary Substance Cannabis | 90 participants | 32 participants | 31 participants | 27 participants |
| Primary Substance Nicotine | 251 participants | 81 participants | 90 participants | 80 participants |
| Primary Substance Other illicit drug | 47 participants | 17 participants | 17 participants | 13 participants |
| Primary substance use | 23.7 days per month STANDARD_DEVIATION 7.9 | 23.2 days per month STANDARD_DEVIATION 8.3 | 24.2 days per month STANDARD_DEVIATION 7.7 | 23.7 days per month STANDARD_DEVIATION 7.7 |
| Race/Ethnicity, Customized Afican-American, non-Hispanic | 293 participants | 102 participants | 98 participants | 93 participants |
| Race/Ethnicity, Customized Caucasian-American, non-Hispanic | 58 participants | 19 participants | 23 participants | 16 participants |
| Race/Ethnicity, Customized Hispanic | 65 participants | 19 participants | 24 participants | 22 participants |
| Race/Ethnicity, Customized Other race/ethnicity | 23 participants | 5 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 439 Participants | 145 Participants | 151 Participants | 143 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Substance Use Disorders Alcohol | 51 participants | 15 participants | 13 participants | 23 participants |
| Substance Use Disorders Cannabis | 90 participants | 32 participants | 31 participants | 27 participants |
| Substance Use Disorders Nicotine | 251 participants | 81 participants | 90 participants | 80 participants |
| Substance Use Disorders Other illicit drug | 47 participants | 17 participants | 17 participants | 13 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 145 | 0 / 143 | 0 / 151 |
| serious Total, serious adverse events | 0 / 145 | 0 / 143 | 0 / 151 |
Outcome results
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.
Time frame: 7 non-overlapping monthly intervals from baseline to month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interview-Nurse | Days Per Month of Primary Substance Use | baseline | 23.2 days per month | Standard Deviation 8.3 |
| Motivational Interview-Nurse | Days Per Month of Primary Substance Use | Month 6 | 17.0 days per month | Standard Deviation 12.3 |
| Motivational Interview-Nurse | Days Per Month of Primary Substance Use | Month 3 | 18.0 days per month | Standard Deviation 12 |
| Motivational Interview-Nurse | Days Per Month of Primary Substance Use | Month 5 | 17.6 days per month | Standard Deviation 12.5 |
| Motivational Interview-Nurse | Days Per Month of Primary Substance Use | Month 1 | 19.3 days per month | Standard Deviation 11.2 |
| Motivational Interview-Nurse | Days Per Month of Primary Substance Use | Month 4 | 18.0 days per month | Standard Deviation 12.2 |
| Motivational Interview-Nurse | Days Per Month of Primary Substance Use | Month 2 | 18.7 days per month | Standard Deviation 11.8 |
| Motivational Interview-Computer | Days Per Month of Primary Substance Use | Month 4 | 16.8 days per month | Standard Deviation 12.3 |
| Motivational Interview-Computer | Days Per Month of Primary Substance Use | Month 5 | 16.3 days per month | Standard Deviation 12.6 |
| Motivational Interview-Computer | Days Per Month of Primary Substance Use | Month 6 | 16.2 days per month | Standard Deviation 12.5 |
| Motivational Interview-Computer | Days Per Month of Primary Substance Use | Month 2 | 17.9 days per month | Standard Deviation 12.1 |
| Motivational Interview-Computer | Days Per Month of Primary Substance Use | baseline | 23.7 days per month | Standard Deviation 7.7 |
| Motivational Interview-Computer | Days Per Month of Primary Substance Use | Month 3 | 17.8 days per month | Standard Deviation 11.9 |
| Motivational Interview-Computer | Days Per Month of Primary Substance Use | Month 1 | 19.7 days per month | Standard Deviation 11.2 |
| Treatment as Usual | Days Per Month of Primary Substance Use | Month 6 | 19.1 days per month | Standard Deviation 11.8 |
| Treatment as Usual | Days Per Month of Primary Substance Use | Month 1 | 22.8 days per month | Standard Deviation 8.9 |
| Treatment as Usual | Days Per Month of Primary Substance Use | Month 2 | 22.2 days per month | Standard Deviation 10.1 |
| Treatment as Usual | Days Per Month of Primary Substance Use | Month 3 | 21.4 days per month | Standard Deviation 10.6 |
| Treatment as Usual | Days Per Month of Primary Substance Use | Month 4 | 20.0 days per month | Standard Deviation 11.4 |
| Treatment as Usual | Days Per Month of Primary Substance Use | Month 5 | 19.7 days per month | Standard Deviation 11.4 |
| Treatment as Usual | Days Per Month of Primary Substance Use | baseline | 24.2 days per month | Standard Deviation 7.7 |
Comparison: Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.p-value: <0.00195% CI: [-0.118, -0.038]Generalized Estimating Equation
Comparison: Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.p-value: 0.06695% CI: [-0.0004, 0.011]Generalized Estimating Equation
Comparison: Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.p-value: 0.03895% CI: [-0.151, -0.004]Generalized Estimating Equation
Comparison: Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.p-value: 0.00895% CI: [-0.157, -0.023]Generalized Estimating Equation
Comparison: Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.p-value: 0.03195% CI: [0.001, 0.022]Generalized Estimating Equation
Comparison: Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.p-value: 0.0195% CI: [0.002, 0.021]Generalized Estimating Equation
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).
Time frame: baseline to 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Motivational Interview-Nurse | Treatment Utilization | utilized treatment | 39 participants |
| Motivational Interview-Nurse | Treatment Utilization | no tretment | 106 participants |
| Motivational Interview-Computer | Treatment Utilization | utilized treatment | 39 participants |
| Motivational Interview-Computer | Treatment Utilization | no tretment | 104 participants |
| Treatment as Usual | Treatment Utilization | utilized treatment | 43 participants |
| Treatment as Usual | Treatment Utilization | no tretment | 108 participants |
p-value: 0.8195% CI: [0.559, 1.551]Regression, Logistic
p-value: 0.9995% CI: [0.579, 1.617]Regression, Logistic
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
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview-Nurse | Mean Cost for Each Intervention | 57.56 dollars | Standard Deviation 16.12 |
| Motivational Interview-Computer | Mean Cost for Each Intervention | 21.07 dollars | Standard Deviation 4.43 |
| Treatment as Usual | Mean Cost for Each Intervention | 21.21 dollars | Standard Deviation 7.3 |
Secondary
Rates of STDs
rates of incident std's per patient's medical records
Time frame: baseline to 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Motivational Interview-Nurse | Rates of STDs | Non-incident case | 135 participants |
| Motivational Interview-Nurse | Rates of STDs | Incident case | 8 participants |
| Motivational Interview-Nurse | Rates of STDs | Missing | 2 participants |
| Motivational Interview-Computer | Rates of STDs | Non-incident case | 138 participants |
| Motivational Interview-Computer | Rates of STDs | Incident case | 4 participants |
| Motivational Interview-Computer | Rates of STDs | Missing | 1 participants |
| Treatment as Usual | Rates of STDs | Incident case | 6 participants |
| Treatment as Usual | Rates of STDs | Missing | 3 participants |
| Treatment as Usual | Rates of STDs | Non-incident case | 152 participants |
p-value: 0.46595% CI: [0.409, 3.871]Regression, Logistic
p-value: 0.4995% CI: [0.205, 2.732]Regression, Logistic