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Randomized Controlled Trial
. 2018 Mar;218(3):322.e1-322.e12.
doi: 10.1016/j.ajog.2017.12.005. Epub 2017 Dec 14.

A randomized controlled trial of screening and brief interventions for substance misuse in reproductive health

Affiliations
Randomized Controlled Trial

A randomized controlled trial of screening and brief interventions for substance misuse in reproductive health

Steve Martino et al. Am J Obstet Gynecol. 2018 Mar.

Abstract

Background: Screening, brief intervention, and referral to treatment may reduce substance misuse but has received minimal study among women who are treated in reproductive health settings.

Objective: The purpose of this study was to determine whether "screening, brief intervention and referral to treatment" that is delivered either electronically or by clinician are more effective than enhanced usual care in decreasing days of primary substance use.

Study design: Women from 2 reproductive centers who smoked cigarettes or misused alcohol, illicit drugs, or prescription medication were allocated randomly to "screening, brief intervention and referral to treatment" delivered electronically or by clinician or to enhanced usual care. Assessments were completed at baseline and at 1-, 3-, and 6-months after a baseline has been established. Coprimary outcomes were days/months of primary substance use and postintervention treatment use. A sample size of 660 women was planned; randomization was stratified by primary substance use and pregnancy status. "Screening, brief intervention and referral to treatment" groups were compared with enhanced usual care groups with the use of generalized estimation equations, and effect sizes were calculated with the use of Cohen's d.

Results: Between September 2011 and January 2015, women were assigned randomly to a group: 143 women (16.8% pregnant) in the electronic-delivered "screening, brief intervention and referral to treatment" group, 145 women (18.6% pregnant) in the clinician-delivered "screening, brief intervention and referral to treatment" group, and 151 women (19.2% pregnant) in the enhanced usual care group; the retention was >84%. Based on the generalized estimating equations model, predicted mean days per month of use at baseline for primary substance were 23.9 days (95% confidence interval, 22.4-25.5) for the electronic-delivered group, 22.8 days (95% confidence interval, 21.4-24.3) for the clinician-delivered group, and 23.5 days (95% confidence interval, 22.2, 24.9) for enhanced usual care, which respectively declined to 20.5 days (95% confidence interval, 19.0-22.2), 19.8 days (95% confidence interval,18.5-21.3), and 21.9 days (95% confidence interval, 20.7-23.1) at 1 month; 16.9 days (95% confidence interval, 15.0-19.0), 16.6 days (95% confidence interval, 14.8-18.6), and 19.5 days (95% confidence interval, 18.1-21.1) at 3 months; and 16.3 days (95% confidence interval, 14.3-18.7), 16.3 days (95% confidence interval, 14.4-18.5), and 17.9 days (95% confidence interval, 16.1-19.9) at 6 months. Estimated declines were greater in the electronic-delivered group (β [standard error]=-0.090[0.034]; P=.008; Cohen's d, 0.19 at 1 month, 0.30 at 3 months, and 0.17 at 6 months) and the clinician-delivered group (β [standard error]=-0.078[0.037]; P=.038; Cohen's d, 0.17 at 1 month, 0.22 at 3 months, and 0.06 at 6 months) compared with enhanced usual care. Treatment use did not differ between groups.

Conclusion: "Screening, brief intervention and referral to treatment" significantly decreased days of primary substance use among women in reproductive healthcare centers; neither resulted in more treatment use than enhanced usual care.

Keywords: brief intervention; motivational interviewing; primary care; reproductive health; screening; substance use; treatment use.

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Conflict of interest statement

Conflict of Interest: Dr. Ondersma discloses that he is part-owner of Interva, Inc., which markets the intervention authoring tool that was used to develop the electronic intervention for this study. Dr. Yonkers discloses royalties from Up-To-Date, Marinus Pharmaceuticals and Juniper Pharmaceuticals. Other authors have nothing to disclose.

Figures

Figure 1.
Figure 1.. Participant Flow in the Trial of Electronic- and Clinician-Delivered SBIRT
Participant flow diagram according to CONSORT guidelines. ano use in 28 days prior to randomization; bpatient in treatment prior to randomization
Figure 2:
Figure 2:. Mean Days of Any Substance Use By Treatment Group and Stratified By Pregnancy Status
EUC, Enhanced Usual Care e-SBIRT, electronically delivered Screening, Brief Intervention and Referral to Treatment; SBIRT, clinician delivered Screening, Brief Intervention and Referral to Treatment. Notes: i. Results are based upon a Generalized Estimating Equation Model Predicting Days/Month of primary substance use, adjusted for treatment group, linear and quadratic effects of time, treatment x (linear and quadratic) time interactions, pregnancy status and primary substance use; ii. Pregnancy status and primary substance use was fixed at not pregnant and nicotine (the largest groups); iii. Standard error bars are shown; iv. Numbers at the bottom, inside of graph represent modeled mean number of days/month of primary substance use by month and treatment group.

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