Provider-patient relationships and trauma among pregnant patients with opioid-use disorder.

BACKGROUND AND OBJECTIVES: The provider-patient relationship is integral to medical practice and health outcomes, particularly among vulnerable patient populations. This study compared the provider-patient relationship among pregnant patients with opioid-use disorder (OUD), who did or did not have a history of moderate to severe trauma. METHODS: This was an exploratory data analysis of 119 patients enrolled in the Support Models for Addiction Related Treatment trial. Probable posttraumatic stress disorder (PTSD) was determined by a score ≥ 31 on the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The provider-patient relationship was assessed at 26 ± 4 weeks of pregnancy using the Kim Alliance Scale (KAS). Multivariable regression was used to examine the association of KAS with probable PTSD among pregnant people with OUD. RESULTS: The mean KAS score for pregnant participants without probable PTSD (N = 88) was 61.4 (SD ± 2.8) and for pregnant participants with probable PTSD (N = 31) was 59.6 (SD ± 3.7). Results demonstrated significant differences in KAS scores between those with and without probable PTSD after adjusting for demographic variables. Adjusted mean total KAS scores and scores on Empowerment and Communication subscales were significantly lower among those with probable PTSD compared to those without (p = .04 and 0.02, respectively) but did not differ significantly on Collaboration and Integration subscales. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Analyses show an association between probable PTSD and provider-patient relationship among pregnant patients with OUD, with those with probable PTSD having a worse alliance with obstetric providers. This novel finding helps characterize the provider-patient relationship among a uniquely vulnerable population and can inform efforts to integrate trauma-informed practices into prenatal care.

Do veterans with risky substance use (RSU) use distinct pain treatment modalities?

BACKGROUND AND OBJECTIVES: Risky substance use (RSU) is common among people with chronic pain and is associated with worse pain treatment outcomes. Nonopioid treatment is recommended, but it is unknown whether people with RSU use different or fewer pain treatment modalities. This study describes use of different pain treatments by veterans with and without RSU and those receiving versus not receiving opioid medication. METHODS: Veterans (N = 924) who filed service-connected disability claims related to musculoskeletal conditions and rated their pain four or higher on the Numeric Rating Scale, reported on 25 different pain services in the preceding 90 days. Recent RSU was identified via Alcohol, Smoking, and Substance Involvement Test (ASSIST) cutoffs and/or nail sample toxicology. RESULTS: Overall, RSU was not associated with number of provider-delivered or self-delivered pain modalities. Over-the-counter medications (71%), self-structured exercise (69%), and nonopioid prescription medications (38%) were the most used modalities. Veterans receiving prescribed opioids (8.4%) were more likely to see primary care, receive injections, and attend exercise and/or meditation classes, compared to those without opioid prescriptions. DISCUSSION AND CONCLUSIONS: Opioid and nonopioid pain treatment utilization did not differ based on RSU, and those prescribed opioids were more likely to engage in other nonopioid pain treatments. Regardless of RSU, veterans appear willing to try provider-delivered (58%) and self-delivered (79%) pain treatment. SCIENTIFIC SIGNIFICANCE: In this first-ever evaluation of 25 different pain treatment modalities among veterans with and without RSU, people with RSU did not use less treatment modalities.

Does Symptom-Onset Treatment With Sertraline Improve Functional Impairment for Individuals With Premenstrual Dysphoric Disorder?: A Randomized Controlled Trial.

PURPOSE/BACKGROUND: Daily treatment with sertraline improves functional impairment among individuals with premenstrual dysphoric disorder (PMDD). We do not know whether treatment initiated at symptom onset also improves functional impairment. METHODS/PROCEDURES: This 3-site, double blind, randomized, clinical trial compared sertraline (25-100 mg) to similar appearing placebo, both administered at symptom onset, for reduction of PMDD symptoms. Ninety participants were allocated to sertraline and 94 participants to placebo. Functional outcomes from the Daily Ratings of the Severity of Problems included (1) reduced productivity or efficiency at work, school, home, or daily routine; (2) interference with hobbies or social activities; and (3) interference with relationships. Items were measured from 1 (no interference) to 6 (extreme interference) and averaged for the final 5 luteal phase days. This secondary analysis examined whether improvement in functional domains was greater for those allocated to sertraline compared with placebo. Second, we used causal mediation analyses to explore whether specific PMDD symptoms mediated functional improvement. RESULTS/FINDINGS: Only relationship functioning improved significantly with active treatment between baseline and the end of the second cycle (active group mean [SD] change, -1.39 [1.38]; placebo group mean change, -0.76 [1.20]; ß = -0.40; SE, 0.15; P = 0.009). The total effect of treatment on interference was -0.37 (95% confidence interval [CI], -0.66 to -0.09; P = 0.011). Given the nonsignificant direct effect (0.11; 95% CI, -0.07 to 0.29; P = 0.24) and significant indirect effect (-0.48; 95% CI, -0.71 to -0.24; P < 0.001), amelioration of anger/irritability likely mediated reductions in relationship interference. IMPLICATIONS/CONCLUSIONS: That anger/irritability mediates impairments in relationship functioning has face validity but should be replicated in other data sets. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00536198 .

The acceptability and feasibility of screening, brief intervention, and referral to treatment for pain management among new England veterans with chronic pain: A pilot study.

OBJECTIVES: Musculoskeletal disorders often lead to chronic pain in Veterans. Chronic pain puts sufferers at risk for substance misuse, and early intervention is needed for both conditions. This pilot study tested the feasibility and acceptability of a Screening, Brief Intervention, and Referral to Treatment for Pain Management intervention (SBIRT-PM) to help engage Veterans seeking disability compensation for painful musculoskeletal disorders in multimodal pain treatment and to reduce risky substance use, when indicated. METHODS: This pilot study enrolled 40 Veterans from 8 medical centers across New England in up to 4 sessions of telephone-based counseling using a motivational interviewing framework. Counseling provided education about, and facilitated engagement in, multimodal pain treatments. Study eligibility required Veterans be engaged in no more than 2 Veteran Affairs (VA) pain treatment modalities, and study participation involved a 12-week postassessment and semistructured interview about the counseling process. RESULTS: Majorities of enrolled Veterans screened positive for comorbid depression and problematic substance use. Regarding the offered counseling, 80% of participants engaged in at least one session, with a mean of 3 sessions completed. Ninety percent of participants completed the postassessment. Numerically, most measures improved slightly from baseline to week 12. In semistructured interviews, participants described satisfaction with learning about new pain care services, obtaining assistance connecting to services, and receiving support from their counselors. DISCUSSION: It was feasible to deliver SBIRT-PM to Veterans across New England to promote engagement in multimodal pain treatment and to track study outcomes over 12 weeks. Preliminary results suggest SBIRT-PM was well-received and has promise for the targeted outcomes.

Substance Use Disorder Detection Rates Among Providers of General Medical Inpatients.

BACKGROUND: The prevalence of substance use disorders is higher among medical inpatients than in the general population, placing inpatient providers in a prime position to detect these patients and intervene. OBJECTIVE: To assess provider detection rates of substance use disorders among medical inpatients and to identify patient characteristics associated with detection. DESIGN: Data drawn from a cluster randomized controlled trial that tested the effectiveness of three distinct implementation strategies for providers to screen patients for substance use disorders and deliver a brief intervention (Clinical Trials.gov : NCT01825057). PARTICIPANTS: A total of 1076 patients receiving care from 13 general medical inpatient units in a large teaching hospital participated in this study. MAIN MEASURES: Data sources included patient self-reported questionnaires, a diagnostic interview for substance use disorders, and patient medical records. Provider detection was determined by diagnoses documented in medical records. KEY RESULTS: Provider detection rates were highest for nicotine use disorder (72.2%) and lowest for cannabis use disorder (26.4%). Detection of alcohol use disorder was more likely among male compared to female patients (OR (95% CI) = 4.0 (1.9, 4.8)). When compared to White patients, alcohol (OR (95% CI) = 0.4 (0.2, 0.6)) and opioid (OR (95% CI) = 0.2 (0.1, 0.7)) use disorders were less likely to be detected among Black patients, while alcohol (OR (95% CI) = 0.3 (0.0, 2.0)) and cocaine (OR (95% CI) = 0.3 (0.1, 0.9)) use disorders were less likely to be detected among Hispanic patients. Providers were more likely to detect nicotine, alcohol, opioid, and other drug use disorders among patients with higher addiction severity (OR (95% CI) = 1.20 (1.08-1.34), 1.62 (1.48, 1.78), 1.46 (1.07, 1.98), 1.38 (1.00, 1.90), respectively). CONCLUSIONS: Findings indicate patient characteristics, including gender, race, and addiction severity impact rates of provider detection. Instituting formal screening for all substances may increase provider detection and inform treatment decisions.

Screening, Brief Intervention, and Referral to Treatment for Pain Management for Veterans Seeking Service-Connection Payments for Musculoskeletal Disorders: SBIRT-PM Study Protocol.

BACKGROUND: Veterans with significant chronic pain from musculoskeletal disorders are at risk of substance misuse. Veterans whose condition is the result of military service may be eligible for a disability pension. Department of Veterans Affairs compensation examinations, which determine the degree of disability and whether it was connected to military service, represent an opportunity to engage Veterans in pain management and substance use treatments. A multisite randomized clinical trial is testing the effectiveness and cost-effectiveness of Screening, Brief Intervention, and Referral to Treatment for Pain Management (SBIRT-PM) for Veterans seeking compensation for musculoskeletal disorders. This telephone-based intervention is delivered through a hub-and-spoke configuration. DESIGN: This study is a two-arm, parallel-group, 36-week, multisite randomized controlled single-blind trial. It will randomize 1,100 Veterans experiencing pain and seeking service-connection for musculoskeletal disorders to either SBIRT-PM or usual care across eight New England VA medical centers. The study balances pragmatic with explanatory methodological features. Primary outcomes are pain severity and number of substances misused. Nonpharmacological pain management and substance use services utilization are tracked in the trial. SUMMARY: Early trial enrollment targets were met across sites. SBIRT-PM could help Veterans, at the time of their compensation claims, use multimodal pain treatments and reduce existing substance misuse. Strategies to address COVID-19 pandemic impacts on the SBIRT-PM protocol have been developed to maintain its pragmatic and exploratory integrity.

Implementing Motivational Interviewing for Substance Misuse on Medical Inpatient Units: a Randomized Controlled Trial.

BACKGROUND: General medical hospitals provide care for a disproportionate share of patients who misuse substances. Hospitalization provides a unique opportunity to identify and motivate patients to address their substance misuse. OBJECTIVE: To determine the effectiveness of three strategies for implementing motivational interviewing for substance misuse with general medical inpatients. DESIGN: Type 3 hybrid effectiveness-implementation randomized controlled trial (Clinical Trials.gov: NCT01825057). PARTICIPANTS: Thirty-eight providers (physicians, physician assistants, nurses) from 13 general medical inpatient services, and 1173 of their patients admitted to an academically affiliated acute care hospital. INTERVENTIONS: Implementation strategies included (1) a continuing medical education workshop on detection of substance misuse and provision of a motivational interview; (2) workshop plus bedside supervision (apprenticeship condition); and (3) a workshop plus ability to place a medical order for an interview from a consultation-liaison service (consult condition). MAIN MEASURES: Primary outcomes were the percentage of study-eligible patients who received an interview for substance misuse and the integrity (adherence, competence) of the interviews. The secondary outcome was the percent of patient statements within the interviews that indicated motivation for reducing substance misuse. KEY RESULTS: 20.5% of patients in the consult condition received an interview, compared to 0.8% (Hedge's g = 1.49) and 3.0% (Hedge's g = 1.26) in the respective workshop only and apprenticeship conditions (p < 0.001). Motivational interviews in the consult condition were performed with more fundamental motivational interviewing adherence and competence than the other conditions. Most statements made by patients during the interviews favored reducing substance misuse, with no differences between conditions. CONCLUSIONS: Providers' ability to place an order to have experts from the consultation-liaison service deliver a motivational interview was a more effective implementation strategy than a workshop or apprenticeship method for ensuring motivational interviewing is available to medical inpatients who misuse substances. TRIAL REGISTRY: NCT01825057.

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

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 (ß [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 (ß [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.

Associations of Neighborhood and School Socioeconomic and Social Contexts With Body Mass Index Among Urban Preadolescent Students.

OBJECTIVES: We examined independent and synergistic effects of school and neighborhood environments on preadolescent body mass index (BMI) to determine why obesity rates nearly double during preadolescence. METHODS: Physical measures and health surveys from fifth and sixth graders in 12 randomly selected schools in New Haven, Connecticut, in 2009 were matched to student sociodemographics and school- and residential census tract-level data, for a total of 811 urban preadolescents. Key independent variables included school connectedness, neighborhood social ties, and school and neighborhood socioeconomic status. We estimated cross-classified random-effects hierarchical linear models to examine associations between key school and neighborhood characteristics with student BMI. RESULTS: Greater average connectedness felt by students to their school was significantly associated with lower BMI. This association was stronger among students living in neighborhoods with higher concentrations of affluent neighbors. CONCLUSIONS: How schools engage and support students may affect obesity rates preferentially in higher-income neighborhoods. Further research should explore the associations between multiple environments to which children are exposed and obesity-related behaviors and outcomes. This understanding of the multiple social-spatial contexts that children occupy has potential to inform comprehensive and sustainable child obesity prevention efforts.

Association of influenza vaccine uptake with health, access to health care, and medical mistreatment among adults from low-income neighborhoods in New Haven, CT: a classification tree analysis.

OBJECTIVE: The aim of this study is to identify population subgroups under-vaccinated for influenza through classification tree analysis to inform interventions aimed at improving future vaccine uptake. METHOD: A cross-sectional community health needs assessment was conducted from 09/2012 through 11/2012 among randomly selected households in six low-income neighborhoods in New Haven, CT (N=1300 adults, aged 18-65). Known correlates of influenza vaccine uptake plus experience of medical mistreatment were used to develop a classification tree to identify under-vaccinated population subgroups RESULTS: Forty-five percent of respondents reported receiving the influenza vaccine. The classification tree identified healthy adults and uninsured adults at increased risk of influenza complications as subgroups with low vaccine uptake (40% and 30%, respectively). The subgroup representing insured, high-risk adults who reported experience of medical mistreatment had moderate vaccine uptake (45%). Sensitivity of the classification tree was high (83%, 95% CI=80% to 86%), indicating a strong true positive rate using these subgroups. CONCLUSION: Results highlight the need for renewed attention to promoting the influenza vaccination recommendation for all adults, particularly among healthy adults, uninsured, high-risk adults and insured, high-risk adults who have experienced medical mistreatment. Further research is needed to better understand how to reach these population subgroups.

Sensitivity, specificity, and discordance with self-report of nail sample testing for alcohol and cannabis.

BACKGROUND: Nails accumulate the alcohol metabolite, ethyl glucuronide (ETG), and the cannabis metabolite, carboxy- delta-9-THC over 3-6 months. Few studies have examined nail toxicology testing's sensitivity and specificity and the agreement between nail testing and self-reported alcohol and marijuana use. METHODS: In an ongoing clinical trial, 1101 veterans completed initial telephone questionnaires and were then asked to mail nail clippings for substance use analysis. We examined sensitivity and specificity of ETG and carboxy- delta-9-THC in nails compared to self-report of alcohol use patterns (the AUDIT-C) and substance-related harms (alcohol and THC subscales of the ASSIST). We then examined factors associated with discordance between nails and self-report. RESULTS: Almost two-thirds (707/1101) of respondents mailed in nail clippings. Those with returned nails were disproportionately married, white race, older, and less depressed. At a threshold of 8pg/mg, sensitivity was only.50 to detect risky alcohol use and.49 to detect alcohol-related issues. Sensitivity for marijuana issues was only.61. Specificity was greater than.77 for all measures. Factors associated with positive nails/negative self-report (i.e. false positives) for risky alcohol use on the Audit-C included more pain and being unmarried; false positive nails for alcohol-related issues on the ASSIST were associated with being unmarried and non-Hispanic ethnicity. False positive nails for THC-related issues on the ASSIST were associated with being African American, Hispanic, and having had legal issues. CONCLUSIONS: At standard cut-offs, nail measures had low sensitivity and higher specificity. The groups who disproportionately submit positive nails/negative self-report could have substance use patterns not adequately captured by self-report, inaccurate self-report due to social pressures, or distinct drug metabolism.

Progression of depression and anxiety symptoms in pregnancies conceived by assisted reproductive technology in the United States.

PURPOSE: Women who utilize assisted-reproductive technology (ART) to achieve pregnancy experience unique circumstances before and during their pregnancy. This study aims to examine the progression of mental health in pregnant women who conceived via various methods of ART to understand gestational time periods of emotional stability or risk specific to these populations. METHODS: Secondary analysis of the Yale Pink and Blue Study - a prospective cohort involving women from 137 obstetrical practices in the northeastern United States between 2005-2009. Depressive and anxiety symptoms among spontaneous, planned pregnancies were compared to ART pregnancies using the Edinburgh Postnatal Depression Scale (EPDS) and its anxiety subscale (EPDS-3A), respectively. Generalized Estimating Equations were used to compare group changes (EPDS and EPDS-3A score threshold ≥10) at timepoints of <17 weeks (T1), 28(±2) weeks (T2), and 8(±4) weeks postpartum (T3). RESULTS: 1,466 spontaneous, planned pregnancies were compared to 191 pregnancies conceived via ART. Prevalence of depressive symptoms were similar between conception groups. Change in prevalence over time differed significantly between those groups (from T1 to T3 (ß 0.59), as well as between spontaneous pregnancies compared to autologous gamete ART pregnancies (from T1 to T2 (ß 0.48) and T1 to T3 (ß 0.65). Course of anxiety did not differ between conception groups. CONCLUSIONS: Women who conceive via ART have different rates of change in depressive symptoms throughout gestation compared to women with spontaneous pregnancies.

Association of Prepregnancy Substance Use and Substance Use Disorders with Pregnancy Timing and Intention.

Background: Limited research exists on the association between substance use disorders (SUDs) and dimensions of pregnancy intention. This study sought to examine the independent relationships between prepregnancy substance use and SUDs with pregnancy timing and intentions. Materials and Methods: Secondary analysis of data from three prenatal care sites in Connecticut, Massachusetts, and Michigan, 2016-2017. Associations were estimated using modified Poisson regression with robust error variance to calculate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs), controlling for relevant covariates. Results: The total sample size was 1115 women. Respectively, 61.1% and 15.5% of women used any substance in the 30 days prepregnancy or had any SUD in the past 12 months. After adjustment, any prepregnancy substance use was associated with a reduced likelihood of a well-timed (aPR 0.85; 95% CI: 0.77-0.93) and intended (aPR 0.80; 95% CI: 0.72-0.89) pregnancy; similarly, any SUD was associated with a reduced likelihood of a well-timed (aPR 0.66; 95% CI: 0.55-0.80) and intended (aPR 0.79; 95% CI: 0.67-0.93) pregnancy. Conclusions: Women with prepregnancy substance use or SUD have decreased prevalence of well-timed and intended pregnancies. Greater efforts are needed to address substance use and family planning in routine, well-woman, prenatal, and postpartum care.

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol.

INTRODUCTION: Approximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial. METHOD AND ANALYSIS: This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 120-minute session and single session plus two 5-minute boosters) with two levels of tailored text messaging (none vs twice weekly messages). The primary analysis will test for dose-response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks' gestation, and negative results for ethyl glucuronide analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes. ETHICS AND DISSEMINATION: Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04332172).

Support Models for Addiction Related Treatment (SMART) for pregnant women: Study protocol of a cluster randomized trial of two treatment models for opioid use disorder in prenatal clinics.

INTRODUCTION: The prevalence of opioid use disorder (OUD) in pregnancy increased nearly five-fold over the past decade. Despite this, obstetric providers are less likely to treat pregnant women with medication for OUD than non-obstetric providers (75% vs 91%). A major reason is many obstetricians feel unprepared to prescribe medication for opioid use disorder (MOUD). Education and support may increase prescribing and overall comfort in delivering care for pregnant women with OUD, but optimal models of education and support are yet to be determined. METHODS AND ANALYSIS: We describe the rationale and conduct of a matched-pair cluster randomized clinical trial to compare the effectiveness of two models of support for reproductive health clinicians to provide care for pregnant and postpartum women with OUD. The primary outcomes of this trial are patient treatment engagement and retention in OUD treatment. This study compares two support models: 1) a collaborative care approach, based upon the Massachusetts Office-Based-Opioid Treatment Model, that provides practice-level training and support to providers and patients through the use of care managers, versus 2) a telesupport approach based on the Project Extension for Community Healthcare Outcomes, a remote education model that provides mentorship, guided practice, and participation in a learning community, via video conferencing. DISCUSSION: This clustered randomized clinical trial aims to test the effectiveness of two approaches to support practitioners who care for pregnant women with an OUD. The results of this trial will help determine the best model to improve the capacity of obstetrical providers to deliver treatment for OUD in prenatal clinics. TRIAL REGISTRATION: Clinicaltrials.gov trial registration number: NCT0424039.

The short-term impact on economic outcomes of SBIRT interventions implemented in reproductive health care settings.

OBJECTIVE: To estimate the impact of screening, brief intervention, and referral to treatment (SBIRT) administered in reproductive health care settings on a variety of economic outcomes, including general health care utilization, criminal activity, and motor vehicle crashes. Whether and by how much SBIRT affects economic outcomes are important unanswered questions related to the economic impact of this technique. METHODS: We collected data as part of a randomized clinical trial that examined whether SBIRT delivered electronically (e-SBIRT) or by a clinician (SBIRT) is superior to enhanced usual care (EUC) for substance misuse. Participants were a convenience sample of 439 women from two reproductive health care centers who used cigarettes, risky amounts of alcohol, illicit drugs, or misused prescription medication. For each participant, we measured economic outcomes by self-report 6 months pre- and post-intervention. We used difference-in-differences regression models to estimate the impact of e-SBIRT and SBIRT, compared to EUC, on changes in each of the economic outcomes from pre- to post-intervention. RESULTS: None of the difference-in-differences estimates weas statistically significant after adjusting for multiple comparisons. CONCLUSION: In a population of women receiving routine care in reproductive health care settings, we did not find a significant effect of either e-SBIRT or SBIRT, compared to EUC, on general health care utilization, criminal activity, or motor vehicle outcomes. However, individual trials are typically underpowered to detect effects that are small but important from a public health perspective. These results may be crucial for future systematic reviews and meta-analyses to determine the economic impact of SBIRT programs from a variety of perspectives.

Cost and cost-effectiveness of three strategies for implementing motivational interviewing for substance misuse on medical inpatient units.

BACKGROUND: This study conducted cost and cost-effectiveness analyses of three strategies for implementing motivational interviewing for substance misuse on general medical inpatient units: workshop, apprenticeship, and consult. METHODS: The economic analyses were conducted prospectively alongside a type 3 hybrid effectiveness-implementation randomized trial comprising 38 medical providers, 1173 inpatients, and four consultation-liaison motivational interviewing experts. The trial took place in a university affiliated teaching hospital in New Haven, CT, USA. After completing a 1-day workshop on motivational interviewing, providers were randomized to conditions. The primary outcome measure was the number of study-eligible patients who received a motivational interview. The economic analyses included the costs of both start-up and on-going activities in each condition. Incremental cost-effectiveness ratios were used to determine cost effectiveness. Results are presented from the healthcare provider (i.e., hospital) perspective in 2018 US dollars. RESULTS: The total cost per patient receiving a motivational interview averaged $804.53, $606.52, and $185.65 for workshop, apprenticeship, and consult, respectively. Workshop and apprenticeship were extended dominated by the combination of consult and doing nothing. Doing nothing is cost effective when the willingness-to-pay for an additional patient receiving a motivational interview is less than $185.65, and consult is cost-effective when the willingness-to-pay for an additional patient receiving a motivational interview is greater than $185.65. CONCLUSIONS: Given that typical reimbursements for brief intervention services for substance misuse are $35-$65, none of the three implementation strategies is likely to be economically viable from the healthcare provider perspective.

Abstinence outcomes among women in reproductive health centers administered clinician or electronic brief interventions.

Treatment of substance use in women seeking reproductive healthcare is crucial for the health of both women and their offspring. Although abstinence from all substance use during pregnancy is optimal, it is difficult to achieve. This secondary analysis reports abstinence outcomes from a randomized clinical trial of screening, brief intervention, and referral to treatment (SBIRT) for substance use among women seeking reproductive healthcare services. Women who screened positive for substance use were randomly assigned to either clinician-administered SBIRT, an electronically-administered brief intervention (e-SBIRT), or an enhanced usual care condition. At a 6-month follow-up assessment, compared to enhanced usual care, the clinician-administered SBIRT increased 1-month point prevalence of abstinence from the primary substance by 7.7%, and e-SBIRT increased abstinence by 12.8%. Both brief interventions were more useful than enhanced usual care and could increase substance use abstinence rates among women in reproductive healthcare clinics. The electronic brief intervention is particularly attractive given that it appears as efficacious as, but requires fewer resources than, clinician-delivered brief interventions.

Comparing satisfaction, alliance and intervention components in electronically delivered and in-person brief interventions for substance use among childbearing-aged women.

Electronic delivery of Screening, Brief Intervention, and Referral to Treatment (e-SBIRT) may be a low-cost and high-reach method for screening and brief intervention in health care settings. However, its relative acceptability, ability to build a therapeutic alliance, and delivery of key intervention components compared to in-person SBIRT (SBIRT) is unclear. The association of these factors with intervention outcomes is also not known. We compared SBIRT and e-SBIRT on satisfaction, alliance, and receipt of intervention components, and evaluated the extent to which these intervention dimensions were related to later substance use. Data were collected as part of a randomized clinical trial (N = 439) examining SBIRT, e-SBIRT, and enhanced usual care for childbearing-aged women in two reproductive healthcare clinics (see Martino et al. (2018) for main trial findings). Participants receiving SBIRT or e-SBIRT (N = 270) rated satisfaction and alliance following a single-session, brief intervention, based on motivational interviewing that targeted hazardous substance use (tobacco, alcohol, illicit drugs and prescribed medications). Trained raters coded audio-recorded SBIRT sessions for the presence of six major intervention components, and evaluated the occurrence of these components in the e-SBIRT software. Overall, participants in both groups reported strong satisfaction (on average, "considerably" to "extremely" satisfied) and perceived working alliance (on average, "very often" to "always" allied). SBIRT participants provided higher overall alliance ratings, felt more encouraged to make their own decisions, and rated the intervention's likely helpfulness to other women higher. Fewer e-SBIRT participants received intervention components focusing on personalized feedback, developing importance of and confidence in making changes to substance use, and developing a plan to change, compared to SBIRT participants. However, e-SBIRT participants were equally or more likely to receive components seeking to help them understand their use, discussing reasons for use, and summarizing and supporting what the patients elected to do. Notably, satisfaction, alliance, and number of intervention components received were not associated with total days of substance use. Although we found no evidence that the intervention characteristics evaluated in this study were associated with outcomes, acceptability and alliance may have other important implications. Findings suggest areas for improvement with respect to e-SBIRT satisfaction and alliance formation. ClinicalTrials.govregistration number: NCT01539525.

Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic.

BACKGROUND: Women are at highest risk for development of a substance use disorder during their reproductive years. We recently evaluated the efficacy of an electronic screening, brief intervention and referral to treatment (e-SBIRT) and a clinician-delivered SBIRT (SBIRT) compared with enhanced usual care (EUC) for reducing overall substance use among women recruited from reproductive health clinics. The present study assessed the impact of the SBIRT interventions within three primary substance subgroups: cigarettes, illicit drugs, and alcohol. METHODS: This is a secondary analysis from a 3-group randomized trial comparing e-SBIRT and SBIRT to EUC. For the present study, participants (N = 439) were grouped according to their primary substance: cigarettes, alcohol, or illicit drugs. Differences in days per month of primary substance use over time between treatment groups were examined using generalized estimating equations, modelling linear as well as quadratic effects of time. RESULTS: Cigarettes were the most frequently reported primary substance (n = 251), followed by illicit drugs (n = 137) and alcohol (n = 51). For primary cigarette use the interaction between the linear effect of time and treatment was significant for SBIRT (ß (SE) = -0.067 (0.029), p = .020), but not e-SBIRT, suggesting greater reductions in cigarette use over the first 3 months following treatment with SBIRT compared to EUC. However, the significant interaction of SBIRT with time-squared (ß (SE) = 0.009 (0.004), p = .049) showed that reductions in cigarette use attenuated over time, such that after month 3, monthly reductions in cigarette use were similar between groups. Results followed a similar pattern for primary illicit drug use among the e-SBIRT group in which the interaction of e-SBIRT treatment with linear time (ß (SE) = -0.181 (0.085), p = .033) and quadratic time (ß (SE) = 0.028 (0.012), p = .018) were statistically significant suggesting greater reductions in illicit drug use with e-SBIRT versus EUC, which attenuated with time. Neither SBIRT nor e-SBIRT was associated with a significant reduction in days of alcohol use per month, as compared to EUC. CONCLUSIONS: Reproductive-age women appear to respond differently to electronic- and clinician-delivered interventions, depending on their primary substance. SBIRT reduced use of cigarettes, and e-SBIRT reduced illicit drug use. Although neither intervention reduced primary alcohol use, the sample size was small (n = 51), suggesting a need for further testing in a larger sample.