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Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial.

ABSTRACT: Importance:There are high rates of maternal and newborn morbidity and mortality associated with opioid use disorder (OUD). Integrating OUD treatment in obstetric practices for pregnant and postpartum women via telemedicine can increase access to care and reduce the consequences of OUD. Evaluation of this care delivery model, however, is needed before widespread adoption. Objective:To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine vs in person. Design, Setting, and Participants:A nonrandomized controlled trial including 98 women receiving perinatal OUD treatment in 4 outpatient obstetric practices by telemedicine or in person and followed up until 6 to 8 weeks post partum was conducted from September 4, 2017, to December 31, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables. Interventions:Participants were seen weekly for 4 weeks, every 2 weeks for 4 weeks, and monthly thereafter and provided relapse prevention therapy and buprenorphine. Main Outcomes and Measures:The outcomes were retention in treatment, defined as uninterrupted addiction treatment during pregnancy through 6 to 8 weeks post partum; urine drug screen results at delivery and 6 to 8 weeks post partum; and a neonatal abstinence syndrome (NAS) diagnosis collected via electronic health records. Results:The mean (SD) age of the 98 pregnant women was 30.23 (5.12) years. Of these, 41 of 44 women (93.2%) in the telemedicine group and 48 of 54 women (88.9%) in the in-person group chose to continue treatment in the program after an initial evaluation. After propensity score weighting and doubly robust estimation, no significant differences were found between groups in retention in treatment at 6 to 8 weeks post partum (telemedicine: 80.4% vs in person: 92.7%; treatment effect, -12.2%; 95% CI, -32.3% to -4.4%). Similarly, after propensity score weighting and doubly robust estimation, there were no significant group differences in rates of NAS (telemedicine: 45.4% vs in person: 63.2%; treatment effect, -17.8%; 95% CI, -41.0% to 8.9%). Conclusions and Relevance:In this nonrandomized controlled trial, virtually integrated OUD care in obstetric practices produced similar maternal and newborn outcomes compared with in-person care. These findings may have important public health implications for combatting the opioid crisis and its consequences on pregnant women and their families. Future large randomized clinical trials are needed. Clinical Trial Registration:ClinicalTrials.gov identifier: NCT04049032.

SUBMITTER: Guille C

PROVIDER: S-EPMC7042863 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial.

Guille Constance C Simpson Annie N AN Douglas Edie E Boyars Lisa L Cristaldi Kathryn K McElligott James J Johnson Donna D Brady Kathleen K

JAMA network open 20200103 1

<h4>Importance</h4>There are high rates of maternal and newborn morbidity and mortality associated with opioid use disorder (OUD). Integrating OUD treatment in obstetric practices for pregnant and postpartum women via telemedicine can increase access to care and reduce the consequences of OUD. Evaluation of this care delivery model, however, is needed before widespread adoption.<h4>Objective</h4>To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicin ...[more]

PMID: 32003816

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Project description:ObjectiveTo assess trends in polysubstance use among pregnant women with opioid use disorder in the United States.MethodsWe conducted a time trend analysis of pooled, cross-sectional data from the National Inpatient Sample, an annual nationally representative sample of U.S. hospital discharge data. Among 38.0 million females aged 15-44 years with a hospitalization for delivery from 2007 to 2016, we identified 172,335 pregnant women with an International Classification of Diseases, Ninth Revision, Clinical Modification or International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis of opioid use disorder. Polysubstance use among pregnant women with opioid use disorder was defined as at least one co-occurring diagnosis of other substance use, including alcohol, amphetamine, cannabis, cocaine, sedative, or tobacco. We fit weighted multivariable logistic regression models to produce nationally representative estimates, including an interaction between year and rural compared with urban county of residence; controlled for age, race, and insurance type. Average predicted probabilities and 95% CIs were derived from regression results.ResultsPolysubstance use among women with opioid use disorder increased from 60.5% (95% CI 58.3-62.8%) to 64.1% (95% CI 62.8%-65.3%). Differential time trends in polysubstance use among women with opioid use disorder were found in rural compared with urban counties. Large increases in amphetamine use occurred among those in both rural and urban counties (255.4%; 95% CI 90.5-562.9% and 150.7%; 95% CI 78.2-52.7%, respectively), similarly to tobacco use (30.4%; 95% CI 16.9-45.4% and 23.2%; 95% CI 15.3-31.6%, respectively). Cocaine use diagnoses declined among women with opioid use disorder at delivery in rural (-70.5%; 95% CI -80.4% to -55.5%) and urban (-61.9%; 95% CI -67.6% to -55.1%) counties. Alcohol use diagnoses among those with opioid use disorder declined -57% (95% CI -70.8% to -37.7%) in urban counties but did not change among those in rural counties.ConclusionOver the past decade, polysubstance use among pregnant women with opioid use disorder has increased more rapidly in rural compared with urban counties in the United States, with amphetamines and tobacco use increasing most rapidly.

Project description:BackgroundOpioid use disorder (OUD) among women delivering at a hospital has increased 400% from 1999-2014 in the United States. From the years 2007 to 2016, opioid-related mortality during pregnancy increased over 200%, and drug-overdose deaths made up nearly 10% of all pregnancy-associated mortality in 2016 in the US. Disproportionately higher rates of neonatal opioid withdrawal syndrome (NOWS) have been reported in rural areas of the country, suggesting that perinatal OUD is a pressing issue among these communities. There is an urgent need for comprehensive, evidence-based treatment services for pregnant women experiencing OUD. The purpose of this article is to describe a study protocol aimed at developing and evaluating a perinatal OUD curriculum, enhancing evidence-based perinatal OUD treatment in a rural setting, and evaluating the implementation of such collaborative care for perinatal OUD.MethodsThis two-year study employed a one group, repeated measures, hybrid type-1 effectiveness-implementation design. This study delivered interventions at 2 levels, both targeting improvement of care for pregnant women with OUD. The first area of focus was at the community healthcare provider-level, which aimed to evaluate the acceptability and feasibility of perinatal OUD education across time and to improve provider education by increasing knowledge specific to: MOUD provision; screening, brief intervention, and referral to treatment (SBIRT) utilization; and NOWS treatment. The second area of intervention focus was at the patient-level, which assessed the preliminary effect of perinatal OUD provider education in promoting illicit opioid abstinence and treatment engagement among pregnant women with OUD. We adopted constructs from the Consolidated Framework for Implementation Research (CFIR) to assess contextual factors that may influence implementation, and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model to comprehensively evaluate implementation outcomes.DiscussionThis article presents the protocol of an implementation study that is employing the CFIR and RE-AIM frameworks to implement and evaluate a perinatal OUD education and service coordination program in two rural counties. This protocol could serve as a model for clinicians and researchers seeking to implement improvements in perinatal care for women with OUD in other rural communities. Trial registration NCT04448015 clinicaltrials.gov.

Project description:ImportanceThe demand for medications for opioid use disorder (MOUD) in rural US counties far outweighs their availability. Novel approaches to extend treatment capacity include telemedicine (TM) and mobile treatment on demand; however, their combined use has not been reported or evaluated.ObjectiveTo evaluate the use of a TM mobile treatment unit (TM-MTU) to improve access to MOUD for individuals living in an underserved rural area.Design, setting, and participantsThis quality improvement study evaluated data collected from adult outpatients with a diagnosis of OUD enrolled in the TM-MTU initiative from February 2019 (program inception) to June 2020. Program staff traveled to rural areas in a modified recreational vehicle equipped with medical, videoconferencing, and data collection devices. Patients were virtually connected with physicians based more than 70 miles (112 km) away. Data analysis was performed from June to October 2020.InterventionPatients received buprenorphine prescriptions after initial teleconsultation and follow-up visits from a study physician specialized in addiction psychiatry and medicine.Main outcomes and measuresThe primary outcome was 3-month treatment retention, and the secondary outcome was opioid-positive urine screens. Exploratory outcomes included use of other drugs and patients' travel distance to treatment.ResultsA total of 118 patients were enrolled in treatment, of whom 94 were seen for follow-up treatment predominantly (at least 2 of 3 visits [>50%]) on the TM-MTU; only those 94 patients' data are considered in all analyses. The mean (SD) age of patients was 36.53 (9.78) years, 59 (62.77%) were men, 71 (75.53%) identified as White, and 90 (95.74%) were of non-Hispanic ethnicity. Fifty-five patients (58.51%) were retained in treatment by 3 months (90 days) after baseline. Opioid use was reduced by 32.84% at 3 months, compared with baseline, and was negatively associated with treatment duration (F = 12.69; P = .001). In addition, compared with the nearest brick-and-mortar treatment location, TM-MTU treatment was a mean of 6.52 miles (range, 0.10-58.70 miles) (10.43 km; range, 0.16-93.92 km) and a mean of 10 minutes (range, 1-49 minutes) closer for patients.Conclusions and relevanceThese data demonstrate the feasibility of combining TM with mobile treatment, with outcomes (retention and opioid use) similar to those obtained from office-based TM MOUD programs. By implementing a traveling virtual platform, this clinical paradigm not only helps fill the void of rural MOUD practitioners but also facilitates access to underserved populations who are less likely to reach traditional medical settings, with critical relevance in the context of the COVID-19 pandemic.

Project description:BackgroundA key strategy for mitigating the current opioid epidemic is expanded access to medications for treating opioid use disorder (MOUD). However, interventions developed to expand MOUD access have limited ability to engage opioid users at higher levels of overdose risk, such as those who inject opioids. This paper describes the study protocol for testing STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention through NAvigation), an intervention that engages high-risk opioid users at community-based syringe service programs (SSP) and quickly links them to MOUD using a telemedicine platform.MethodsThis randomized control trial will be conducted at three SSP sites in Chicago. All participants will complete an initial assessment with a provider from a Federally Qualified Health Center who can prescribe or refer MOUD services as appropriate. The control arm will receive standard referral to treatment and the intervention arm will receive immediate telemedicine linkage to the provider and (depending on the type of MOUD prescribed) provided transportation to pick up their induction prescription (for buprenorphine or naltrexone) or attend their intake appointment (for methadone). We aim to recruit a total of 273 participants over two years to provide enough power to detect a difference in our primary outcome of MOUD treatment linkage. Secondary outcomes include treatment engagement, treatment retention, and non-MOUD opioid use. Data will be collected using structured interviews and saliva drug tests delivered at baseline, three months, and six months. Fixed and mixed effects generalized linear regression analyses and survival analysis will be conducted to compare the probabilities of a successful treatment linkage between the two arms, days retained in treatment, and post-baseline opioid and other drug use.DiscussionIf successful, STAMINA's telemedicine approach will significantly reduce the amount of time between SSP clients' initial indication of interest in the medication and treatment initiation. Facilitating this process will likely lead to stronger additional treatment- and recovery-oriented outcomes. This study is also timely given the need for more rigorous testing of telemedicine interventions in light of temporary regulatory changes that have occurred during the COVID-19 pandemic.Trial registrationClinicalTrials.gov (Clinical Trials ID: NCT04575324 and Protocol Number: 1138-0420). Registered 29 September 2020. The study protocol is also registered on the Open Science Framework (DOI 10.17605/OSF.IO/4853 M).

Dataset Information

Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial.

Publications

Treatment of Opioid Use Disorder in Pregnant Women via Telemedicine: A Nonrandomized Controlled Trial.

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