Implementing Programs to Initiate Buprenorphine for Opioid Use Disorder Treatment in High-Need, Low-Resource Emergency Departments: A Nonrandomized Controlled Trial.

STUDY OBJECTIVE: We hypothesized that implementation facilitation would enable us to rapidly and effectively implement emergency department (ED)-initiated buprenorphine programs in rural and urban settings with high-need, limited resources and dissimilar staffing structures. METHODS: This multicenter implementation study employed implementation facilitation using a participatory action research approach to develop, introduce, and refine site-specific clinical protocols for ED-initiated buprenorphine and referral in 3 EDs not previously initiating buprenorphine. We assessed feasibility, acceptability, and effectiveness by triangulating mixed-methods formative evaluation data (focus groups/interviews and pre/post surveys involving staff, patients, and stakeholders), patients' medical records, and 30-day outcomes from a purposive sample of 40 buprenorphine-receiving patient-participants who met research eligibility criteria (English-speaking, medically stable, locator information, nonprisoners). We estimated the primary implementation outcome (proportion receiving ED-initiated buprenorphine among candidates) and the main secondary outcome (30-day treatment engagement) using Bayesian methods. RESULTS: Within 3 months of initiating the implementation facilitation activities, each site implemented buprenorphine programs. During the 6-month programmatic evaluation, there were 134 ED-buprenorphine candidates among 2,522 encounters involving opioid use. A total of 52 (41.6%) practitioners initiated buprenorphine administration to 112 (85.1%; 95% confidence interval [CI] 79.7% to 90.4%) unique patients. Among 40 enrolled patient-participants, 49.0% (35.6% to 62.5%) were engaged in addiction treatment 30 days later (confirmed); 26 (68.4%) reported attending one or more treatment visits; there was a 4-fold decrease in self-reported overdose events (odds ratio [OR] 4.03; 95% CI 1.27 to 12.75). The ED clinician readiness increased by a median of 5.02 (95% CI: 3.56 to 6.47) from 1.92/10 to 6.95/10 (n(pre)=80, n(post)=83). CONCLUSIONS: The implementation facilitation enabled us to effectively implement ED-based buprenorphine programs across heterogeneous ED settings rapidly, which was associated with promising implementation and exploratory patient-level outcomes.

Patient Perceptions of Three Substance Use Screening Tools for Use During Pregnancy.

OBJECTIVES: The purpose of this study was to understand pregnant women's perceptions of three validated substance use screening tools and identify a preferred tool for use during pregnancy. The three screening tools studied included the 4P's Plus, the NIDA Quick Screen/ NIDA-Modified Alcohol, Smoking and Substance Involvement Screening Test, and the Substance Use Risk Profile-Pregnancy Scale. METHODS: A total of 493 cognitive interviews were completed with a diverse sample of pregnant women presenting to two obstetrics practices in Baltimore, MD from January 2017 to January 2018. This study served as a qualitative companion to a larger study comparing the accuracy and acceptability of substance use screening tools in prenatal care. After completing each screening tool, participants were asked their perceptions of the tool and to choose their preferred tool. Interviews were recorded, transcribed verbatim, coded, and analyzed using NVivo software. RESULTS: The plurality of participants (43.4%) reported they preferred the 4P's Plus. Fewer participants preferred the NIDA Quick Screen (32.5%) and the SURP-P (24.1%). Participants felt that the 4P's Plus was both comprehensive and concise. While many participants felt that disclosure of substance use would vary by individual, participants also suggested that when screening is confidential, includes questions about a patient's background, and administered by a non-judgmental provider, pregnant people may be more likely to answer honestly. CONCLUSIONS FOR PRACTICE: The 4P's Plus is a promising and acceptable substance use screening tool for use in prenatal care. Clinicians can use several methods to increase acceptability of substance use screening and encourage disclosure of prenatal substance use.

Eye tracker outcomes in a randomized trial of 40 sessions of hyperbaric oxygen or sham in participants with persistent post concussive symptoms.

PURPOSE: Eye movements may offer a sensitive method to measure response to intervention in mild traumatic brain injury (mTBI). METHODS: The Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury Study (BIMA) randomized 71 participants to 40 sessions of hyperbaric oxygen or sham. A companion normative study (Normal) enrolled 75 participants. An eye tracking system measured left and right eye movements for saccadic and smooth pursuit. At baseline two smooth pursuit tasks, circular and horizontal ramp, and four saccadic tasks, horizontal and vertical step, reading, and memory guided-on tasks differentiated BIMA from Normal participants. The change from baseline in these tasks were measured and compared between interventions and against Normal participants at 13 weeks and six-month follow-up using the two-sample t-test. The Holm-Bonferroni procedure was used to adjust for multiple testing. RESULTS: Change from baseline in eyetracker measures for participants assigned to the hyperbaric oxygen arm did not significantly differ from those assigned to the sham arm at post-randomization time points 13 weeks and six months. Consistent shifts of BIMA participant values toward Normal values at 13 weeks and six months were observed for overall fixation duration, forward saccadic duration, and number of lines read for the reading task, number of misses on the memory guided-on task, and absolute intersaccadic interval velocity and absolute saccadic amplitude on the circular task. The distributions between Normal and BIMA participants were no longer statistically significantly different at 13 weeks and six months post enrollment for these measures. CONCLUSION: The baseline differences between BIMA and Normal suggest potential vulnerability of the smooth pursuit system and the saccadic system. During the six-month follow-up period, improvement toward Normal was seen on some measures in both the hyperbaric oxygen and sham intervention arms without difference between intervention groups. IDS: clinicaltrials.gov Identifiers NCT01611194 and NCT01925963.

Estimating time to event characteristics via longitudinal threshold regression models - an application to cervical dilation progression.

In longitudinal studies, it is sometimes of interest to estimate the distribution of the time a longitudinal process takes to traverse from one threshold to another. For example, the distribution of the time it takes a woman's cervical dilation to progress from 3 to 4 cm can aid the decision-making of obstetricians as to whether a stalled labor should be allowed to proceed or stopped in favor of other options. Often researchers treat this type of data structure as interval censored and employ traditional survival analysis methods. However, the traditional interval censoring approaches are inefficient in that they do not use all of the available data. In this paper, we propose utilizing a longitudinal threshold model to estimate the distribution of the elapsed time between two thresholds of the longitudinal process from repeated measurements. We extend this modeling framework to be used with multiple thresholds. A Wiener process under the first hitting time framework is used to represent survival distribution. We demonstrate our model through simulation studies and an analysis of data from the Consortium on Safe Labor study. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

Implementation facilitation to introduce and support emergency department-initiated buprenorphine for opioid use disorder in high need, low resource settings: protocol for multi-site implementation-feasibility study.

BACKGROUND: For many reasons, the emergency department (ED) is a critical venue to initiate OUD interventions. The prevailing culture of the ED has been that substance use disorders are non-emergent conditions better addressed outside the ED where resources are less constrained. This study, its rapid funding mechanism, and accelerated timeline originated out of the urgent need to learn whether ED-initiated buprenorphine (BUP) with referral for treatment of OUD is generalizable, as well as to develop strategies to facilitate its adoption across a variety of ED settings and under real-world conditions. It both complements and uses methods adapted from Project ED Health (CTN-0069), a Hybrid Type 3 implementation-effectiveness study of using Implementation Facilitation (IF) to integrate ED-initiated BUP and referral programs. METHODS: ED-CONNECT (CTN 0079) was a three-site implementation study exploring the feasibility, acceptability, and impact of introducing ED-initiated BUP in rural and urban settings with high-need, limited resources, and different staffing structures. We used a multi-faceted approach to develop, introduce and iteratively refine site-specific ED clinical protocols and implementation plans for opioid use disorder (OUD) screening, ED-initiated BUP, and referral for treatment. We employed a participatory action research approach and use mixed methods incorporating data derived from abstraction of medical records and administrative data, assessments of recruited ED patient-participants, and both qualitative and quantitative inquiry involving staff from the ED and community, patients, and other stakeholders. DISCUSSION: This study was designed to provide the necessary, time-sensitive understanding of how to identify OUD and initiate treatment with BUP in the EDs previously not providing ED-initiated BUP, in communities in which this intervention is most needed: high need, low resource settings. TRIAL REGISTRATION: The study was prospectively registered on ClinicalTrials.gov (NCT03544112) on June 01, 2018: https://clinicaltrials.gov/ct2/show/NCT03544112 .

Comparing Web-Based Platforms for Promoting HIV Self-Testing and Pre-Exposure Prophylaxis Uptake in High-Risk Men Who Have Sex With Men: Protocol for a Longitudinal Cohort Study.

BACKGROUND: The majority of those living with HIV in the United States are men who have sex with men (MSM), and young, minority MSM account for more new HIV infections than any other group. HIV transmission can be reduced through detection and early treatment initiation or by starting pre-exposure prophylaxis (PrEP), but rates of testing are lower than recommended among MSM, and PrEP uptake has been slow. Although promoting HIV testing and PrEP uptake by placing advertisements on web-based platforms - such as social media websites and dating apps - is a promising approach for promoting HIV testing and PrEP, the relative effectiveness of HIV prevention advertising on common web-based platforms is underexamined. OBJECTIVE: This study aims to evaluate the relative effectiveness of advertisements placed on 3 types of web-based platforms (social media websites, dating apps, and informational websites) for promoting HIV self-testing and PrEP uptake. METHODS: Advertisements will be placed on social media websites (Facebook, Instagram, and Twitter), dating apps (Grindr, Jack'd, and Hornet), and informational search websites (Google, Yahoo, and Bing) to recruit approximately 400 young (18-30 years old), minority (Black or Latino) MSM at elevated risk of HIV exposure. Recruitment will occur in 3 waves, with each wave running advertisements on 1 website from each type of platform. The number of participants per platform is not prespecified, and recruitment in each wave will occur until approximately 133 HIV self-tests are ordered. Participants will complete a baseline survey assessing risk behavior, substance use, psychological readiness to test, and attitudes and then receive an electronic code to order a free home-based HIV self-test kit. Two follow-ups are planned to assess HIV self-test results and PrEP uptake. RESULTS: Recruitment was completed in July 2020. CONCLUSIONS: Findings may improve our understanding of how the platform users' receptivity to test for HIV differs across web-based platforms and thus may assist in facilitating web-based HIV prevention campaigns. TRIAL REGISTRATION: ClinicalTrials.gov NCT04155502; https://clinicaltrials.gov/ct2/show/NCT04155502. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20417.

Age-Accelerated Reduction in Cortical Surface Area in United States Service Members and Veterans with Mild Traumatic Brain Injury and Post-Traumatic Stress Disorder.

Despite the prevalence of combat-related mild traumatic brain injury (mTBI) and relatively high incidence of concurrent post-traumatic stress disorder (PTSD), the joint effect of these conditions on the brain is not well understood. Further, few studies in the mTBI or PTSD populations focus on cortical surface area measures, despite known disruptions to cytoarchitecture of the cortex. This study examines the effects of comorbid mTBI and PTSD on age-related surface area changes across the cortex, as compared with a group with mTBI only. While a direct comparison of PTSD versus non-PTSD groups showed little difference on surface area measures, several regions showed a decline in surface area, with increasing age and a significant PTSD-by-age interaction effect, indicating an age-dependent decrease in surface area in those with both mTBI and PTSD. The findings suggest an apparent age-accelerated shrinking of the cortical surface area in some regions when mTBI and PTSD are present, a pattern that was not consistently found in those with mTBI only. Among the several cortical regions with significant age-by-group interactions were bilateral posterior cingulate cortex (left: p = 0.03; right: p = 0.02), isthmus of the cingulate (left: p = 0.016; right: p = 0.001), and lateral orbitofrontal cortex (left: p = 0.038; right: p = 0.02). It is possible that these findings are related to a larger pattern of premature neurodegeneration and age-acceleration noted in those with long-term PTSD.

Sleep assessment in a randomized trial of hyperbaric oxygen in U.S. service members with post concussive mild traumatic brain injury compared to normal controls.

STUDY OBJECTIVE: In this exploratory, double-blind, longitudinal sham-controlled trial of hyperbaric oxygen (HBO2) for military personnel with post concussive mild traumatic brain injury (mTBI), self-reports and objective measures of sleep-wake disturbances were assessed and compared to normals. METHODS: Self-reports consisting of Pittsburg Sleep Quality Index (PSQI), sleep diary, screening for obstructive sleep apnea (OSA) risk, restless legs syndrome (RLS), cataplexy, and objective actigraphic measures of sleep-wake were obtained on 71 military personnel with mTBI [baseline, 13 weeks and six months post-randomization (post-intervention)], of which 35 met post-traumatic stress disorder (PTSD) criteria, and 75 healthy volunteers (baseline). Baseline between-group and follow-up changes from baseline overall and within subgroups were evaluated. Mild TBI was defined as consisting of head injury associated loss of consciousness (<24 h), post-traumatic amnesia, and neurological deficits. RESULTS: Sleep quality by self-reports was markedly degraded in the mTBI group at baseline compared to a normative cohort; insomnia 87.3 versus 2.8%, OSA risk 70% versus 1.3%, RLS 32.4% versus and 2.7%. (all p-values <0.001), but actigraphy measures did not differentiate between groups. HBO2 compared to sham treatment improved self-reports of PSQI sleep measures, reports (five out of eight at 13-weeks and two out of eight at six-months). However, other sleep-wake measures were not different. CONCLUSIONS: Perceived sleep quality was markedly disrupted in mTBI military personnel and sleep-wake disturbances were prevalent compared to a normative cohort. HBO2 relative to sham improved some measures of sleep quality on the PSQI, but other measures of sleep were not significantly different.

Eye Tracking Results in Postconcussive Syndrome Versus Normative Participants.

Purpose: Standard physical, neurologic, and neuropsychologic examinations may not detect abnormalities after mild traumatic brain injury (mTBI). An analysis of eye movements may be more sensitive to neurologic dysfunction. Methods: We performed eye tracking assessments in 71 active duty and veteran military personnel with persistent postconcussive symptoms (3 months to 5 years after mTBI) and 75 volunteers with no history of brain injury. Both eyes were sampled at 500 Hz and analyzed for various eye measurement parameters during visual tasks involving the saccadic and smooth systems. Results: No difference between mTBI and normal participants in main sequence profiles was observed. On the circular task, intersaccadic interval duration was shorter in mTBI compared with normal subjects (horizontal: Cohen's D = -0.65; vertical: Cohen's D = -0.75). For reading, absolute saccadic amplitudes (Cohen's D = -0.76) and average forward saccadic amplitudes were lower (Cohen's D = -0.61). Absolute fixation velocity was higher (Cohen's D = 1.02), and overall fixation durations (Cohen's D = 0.58), regression durations (Cohen's D = 0.49), and forward saccadic durations (Cohen's D=0.54) were longer. mTBI participants had more fixations (Cohen's D = 0.54) and regressions per line (Cohen's D = 0.70) and read fewer lines (Cohen's D = -0.38) than normal subjects. On the horizontal ramp task, mTBI participants had lower weighted smooth pursuit gains (Cohen's D = -0.55). On the horizontal step task, mTBI participants had shorter mean fixation times (Cohen's D = -0.55). Conclusions: These results suggest vulnerability of the smooth pursuit and saccadic systems in mTBI. Eye tracking shows promise as an objective, sensitive assessment of damage after mTBI. (ClinicalTrials.gov number, NCT01611194, NCT01925963.).

Types of oral contraceptives and breast cancer survival among women enrolled in Medicaid: A competing-risk model.

INTRODUCTION: Oral contraceptive pills have been implicated in the pathophysiology of breast cancer. Although many studies have examined the relationship between combined oral contraceptives (COCs) and breast cancer, there is a paucity of literature that discusses progestin-only oral contraceptives (POCs) and breast cancer. The purpose of this investigation is to examine potential associations between different types of oral contraceptives and breast cancer mortality in the South Carolina Medicaid population among different racial/ethnic groups. METHODS: Subjects included 4816 women diagnosed with breast cancer between 2000 and 2013. Kaplan-Meier curves were calculated to determine time-to-mortality rates among users of oral contraceptives. Competing-risks models and Cox multivariate survival models were used to estimate the hazard ratios (HRs) and 95% confidence intervals (CIs) of breast cancer and other-cause mortality, as well as all-cause mortality. RESULTS: POCs were associated with a significantly decreased risk of breast cancer mortality (HR: 0.07; 95% CI: 0.01, 0.52) and a non-significant increased risk of all-cause mortality (HR: 1.04; 95% CI: 0.52, 2.07). COCs increased the risk of breast cancer mortality (HR: 1.61; 95% CI: 1.14, 2.28) and all-cause mortality (HR: 1.83; 95% CI: 1.30, 2.57). CONCLUSION: Use of POCs may be associated with a decreased risk of breast cancer mortality. Due to the small sample size of POC users in the current study, additional research is needed to confirm these findings.