Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Dentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. Most opioids are prescribed after tooth extraction, but non-opioid analgesics provide similar analgesia and are recommended by multiple professional organizations. METHODS: This multi-site stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists/oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of prescriber education via academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen and ibuprofen. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics. The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to usual practice. Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management. Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.). DISCUSSION: This real-world study will address an important need, providing information on the effectiveness of a multicomponent intervention at modifying dental prescribing behavior and reducing opioid prescriptions to AYA. CLINICALTRIALS: GOV: NCT06275191.

Reconsidering stepped wedge cluster randomized trial designs with implementation periods: Fewer sequences or the parallel-group design with baseline and implementation periods are potentially more efficient.

BACKGROUND/AIMS: When designing a cluster randomized trial, advantages and disadvantages of tentative designs must be weighed. The stepped wedge design is popular for multiple reasons, including its potential to increase power via improved efficiency relative to a parallel-group design. In many realistic settings, it will take time for clusters to fully implement the intervention. When designing the HEALing (Helping to End Addiction Long-termSM) Communities Study, implementation time was a major consideration, and we examined the efficiency and practicality of three designs. Specifically, a three-sequence stepped wedge design with implementation periods, a corresponding two-sequence modified design that is created by removing the middle sequence, and a parallel-group design with baseline and implementation periods. In this article, we study the relative efficiencies of these specific designs. More generally, we study the relative efficiencies of modified designs when the stepped wedge design with implementation periods has three or more sequences. We also consider different correlation structures. METHODS: We compare efficiencies of stepped wedge designs with implementation periods consisting of three to nine sequences with a variety of corresponding designs. The three-sequence design is compared to the two-sequence modified design and to the parallel-group design with baseline and implementation periods analysed via analysis of covariance. Stepped wedge designs with implementation periods consisting of four or more sequences are compared to modified designs that remove all or a subset of 'middle' sequences. Efficiencies are based on the use of linear mixed effects models. RESULTS: In the studied settings, the modified design is more efficient than the three-sequence stepped wedge design with implementation periods. The parallel-group design with baseline and implementation periods with analysis of covariance-based analysis is often more efficient than the three-sequence design. With respect to stepped wedge designs with implementation periods that are comprised of more sequences, there are often corresponding modified designs that improve efficiency. However, use of only the first and last sequences has the potential to be either relatively efficient or inefficient. Relative efficiency is impacted by the strength of the statistical correlation among outcomes from the same cluster; for example, the relative efficiencies of modified designs tend to be greater for smaller cluster auto-correlation values. CONCLUSION: If a three-sequence stepped wedge design with implementation periods is being considered for a future cluster randomized trial, then a corresponding modified design using only the first and last sequences should be considered if sole focus is on efficiency. However, a parallel-group design with baseline and implementation periods and analysis of covariance-based analysis can be a practical, efficient alternative. For stepped wedge designs with implementation periods and a larger number of sequences, modified versions that remove 'middle' sequences should be considered. Due to the potential sensitivity of design efficiencies, statistical correlation should be carefully considered.

Effects of the Communities that Heal (CTH) intervention on perceived opioid-related community stigma in the HEALing Communities Study: results of a multi-site, community-level, cluster-randomized trial.

Background: Community stigma against people with opioid use disorder (OUD) and intervention stigma (e.g., toward naloxone) exacerbate the opioid overdose crisis. We examined the effects of the Communities that HEAL (CTH) intervention on perceived opioid-related community stigma by stakeholders in the HEALing Communities Study (HCS). Methods: We collected three surveys from community coalition members in 66 communities across four states participating in HCS. Communities were randomized into Intervention (Wave 1) or Wait-list Control (Wave 2) arms. We conducted multilevel linear mixed models to compare changes in primary outcomes of community stigma toward people treated for OUD, naloxone, and medication for opioid use disorder (MOUD) by arm from time 1 (before the start of the intervention) to time 3 (end of the intervention period in the Intervention arm). Findings: Intervention stakeholders reported a larger decrease in perceived community stigma toward people treated for OUD (adjusted mean change (AMC) -3.20 [95% C.I. -4.43, -1.98]) and toward MOUD (AMC -0.33 [95% C.I. -0.56, -0.09]) than stakeholders in Wait-list Control communities (AMC -0.18 [95% C.I. -1.38, 1.02], p = 0.0007 and AMC 0.11 [95% C.I. -0.09, 0.31], p = 0.0066). The relationship between intervention status and change in stigma toward MOUD was moderated by rural-urban status (urban AMC -0.59 [95% CI, -0.87, -0.32], rural AMC not sig.) and state. The difference in stigma toward naloxone between Intervention and Wait-list Control stakeholders was not statistically significant (p = 0.18). Interpretation: The CTH intervention decreased stakeholder perceptions of community stigma toward people treated for OUD and stigma toward MOUD. Implementing the CTH intervention in other communities could decrease OUD stigma across diverse settings nationally. Funding: US National Institute on Drug Abuse.

Neonatal Abstinence Signs during Treatment: Trajectory, Resurgence and Heterogeneity.

Neonatal abstinence syndrome (NAS) presents with a varying severity of withdrawal signs and length of treatment (LOT). We examined the course and relevance of each of the NAS withdrawal signs during treatment in a sample of 182 infants with any prenatal opioid exposure, gestational age ≥ 35 weeks, without other medical conditions, and meeting the criteria for pharmacological treatment. Infants were monitored using the Finnegan Neonatal Abstinence Scoring Tool. Daily mean Finnegan scores were estimated using linear mixed models with random subject effects to account for repeated withdrawal scores from the same subject. Daily item prevalence was estimated using generalized estimating equations with a within-subject exchangeable correlation structure. The median LOT was 12.86 days. The prevalence of withdrawal signs decreased from day one to day three of treatment. However, certain central nervous system (CNS) and gastrointestinal (GI) signs showed sporadic increases in prevalence notable around two weeks of treatment, accounting for increases in Finnegan scores that guided pharmacotherapy. We question whether the resurgence of signs with a prolonged LOT is mainly a consequence of opioid tolerance or withdrawal. Monitoring CNS and GI signs throughout treatment is crucial. Future studies directed to better understand this clinical phenomenon may lead to the refining of NAS pharmacotherapy and perhaps the discovery of treatment alternatives.

Equity of overdose education and naloxone distribution provided in the Kentucky HEALing Communities Study.

Background: Opioid overdoses differentially affect demographic groups. Strategies to reduce overdose deaths, specifically overdose education and naloxone distribution (OEND), are not consistently delivered equitably. Methods: The HEALing Communities StudySM (HCS) is a cluster-randomized trial designed to implement evidence-based practices, including OEND, to reduce overdose deaths across communities. Individuals receiving OEND in eight Kentucky counties between January 2020 and June 2022 provided demographics and overdose history. Recipient characteristics were compared to opioid overdose decedent characteristics to evaluate whether OEND was equitably delivered to the target population. Recipient characteristics were also analyzed based on whether OEND was delivered in criminal justice, behavioral health, or health care facilities. Results: A total of 26,273 demographic records were analyzed from 137 partner agencies. Most agencies were in behavioral health (85.6 %) or criminal justice sectors (10.4 %). About half of OEND recipients were male (50.6 %), which was significantly lower than the 70.3 % of overdose decedents who were male, (p<0.001). OEND recipients tended to be younger than overdose decedents, but there were not significant differences in race/ethnicity between OEND recipients and overdose decedents. Over 40 % of OEND recipients had overdosed, and 68.9 % had witnessed a prior overdose. There were notable differences across facility types, as males and Black individuals accounted for fewer OEND recipients in addiction treatment facilities compared to jails. Conclusion: Although OEND recipients' demographics resembled those of decedents, specific attention should be paid to ensuring equitable OEND access. Variation in OEND uptake by facility type may reflect biases and barriers to care.

Examination of naloxone dosing patterns for opioid overdose by emergency medical services in Kentucky during increased fentanyl use from 2018 to 2021.

BACKGROUND: Fatal overdoses involving fentanyl/fentanyl analogs (F/FA) have increased in the US, raising questions about naloxone doses for F/FA overdose reversal. Emergency medical services (EMS) data provide an opportunity to examine naloxone administration changes as fentanyl increases in the illicit opioid supply. METHODS: Administered naloxone intranasal-equivalent total dose (INTD) in milligrams (mg) was calculated for Kentucky EMS suspected opioid overdose (SOO) encounters (n=33,846), 2018-2021, and patterns of administration were examined. County-level F/FA availability was measured as 1) proportion of fatal drug overdoses involving F/FA, and 2) F/FA police seizures. Linear mixed models estimated changes in INTD in relation to local F/FA availability accounting for patient characteristics. RESULTS: From 2018-2021, SOOs increased by 44% (6853 to 9888) with an average INTD increase from 4.5mg to 4.7mg, with more than 99% of encounters resulting in successful reversal each year. For SOO encounters examined by outcome at the scene (i.e., non-fatal fatal vs fatal), average INTD for non-fatal were 4.6mg compared to 5.9mg for fatal overdoses. Mixed modeling found no significant relationship between INTD and the two measures for local F/FA availability. CONCLUSION: As F/FA-involved overdose risk increased, we observed a modest increase in INTD administered in SOO EMS encounters - just slightly higher than the 4mg standard dose. The lack of significant relationship between F/FA and naloxone dose suggests that naloxone utilization in SOO with EMS involvement remains effective for overdose reversal, and that EMS naloxone dosing patterns have not changed substantially.

The relationship between psychosocial factors, self-care, and blood sugar in an Appalachian population.

Introduction: Appalachian residents are more likely than other populations to have Type 2 Diabetes Mellitus (T2DM) and to experience more severe complications from the disease, including excess and premature mortality. Methods: This study examines health alongside sociodemographic factors, psychosocial factors (including knowledge, empowerment, social support/function, religiosity, distress), and perceived problems in diabetes management that may influence self-care and HbA1c among vulnerable rural residents. A survey of a community-based sample of 356 adults with diagnosed diabetes or HbA1c > 6.5 was conducted in six counties in Appalachian Kentucky. Results: Findings suggest that neither religiosity nor social support/function mediate/moderate the relationship between psychosocial factors and dependent variables (problem areas in diabetes, T2DM self-care or HbA1c). Results also suggest that distress is a predictor of problem areas in diabetes, and both distress and empowerment are predictors of T2DM self-care. Implications: This study addresses the gap in the literature concerning the influence of psychosocial factors on problem areas in diabetes, T2DM self-care and HbA1c among vulnerable rural residents, as well as the potential mediating/modifying effects of religiosity and social function/support. Future research is needed to inform strategies for identifying and addressing distress among vulnerable populations burdened by T2DM, including Appalachian adults.

Telemedicine Buprenorphine Initiation and Retention in Opioid Use Disorder Treatment for Medicaid Enrollees.

Importance: Early COVID-19 mitigation strategies placed an additional burden on individuals seeking care for opioid use disorder (OUD). Telemedicine provided a way to initiate and maintain transmucosal buprenorphine treatment of OUD. Objective: To examine associations between transmucosal buprenorphine OUD treatment modality (telemedicine vs traditional) during the COVID-19 public health emergency and the health outcomes of treatment retention and opioid-related nonfatal overdose. Design, Setting, and Participants: This retrospective cohort study was conducted using Medicaid claims and enrollment data from November 1, 2019, to December 31, 2020, for individuals aged 18 to 64 years from Kentucky and Ohio. Data were collected and analyzed in June 2022, with data updated during revision in August 2023. Exposures: The primary exposure of interest was the modality of the transmucosal buprenorphine OUD treatment initiation. Relevant patient demographic and comorbidity characteristics were included in regression models. Main Outcomes and Measures: There were 2 main outcomes of interest: retention in treatment after initiation and opioid-related nonfatal overdose after initiation. For outcomes measured after initiation, a 90-day follow-up period was used. The main analysis used a new-user study design; transmucosal buprenorphine OUD treatment initiation was defined as initiation after more than a 60-day gap in buprenorphine treatment. In addition, uptake of telemedicine for buprenorphine was examined, overall and within patients initiating treatment, across quarters in 2020. Results: This study included 41 266 individuals in Kentucky (21 269 women [51.5%]; mean [SD] age, 37.9 [9.0] years) and 50 648 individuals in Ohio (26 425 women [52.2%]; mean [SD] age, 37.1 [9.3] years) who received buprenorphine in 2020, with 18 250 and 24 741 people initiating buprenorphine in Kentucky and Ohio, respectively. Telemedicine buprenorphine initiations increased sharply at the beginning of 2020. Compared with nontelemedicine initiation, telemedicine initiation was associated with better odds of 90-day retention with buprenorphine in both states (Kentucky: adjusted odds ratio, 1.13 [95% CI, 1.01-1.27]; Ohio: adjusted odds ratio, 1.19 [95% CI, 1.06-1.32]) in a regression analysis adjusting for patient demographic and comorbidity characteristics. Telemedicine initiation was not associated with opioid-related nonfatal overdose (Kentucky: adjusted odds ratio, 0.89 [95% CI, 0.56-1.40]; Ohio: adjusted odds ratio, 1.08 [95% CI, 0.83-1.41]). Conclusions and Relevance: In this cohort study of Medicaid enrollees receiving buprenorphine for OUD, telemedicine buprenorphine initiation was associated with retention in treatment early during the COVID-19 pandemic. These findings add to the literature demonstrating positive outcomes associated with the use of telemedicine for treatment of OUD.

Risk factors of carbapenemase-producing Enterobacterales acquisition among adult intensive care unit patients at a Kentucky Academic Medical Center.

Background: Acquisition of carbapenemase-producing carbapenem-resistant Enterobacterales (CP-CRE) are associated with negative health outcomes. Our adult intensive care unit (ICU) population has experienced low levels of CP-CRE acquisition; however, specific risk factors for this population at our medical facility have not been studied. Aims: To identify risk factors of CP-CRE acquisition and describe CP-CRE epidemiology among adult ICU patients at our medical facility. Methods: A retrospective cohort study was performed at a Kentucky Academic Medical Center. Surveillance specimens were collected at admission and weekly thereafter to identify CP-CRE colonization. Clinical data were extracted from patient medical records. Cases were defined as those who tested positive for CP-CRE on ICU admission day 3 or greater. Risk of CP-CRE acquisition was calculated using Modified Poisson regression. Findings: Independent risk factors of CP-CRE acquisition included administration of enteral tube feeds (risk ratio [RR], 4.46; 95% confidence interval [CI], 1.74-11.43); diagnosis of Clostridioides difficile enterocolitis (RR, 3.51; 95% CI, 1.27-9.68), pressure ulcer (RR, 3.48; 95% CI, 1.91-6.36), and morbid obesity (RR, 2.10; 95% CI, 1.12-3.95); having a drainage tube (RR, 2.63; 95% CI, 1.38-4.98); admission to a medical ICU (RR, 2.39; 95% CI, 1.32-4.35); 90-day use of a carbapenem (RR, 2.27; 95% CI, 1.21-4.26); and dialysis procedure (RR, 2.22; 95% CI, 1.15-4.27). Conclusion: Most CP-CRE risk factors were associated with alteration of colon microbiota and/or invasive procedures/devices. These results will assist in creating a more targeted CP-CRE active surveillance system and highlight areas for infection prevention intervention.

Factors Associated with No-Show Rates in a Pediatric Audiology Clinic.

OBJECTIVE: To evaluate factors associated with no-show rates in a pediatric audiology clinic. STUDY DESIGN: Retrospective review. SETTING: Tertiary referral center. PARTICIPANTS: All pediatric patients younger than 18 years whose parents/guardians scheduled an appointment at a tertiary Audiology Clinic between June 1, 2015, and July 1, 2017. MAIN OUTCOME MEASURES: Data included whether the patient came to their appointment, patient age, sex, race, insurance type, appointment type, location, season of appointment, and day of the week of the appointment. RESULTS: Of the 7,784 pediatric appointments scheduled with audiology, the overall no-show rate was 24.3% (n = 1893). Lower age was significantly associated with no-shows ( p = 0.0003). Black/African American children were more likely to no-show compared with White/Caucasians ( p = 0.0001). Compared with self-pay/military/other insurance, those with Medicaid were more likely to no-show ( p = 0.0001). The highest rate of no-shows occurred during summer (27%). On multivariate analysis, younger age, Black/African American race, and Medicaid insurance were associated with increased no-show rates. CONCLUSION: A variety of factors influence no-show rates in a pediatric audiology setting. No-shows can affect treatment quality and affect overall hearing outcomes. Further investigation is necessary to assess barriers to appointment adherence and to develop interventions to improve adherence and care.

Examination of Dry Needling Dose and Effect Duration for Individuals With Chronic Ankle Instability.

OBJECTIVE: The purpose of this study was to evaluate the effect of a single treatment vs serial dry needling (DN) treatments of the fibularis longus on individuals with chronic ankle instability and to determine the longevity of any effect found. METHODS: Thirty-five adults with chronic ankle instability (24.17 ± 7.01 years, 167.67 ± 9.15 cm, 74.90 ± 13.23 kg) volunteered for a university laboratory repeated-measures study. All participants completed patient-reported outcomes and were objectively tested using the Star Excursion Balance Test (SEBT), threshold to detect passive motion (TTDPM) measurements, and single limb time-to-boundary measurements. Participants received DN treatment to the fibularis longus once weekly for 4 weeks on the affected lower extremity by a single physical therapist. Data were collected 5 times: baseline 1 week before initial treatment (T0), pre-treatment (T1A), immediately after the first treatment (T1B), after 4 weekly treatments (T2), and 4 weeks after the cessation of treatment (T3). RESULTS: Significant improvements were found for clinician-oriented (SEBT-Composite P < .001; SEBT-Posteromedial P = .024; SEBT-Posterolateral P < .001; TTDPM-Inversion P = .042) and patient-oriented outcome measures (Foot and Ankle Ability Measure-Activities of Daily Living P < .001; Foot and Ankle Ability Measure-Sport P = .001; Fear Avoidance Belief Questionnaire P = .021) following a single DN treatment. Compounding effects from additional treatments exhibited improvement of TTDPM (T1B to T2). No significant losses were noted 4 weeks after cessation of treatment (T2 to T3). CONCLUSION: For the participants in this study, outcomes improved immediately following the first DN treatment. This improvement was sustained but not further improved with subsequent treatments.

A New Look at Barriers to Clinical Care Among Appalachian Residents Living With Diabetes.

In the United States, diabetes is the seventh leading cause of death and continues to rise in prevalence, with type 2 diabetes accounting for 90-95% of all cases. Rates of diabetes in Kentucky, and, in particular, the Appalachian region, are among the highest in the nation and are increasing faster than the national average. Despite this disproportionate burden, barriers to clinical appointment attendance have not been fully explored in this population. This article examines the association among perceived barriers to clinical attendance, glycemic control, and diabetes self-care as part of an ongoing study. We used a 25-item checklist developed using the Chronic Care Model to assess participants' barriers to clinic attendance. Glycemic control was assessed via A1C measurement. Diabetes self-care was assessed using the Summary of Diabetes Self-Care Activities measure. At the time of analysis, 123 of the 356 participants (34.6%) did not report any barriers to clinic attendance. For the remainder, the major reported barriers included forgetting appointments, inability to afford medicines or other treatment, and placing faith above medical care. The average A1C was 7.7%, and the average diabetes self-care summary score was 17.1 out of 35 points (with higher values indicating better self-care). Missing clinic appointments is associated with lower health outcomes, especially in vulnerable populations. This study can help educate clinic staff on perceived barriers to type 2 diabetes management among people with diabetes in Appalachia.

Effects of dynamic body weight support on functional independence measures in acute ischemic stroke: a retrospective cohort study.

BACKGROUND: Stroke remains a major public health concern in the United States and a leading cause of long-term disability in adults. Dynamic body weight support (DBWS) systems are popular technology available for use in clinical settings such inpatient rehabilitation. However, there remains limited studies in such inpatient settings that compare DBWS to standard of care (SOC) using real world outcome measures. For survivors of acute ischemic stroke, we determine if incorporating a dynamic body weight support (DBWS) system into inpatient therapy offers greater improvement than standard of care (SOC). METHODS: A retrospective chart review included 52 individuals with an acute ischemic stroke admitted to an inpatient rehabilitation facility. Functional Independence Measure (FIM) data, specifically changes in FIM at discharge, served as the primary outcome measure. Patient cohorts received either therapies per SOC or therapies incorporating DBWS. Regardless of cohort group, all patients underwent therapies for 3 h per day for 5 days a week. RESULTS: For both groups, a statistically and clinically significant increase in total FIM (P < 0.0001) was observed at discharge compared to at admission. Improvements for the DBWS group were significantly greater than the SOC group as evidenced by higher gains in total FIM (p = 0.04) and this corresponded to a medium effect size (Cohen's d = 0.58). Among FIM subscores, the DBWS group achieved a significant increase in sphincter control while all other subscore changes remained non-significant. CONCLUSIONS: This preliminary evidence supports the benefit of using DBWS during inpatient rehabilitation in individuals who have experienced an acute ischemic stroke. This may be due to the greater intensity and repetitions of tasks allowed by DBWS. These preliminary findings warrant further investigations on the use of DBWS in inpatient settings.

A Field-expedient Arm Care Screening Tool Can Identify Musculoskeletal Risk Factors in Baseball Players.

BACKGROUND: Preseason movement screening can identify modifiable risk factors, deterioration of function, and potential for injury in baseball players. Limited resources and time prevent high school baseball coaches from performing movement screens on their players. HYPOTHESIS: The arm care screen (ACS) will be highly sensitive to detecting musculoskeletal risk factors. STUDY DESIGN: Cross-sectional. LEVEL OF EVIDENCE: Level 3. METHODS: A total of 150 baseball players were independently scored on the ACS electronically by reviewing a video recording of each player's screening performance. Discriminability of the ACS was determined with a 2 × 2 contingency table dichotomizing musculoskeletal risk factors as present or absent based on a predetermined cutoff value and those who passed or failed the corresponding ACS subtest. RESULTS: High sensitivity was observed on the reciprocal shoulder mobility (0.89; 95% CI 0.81-0.94), 90/90 total body rotation (0.86; 95% CI 0.79-0.92), and lower body diagonal reach (0.85; 95% CI 0.78-0.91) tests of the ACS suggesting sufficient ability to identify musculoskeletal impairments and risk factors. CONCLUSION: The ACS is a simplistic screening tool that the coach can administer to discriminate between youth, high school, and college-level baseball players who possess musculoskeletal risk factors. The ACS subtests demonstrated high sensitivity for correctly identifying musculoskeletal risk factors common in baseball players and can be useful as a screening tool for baseball coaches developing arm care exercise programs. CLINICAL RELEVANCE: A field-expedient screen could provide coaches the ability to identify musculoskeletal risk factors that need to be addressed to minimize injury risk factors in a time-efficient manner.

Understanding the effects of opioids vs non-opioids in the treatment of neonatal abstinence syndrome, an in vitro model.

Neonatal abstinence syndrome (NAS) refers to cadre of withdrawal manifestations in infants born to mothers who used illicit and licit substances during pregnancy. The increasing prevalence of NAS has been largely due to the maternal use of opioids during pregnancy. NAS contributes to increased morbidity and long-term disability in surviving infants. Clinically, oral opioid therapies for opioid exposure have been a standard treatment with morphine (MO) being the most commonly used medication. Recently, a non-opioid agent, clonidine (CD) has also been used with potentially favorable short- and long-term outcomes in infants. However, data regarding the cellular and molecular effects of these treatments on the developing brain is still lacking due to a lack of a reliable animal model that targets the neonatal brain. To address this gap in knowledge we determined the effects of MO or CD on the cell death of neonatal cortical explant cultures that were exposed to oxycodone (OXY) in utero. Sprague Dawley rats were randomized and implanted with programmable infusion pumps before mating to receive either the OXY (dose increasing from 1.21-1.90 mg/kg/day to a maximum dose of 2.86-3.49 mg/kg/day) or normal saline (NS) throughout pregnancy and until one week after delivery. Male and female rat pups were sacrificed on postnatal day 4, and the prefrontal cortex (PFC) and hippocampus (HC) were dissected and treated with MO (0.10-1.00 µM) or CD (1.20-120.00 µM) in culture media. After 5 days of treatment the explants were labeled with propidium iodide to detect cell death. Dead cells were analyzed and counted under fluorescence microscopy. In explants from the PFC, cell death was greater in those prenatally exposed to OXY and postnatally treated with MO (OXY/MO) (736.8 ± 76.5) compared to OXY/CD (620.9 ± 75.0; p = 0.005). In the HC explants, mean cell death counts were not significantly different between groups regardless of prenatal exposure or postnatal treatment (p = 0.19). The PFC is vital in controlling higher-order executive functions such as behavioral flexibility, learning and working memory. Therefore, our finding is consistent with executive function problems in children with prenatal opioid exposure.

Performance of model-based vs. permutation tests in the HEALing (Helping to End Addiction Long-termSM) Communities Study, a covariate-constrained cluster randomized trial.

BACKGROUND: The HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) is a multi-site parallel group cluster randomized wait-list comparison trial designed to evaluate the effect of the Communities That Heal (CTH) intervention compared to usual care on opioid overdose deaths. Covariate-constrained randomization (CCR) was applied to balance the community-level baseline covariates in the HCS. The purpose of this paper is to evaluate the performance of model-based tests and permutation tests in the HCS setting. We conducted a simulation study to evaluate type I error rates and power for model-based and permutation tests for the multi-site HCS as well as for a subgroup analysis of a single state (Massachusetts). We also investigated whether the maximum degree of imbalance in the CCR design has an impact on the performance of the tests. METHODS: The primary outcome, the number of opioid overdose deaths, is count data assessed at the community level that will be analyzed using a negative binomial regression model. We conducted a simulation study to evaluate the type I error rates and power for 3 tests: (1) Wald-type t-test with small-sample corrected empirical standard error estimates, (2) Wald-type z-test with model-based standard error estimates, and (3) permutation test with test statistics calculated by the difference in average residuals for the two groups. RESULTS: Our simulation results demonstrated that Wald-type t-tests with small-sample corrected empirical standard error estimates from the negative binomial regression model maintained proper type I error. Wald-type z-tests with model-based standard error estimates were anti-conservative. Permutation tests preserved type I error rates if the constrained space was not too small. For all tests, the power was high to detect the hypothesized 40% reduction in opioid overdose deaths for the intervention vs. comparison group both for the overall HCS and the subgroup analysis of Massachusetts (MA). CONCLUSIONS: Based on the results of our simulation study, the Wald-type t-test with small-sample corrected empirical standard error estimates from a negative binomial regression model is a valid and appropriate approach for analyzing cluster-level count data from the HEALing Communities Study. TRIAL REGISTRATION: ClinicalTrials.gov http://www. CLINICALTRIALS: gov ; Identifier: NCT04111939.

Behavioral Parent Training for Families With Young Deaf or Hard of Hearing Children Followed in Hearing Health Care.

PURPOSE: It is well established that individuals with a communication disability, including being deaf or hard of hearing (DHH), experience inequities in health services and outcomes. These inequities extend to DHH children's access to psychosocial evidence-based interventions (EBIs). Behavioral parent training is an EBI that can be used to improve caregiver and child outcomes. Despite being supported by decades of effectiveness research, this EBI is rarely accessed by, or studied with, caregivers of DHH children. The purpose of this article is to describe a program of stakeholder-engaged research adapting and assessing behavioral parent training with caregivers of young DHH children followed in hearing health care, aimed at reducing inequities in access to this EBI. METHOD: The first section briefly summarizes the literature on disruptive behavior problems in young children, with a focus on preschool-age DHH children. The evidence base for behavioral parent training is described. Next, the gaps in knowledge and practice regarding disruptive behaviors among DHH children are highlighted, and the potential integration of behavioral parent training into the standard of care for this population is proposed. CONCLUSIONS: Young DHH children who use hearing aids and/or cochlear implants experience disruptive behavior problems at rates at least as high as typically hearing children, but their access to EBIs is limited, and behavioral parent training programs tailored to this population have not been rigorously tested. Caregivers and hearing health care service providers affirm the potential benefits of behavioral parent training and were partners in adapting this EBI. This research highlights several principles and approaches essential for reducing inequities and improving the quality of life not only for DHH children and their families but also for individuals with communication disabilities more broadly: engagement of key stakeholders in research, collaboration across disciplines, and using implementation science methods and models to design for implementation, dissemination, and sustainment. Presentation Video: https://doi.org/10.23641/asha.21215900.

Assessment of the relative clinical utility of shortened Finnegan neonatal abstinence scoring tools.

OBJECTIVE: To assess the proposed shortened tools based on the Finnegan neonatal abstinence scoring tool (FNAS) for relative clinical utility. STUDY DESIGN: Retrospective study comparing shortened tools with FNAS on need for treatment, medication initiation cutoff score agreement, and length of treatment in 369 infants with prenatal opioid exposure using estimated areas under the receiver operating characteristic curves, Pearson and Spearman correlations, and proportion correctly classified, sensitivity, and specificity. RESULTS: The tools by Gomez et al. and Chervoneva et al. are most predictive of the FNAS cut-off values to initiate treatment, have cutoff values that best align with the FNAS cutoff values, and strongly correlate with the FNAS (r ≥ 0.88 corresponding to treatment initiation, r ≥ 0.83 during first 10 days of treatment). CONCLUSION: The tools of Gomez and Chervoneva demonstrated potential clinical usefulness by strongly associating with the need for treatment and monitoring the course of NAS therapy.

Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol.

INTRODUCTION: As the most common neonatal sensory disorder in the USA, infant hearing loss has an incidence of 1.7 per 1000 births. The consequences of delayed diagnosis and failure to obtain timely intervention include significant communication impairment and negative socioeconomic effects. Early Hearing Detection and Intervention (EHDI) national standards dictate that all infants should be screened and diagnosed by 3 months of age and there is a need for interventions that promote adherence to timely diagnosis. Patient navigation (PN) has been shown to be efficacious to decrease non-adherence with infant hearing diagnostic care; however, PN has yet to be tested in diverse communities or implemented into real-world settings. METHODS AND ANALYSIS: The proposed research is a community-engaged, type 1 hybrid effectiveness-implementation trial of a PN intervention aimed at decreasing infant hearing diagnosis non-adherence after failed newborn hearing screening, delivered in state-funded EHDI clinics. Guided by our community advisory board and partners, we aim to (1) test the effectiveness of PN to decrease non-adherence to receipt of infant hearing diagnosis within 3 months after birth using a stepped-wedge trial design, (2) investigate implementation outcomes and factors influencing implementation and (3) determine the cost-effectiveness of PN from the perspective of third-party payers. The study will be conducted from April 2019 until March 2024. ETHICS AND DISSEMINATION: This protocol was approved by the University of Kentucky Institutional Review Board. Although all research involving human subjects contains some risk, there are no known serious risks anticipated from participating in this study. We will seek to disseminate our results in a systematic fashion to patients, key stakeholder, policymakers and the scientific community. Our results will impact the field by partnering with communities to inform the scale-up of this innovative patient supportive intervention to create efficient and effective EHDI programmes and maximise public health impact. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (Pre-results phase): NCT03875339.

Study Protocol: Type 1 Hybrid Effectiveness-Implementation Trial of a Behavioral Parent Training Intervention for Parents of Young Children Who Are Deaf or Hard of Hearing.

PURPOSE: Children who are deaf or hard of hearing (DHH) and who use hearing aids or cochlear implants are more likely than their peers with typical hearing to exhibit behavior problems. Although multiple evidence-based interventions for child behavior problems exist, they are rarely delivered to children who are DHH, and no rigorous randomized controlled trials have been conducted to determine their effects with this population. This protocol describes a study aiming to test the effectiveness of an evidence-based behavioral parent training intervention adapted for parents of young children who are DHH and simultaneously to assess key implementation outcomes and multilevel contextual factors influencing implementation. METHOD: The protocol for a Type 1 hybrid effectiveness-implementation trial of a behavioral parent training intervention for parents of young children who are DHH is presented, including details of the study design, participants, assessments, and analyses. Using a stakeholder-engaged, mixed-methods approach, we will test the effects of the intervention versus treatment as usual on parenting behaviors, child behaviors, and a range of secondary effectiveness outcomes, including adherence to using hearing aids and cochlear implants as well as measures of child speech and language. We will assess the acceptability, feasibility, fidelity, and costs of the intervention from the perspectives of peer coaches who deliver the intervention, hearing health care clinicians (including audiologists and speech-language pathologists), and administrators of programs serving young children who are DHH. CONCLUSIONS: Results of this trial will inform future efforts to close the gap between prevalence of behavioral problems in young children who are DHH and access to and use of evidence-based interventions to prevent and treat them. If effective, this intervention could be widely implemented using strategies informed by the findings of this study to benefit young children who are DHH and followed in hearing health care and their families.