Adopting the RE-AIM analytic framework for rural program evaluation: experiences from the Advance Care Planning via Group Visits (ACP-GV) national evaluation.

Introduction: To support rigorous evaluation across a national portfolio of grants, the United States Department of Veterans Affairs (VA) Office of Rural Health (ORH) adopted an analytic framework to guide their grantees' evaluation of initiatives that reach rural veterans and to standardize the reporting of outcomes and impacts. Advance Care Planning via Group Visits (ACP-GV), one of ORH's Enterprise-Wide Initiatives, also followed the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. ACP-GV is a national patient-centered intervention delivered in a large, veterans integrated healthcare system. This manuscript describes how RE-AIM was used to evaluate this national program and lessons learned from ORH's annual reporting feedback to ACP-GV on their use of the framework to describe evaluation impacts. Methods: We used patient, provider, and site-level administrative health care data from the VA Corporate Data Warehouse and national program management databases for federal fiscal years (FY) spanning October 1, 2018-September 30, 2023. Measures included cumulative and past FY metrics developed to assess program impacts. Results: RE-AIM constructs included the following cumulative and annual program evaluation results. ACP-GV reached 54,167 unique veterans, including 19,032 unique rural veterans between FY 2018 to FY 2023. During FY 2023, implementation adherence to the ACP-GV model was noted in 91.7% of program completers, with 55% of these completers reporting a knowledge increase and 14% reporting a substantial knowledge increase (effectiveness). As of FY 2023, 66 ACP-GV sites were active, and 1,556 VA staff were trained in the intervention (adoption). Of the 66 active sites in FY 2023, 27 were sites previously funded by ORH and continued to offer ACP-GV after the conclusion of three years of seed funding (maintenance). Discussion: Lessons learned developing RE-AIM metrics collaboratively with program developers, implementers, and evaluators allowed for a balance of clinical and scientific input in decision-making, while the ORH annual reporting feedback provided specificity and emphasis for including both cumulative, annual, and rural specific metrics. ACP-GV's use of RE-AIM metrics is a key step towards improving rural veteran health outcomes and describing real world program impacts.

Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial.

Importance: The function-based eat, sleep, console (ESC) care approach substantially reduces the proportion of infants who receive pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS). This reduction has led to concerns for increased postnatal opioid exposure in infants who receive pharmacologic treatment. However, the effect of the ESC care approach on hospital outcomes for infants pharmacologically treated for NOWS is currently unknown. Objective: To evaluate differences in opioid exposure and total length of hospital stay (LOS) for pharmacologically treated infants managed with the ESC care approach vs usual care with the Finnegan tool. Design, Setting, and Participants: This post hoc subgroup analysis involved infants pharmacologically treated in ESC-NOW, a stepped-wedge cluster randomized clinical trial conducted at 26 US hospitals. Hospitals maintained pretrial practices for pharmacologic treatment, including opioid type, scheduled opioid dosing, and use of adjuvant medications. Infants were born at 36 weeks' gestation or later, had evidence of antenatal opioid exposure, and received opioid treatment for NOWS between September 2020 and March 2022. Data were analyzed from November 2022 to January 2024. Exposure: Opioid treatment for NOWS and the ESC care approach. Main Outcomes and Measures: For each outcome (total opioid exposure, peak opioid dose, time from birth to initiation of first opioid dose, length of opioid treatment, and LOS), we used generalized linear mixed models to adjust for the stepped-wedge design and maternal and infant characteristics. Results: In the ESC-NOW trial, 463 of 1305 infants were pharmacologically treated (143/603 [23.7%] in the ESC care approach group and 320/702 [45.6%] in the usual care group). Mean total opioid exposure was lower in the ESC care approach group with an absolute difference of 4.1 morphine milligram equivalents per kilogram (MME/kg) (95% CI, 1.3-7.0) when compared with usual care (4.8 MME/kg vs 8.9 MME/kg, respectively; P = .001). Mean time from birth to initiation of pharmacologic treatment was 22.4 hours (95% CI, 7.1-37.7) longer with the ESC care approach vs usual care (75.4 vs 53.0 hours, respectively; P = .002). No significant difference in mean peak opioid dose was observed between groups (ESC care approach, 0.147 MME/kg, vs usual care, 0.126 MME/kg). The mean length of treatment was 6.3 days shorter (95% CI, 3.0-9.6) in the ESC care approach group vs usual care group (11.8 vs 18.1 days, respectively; P < .001), and mean LOS was 6.2 days shorter (95% CI, 3.0-9.4) with the ESC care approach than with usual care (16.7 vs 22.9 days, respectively; P < .001). Conclusion and Relevance: When compared with usual care, the ESC care approach was associated with less opioid exposure and shorter LOS for infants pharmacologically treated for NOWS. The ESC care approach was not associated with a higher peak opioid dose, although pharmacologic treatment was typically initiated later. Trial Registration: ClinicalTrials.gov Identifier: NCT04057820.

Addressing COVID-19 vaccine hesitancy in rural community pharmacies: a protocol for a stepped wedge randomized clinical trial.

BACKGROUND: Uptake of COVID-19 vaccines remains problematically low in the USA, especially in rural areas. COVID-19 vaccine hesitancy is associated with lower uptake, which translates to higher susceptibility to SARS-CoV-2 variants in communities where vaccination coverage is low. Because community pharmacists are among the most accessible and trusted health professionals in rural areas, this randomized clinical trial will examine implementation strategies to support rural pharmacists in delivering an adapted evidence-based intervention to reduce COVID-19 vaccine hesitancy. METHODS: We will use an incomplete stepped wedge trial design in which we will randomize 30 rural pharmacies (unit of analysis) to determine the effectiveness and incremental cost-effectiveness of a standard implementation approach (consisting of online training that describes the vaccine hesitancy intervention, live webinar, and resource website) compared to adding on a virtual facilitation approach (provided by a trained facilitator in support of the delivery of the vaccine hesitancy counseling intervention by pharmacists). The intervention (ASORT) has been adapted from an evidence-based vaccine communication intervention for HPV vaccines through a partnership with rural pharmacies in a practice-based research network in seven southern US states. ASORT teaches pharmacists how to identify persons eligible for COVID-19 vaccination (including a booster), solicit and address vaccine concerns in a non-confrontational way, recommend the vaccine, and repeat the steps later if needed. The primary trial outcome is fidelity to the ASORT intervention, which will be determined through ratings of recordings of pharmacists delivering the intervention. The secondary outcome is the effectiveness of the intervention, determined by rates of patients who agree to be vaccinated after receiving the intervention. Other secondary outcomes include feasibility, acceptability, adoption, reach, and cost. Cost-effectiveness and budget impact analyses will be conducted to maximize the potential for future dissemination and sustainability. Mixed methods will provide triangulation, expansion, and explanation of quantitative findings. DISCUSSION: This trial contributes to a growing evidence base on vaccine hesitancy interventions and virtual-only facilitation of evidenced-based practices in community health settings. The trial will provide the first estimate of the relative value of different implementation strategies in pharmacy settings. TRIAL REGISTRATION: NCT05926544 (clinicaltrials.gov); 07/03/2023.

Amniotic fluid volume and pregnancy outcomes in twin pregnancies: A systematic review and meta-analysis.

Objective: To analyse amniotic fluid volume (AFV), specifically oligohydramnios or polyhydramnios, and associated pregnancy and neonatal outcomes in twin gestations through systematic review and meta-analysis. Methods: We utilised systematic review methodology to identify items within published and grey literature resources. Prospective and retrospective studies with a control group were included. Inclusion criteria were as follows: studies in English, twin pregnancy in which AFVs and associated pregnancy and/or neonatal outcomes were evaluated. Exclusion criteria included the presence of an anomalous fetus, chromosome abnormality, monochorionic diamniotic twin pregnancy complicated by twin-twin transfusion syndrome or twin-reversed arterial perfusion, twin gestations undergoing therapeutic interventions (i.e. fetoscopic laser photocoagulation and serial amniocentesis) and monochorionic monoamniotic twin pregnancy. Results: The literature search identified 1068 abstracts, only four met criteria for inclusion and analysis. The pooled data (two studies per outcome) revealed no significant difference in rate of pre-term delivery (OR: 2.94; CI: 0.20-43.81), pre-term delivery less than 32 weeks (OR: 1.97; CI: 0.43-9.12), umbilical cord pH < 7 (OR: 2.66; CI: 0.22-32.51), rate of stillbirth (OR: 4.13; CI: 0.40-42.70), neonatal death (OR: 1.48; CI: 0.05-43.94), rate of NICU admission (OR: 1.38; CI: 0.61-3.11) or rate of small-for-gestational-age (SGA) infants (OR: 1.39; CI: 0.33-5.94). Conclusion: Based on the pooled data (two studies per outcome), there was no difference in the fate of pre-term delivery, umbilical cord pH < 7, stillbirth, neonatal death or SGA infants. What is disturbing is the lack of studies (1946-2020) that analysed the association between AFV and pregnancy outcomes in twin pregnancies.

Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.

BACKGROUND: Although clinicians have traditionally used the Finnegan Neonatal Abstinence Scoring Tool to assess the severity of neonatal opioid withdrawal, a newer function-based approach - the Eat, Sleep, Console care approach - is increasing in use. Whether the new approach can safely reduce the time until infants are medically ready for discharge when it is applied broadly across diverse sites is unknown. METHODS: In this cluster-randomized, controlled trial at 26 U.S. hospitals, we enrolled infants with neonatal opioid withdrawal syndrome who had been born at 36 weeks' gestation or more. At a randomly assigned time, hospitals transitioned from usual care that used the Finnegan tool to the Eat, Sleep, Console approach. During a 3-month transition period, staff members at each hospital were trained to use the new approach. The primary outcome was the time from birth until medical readiness for discharge as defined by the trial. Composite safety outcomes that were assessed during the first 3 months of postnatal age included in-hospital safety, unscheduled health care visits, and nonaccidental trauma or death. RESULTS: A total of 1305 infants were enrolled. In an intention-to-treat analysis that included 837 infants who met the trial definition for medical readiness for discharge, the number of days from birth until readiness for hospital discharge was 8.2 in the Eat, Sleep, Console group and 14.9 in the usual-care group (adjusted mean difference, 6.7 days; 95% confidence interval [CI], 4.7 to 8.8), for a rate ratio of 0.55 (95% CI, 0.46 to 0.65; P<0.001). The incidence of adverse outcomes was similar in the two groups. CONCLUSIONS: As compared with usual care, use of the Eat, Sleep, Console care approach significantly decreased the number of days until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes. (Funded by the Helping End Addiction Long-term (HEAL) Initiative of the National Institutes of Health; ESC-NOW ClinicalTrials.gov number, NCT04057820.).

Comparing Medical Record Abstraction (MRA) Error Rates in an Observational Study to Pooled Rates Identified in the Data Quality Literature.

Background: Medical record abstraction (MRA) is a commonly used method for data collection in clinical research, but is prone to error, and the influence of quality control (QC) measures is seldom and inconsistently assessed during the course of a study. We employed a novel, standardized MRA-QC framework as part of an ongoing observational study in an effort to control MRA error rates. In order to assess the effectiveness of our framework, we compared our error rates against traditional MRA studies that had not reported using formalized MRA-QC methods. Thus, the objective of this study was to compare the MRA error rates derived from the literature with the error rates found in a study using MRA as the sole method of data collection that employed an MRA-QC framework. Methods: Using a moderator meta-analysis employed with Q-test, the MRA error rates from the meta-analysis of the literature were compared with the error rate from a recent study that implemented formalized MRA training and continuous QC processes. Results: The MRA process for data acquisition in clinical research was associated with both high and highly variable error rates (70 - 2,784 errors per 10,000 fields). Error rates for the study using our MRA-QC framework were between 1.04% (optimistic, all-field rate) and 2.57% (conservative, populated-field rate) (or 104 - 257 errors per 10,000 fields), 4.00 - 5.53 percentage points less than the observed rate from the literature (p<0.0001). Conclusions: Review of the literature indicated that the accuracy associated with MRA varied widely across studies. However, our results demonstrate that, with appropriate training and continuous QC, MRA error rates can be significantly controlled during the course of a clinical research study.

The Influence of Mediators on the Relationship Between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome.

OBJECTIVES: (1) To evaluate the direct (un-mediated) and indirect (mediated) relationship between antenatal exposure to opioid agonist medication as treatment for opioid use disorder (MOUD) and the severity of neonatal opioid withdrawal syndrome (NOWS), and (2) to understand the degree to which mediating factors influence the direct relationship between MOUD exposure and NOWS severity. METHODS: This cross-sectional study includes data abstracted from the medical records of 1294 opioid-exposed infants (859 MOUD exposed and 435 non-MOUD exposed) born at or admitted to one of 30 US hospitals from July 1, 2016, to June 30, 2017. Regression models and mediation analyses were used to evaluate the relationship between MOUD exposure and NOWS severity (i.e., infant pharmacologic treatment and length of newborn hospital stay (LOS)) to identify potential mediators of this relationship in analyses adjusted for confounding factors. RESULTS: A direct (un-mediated) association was found between antenatal exposure to MOUD and both pharmacologic treatment for NOWS (aOR 2.34; 95%CI 1.74, 3.14) and an increase in LOS (1.73 days; 95%CI 0.49, 2.98). Delivery of adequate prenatal care and a reduction in polysubstance exposure were mediators of the relationship between MOUD and NOWS severity and as thus, were indirectly associated with a decrease in both pharmacologic treatment for NOWS and LOS. CONCLUSIONS FOR PRACTICE: MOUD exposure is directly associated with NOWS severity. Prenatal care and polysubstance exposure are potential mediators in this relationship. These mediating factors may be targeted to reduce the severity of NOWS while maintaining the important benefits of MOUD during pregnancy.

Title: Is Mild Idiopathic Polyhydramnios Associated with an Increased Risk for an Intrauterine Fetal Demise? A Retrospective Cohort Study.

Objective: Antenatal fetal surveillance has been recommended for moderate/severe idiopathic polyhydramnios but not for mild idiopathic polyhydramnios. The purpose of this study is to determine if pregnancies with mild idiopathic polyhydramnios have an increased risk for an intrauterine fetal demise (IUFD). Methods: Medical records and amniotic fluid volume ultrasound data from 2016 to 2021 at a university medical center were examined. Pregnancies with fetal anomalies, fetal infection, isoimmunization, multiple gestation, maternal diabetes and oligohydramnios were excluded. Normal amniotic fluid volume was defined as an amniotic fluid index (AFI) <24 cm which was compared to mild idiopathic polyhydramnios, AFI of ≥24.0 cm-29.9 cm, and moderate/severe polyhydramnios which is an AFI ≥30 cm. Results: Of 12,725 patients meeting inclusion study criteria, there were 249 with idiopathic polyhydramnios (n = 249) which was associated with an increased odds of IUFD (aOR) of 3.27 (CI 1.50-7.15), NICU admission (aOR 1.28, CI 0.96-1.70), 5-minute APGAR score less than 7 (aOR 2.16, CI 1.52-3.07), and large for gestational age infant (LGA) (aOR 4.04, CI 2.83-5.78) compared to normal amniotic fluid volume (AFV). In the mild polyhydramnios group (n = 204, out of the 249 women with polyhydramnios) compared to the 12,476 pregnancies with normal AFV group, IUFD (aOR 3.38, CI 1.46-7.82), NICU admission (aOR 1.19, CI 0.87-1.64), 5-minute APGAR score less than 7 (aOR 1.68, CI 1.10-2.55) and LGA (aOR 3.87, CI 2.59-5.78). In moderate/severe polyhydramnios group (n = 45) compared to the normal AFV group, there was no increased odds of IUFD (aOR 2.78, CI 0.38-20.29) or NICU admission (aOR 1.74, CI 0.93-3.26) but an increased odds for a 5-minute APGAR score less than 7 (aOR 4.94, CI 2.57-9.53) and LGA fetus (aOR 4.80, CI 2.26-10.22). Conclusion: There is an increased odds of IUFD in pregnancies complicated by mild idiopathic polyhydramnios. Patients should be counseled on an increased odds of adverse pregnancy outcomes associated with idiopathic polyhydramnios, and in those pregnancies with mild idiopathic polyhydramnios, antenatal fetal surveillance should be considered.

Maternal comorbidity index and severe maternal morbidity among medicaid covered pregnant women in a US Southern rural state.

BACKGROUND: The rates of SMM have been steadily increasing in Arkansas, a southern rural state, which has the 5th highest maternal death rate among the US states. The aims of the study were to test the functionality of the Bateman index in association to SMM, in clustering the risks of pregnancies to SMM, and to study the predictability of SMM using the Bateman index. STUDY DESIGN: From the ANGELS database, 72,183 pregnancies covered by Medicaid in Arkansas between 2013 and 2016 were included in this study. The expanded CDC ICD-9/ICD-10 criteria were used to identify SMM. The Bateman comorbidity index was applied in quantifying the comorbidity burden for a pregnancy. Multivariable logistic regressions, KMeans method, and five widely used predictive models were applied respectively for each of the study aims. RESULTS: SMM prevalence remained persistently high among Arkansas women covered by Medicaid (195 per 10,000 deliveries) during the study period. Using the Bateman comorbidity index score, the study population was divided into four groups, with a monotonically increasing odds of SMM from a lower score group to a higher score group. The association between the index score and the occurrence of SMM is confirmed with statistical significance: relative to Bateman score falling in 0-1, adjusted Odds Ratios and 95% CIs are: 2.1 (1.78, 2.46) for score in 2-5; 5.08 (3.81, 6.79) for score in 6-9; and 8.53 (4.57, 15.92) for score ≥10. Noticeably, more than one-third of SMM cases were detected from the studied pregnancies that did not have any of the comorbid conditions identified. In the prediction analyses, we observed minimal predictability of SMM using the comorbidity index: the calculated c-statistics ranged between 62% and 67%; the Precision-Recall AUC values are <7% for internal validation and <9% for external validation procedures. CONCLUSIONS: The comorbidity index can be used in quantifying the risk of SMM and can help cluster the study population into risk tiers of SMM, especially in rural states where there are disproportionately higher rates of SMM; however, the predictive value of the comorbidity index for SMM is inappreciable.

Factors Related to Patients' Self-care and Self-care Confidence in Korean Patients With Heart Failure and Their Caregivers: A Cross-sectional, Correlational Study.

BACKGROUND: The relationships of patient factors and caregiver contribution to patients' self-care to different types of self-care have been rarely examined in Korean patients with heart failure. OBJECTIVE: The aim of this study was to examine patient (ie, age, depressive symptoms, and self-care confidence) and caregiver (ie, caregiver contribution to self-care maintenance and self-care management, and caregiver confidence in contributing to self-care) factors related to different types of self-care (ie, self-care maintenance, symptom perception, and self-care management) and self-care confidence in Korean patients with heart failure. METHODS: In this cross-sectional, correlational study, data from 41 pairs of patients (mean age, 68.0 years) and caregivers (mean age, 54.1 years) were collected and analyzed using multiple regression. RESULTS: Higher levels of self-care confidence in patients were related to higher levels of self-care maintenance in patients. Higher levels of self-care confidence in patients were related to higher levels of symptom perception. Higher levels of self-care confidence in patients and caregiver contribution to self-care maintenance were related to higher levels of self-care management. Less severe depressive symptoms in patients and higher levels of caregiver confidence in contributing to self-care were related to higher levels of self-care confidence. CONCLUSION: Different patient and caregiver factors were related to different types of self-care and self-care confidence in Korean patients, but patients' self-care confidence was related to all types of self-care. Clinicians and researchers need to develop and deliver effective interventions to both patients and their caregivers to improve patients' self-care confidence and, in turn, self-care, considering different factors associated with each type of self-care.

Facilitators and barriers to providing affirming care for transgender patients in primary care practices in Arkansas.

PURPOSE: This study assessed factors affecting the provision of affirming-care best practices (ACBPs) for transgender individuals by primary care providers (PCPs) in a rural, southern state METHODS: We conducted a sequential explanatory mixed-methods study in 2020, including a statewide survey (phase 1) and interviews (phase 2). Surveyed PCPs (phase 1) included Medical Doctors/Doctors of Osteopathy (MDs/DOs), nurse practitioners, and 1 physician assistant. Interview participants (phase 2) included providers and staff in 6 practices throughout the state. We used an exploratory approach to data collection and performed content analysis to classify interview data into categories representing overarching themes RESULTS: Among surveyed PCPs who reported they had provided care to transgender patients (n = 35), the most common reason for providing gender-affirming medical services was "because of my ethical obligation to treat patients equally" (n = 27, 77%). The most common reason for not providing such services was because the PCPs "have not been trained/don't feel competent to provide these services" (n = 12, 34%). Interviews revealed the following themes: (1) willingness to provide "culturally competent care"; (2) continuum of accepting to affirming attitudes toward transgender individuals; (3) basic understanding of stigma and an awareness of its impact; (4) changes needed to provide "culturally competent care"; and (5) preferred clinical support strategies. CONCLUSION: Training and education to provide ACBPs are warranted and would meet the needs of patients and providers. Facilitating telemedicine visits for transgender patients with gender-affirming care experts was a favorable implementation strategy for clinical support and is recommended to address access to affirming care.

Assessing work role strain, burnout, and job satisfaction among remotely piloted aircraft operators: the moderating role of unit social support.

Utilizing the Job Demands-Resources (JD-R) theory as a guiding framework, the current study examined the relationships between job demands (work role strain) and occupational outcomes (burnout and job satisfaction) and assessed how job resources (team member social support and leader social support) mitigated the impact of high job demands for U.S. Air Force remotely piloted aircraft (RPA) operators. A total of 905 active duty U.S. Air Force RPA operators participated in a web-based occupational health assessment. Study findings confirmed that work role strain proved to be strongly related to negative occupational outcomes - increased burnout and reduced job satisfaction. Compelling evidence emerged suggesting that boosting job resources (i.e., team member and leader social support) may be a promising point of intervention to mitigate negative occupational outcomes. By investigating ongoing job demands that result in a higher incidence of burnout and job dissatisfaction, as well as job resources that protect against burnout and job dissatisfaction, researchers and practitioners can continue to introduce supportive resources at crucial points to alleviate the adverse consequences of occupational stress and burnout. Applying the JD-R theory to these findings highlights the importance of job resources for RPA operators and other employees working in high-risk, high-demand career fields. Implications and future directions are discussed.

"Advancing" Advance Care Planning to Veterans in the Veterans Health Administration.

INTRODUCTION: The completion rate of Advance Directive (ADs) in the Veterans Health Administration (VHA) is unknown. There is substantial literature on the need for effective Advance Care Planning (ACP) that leads to an AD to ensure that health care preferences for patients are known. Advance Directive are essential to consider since ACP, which explains and plans Advance Directive, does not reach all individuals. Health inequities, such as those experienced in rural areas, continue to exist. While ACP may disproportionately affect rural-residing veterans and their providers, a VHA program was specifically designed to increase ACP engagement with rural veterans and to address several systemic barriers to ACP. MATERIALS AND METHODS: This descriptive analysis seeks to identify patient, provider, and geographic characteristics associated with higher rates of ACP participation in VHA. An observational examination of the profile of veterans and the types of ACP (e.g., individual or in groups) using administrative data for all beneficiaries receiving VHA health care services in federal fiscal year (FY) 2020 was conducted as part of a national program evaluation. The measures include patient-level data on demographics (e.g., race, ethnicity, gender), unique patient identifiers (e.g., name, social security number), geographic characteristics of patient's location (e.g., rurality defined as Rural-Urban Commuting Areas [RUCA]), VHA priority group; provider-level data (e.g., type of document definition, clinic stop codes, visit date used to verify Advance Care Planning via Group Visits [ACP-GV] attendance; data not shown), and electronic health record note titles that indicated the presence of ACP in VHA (e.g., "Advance Directive [AD] Discussion" note title, "ACP-GV CHAR 4 code"). Pearson's chi-square statistics were used for between-group comparisons based on a two-sided test with a significance level of 0.05. RESULTS: The overall rate of AD discussions among unique VHA users in FY2020 was 5.2% (95% CI: 5.2%-5.2%) and for Advance Care Planning via Group Visits, which targets rural veterans using groups, it was 1.8% (95% CI: 1.8%-1.9%). Advance Directive discussions in VHA are more successful at reaching middle age (M = 64; SD = 16), African Americans, males, veterans living in urban areas, and veterans with a VA disability (Priority Group 1-4). Advance Care Planning delivered in groups is reaching slightly younger veterans under the age of 75 years (M = 62; SD = 15), African Americans, females, disabled veterans (e.g., Priority Group 1-4), and more veterans residing in rural communities compared to the national population of VHA users. CONCLUSION: Advance Directive discussion rates are low across VHA, yet intentional efforts with ACP via group visits are reaching veterans who are considered underserved owing to residing in rural areas. Advance Care Planning needs to be a well-informed clinical priority for VHA to engage with the entire veteran population and to support the completion of ADs.

Factors associated with attitudes toward advance directives in nurses and comparisons of the levels between emergency nurses and palliative care nurses.

AIM: Little is known about attitudes toward advance directives and factors associated with them among emergency and palliative care nurses who often or daily face end-of-life circumstances. Thus, we aimed to compare the levels of attitudes toward advance directives, communication skills, knowledge about end-of-life care (knowledge), and awareness of the concept of a good death (good death awareness) between emergency and palliative care nurses, and to examine factors associated with attitudes toward advance directives in the total sample. METHODS: In this cross-sectional, correlational study, data were collected from 153 nurses (59 emergency and 94 palliative care nurses) at three tertiary hospitals using online or offline surveys and were analyzed using t-tests and multiple linear regression analysis. RESULTS: The levels of attitudes, communication skills, knowledge, and good death awareness were moderate in both groups. Attitudes in emergency compared to palliative care nurses were less positive (46.78 vs. 48.38; p = .044), and knowledge was significantly lower (13.64 vs. 15.00; p = .004). Communication skills and good death awareness between the two groups were similar. In the total sample, emergency practice (B = -1.59, p = .024), and lower levels of good death awareness (B = 0.30, p < .001), communication skills (B = 0.18, p = .001), and education (B = -2.84, p = .015) were associated with less positive attitudes (F = 9.52, p < .001; R2  = 0.35). CONCLUSIONS: The findings demonstrate the need for improvements in attitudes, knowledge, communication skills, and good death awareness in both groups, especially emergency nurses. Two modifiable targets of interventions to improve nurses' attitudes were also noted.

Error Rates of Data Processing Methods in Clinical Research: A Systematic Review and Meta-Analysis of Manuscripts Identified Through PubMed.

Background: In clinical research, prevention of systematic and random errors of data collected is paramount to ensuring reproducibility of trial results and the safety and efficacy of the resulting interventions. Over the last 40 years, empirical assessments of data accuracy in clinical research have been reported in the literature. Although there have been reports of data error and discrepancy rates in clinical studies, there has been little systematic synthesis of these results. Further, although notable exceptions exist, little evidence exists regarding the relative accuracy of different data processing methods. We aim to address this gap by evaluating error rates for 4 data processing methods. Methods: A systematic review of the literature identified through PubMed was performed to identify studies that evaluated the quality of data obtained through data processing methods typically used in clinical trials: medical record abstraction (MRA), optical scanning, single-data entry, and double-data entry. Quantitative information on data accuracy was abstracted from the manuscripts and pooled. Meta-analysis of single proportions based on the Freeman-Tukey transformation method and the generalized linear mixed model approach were used to derive an overall estimate of error rates across data processing methods used in each study for comparison. Results: A total of 93 papers (published from 1978 to 2008) meeting our inclusion criteria were categorized according to their data processing methods. The accuracy associated with data processing methods varied widely, with error rates ranging from 2 errors per 10,000 fields to 2,784 errors per 10,000 fields. MRA was associated with both high and highly variable error rates, having a pooled error rate of 6.57% (95% CI: 5.51, 7.72). In comparison, the pooled error rates for optical scanning, single-data entry, and double-data entry methods were 0.74% (0.21, 1.60), 0.29% (0.24, 0.35) and 0.14% (0.08, 0.20), respectively. Conclusions: Data processing and cleaning methods may explain a significant amount of the variability in data accuracy. MRA error rates, for example, were high enough to impact decisions made using the data and could necessitate increases in sample sizes to preserve statistical power. Thus, the choice of data processing methods can likely impact process capability and, ultimately, the validity of trial results.

Examination of a Stillbirth Workup: A Rural Statewide Experience.

OBJECTIVE: The objective of our study was to determine whether recommended assessments were conducted on stillbirths delivered in our predominantly rural state. METHODS: This was a descriptive study of stillbirths delivered in a rural state and included in one site of the Birth Defects Study to Evaluate Pregnancy Exposures stillbirth study. Hospital and fetal death records were examined to determine whether the following areas were evaluated: genetic testing (noninvasive perinatal testing, quad screen, amniocentesis/chorionic villus sampling with karyotype, microarrays, fetal tissue specimen), placenta/membrane/cord sent for pathologic examination, examination of the stillbirth after delivery by the healthcare provider, and fetal autopsy was performed. RESULTS: From July 1, 2015 to June 30, 2020, there were 1108 stillbirths delivered in Arkansas. The most frequent assessments undertaken were placental pathology (72%), genetic testing (67%), fetal inspection (31%), and autopsy (13%). All four assessments were done in 2% of stillbirth cases, three assessments in 27%, two assessments in 47%, one assessment in 14%, and no assessment in 15%. There was no association between stillbirth assessment evaluation by gestational age (<28 weeks and > 28 weeks; P = 0.221); however, there was an overall association between hospital delivery volume with number of components completed (P < 0.0001). Hospitals with >2000 deliveries had a higher proportion of three or four completions compared with those hospitals with <1000 deliveries or 1000 to 2000 deliveries (P = 0.021 and P < 0.0001). CONCLUSIONS: Fetal stillbirth assessment is suboptimal in our rural state, with 15% of stillbirths having no assessment and only 2% having all four assessments. There is no association between stillbirth assessment and gestational age (<28 weeks vs >28 weeks), but there is a correlation between delivery volume and stillbirth assessment.

Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUP): a randomized, controlled trial.

Background: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. Methods: Custodial parents/caregivers with ≥1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. Discussion: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine-uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. Clinical Trials Registration: Name of the registry: clinicaltrials.gov Trial registration number: NCT05386355 Date of registration: May 23, 2022 URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT05386355.

Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial.

BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. METHODS: Custodial parents/caregivers with ≥ 1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥ 1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. DISCUSSION: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT05386355 . Registered on May 23, 2022.

Measuring and controlling medical record abstraction (MRA) error rates in an observational study.

BACKGROUND: Studies have shown that data collection by medical record abstraction (MRA) is a significant source of error in clinical research studies relying on secondary use data. Yet, the quality of data collected using MRA is seldom assessed. We employed a novel, theory-based framework for data quality assurance and quality control of MRA. The objective of this work is to determine the potential impact of formalized MRA training and continuous quality control (QC) processes on data quality over time. METHODS: We conducted a retrospective analysis of QC data collected during a cross-sectional medical record review of mother-infant dyads with Neonatal Opioid Withdrawal Syndrome. A confidence interval approach was used to calculate crude (Wald's method) and adjusted (generalized estimating equation) error rates over time. We calculated error rates using the number of errors divided by total fields ("all-field" error rate) and populated fields ("populated-field" error rate) as the denominators, to provide both an optimistic and a conservative measurement, respectively. RESULTS: On average, the ACT NOW CE Study maintained an error rate between 1% (optimistic) and 3% (conservative). Additionally, we observed a decrease of 0.51 percentage points with each additional QC Event conducted. CONCLUSIONS: Formalized MRA training and continuous QC resulted in lower error rates than have been found in previous literature and a decrease in error rates over time. This study newly demonstrates the importance of continuous process controls for MRA within the context of a multi-site clinical research study.