Faculty Bibliography

OBJECTIVES/OBJECTIVE:The aim of this study was to assess the performance and impact of multilevel modelling (MLM) compared with ordinary least squares (OLS) regression in trial-based economic evaluations with clustered data. METHODS:Three thousand datasets with balanced and unbalanced clusters were simulated with correlation coefficients between costs and effects of - 0.5, 0, and 0.5, and intraclass correlation coefficients (ICCs) varying between 0.05 and 0.30. Each scenario was analyzed using both MLM and OLS. Statistical uncertainty around MLM and OLS estimates was estimated using bootstrapping. Performance measures were estimated and compared between approaches, including bias, root mean squared error (RMSE) and coverage probability. Cost and effect differences, and their corresponding confidence intervals and standard errors, incremental cost-effectiveness ratios, incremental net-monetary benefits and cost-effectiveness acceptability curves were compared. RESULTS:Cost-effectiveness outcomes were similar between OLS and MLM. MLM produced larger statistical uncertainty and coverage probabilities closer to nominal levels than OLS. The higher the ICC, the larger the effect on statistical uncertainty between MLM and OLS. Significant cost-effectiveness outcomes as estimated by OLS became non-significant when estimated by MLM. At all ICCs, MLM resulted in lower probabilities of cost effectiveness than OLS, and this difference became larger with increasing ICCs. Performance measures and cost-effectiveness outcomes were similar across scenarios with varying correlation coefficients between costs and effects. CONCLUSIONS:Although OLS produced similar cost-effectiveness outcomes, it substantially underestimated the amount of variation in the data compared with MLM. To prevent suboptimal conclusions and a possible waste of scarce resources, it is important to use MLM in trial-based economic evaluations when data are clustered.

This study examined longitudinal relations between emotion knowledge (EK) in pre-kindergarten (pre-K; M_age  = 4.8 years) and math and reading achievement 1 and 3 years later in a sample of 1,050 primarily Black children (over half from immigrant families) living in historically disinvested neighborhoods. Participants were part of a follow-up study of a cluster randomized controlled trial. Controlling for pre-academic skills, other social-emotional skills, sociodemographic characteristics, and school intervention status, higher EK at the end of pre-K predicted higher math and reading achievement test scores in kindergarten and second grade. Moderation analyses suggest that relations were attenuated among children from immigrant families. Findings suggest the importance of enriching pre-K programs for children of color with EK-promotive interventions and strategies.

BACKGROUND: Alcohol and drug use are often under-identified in primary care settings. While prior research indicates that patients are generally supportive of alcohol screening, less is known about attitudes toward drug screening or the collection of this information in electronic health records (EHRs). As a part of an implementation study of EHRintegrated substance use screening in primary care, conducted in the NIDA Clinical Trials Network, patients were surveyed on their attitudes toward screening for substance use during medical visits.
METHOD(S): Surveys were administered to patients in four urban academic primary care clinics on a quarterly basis, for one year following the introduction of a screening program. English-speaking adult patients presenting for a primary care visit were eligible. Participants were recruited from the waiting room and self-administered an 18-item survey exploring attitudes toward screening and discussing substance use with healthcare providers.
RESULT(S): A total of 479 patients completed the survey (mean age 54.1; 58% female; 58% white, 23% black; 19% Hispanic/Latino). Participants overwhelmingly felt that they should be asked about their substance use (91%), and deemed it appropriate for their doctor to recommend reducing use if it could adversely affect their health (92%). Most (87%) were equally comfortable discussing alcohol or drug use. A majority (63%) preferred discussing substance use with their doctor over other medical staff. Responses weremixed regarding screening modality: 55%preferred face-to-face, 22% had no preference, 14% preferred self- administration. Participants reported that they would be honest with their provider (94%), but 32% were concerned about medical record confidentiality.
CONCLUSION(S): Primary care patients strongly supported being screened for drug and alcohol use, and would be comfortable discussing it with their doctor. However, patients' concerns about having their substance use documented in their medical record could pose a barrier to achieving accurate responses. These findings suggest a need to educate patients on the confidentiality of medical records and the value of disclosing substance use for their medical care

There is overwhelming need for nonpharmacological interventions to improve the health and well-being of people living with dementia (PLWD). The National Institute on Aging Imbedded Pragmatic Alzheimer's Disease (AD) and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory supports clinical trials of such interventions embedded in healthcare systems. The embedded pragmatic clinical trial (ePCT) is ideally suited to testing the effectiveness of complex interventions in vulnerable populations at the point of care. These trials, however, are complex to conduct and interpret, and face challenges in efficiency (i.e., statistical power) and reproducibility. In addition, trials conducted among PLWD present specific statistical challenges, including difficulty in outcomes ascertainment from PLWD, necessitating reliance on reports by caregivers, and heterogeneity in measurements across different settings or populations. These and other challenges undercut the reliability of measurement, the feasibility of capturing outcomes using pragmatic designs, and the ability to validly estimate interventions' effectiveness in real-world settings. To address these challenges, the IMPACT Collaboratory has convened a Design and Statistics Core, the goals of which are: to support the design and conduct of ePCTs directed toward PLWD and their caregivers; to develop guidance for conducting embedded trials in this population; and to educate quantitative and clinical scientists in the design, conduct, and analysis of these trials. In this article, we discuss some of the contemporary methodological challenges in this area and develop a set of research priorities the Design and Statistics Core will undertake to meet these goals. J Am Geriatr Soc 68:S68-S73, 2020.

BACKGROUND: Under-treatment of drug and alcohol use in primary care settings has been attributed, in part, to medical providers' negative attitudes toward substance use. As a part of an implementation study of electronic health record-integrated substance use screening in primary care clinics, conducted in the NIDA Clinical Trials Network, we assessed baseline attitudes among medical staff.
METHOD(S): Eligible participants were primary care providers and medical assistants in 4 urban academic primary care clinics. Prior to implementation of a substance use screening program, participants completed the Substance Abuse Attitudes Survey (SAAS), a validated 50-item self-administered survey that measures attitudes to substance use in 5 domains: permissiveness, non-moralism, nonstereotyping, treatment intervention, and treatment optimism. Participants were asked to rate their level of agreement with each item on a five-point Likert scale.
RESULT(S): In total, 131/191 (69% response rate) eligible staff completed the survey. Participants had mean age 42; 76% were female; 11% Hispanic/Latino, 6% Black, 25% Asian. The majority of the sample was physicians (78%), while 11% were nurse practitioners, and 11% were medical assistants. Participants had an overall average of 13.2 years in practice. Approximately onethird reported moderate to high satisfaction treating patients with drug problems (35.1%) and alcohol problems (33.6%). The proportion of participants having positive attitudes in each of the following domains were: non-moralism (64.1%); non-stereotyping (55.7%); treatment intervention (47.3%); treatment optimism (48.9%); and permissiveness (44.3%). Negative attitudes toward permissiveness reflect responses to items addressing health effects of substance use, especially among teens.
CONCLUSION(S): While most primary care staff did not endorse moralistic or stereotyping statements about alcohol and drug use, attitudes toward addiction treatment were mixed, with less than half endorsing positive attitudes toward treatment effectiveness. These results suggest a need to improve attitudes, particularly toward addiction treatment. This could be accomplished through education and increased exposure to effective interventions that can be delivered by primary care providers, including officebased treatment for alcohol and opioid use disorder

BACKGROUND:Electronic health record (EHR)-based interventions that use registries and alerts can improve chronic disease care in primary care settings. Community health worker (CHW) interventions also have been shown to improve chronic disease outcomes, especially in minority communities. Despite their potential, these two approaches have not been tested together, including in small primary care practice (PCP) settings. This paper presents the protocol of Diabetes Research, Education, and Action for Minorities (DREAM) Initiative, a 5-year randomized controlled trial integrating both EHR and CHW approaches into a network of PCPs in New York City (NYC) in order to support weight loss efforts among South Asian patients at risk for diabetes. METHODS/DESIGN/METHODS:The DREAM Initiative was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health). A total of 480 individuals at risk for type 2 diabetes will be enrolled into the intervention group, and an equal number will be included in a matched control group. The EHR intervention components include the provision of technical assistance to participating PCPs regarding prediabetes-related registry reports, alerts, and order sets. The CHW intervention components entail group education sessions on diabetes prevention, including weight loss and nutrition. A mixed-methods approach will be used to evaluate the feasibility, adoption, and impact (≥ 5% weight loss) of the integrated study components. Additionally, a cost effectiveness analysis will be conducted using outcomes, implementation costs, and healthcare claims data to determine the incremental cost per person achieving 5% weight loss. DISCUSSION/CONCLUSIONS:This study will be the first to test the efficacy of an integrated EHR-CHW intervention within an underserved, minority population and in a practical setting via a network of small PCPs in NYC. The study's implementation is enhanced through cross-sector partnerships, including the local health department, a healthcare payer, and EHR vendors. Through use of a software platform, the study will also systematically track and monitor CHW referrals to social service organizations. Study findings, including those resulting from cost-effectiveness analyses, will have important implications for translating similar strategies to other minority communities in sustainable ways. TRIAL REGISTRATION/BACKGROUND:This study protocol has been approved and is made available on ClinicalTrials.gov by NCT03188094 as of 15 June 2017.

INTRODUCTION/BACKGROUND:Emergency departments (ED) care for society's most vulnerable older adults who present with exacerbations of chronic disease at the end of life, yet the clinical paradigm focuses on treatment of acute pathologies. Palliative care interventions in the ED capture high-risk patients at a time of crisis and can dramatically improve patient-centred outcomes. This study aims to implement and evaluate Primary Palliative Care for Emergency Medicine (PRIM-ER) on ED disposition, healthcare utilisation and survival in older adults with serious illness. METHODS AND ANALYSIS/UNASSIGNED:This is the protocol for a pragmatic, cluster-randomised stepped wedge trial to test the effectiveness of PRIM-ER in 35 EDs across the USA. The intervention includes four core components: (1) evidence-based, multidisciplinary primary palliative care education; (2) simulation-based workshops; (3) clinical decision support; and (4) audit and feedback. The study is divided into two phases: a pilot phase, to ensure feasibility in two sites, and an implementation and evaluation phase, where we implement the intervention and test the effectiveness in 33 EDs over 2 years. Using Centers for Medicare and Medicaid Services (CMS) data, we will assess the primary outcomes in approximately 300 000 patients: ED disposition to an acute care setting, healthcare utilisation in the 6 months following the ED visit and survival following the index ED visit. Analysis will also determine the site, provider and patient-level characteristics that are associated with variation in impact of PRIM-ER. ETHICS AND DISSEMINATION/UNASSIGNED:Institutional Review Board approval was obtained at New York University School of Medicine to evaluate the CMS data. Oversight will also be provided by the National Institutes of Health, an Independent Monitoring Committee and a Clinical Informatics Advisory Board. Trial results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT03424109; Pre-results.

Purpose: Most built environment studies have quantified characteristics of the areas around participants' homes. However, the environmental exposures for physical activity (PA) are spatially dynamic rather than static. Thus, merged accelerometer and global positioning system (GPS) data were utilized to estimate associations between the built environment and PA among adults. Methods: Participants (N = 142) were recruited on trails in Massachusetts and wore an accelerometer and GPS unit for 1-4 days. Two binary outcomes were created: moderate-to-vigorous PA (MVPA vs. light PA-to-sedentary); and light-to-vigorous PA (LVPA vs. sedentary). Five built environment variables were created within 50-meter buffers around GPS points: population density, street density, land use mix (LUM), greenness, and walkability index. Generalized linear mixed models were fit to examine associations between environmental variables and both outcomes, adjusting for demographic covariates. Results: Overall, in the fully adjusted models, greenness was positively associated with MVPA and LVPA (odds ratios [ORs] = 1.15, 95% confidence interval [CI] = 1.03, 1.30 and 1.25, 95% CI = 1.12, 1.41, respectively). In contrast, street density and LUM were negatively associated with MVPA (ORs = 0.69, 95% CI = 0.67, 0.71 and 0.87, 95% CI = 0.78, 0.97, respectively) and LVPA (ORs = 0.79, 95% CI = 0.77, 0.81 and 0.81, 95% CI = 0.74, 0.90, respectively). Negative associations of population density and walkability with both outcomes reached statistical significance, yet the effect sizes were small. Conclusions: Concurrent monitoring of activity with accelerometers and GPS units allowed us to investigate relationships between objectively measured built environment around GPS points and minute-by-minute PA. Negative relationships between street density and LUM and PA contrast evidence from most built environment studies in adults. However, direct comparisons should be made with caution since most previous studies have focused on spatially fixed buffers around home locations, rather than the precise locations where PA occurs.