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Primary Palliative Care for Emergency Medicine (PRIM-ER): Protocol for a Pragmatic, Cluster-Randomised, Stepped Wedge Design to Test the Effectiveness of Primary Palliative Care Education, Training and Technical Support for Emergency Medicine

Grudzen, Corita R; Brody, Abraham A; Chung, Frank R; Cuthel, Allison M; Mann, Devin; McQuilkin, Jordan A; Rubin, Ada L; Swartz, Jordan; Tan, Audrey; Goldfeld, Keith S
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.
PMID: 31352424
ISSN: 2044-6055
CID: 4010352

Accelerometer and GPS Data to Analyze Built Environments and Physical Activity

Tamura, Kosuke; Wilson, Jeffrey S; Goldfeld, Keith; Puett, Robin C; Klenosky, David B; Harper, William A; Troped, Philip J
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.
PMID: 31199713
ISSN: 2168-3824
CID: 4038792

Feasibility and Outcomes of an Electronic Health Record Intervention to Improve Hypertension Management in Immigrant-serving Primary Care Practices

Lopez, Priscilla M; Divney, Anna; Goldfeld, Keith; Zanowiak, Jennifer; Gore, Radhika; Kumar, Rashi; Laughlin, Phoebe; Sanchez, Ronald; Beane, Susan; Trinh-Shevrin, Chau; Thorpe, Lorna; Islam, Nadia
BACKGROUND:South Asians experience a disproportionate burden of high blood pressure (BP) in the United States, arguably the most preventable risk factor for cardiovascular disease. OBJECTIVE:We report 12-month results of an electronic health record (EHR)-based intervention, as a component of a larger project, "Implementing Million Hearts for Provider and Community Transformation." The EHR intervention included launching hypertension patient registries and implementing culturally tailored alerts and order sets to improve hypertension control among patients treated in 14 New York City practices located in predominantly South Asian immigrant neighborhoods. DESIGN/METHODS:Using a modified stepped-wedge quasi-experimental study design, practice-level EHR data were extracted, and individual-level data were obtained on a subset of patients insured by a Medicaid insurer via their data warehouse. The primary aggregate outcome was change in proportion of hypertensive patients with controlled BP; individual-level outcomes included average systolic BP (SBP) and diastolic BP (DBP) at last clinic visit. Qualitative interviews were conducted to assess intervention feasibility. MEASURES/METHODS:Hypertension was defined as having at least 1 hypertension ICD-9/10 code. Well-controlled hypertension was defined as SBP<140 and DBP<90 mm Hg. RESULTS:Postintervention, we observed a significant improvement in hypertension control at the practice level, adjusting for age and sex patient composition (adjusted relative risk, 1.09; 95% confidence interval, 1.04-1.14). Among the subset of Medicaid patients, we observed a significant reduction in average SBP and DBP adjusting for time, age, and sex, by 1.71 and 1.13 mm Hg, respectively (P<0.05). Providers reported feeling supported and satisfied with EHR components. CONCLUSIONS:EHR initiatives in practices serving immigrants and minorities may enhance practice capabilities to improve hypertension control.
PMCID:6527132
PMID: 31095056
ISSN: 1537-1948
CID: 3903352

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care [Meeting Abstract]

Malone, M; Vittitow, A; McDonald, R D; Tofighi, B; Garment, A; Schatz, D; Laska, E; Goldfeld, K; Rotrosen, J; Lee, J D
Aim: Naltrexone is first-line pharmacotherapy for alcohol use disorders (AUD). Oral naltrexone (ONTX) is under-prescribed in primary care and possibly limited by poor adherence. Monthly injectable extended-release naltrexone (XR-NTX) may improve adherence and good clinical outcomes.
Method(s): This is a randomized, open-label, comparative effectiveness trial of 24 weeks of XR-NTX vs. O-NTX as AUD treatment in primary care at a public hospital in New York City. Adults (>18 yo) with AUD randomized to XR-NTX (380 mg/month) vs. O-NTX (50 mg/day) with Medical Management. Self-reported daily drinking recall informed the primary outcome, a Good Clinical Outcome (GCO) across weeks 5-24, defined as abstinence or moderate drinking and 0-2 days of heavy drinking per month. Data & Results: N = 237 adults randomized (n = 117 XR-NTX; n = 120 O-NTX); mean age 48.5 (SD 10.6); 71%male; 54%AA, 21% Hispanic; 41%employed. At baseline mean drinks/day were 9.6 (SD 11.6); 29% abstinent days; 61%heavy drinking days; mean Obsessive Compulsive Drinking Scale (OCDS) scores were 17.6 (SD 7.1) and mean AUDIT scores were 24.2 (SD 8.0). 64%of monthly XR-NTX injections were received and 67%ofmonthly O-NTX refills were provided. The primary GCO across weeks 5-24 was reported by 29%XR-NTX and 23%O-NTX (p = 0.29). Mean months with a GCO was 2.9 XR-NTX, 2.5 O-NTX (p = 0.21). Rates of%days abstinent (70%XRNTX vs. 71%O-NTX; p = 0.77) and %heavy drinking days (20%XR-NTX vs. 16%O-NTX; p = 0.28) were similar weeks 1-24. Mean blood pressure decreased from 127/86 mmHg at baseline to 124/83 mmHg at week 25; there was no change in mean weight (180 lb) pre/post, and there were no differences in BP or weight changes by arm. Declines in OCDS scores (17.6 to 7.6) were similar by arm.
Conclusion(s): Initiation and retention on both forms of naltrexone was robust. Overall, participants reported improved longitudinal drinking outcomes. There was insufficient evidence of any differences in primary and secondary self-reported drinking outcomes between monthly XR-NTX and daily ONTX. Additional analysis will examine CDT and LFT levels during treatment, and interactions with OPMR1 genotype status
EMBASE:628239824
ISSN: 1530-0277
CID: 4024702

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care (XON)

Malone, Mia; McDonald, Ryan; Vittitow, Alexandria; Chen, Jenny; Obi, Rita; Schatz, Dan; Tofighi, Babak; Garment, Annie; Goldfeld, Keith; Gold, Heather; Laska, Eugene; Rotrosen, John; Lee, Joshua D
BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol®) and daily oral naltrexone tablets (O-NTX) are FDA-approved mu opioid receptor antagonist medications for alcohol dependence treatment. Despite the efficacy of O-NTX, non-adherence and poor treatment retention have limited its adoption into primary care. XR-NTX is a once-a-month injectable formulation that offers a potentially more effective treatment option in reducing alcohol consumption and heavy drinking episodes among persons with alcohol use disorders. METHODS:This pragmatic, open-label, randomized controlled trial examines the effectiveness of XR-NTX vs. O-NTX in producing a Good Clinical Outcome, defined as abstinence or moderate drinking (<2 drinks/day, men; <1 drink/day, women; and < 2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management treatment for alcohol dependence. Secondary aims will estimate the cost effectiveness of XR-NTX vs. O-NTX, in conjunction with primary-care based Medical Management for both groups, and patient-level characteristics associated with effectiveness in both arms. Alcohol dependent persons are recruited from the community into treatment in a New York City public hospital primary care setting (Bellevue Hospital Center) for 24 weeks of either XR-NTX (n = 117) or O-NTX (n = 120). RESULTS:We describe the rationale, specific aims, design, and recruitment results to date. Alternative design considerations and secondary aims and outcomes are reported. CONCLUSIONS:XR-NTX treatment in a primary care setting is potentially more efficacious, feasible, and cost-effective than oral naltrexone when treating community-dwelling persons with alcohol use disorders. This study will estimate XR-NTX's treatment and cost effectiveness relative to oral naltrexone.
PMID: 30986535
ISSN: 1559-2030
CID: 3810362

Use of online opioid overdose prevention training for first-year medical students: A comparative analysis of online versus in-person training

Berland, Noah; Lugassy, Daniel; Fox, Aaron; Goldfeld, Keith; Oh, So-Young; Tofighi, Babak; Hanley, Kathleen
PURPOSE/OBJECTIVE:In response to the opioid epidemic and efforts to expand substance use education in medical school, the authors introduced opioid overdose prevention training (OOPT) with naloxone for all first-year medical students (MS1s) as an adjunct to required basic life support training (BLST). The authors previously demonstrated improved knowledge and preparedness following in-person OOPT with BLST; however, it remains unclear whether online-administered OOPT would produce comparable results. In this study, the authors perform a retrospective comparison of online-administered OOPT with in-person-administered OOPT. OBJECTIVES/OBJECTIVE:To compare the educational outcomes: knowledge, preparedness, and attitudes, for online versus in-person OOPT. METHODS:In-person OOPT was administered in 2014 and 2015 during BLST, whereas online OOPT was administered in 2016 during BLST pre-work. MS1s completed pre- and post-training tests covering 3 measures: knowledge (11-point scale), attitudes (66-point scale), and preparedness (60-point scale) to respond to an opioid overdose. Online scores from 2016 and in-person scores from 2015 were compared across all 3 measures using analysis of covariance (ANCOVA) methods. RESULTS:After controlling for pre-test scores, there were statistical, but no meaningful, differences across all measures for in-person- and online-administered training. The estimated differences were knowledge: -0.05 (0.5%) points (95% confidence interval [CI]: -0.47, 0.36); attitudes: 0.65 (1.0%) points (95% CI: -0.22, 1.51); and preparedness: 2.16 (3.6%) points (95% CI: 1.04, 3.28). CONCLUSIONS:The educational outcomes of online-administered OOPT compared with in-person-administered OOPT were not meaningfully different. These results support the use of online-administered OOPT. As our study was retrospective, based on data collected over multiple years, further investigation is needed in a randomized controlled setting, to better understand the educational differences of in-person and online training. Further expanding OOPT to populations beyond medical students would further improve generalizability.
PMID: 30767715
ISSN: 1547-0164
CID: 3656442

Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness

Grudzen, Corita R; Shim, Deborah J; Schmucker, Abigail M; Cho, Jeanne; Goldfeld, Keith S
INTRODUCTION/BACKGROUND:Emergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement. METHODS AND ANALYSIS/UNASSIGNED:, or global initiative for chronic obstructive lung disease stage III, IV or oxygen-dependent chronic obstructive pulmonary disease); (2) speak English; (3) are scheduled for ED discharge or observation status; (4) reside locally; (5) have a working telephone and (6) are insured. Patients will be excluded if they: (1) have dementia; (2) have received hospice care or two or more palliative care visits in the last 6 months or (3) reside in a long-term care facility. We will use patient-level block randomisation, stratified by ED site and disease. Effectiveness will be compared by measuring the impact of each intervention on the specified outcomes. The primary outcome will measure change in patient quality of life. ETHICS AND DISSEMINATION/UNASSIGNED:Institutional Review Board approval was obtained at all study sites. Trial results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER/BACKGROUND:NCT03325985; Pre-results.
PMCID:6347856
PMID: 30813112
ISSN: 2044-6055
CID: 3698492

Utility of Using Cancer Registry Data to Identify Patients for Tobacco Treatment Trials

Krebs, Paul; Rogers, Erin; Greenspan, Amanda; Goldfeld, Keith; Lei, Lei; Ostroff, Jamie S; Garrett, Bridgette E; Momin, Behnoosh; Henley, S Jane
Background/UNASSIGNED:Many tobacco dependent cancer survivors continue to smoke after diagnosis and treatment. This study investigated the extent to which hospital-based cancer registries could be used to identify smokers in order to offer them assistance in quitting. The concordance of tobacco use coded in the registry was compared with tobacco use as coded in the accompanying Electronic Health Records (EHRs). Methods/UNASSIGNED:We gathered data from three hospital-based cancer registries in New York City during June 2014 to December 2016. For each patient identified as a current combustible tobacco user in the cancer registries, we abstracted tobacco use data from their EHR to independently code and corroborate smoking status. We calculated the proportion of current smokers, former smokers, and never smokers as indicated in the EHR for the hospitals, cancer site, cancer stage, and sex. We used a logistic regression model to estimate the log odds of the registry-based smoking status correctly predicting the EHR-based smoking status. Results/UNASSIGNED:Agreement in current smoking status between the registry-based smoking status and the EHR-based smoking status was 65%, 71%, and 90% at the three participating hospitals. Logistic regression results indicated that agreement in smoking status between the registry and the EHRs varied by hospital, cancer type, and stage, but not by age and sex. Conclusions/UNASSIGNED:The utility of using tobacco use data in cancer registries for population-based tobacco treatment interventions is dependent on multiple factors including accurate entry into EHR systems, updated data, and consistent smoking status definitions and registry coding protocols. Our study found that accuracy varied across the three hospitals and may not be able to inform interventions at these hospitals at this time. Several changes may be needed to improve the coding of tobacco use status in EHRs and registries.
PMCID:6993933
PMID: 32010425
ISSN: 1945-6123
CID: 4301212

Extended-release vs. oral naltrexone for alcohol dependence treatment in primary care [Meeting Abstract]

Malone, M; Vittitow, A; McDonald, R D; Tofighi, B; Garment, A; Schatz, D; Laska, E; Goldfeld, K; Rotrosen, J; Lee, J D
Aim: Naltrexone is first-line pharmacotherapy for alcohol use disorders (AUD). Oral naltrexone (ONTX) is under-prescribed in primary care and possibly limited by poor adherence. Monthly injectable extended-release naltrexone (XR-NTX) may improve rates of medication adherence, retention, good clinical outcomes (Aim 1), and cost savings (Aim 2). Methods: This is an on-going randomized, open-label, comparative effectiveness trial of 24 weeks of XR-NTX vs. O-NTX as AUD treatment in primary care at a public hospital in New York City. Adults (>18 yo) with a DSM-V diagnosis of AUD randomized to XR-NTX (380 mg/month) vs. O-NTX (50-100 mg/day).Medical Management visits occur biweekly (weeks 1-8), then monthly.Major research assessments occur at baseline, weeks 13, 25, 48. The primary outcome is a Good Clinical Outcome (GCO) across weeks 5-24: abstinence or moderate drinking and 0-2 days of heavy drinking per month. This preliminary, descriptive analysis presentsWeek 0-5 results among all participants. Results: N = 237 participants were randomized from 6/14-9/17: mean age 48.5 (SD = 10.6); 71% male; 54% AA, 21%Hispanic; 41% employed, 81%reported other lifetime substance use. Mean AUDIT scores (instrument range 0-40) at baseline: 24.2 (SD = 8.0); mean OCDS (range 0-40) scores 17.1 (SD = 8.1); mean drinks/day 9.6 (SD = 11.6) with 29%abstinent vs. 61% heavy drinking days. Medication induction was robust, 115 of 117 (98.2%) initiating XR-NTX and 120 (100%) filled or received an initial O-NTX prescription. The GCO was reported by 41%XR-NTX and 47%ONTX atWeek 5. DuringWeek 1-5, mean drinks/day were 3.1 (SD = 6.1), 63% abstinent/22%heavy drinking days for XR-NTX; 2.4 (SD = 4.03), 61%abstinent/22%heavy drinking days for O-NTX. 62%received XR-NTX injection #2 and 67%received O-NTXmonthly refill #2. Adherence self-report for O-NTX at Week 5 indicated moderate average daily adherence,MMAS-8 mean (range <6 low, 6 to <8 moderate, =8 high) score 6.13 (SD = 3.02). Conclusion: This on-going XR vs. oral naltrexone alcohol primary care treatment trial recruited a primarily male, unemployed, ethnic minority adult population. Initial acceptance of both XR and ONTX was high. Primary outcomes will focus on drinking reductions and cost and value comparisons during weeks 5-24
EMBASE:622675985
ISSN: 1530-0277
CID: 3193762

Protocol for project IMPACT (improving millions hearts for provider and community transformation): a quasi-experimental evaluation of an integrated electronic health record and community health worker intervention study to improve hypertension management among South Asian patients

Lopez, Priscilla M; Zanowiak, Jennifer; Goldfeld, Keith; Wyka, Katarzyna; Masoud, Ahmad; Beane, Susan; Kumar, Rashi; Laughlin, Phoebe; Trinh-Shevrin, Chau; Thorpe, Lorna; Islam, Nadia
BACKGROUND:The Million Hearts® initiative aims to prevent heart disease and stroke in the United States by mobilizing public and private sectors around a core set of objectives, with particular attention on improving blood pressure control. South Asians in particular have disproportionately high rates of hypertension and face numerous cultural, linguistic, and social barriers to accessing healthcare. Interventions utilizing Health information technology (HIT) and community health worker (CHW)-led patient coaching have each been demonstrated to be effective at advancing Million Hearts® goals, yet few studies have investigated the potential impact of integrating these strategies into a clinical-community linkage initiative. Building upon this initiative, we present the protocol and preliminary results of a research study, Project IMPACT, designed to fill this gap in knowledge. METHODS:Project IMPACT is a stepped wedge quasi-experimental study designed to test the feasibility, adoption, and impact of integrating CHW-led health coaching with electronic health record (EHR)-based interventions to improve hypertension control among South Asian patients in New York City primary care practices. EHR intervention components include the training and implementation of hypertension-specific registry reports, alerts, and order sets. Fidelity to the EHR intervention is assessed by collecting the type, frequency, and utilization of intervention components for each practice. CHW intervention components consist of health coaching sessions on hypertension and related risk factors for uncontrolled hypertensive patients. The outcome, hypertension control (<140 mmHg systolic blood pressure (BP) and <90 mmHg diastolic BP), is collected at the aggregate- and individual-level for all 16 clinical practices enrolled. DISCUSSION/CONCLUSIONS:Project IMPACT builds upon the evidence base of the effectiveness of CHW and Million Hearts® initiatives and proposes a unique integration of provider-based EHR and community-based CHW interventions. The project informs the effectiveness of these interventions in team-based care approaches, thereby, helping to develop relevant sustainability strategies for improving hypertension control among targeted racial/ethnic minority populations at small primary care practices. TRIAL REGISTRATION/BACKGROUND:This study protocol has been approved and is made available on Clinicaltrials.gov by NCT03159533 as of May 17, 2017.
PMCID:5717844
PMID: 29207983
ISSN: 1472-6963
CID: 2838402