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Building a National Program for Pilot Studies of Embedded Pragmatic Clinical Trials in Dementia Care

Brody, Abraham A; Barnes, Deborah E; Chodosh, Joshua; Galvin, James E; Hepburn, Kenneth W; Troxel, Andrea B; Hom, Kimberly; McCarthy, Ellen P; Unroe, Kathleen T
Sixteen million caregivers currently provide care to more than 5 million persons living with dementia (PLWD) in the United States. Although this population is growing and highly complex, evidence-based management remains poorly integrated within healthcare systems. Therefore, the National Institute on Aging IMPACT Collaboratory was formed to build the nation's ability to conduct embedded pragmatic clinical trials (ePCTs) for PLWD and their caregivers. The pilot core of the IMPACT Collaboratory seeks to provide funds for upward of 40 pilots for ePCTs to accelerate the testing of nonpharmacologic interventions with the goal that these pilots lead to full-scale ePCTs and eventually the embedding of evidence-based care into healthcare systems. The first two challenges for the pilot core in building the pilot study program were (1) to develop a transparent, ethical, and open nationwide process for soliciting, reviewing, and selecting pilot studies; and (2) to begin the process of describing the necessary components of a pilot study for an ePCT. During our initial funding cycle, we received 35 letters of intent, of which 17 were accepted for a full proposal and 14 were submitted. From this process we learned that investigators lack knowledge in ePCTs, many interventions lack readiness for an ePCT pilot study, and many proposed studies lack key pragmatic design elements. We therefore have set three key criteria that future pilot studies must meet at a minimum to be considered viable. We additionally discuss key design decisions investigators should consider in designing a pilot study for an ePCT. J Am Geriatr Soc 68:S14-S20, 2020.
PMID: 32589282
ISSN: 1532-5415
CID: 4493662

Drug checking to detect fentanyl and new psychoactive substances

Palamar, Joseph J; Salomone, Alberto; Barratt, Monica J
PURPOSE OF REVIEW/OBJECTIVE:Drug checking services invite drug consumers to anonymously submit drug samples for chemical analysis and provide feedback of results. Drugs are tested for strength/dose and/or presence of adulterants. Drug checking appears to be more common in recent years in response to increases in fentanyl-related deaths and the proliferation of new psychoactive substances (NPS). We aim to provide information regarding the current state of drug checking in relation to analysis methods, adulteration rates, and behavioral responses to results. RECENT FINDINGS/RESULTS:Various technologies are being used to detect the presence of fentanyl, its analogs, and other NPS in drug samples. Proxy drug checking, which we define as biospecimen testing for drug exposure postconsumption, is also becoming common. However, there appears to a dichotomy between research focusing on populations at high risk for fentanyl exposure and to exposure to NPS such as synthetic cathinones. SUMMARY/CONCLUSIONS:Drug checking research and services largely focus on opioid consumers and nightclub and dance festival attendees, but more focus may be needed on the general population. Drug checking results can inform surveillance efforts, and more research is needed to overcome barriers to drug checking and to focus on whether test results indeed affect behavior change.
PMCID:7255931
PMID: 32187173
ISSN: 1473-6578
CID: 4510212

Responding to the Needs of Early Career Physicians and Fellows in Headache Medicine: Career Planning, Getting Involved, and Considerations in Building a Headache Center

Minen, Mia T; Wells, Rebecca E; Gautreaux, Jessica R; Szperka, Christina L; Rayhill, Melissa; Orlova, Yulia; Metzler, Abby; Halpern, Audrey; Monteith, Teshamae
PMID: 32476142
ISSN: 1526-4610
CID: 4482092

Tissue Plasminogen Activator (tPA) Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Case Series [Case Report]

Wang, Janice; Hajizadeh, Negin; Moore, Ernest E; McIntyre, Robert C; Moore, Peter K; Veress, Livia A; Yaffe, Michael B; Moore, Hunter B; Barrett, Christopher D
A hallmark of severe COVID-19 is coagulopathy, with 71.4% of patients who die of COVID-19 meeting ISTH criteria for disseminated intravascular coagulation (DIC) while only 0.6% of patients who survive meet these criteria (1). Additionally, it has become clear that this is not a bleeding diathesis but rather a predominantly pro-thrombotic DIC with high venous thromboembolism rates, elevated D-dimer levels, high fibrinogen levels in concert with low anti-thrombin levels, and pulmonary congestion with microvascular thrombosis and occlusion on pathology in addition to mounting experience with high rates of central line thrombosis and vascular occlusive events (e.g. ischemic limbs, strokes, etc.) observed by those who care for critically ill COVID-19 patients (1-7). There is evidence in both animals and humans that fibrinolytic therapy in Acute Lung Injury and ARDS improves survival, which also points to fibrin deposition in the pulmonary microvasculature as a contributory cause of ARDS and would be expected to be seen in patients with ARDS and concomitant diagnoses of DIC on their laboratory values such as what is observed in more than 70% of those who die of COVID-19 (8-10).
PMID: 32267998
ISSN: 1538-7836
CID: 4377472

Racial disparities and online health information: YouTube and prostate cancer clinical trials

Borno, Hala T; Zhang, Sylvia; Bakke, Brian; Bell, Alexander; Zuniga, Kyle B; Li, Patricia; Chao, Kelly; Sabol, Alexis; Killeen, Trevor; Hong, Haemin; Walter, Dawn; Loeb, Stacy
PMID: 32275800
ISSN: 1464-410x
CID: 4486002

Effects of Home Particulate Air Filtration on Blood Pressure: A Systematic Review

Walzer, Dalia; Gordon, Terry; Thorpe, Lorna; Thurston, George; Xia, Yuhe; Zhong, Hua; Roberts, Timothy R; Hochman, Judith S; Newman, Jonathan D
Air pollution is a major contributor to cardiovascular morbidity and mortality. Fine particulate matter <2.5 µm in diameter may be a modifiable risk factor for hypertension. The benefits of in-home air filtration on systolic blood pressure (BP) and diastolic BP are unclear. To examine the effects of in-home personal air cleaner use on fine particulate exposure and BP, we queried PubMed, Web of Science, Cochrane Central Register, Inspec, and EBSCO GreenFILE databases for relevant clinical trials. Included studies were limited to nonsmoking participants in smoke-free homes with active or sham filtration on indoor fine particulate concentrations and changes in systolic and diastolic BP. Of 330 articles identified, 10 trials enrolling 604 participants who met inclusion criteria were considered. Over a median 13.5 days, there was a significant reduction of mean systolic BP by ≈4 mm Hg (-3.94 mm Hg [95% CI, -7.00 to -0.89]; P=0.01) but a nonsignificant difference in mean diastolic BP (-0.95 mm Hg [95% CI, -2.81 to 0.91]; P=0.32). Subgroup analyses indicated no heterogeneity of effect by age, level of particulate exposure, or study duration. Given the variation in study design, additional study is warranted to confirm and better quantify the observed benefits in systolic BP found with personal air cleaner use.
PMCID:7289680
PMID: 32475316
ISSN: 1524-4563
CID: 4476662

Concordance and Performance of 4Kscore® and SelectMDx® for Informing Decision to Perform Prostate Biopsy and Detection of Prostate Cancer

Wysock, James Steven; Becher, Ezequiel; Persily, Jesse; Loeb, Stacy; Lepor, Herbert
OBJECTIVES/OBJECTIVE:To compare both the concordance between the 4Kscore® and SelectMDx® for informing decision to perform prostate biopsy (PB) and the performance of these tests for detecting clinically significant prostate cancer (csPCa). Several biomarkers were developed to inform decisions whether to perform a PB based on the probability of detecting csPCa. There is a paucity of studies directly comparing them METHODS: Between 11/2018 and 4/2019, all new referrals with the diagnosis of elevated PSA were advised to undergo 4Kscore® and SelectMDx® in order to guide the selection of candidates for PB. Men were advised to undergo PB if the reported biomarker risk for detecting csPCA was ≥7.5%, or if they presented a PI-RADS ≥1 MRI. Cohen's Kappa was used to assess the concordance between the binary 4Kscore® and SelectMDx® results using externally validated cutoffs of 7.5% and 12%. Receiver operating characteristics curve and area under the curve (AUC) assessed the performance of each biomarker for predicting csPCa. RESULTS:Of 128 consecutive patients referred, 114 (89.1%) underwent 4Kscore® and SelectMDx®, The kappa coefficient between the biomarkers using the 7.5% cutoff was 0.184 (poor concordance) and 0.22 using the 12% cutoff. The two biomarkers yielded discordant guidance whether to proceed with PB in 46% and 38% of cases, respectively. csPCa was found in 22 of the 50 patients who underwent PB (44%). The AUC for 4Kscore® and SelectMDx® was 0.830 (95%CI: 0.710 - 0.949) and 0.672 (95%CI: 0.517 - 0.828) (p=0.036), respectively. CONCLUSION/CONCLUSIONS:The discordance observed between the 4Kscore® and SelectMDx® is disconcerting. The 4Kscore® when combined with MRI was superior to the SelectMDx® for detecting csPCa. Prospective comparative studies must be performed to optimize implementation of biomarkers for selecting candidates for PB.
PMID: 32294481
ISSN: 1527-9995
CID: 4383542

Social determinants of health in a federally qualified health center: Screening, identification of needs, and documentation of Z codes [Meeting Abstract]

Sharif, I; Norton, J; Anderman, J H; Dapkins, I
BACKGROUND: Payors are increasingly recognizing that social determinants of health(SDH) impact on health outcomes and healthcare costs. Z codes can be used to document and stratify patients into risk pools according to SDH. We report on the impact of SDH screening implementation in a federally qualified health center network on the use of Z codes to document SDH. In this study, we describe the prevalence of SDH screening by department, the prevalence of documented SDH, and the prevalence of documented Z codes for each SDH.
METHOD(S): In October 2017, we initiated SDH screening throughout, but focusing on the internal medicine and women's health departments of a large FQHC network (12 service delivery sites) using the OCHIN tool embedded in the elecrtonic health record. In November 2019, we retrieved the following variables from record: % of all patients who were screened, number of patients screened annually by department, % of positive screens (+ response to any question), % abnormal screens(response that triggers a best practice alert to the treating provider), and documentation of a Z code for positive or abnormal screens.
RESULT(S): There were 624,007 encounters over a 2 year study period; 2,844 patients were screened: 194 in 2017, 1068 in 2018;1644 in 2019. Overall, there were 3052 screening events (some patients received multiple screens). The majority of screening events occurred in women's health [1961(64%)], followed by adult medicine[874(29%)]. Overall, 2350(77%) of screens were "positive", of which 433 had no "abnormal" results and hence did not trigger a best practice alert. Of these 433, the most common positive items were: social isolation(63%), stress(44%), financial resource strain(8%), moved 2+ times(7%). There were 1923(63%) abnormal screens. The top 10 abnormal items in Women's Health and Adult Medicine were: Education less than high school(36% and 37%), physical activity <140 minutes(23% and 25%), hard to pay for medicine/medical care(13% and 26%), hard to pay for utilities(14% and 23%), hard to pay for food(13% and 21%), hard to pay for health insurance(11% and 22%), concerns about housing quality(3% and 9%), hard to pay child care(5% and 5%), exposure to violence(4% and 3%), never get together with family/friends(3% and 3%). Overall, encounters with an SDH screen were more likely to have a documented Z code:26% vs. 1%. Z codes were documented for the following documented needs: insufficient social insurance(53%); lack of access to health care(51%), homelessness(49%), inadequate family support(40%), lack of physical exercise(37%), underachievement in school(34%), personal history of abuse(31%), lack of assistance for care at home(29%), inadequate food supply(1%).
CONCLUSION(S): Presence of a documented SDH screen was associated with documentation of Z codes, however documentation was missing more than half the time for most documented needs. The drivers of Z code documentation deserve further exploration. Qualitative interviews and focus groups with providers may be useful
EMBASE:633957350
ISSN: 1525-1497
CID: 4805302

Disparities in HIV testing rates: Does predominant clinic racial/ethnic population play a role? [Meeting Abstract]

Twito, V; Schubert, F D; Bhat, S; Dapkins, I
BACKGROUND: Race, ethnicity, and language have been identified as factors impacting uptake of HIV testing. This project sought to compare testing rates between predominant and non-predominant ethnic, racial, or language populations within neighborhood FQHCs.
METHOD(S): We identified Family Health Center network locations at which more than 50% of patients served identified as the same race, and/ or had the same preferred language, and focused our analysis on these sites. We used Excel and SPSS to compare HIV testing rates between predominant and non-predominant population groups at each clinic.
RESULT(S): At 2 of 5 sites with a predominant non-English preferred language, speakers of the predominant language were more likely to receive an HIV test than speakers of other languages (p<0.001 for both sites). The other sites showed no difference by language. Of 2 clinics with a predominant racial population, there was no difference between predominant and non-predominant populations in terms of HIV testing. At all included sites, with one exception, Hispanic ethnicity was associated with a significantly higher rate of HIV testing.
CONCLUSION(S): Predominant/non-predominant race did not affect HIV testing rates, but language and ethnicity did. One mechanism for this may be increased trust associated with patient-provider language concordance, resulting in greater uptake of tests. There is a need for future research to further explore the factors associated with these findings
EMBASE:633956015
ISSN: 1525-1497
CID: 4805312

Correlates of patient portal activation and use in a federally qualified health center network [Meeting Abstract]

Sharif, I; Anderman, J H; Pina, P; Pilao, R; Colella, D; Dapkins, I
BACKGROUND: Patient Portals(PP) allow access to medical records and interaction with providers; however activation(PPA) and use (PPU) are limited by language barriers, low health/computer literacy, and poor internet access which are prevalent issues in Federally Qualified Health Centers(FQHC). Little is known of the drivers and patterns of PPA in such settings. We aimed to describe the prevalence of PPA and PPU in adult patients of an FQHC; describe PPU activity, and test demographic, condition, and utilization-related correlates of PPA and PPU.
METHOD(S):We conducted a retrospective chart review in an FQHC that launched a PP in September 2016. We extracted demographics, PPA status(active/not) at data pull, PPU activities, presence of a chronic condition on the problem list, # emergency department, inpatient, subspecialty visits over past year (utilization summed, dichotomized >1 vs. 0-1 visit). Missing values for homelessness were coded to majority category( 0). Analyses included descriptive statistics, bivariate analyses, then logistic regression to test odds of PPA and PPU by. demographics, chronic conditions, and utilization. We report [adjusted odds ratios(confidence interval)].
RESULT(S): Data were analyzed for 62,610 adults [mean age 45(SD 17), 21% Black, 47% Hispanic, 46% Medicaid, 25% Selfpay, speaking English( 60%), Spanish (31%), Chinese(6%), Other(3%), with: hypertension( 19%), diabetes(11%), depression(8%), asthma(6%), CVD(5%); 21% had utilization>1. Overall 23,104(37%) activated the PP. PPU included viewing test results(69%), medications(62% ), immunizations( 51%), billing (38%), asking advice (29%), and scheduling appointments( 16%). PPA and PPU varied by demographics, chronic condition, and utilization, but were consistently higher for females, those who were not Medicaid recipients or Self-pay, English speakers and those with asthma, hypertension, and depression.
CONCLUSION(S): PPA was lower for non-whites and poorer patients, but higher for patients speaking the predominant languages of this FQHC, suggesting that language concordance helps engage patients. Patients with chronic conditions and more healthcare utilization had greater odds of PPA and PPU. On the other hand, Spanish-speakers were less likely to actively use the portal for functions such as scheduling appointments, suggesting that improvements in language capabilities of the platform are needed
EMBASE:633955778
ISSN: 1525-1497
CID: 4805322