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Development and performance of a point-of-care rapid antigen test for detection of SARS-COV-2 variants

Liu, Lihong; Meyers, Kathrine; Purpura, Lawrence J; Nguyen, Nadia; Mohri, Hiroshi; Chang, Jennifer Y; Annavajhala, Medini K; Lopez, Leo; Lee, Sang Won; Shah, Jayesh; Lane, Benjamin; Cantos, Anyelina; Tukuru, Sade A; Guo, Yicheng; Ford, Kenra; Chiu, Yueh-Ting; Sheng, Zizhang; Choesang, Tenzin; Castor, Delivette; Wang, Maple; Pili, Christina; Van Hoy, Michael N; Wallach, Andrew; Horton, Jamie; Chen, Zhiqiang; Rosenthal, Susan; McLaren, Son; Jiang, Baowei; Wang, Frank; Lu, Helen H; Uhlemann, Anne-Catrin; Ho, David D; Yin, Michael T
Background/UNASSIGNED:SARS-CoV-2 antigen-based tests are well-calibrated to infectiousness and have a critical role to play in the COVID-19 public health response. We report the development and performance of a unique lateral flow immunoassay (LFA). Methods/UNASSIGNED:Combinations of several monoclonal antibodies targeting multiple antigenic sites on the SARS-CoV-2 nucleocapsid protein (NP) were isolated, evaluated, and chosen for the development of a LFA termed CoV-SCAN (BioMedomics, Inc.). Clinical point-of-care studies in symptomatic and asymptomatic individuals were conducted to evaluate positive predictive agreement (PPA) and negative predictive agreement (NPA) with RT-PCR as comparator. Results/UNASSIGNED:In laboratory testing, CoV-SCAN detected 14 recombinant N-proteins of SARS-CoV-2 variants with sensitivity in the range of 0.2-3.2 ng/mL, and 10 authentic SARS-CoV-2 variants with sensitivity in the range of 1.6-12.5 TCID50/swab. No cross reactivity was observed with other human coronaviruses or other respiratory pathogens. In clinical point-of-care testing on 148 individuals over age 2 with symptoms of ≤5 days, PPA was 87.2% (CI 95: 78.3-94.8%) and NPA was 100% (CI 95: 94.2-100%). In another 884 asymptomatic individuals, PPA was 85.7% (CI 95: 42.1-99.6%) and 99.7% (99.0-99.9%). Overall, CoV-SCAN detected over 97.2% of specimens with CT values <30 and 93.8% of nasal swab specimens with the Omicron variant, even within the first 2 days after symptom onset. Conclusions/UNASSIGNED:The unique construction of CoV-SCAN using two pairs of monoclonal antibodies has resulted in a test with high performance that remains durable across multiple variants in both laboratory and clinical evaluations. CoV-SCAN should identify almost all individuals harboring infectious SARS-CoV-2. Summary/UNASSIGNED:Unique construction of a point-of-care rapid antigen test using two pairs of monoclonal antibodies has led to good performance that remained durable across multiple variants in laboratory and clinical evaluations. Test should identify almost all individuals harboring infectious SARS-CoV-2.
PMCID:9067019
PMID: 35528048
ISSN: 2667-0380
CID: 5214042

The Telemedicine Takeover: Lessons Learned During an Emerging Pandemic

Wilhite, Jeffrey A; Altshuler, Lisa; Fisher, Harriet; Gillespie, Colleen; Hanley, Kathleen; Goldberg, Eric; Wallach, Andrew; Zabar, Sondra
PMID: 34115538
ISSN: 1556-3669
CID: 5183192

Outcomes of 4Ms Assessments during Early Phase of Adoption at an Urban Safety Net Primary Care Geriatrics Clinic [Meeting Abstract]

Khanna, P; Nemytova, E; Ajmal, S; Wallach, A B; Chodosh, J; Ouedraogo, Tall S
Background: We recently implemented the Age-Friendly Health System's 4Ms (What Matters, Medication, Mentation, and Mobility) framework in New York City Health + Hospitals/Bellevue Hospital Center's Geriatrics clinic to improve care of older adults.
Method(s): We examined the impact of 4Ms assessment on patient care and changes in care processes through specific interventions triggered after assessment. We conducted chart reviews of patient visits during March 2021, the first month of 4Ms implementation and identified interventions made during these visits. To assess "What Matters" providers asked "What Matters the most to you;" potentially inappropriate Medications (PIM) were identified using the Beers list; Mentation was evaluated using the Mini-Cog; and Mobility was determined using timed up and go (TUG) test. We used descriptive statistics to characterize findings.
Result(s): Among the 121 patients who had 4Ms assessment in March 2021, 85% (n=103) were asked "What Matters;" providers reviewed Medications for almost all (n=118; 98%) and conducted a Mini-Cog for 64% (n=78). Most not cognitively assessed were either previously screened (n=11; 9%) or had dementia (n=12; 10%). Providers used the TUG test for 87% (n=105). What Mattered to patients most commonly was "getting better" (n=24; 23%). There were 39 (33%) patients with potentially inappropriate Medications (including proton pump inhibitors, gabapentinoids, and NSAIDS) of which 10 (26%) Medications were either discontinued or reduced. Other interventions included further cognitive evaluation (n=2) and home care referrals (n=2) among 14 (18%) with an abnormal Mini- Cog. Among the 51 (42%) patients with an abnormal TUG, providers intervened for 19 (37%) with devices, referrals or home services.
Conclusion(s): The adoption of 4Ms assessment during routine visits identified issues with Medications, Mentation and Mobility, triggering several interventions for common geriatric conditions. 4Ms assessment is a helpful strategy to organize geriatric care, routinely assess patients for common geriatric syndromes, and improve care. Future directions include prioritizing interventions integrated with "What Matters" to maintain patient-centered care
EMBASE:637954694
ISSN: 1531-5487
CID: 5252382

Association of eConsult Implementation With Access to Specialist Care in a Large Urban Safety-Net System

Gaye, Marema; Mehrotra, Ateev; Byrnes-Enoch, Hannah; Chokshi, Dave; Wallach, Andrew; Rodriguez, Laura; Barnett, Michael L
Importance:Accessing specialty care continues to be a persistent problem for patients who use safety-net health systems. To address this access barrier, hospital systems have begun to implement electronic referral systems using eConsults, which allow clinicians to submit referral requests to specialty clinics electronically and enable specialty reviewers to resolve referrals, if appropriate, through electronic dialogue without an in-person visit. Objective:Measure the effect of implementing an eConsult program on access to specialty care. Design Setting and Participants:Using an interrupted time series design with data from 2016 to 2020, this study analyzed 50 260 referral requests submitted during the year before and the year after eConsult implementation at 19 New York City Health + Hospitals (NYC H+H) specialty clinics that spanned 7 NYC H+H hospital facilities and 6 unique specialties. Exposures:Referral request was submitted to a specialty clinic in the year following eConsult implementation. Main Outcomes and Measures:Main outcomes included the fraction of referral requests resolved without an in-person visit following eConsult implementation; and, among requests triaged to have an in-person visit, the fraction of referrals with a successfully scheduled appointment, mean wait time to a specialty appointment, and the fraction of referral requests with a completed specialty visit. Changes associated with eConsult implementation were estimated using multivariate linear regression adjusting for patient age, gender, and specialty clinic fixed effects. Results: = .07). Changes in outcomes were mitigated during months when most clinics underwent an electronic health record transition after implementing eConsult. Conclusions and Relevance:In this quality improvement study, implementation of eConsults at a large multi-specialty safety-net system was associated with improvements in appointment scheduling rates and wait times. Despite an additional electronic health record transition, eConsults are a promising health care delivery tool for increasing access to specialty care.
PMCID:8796905
PMID: 35977310
ISSN: 2689-0186
CID: 5336792

Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting

Applegate, Melanie; Scott, Ebony; Taksler, Glen B; Sanchez, Mirtala; Duong, Nguyet; Mark, Laurie; Caniglia, Ellen; Wallach, Andrew; Braithwaite, R Scott
BACKGROUND:Evidence-based preventive care in the USA is underutilized, diminishing population health and worsening health disparities. We developed Project ACTIVE, a program to improve adherence with preventive care goals through personalized and patient-centered care. OBJECTIVE:To determine whether Project ACTIVE improved utilization of preventive care and/or estimated life expectancy compared to usual care. DESIGN/METHODS:Single-site randomized controlled trial. PARTICIPANTS/METHODS:Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations. INTERVENTION/METHODS:Project ACTIVE employs a validated mathematical model to predict and rank individualized estimates of health benefit that would arise from improved adherence to different preventive care guidelines. Clinical staff engaged the participant in a shared medical decision-making (SMD) process to identify highest priority unfulfilled clinical goals, and health coaching staff engaged the participant to develop and monitor action steps to reach those goals. MAIN MEASURES/METHODS:Change in number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy. KEY RESULTS/RESULTS:In an intent-to-treat analysis, Project ACTIVE increased the average number of fulfilled preventive care goals out of 12 by 0.68 in the intervention arm compared with 0.15 in the control arm (mean difference [95% CI] 0.53 [0.19-0.86]), yielding a gain in estimated life expectancy of 8.8 months (3.8, 14.2). In a per-protocol analysis, Project ACTIVE increased fulfilled preventive care goals by 0.80 in the intervention arm compared with 0.16 in the control arm (mean difference [95% CI], 0.65 [0.25-1.04]), yielding a gain in estimated life expectancy of 13.7 months (6.2, 21.2). Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking. CONCLUSIONS:Project ACTIVE improved unfulfilled preventive care goals and improved estimated life expectancy. CLINICAL TRIAL REGISTRATION NUMBER/BACKGROUND:NCT04211883.
PMID: 33443695
ISSN: 1525-1497
CID: 4747142

Supporting a learning healthcare system-using an ongoing unannounced standardized patient program to continuously improve primary care resident education, team training, and healthcare quality [Meeting Abstract]

Gillespie, C; Wilhite, J; Hardowar, K; Fisher, H; Hanley, K; Altshuler, L; Wallach, A; Porter, B; Zabar, S
STATEMENT OF PROBLEM OR QUESTION (ONE SENTENCE): In order to describe quality improvement (QI) methods for health systems, we report on 10-years of using Unannounced Standardized Patient (USP) visits as the core of a program of education, training, and improvement in a system serving vulnerable patients in partnership with an academic medical center. LEARNING OBJECTIVES 1: Consider methods for supporting learning healthcare systems LEARNING OBJECTIVES 2: Identify performance data to improve care DESCRIPTION OF PROGRAM/INTERVENTION, INCLUDING ORGANIZATIONAL CONTEXT (E.G. INPATIENT VS. OUTPATIENT, PRACTICE OR COMMUNITY CHARACTERISTICS): The IOM defines a Learning Healthcare System (LHCS) as one in which science, informatics, incentives and culture are aligned for continuous improvement and innovation and where best practices are seamlessly embedded in the delivery process and new knowledge is captured as an integral by-product of the delivery experience. As essential as electronic health records are to LHCS, such data fail to capture all actionable information needed to sustain learning within complex systems. USPs are trained actors who present to clinics, incognito, to portray standardized chief complaints, histories, and characteristics. We designed and delivered USP visits to two urban, safety net clinics, focusing on assessing physician, team, and clinical micro system functioning. MEASURES OF SUCCESS (DISCUSS QUALITATIVE AND/OR QUANTITATIVEMETRICSWHICHWILL BE USEDTOEVALUATE PROGRAM/INTERVENTION): Behaviorally anchored assessments are used to assess core clinical skills (e.g., communication, information gathering, patient education, adherence to guidelines, patient centeredness, and patient activation). Team functioning assessments include professionalism and coordination. Micro system assessment focuses on safety issues like identity confirmation, hand washing, and navigation. Data from these visits has been provided to the residency, primary care teams, and to leadership and have been used to drive education, team training, and QI. FINDINGS TO DATE (IT IS NOT SUFFICIENT TO STATE FINDINGS WILL BE DISCUSSED): 1111 visits have been sent to internal medicine and primary care residents and their teams/clinics. At the resident level, needs for additional education and training in depression management, opioid prescribing, smoking cessation, and patient activation were identified and informed education. Chart reviews found substantial variation in ordering of labs and tests. At the team level, USPs uncovered needs for staff training, enhanced communication, and better processes for eliciting and documenting Social Determinants of Health (SDoH). Audit/feedback reports on provider responses to embedded SDoH combined with targeted education/resources, were associated with increased rates of eliciting and effectively responding to SDoH. In the early COVID wave, USPs tested clinic response to a potentially infectious patient. Currently, USPs are being deployed to understand variability in patients' experience of telemedicine given the rapid transformation to this modality. Finally, generalizable questions about underlying principles of medical education and quality improvement are being asked & answered using USP data to foster deeper understanding of levers for change. KEY LESSONS FOR DISSEMINATION (WHAT CAN OTHERS TAKE AWAY FOR IMPLEMENTATION TO THEIR PRACTICE OR COMMUNITY): A comprehensive USP program can provide unique insights for driving QI and innovation and help sustain a LHCS
EMBASE:635796917
ISSN: 1525-1497
CID: 4984892

Internal medicine tele-takeover: Lessons learned from the emerging pandemic [Meeting Abstract]

Wilhite, J; Altshuler, L; Fisher, H; Gillespie, C; Hanley, K; Goldberg, E; Wallach, A; Zabar, S
BACKGROUND: Healthcare systems rose to the challenges of COVID-19 by creating or expanding telehealth programs to ensure that patients could access care from home. Traditionally, though, physicians receive limited formal telemedicine training, which made preparedness for this transition uneven. We designed a survey for General Internal Medicine (GIM) physicians within our diverse health system to describe experiences with providing virtual patient care; with the ultimate goal of identifying actionable recommendations for health system leaders and medical educators.
METHOD(S): Surveys were sent to all faculty outpatient GIM physicians working at NYU Langone Health, NYC Health + Hospitals/Bellevue and Gouverneur, and the VA NY Harbor Health System (n=378) in May & June of 2020. Survey items consisted of Likert and open-ended questions on experience with televisits (13 items) and attitudes toward care (24 items). Specific questions covered barriers to communication over remote modalities.
RESULT(S): 195/378 (52%) responded to the survey. 96% of providers reported having problems establishing a connection from the patient's end while 84% reported difficultly establishing connection on the provider's end. Using interpreter services over the phone was also problematic for providers, with 38% reporting troubles. Regarding teamness, 35% of physicians found it difficult to share information with healthcare team members during virtual visits and 42% found it difficult to work collaboratively with team members, both when compared to in-person visits. When subdivided, 24% of private and 40% of public providers found info sharing more difficult (p<0.04). 31% of private providers and 45% of public found team collaboration more difficult (ns). Physicians also identified challenges in several domains including physical exams (97%), establishing relationships with new patients (74%), taking a good history (48%), and educating patients (35%). In thematic analysis of open-ended comments, themes emerged related to technological challenges, new systems issues, and new patient/provider communication experiences. Positives noted by physicians included easier communication with patients who often struggle with keeping in-person appointments, easier remote monitoring, and a more thorough understanding of patients' home lives.
CONCLUSION(S): Provider experience differences were rooted in the type of technology employed. Safety-net physicians conducted mostly telephonic visits while private outpatient physicians utilized video visits, despite both using the same brand of electronic medical record system. As we consider a new normal and prolonged community transmission of COVID-19, it is essential to establish telemedicine training, tools, and protocols that meet the needs of both patients and physicians across diverse settings. LEARNING OBJECTIVE #1: Describe challenges and barriers to effective communication and clinical skill utilization during televisits LEARNING OBJECTIVE #2: Conceptualize recommendations for educational curricula and health service improvement areas
EMBASE:635796421
ISSN: 1525-1497
CID: 4985022

Clinical problem solving and social determinants of health: a descriptive study using unannounced standardized patients to directly observe how resident physicians respond to social determinants of health

Wilhite, Jeffrey A; Hardowar, Khemraj; Fisher, Harriet; Porter, Barbara; Wallach, Andrew B; Altshuler, Lisa; Hanley, Kathleen; Zabar, Sondra R; Gillespie, Colleen C
PMID: 33108337
ISSN: 2194-802x
CID: 4775402

Clinical problem solving and social determinants of health: a descriptive study using unannounced standardized patients to directly observe how resident physicians respond to social determinants of health

Wilhite, Jeffrey A; Hardowar, Khemraj; Fisher, Harriet; Porter, Barbara; Wallach, Andrew B; Altshuler, Lisa; Hanley, Kathleen; Zabar, Sondra R; Gillespie, Colleen C
Objectives While the need to address patients' social determinants of health (SDoH) is widely recognized, less is known about physicians' actual clinical problem-solving when it comes to SDoH. Do physicians include SDoH in their assessment strategy? Are SDoH incorporated into their diagnostic thinking and if so, do they document as part of their clinical reasoning? And do physicians directly address SDoH in their "solution" (treatment plan)? Methods We used Unannounced Standardized Patients (USPs) to assess internal medicine residents' clinical problem solving in response to a patient with asthma exacerbation and concern that her moldy apartment is contributing to symptoms - a case designed to represent a clear and direct link between a social determinant and patient health. Residents' clinical practices were assessed through a post-visit checklist and systematic chart review. Patterns of clinical problem solving were identified and then explored, in depth, through review of USP comments and history of present illness (HPI) and treatment plan documentation. Results Residents fell into three groups when it came to clinical problem-solving around a housing trigger for asthma: those who failed to ask about housing and therefore did not uncover mold as a potential trigger (neglectors - 21%; 14/68); those who asked about housing in negative ways that prevented disclosure and response (negative elicitors - 24%, 16/68); and those who elicited and explored the mold issue (full elicitors - 56%; 28/68). Of the full elicitors 53% took no further action, 26% only documented the mold; and 21% provided resources/referral. In-depth review of USP comments/explanations and residents' notes (HPI, treatment plan) revealed possible influences on clinical problem solving. Failure to ask about housing was associated with both contextual factors (rushed visit) and interpersonal skills (not fully engaging with patient) and with possible differences in attention ("known" vs. unknown/new triggers, usual symptoms vs. changes, not attending to relocation, etc.,). Use of close-ended questions often made it difficult for the patient to share mold concerns. Negative responses to sharing of housing information led to missing mold entirely or to the patient not realizing that the physician agreed with her concerns about mold. Residents who fully elicited the mold situation but did not take action seemed to either lack knowledge or feel that action on SDoH was outside their realm of responsibility. Those that took direct action to help the patient address mold appeared to be motivated by an enhanced sense of urgency. Conclusions Findings provide unique insight into residents' problem solving processes including external influences (e.g., time, distractions), the role of core communication and interpersonal skills (eliciting information, creating opportunities for patients to voice concerns, sharing clinical thinking with patients), how traditional cognitive biases operate in practice (premature closure, tunneling, and ascertainment bias), and the ways in which beliefs about expectancies and scope of practice may color clinical problem-solving strategies for addressing SDoH.
PMID: 32735551
ISSN: 2194-802x
CID: 4540752

A Phone Call Away: New York's Hotline And Public Health In The Rapidly Changing COVID-19 Pandemic

Kristal, Ross; Rowell, Madden; Kress, Marielle; Keeley, Chris; Jackson, Hannah; Piwnica-Worms, Katherine; Hendricks, Lisa; Long, Theodore G; Wallach, Andrew B
In early March 2020 an outbreak of coronavirus disease 2019 (COVID-19) in New York City exerted sudden and extreme pressures on emergency medical services and quickly changed public health policy and clinical guidance. Recognizing this, New York City Health + Hospitals established a clinician-staffed COVID-19 hotline for all New Yorkers. The hotline underwent three phases as the health crisis evolved. As of May 1, 2020, the hotline had received more than ninety thousand calls and was staffed by more than a thousand unique clinicians. Hotline clinicians provided callers with clinical assessment and guidance, registered them for home symptom monitoring, connected them to social services, and provided a source of up-to-date answers to COVID-19 questions. By connecting New Yorkers with hotline clinicians, regardless of their regular avenues of accessing care, the hotline aimed to ease the pressures on the city's overtaxed emergency medical services. Future consideration should be given to promoting easy access to clinician hotlines by disadvantaged communities early in a public health crisis and to evaluating the impact of clinician hotlines on clinical outcomes.
PMID: 32525707
ISSN: 1544-5208
CID: 4573952