Injectable liposome-containing click hydrogel microparticles for release of macromolecular cargos.

Hydrogel microparticles ranging from 0.1-100 µm, referred to as microgels, are attractive for biological applications afforded by their injectability and modularity, which allows facile delivery of mixed populations for tailored combinations of therapeutics. Significant efforts have been made to broaden methods for microgel production including via the materials and chemistries by which they are made. Via droplet-based-microfluidics we have established a method for producing click poly-(ethylene)-glycol (PEG)-based microgels with or without chemically crosslinked liposomes (lipo-microgels) through the Michael-type addition reaction between thiol and either vinyl-sulfone or maleimide groups. Unifom spherical microgels and lipo-microgels were generated with sizes of 74 ± 16 µm and 82 ± 25 µm, respectively, suggesting injectability that was further supported by rheological analyses. Super-resolution confocal microscopy was used to further verify the presence of liposomes within the lipo-microgels and determine their distribution. Atomic force microscopy (AFM) was conducted to compare the mechanical properties and network architecture of bulk hydrogels, microgels, and lipo-microgels. Further, encapsulation and release of model cargo (FITC-Dextran 5 kDa) and protein (equine myoglobin) showed sustained release for up to 3 weeks and retention of protein composition and secondary structure, indicating their ability to both protect and release cargos of interest.

Microgels Formed by Spontaneous Click Chemistries Utilizing Microfluidic Flow Focusing for Cargo Release in Response to Endogenous or Exogenous Stimuli.

Protein therapeutics have become increasingly popular for the treatment of a variety of diseases owing to their specificity to targets of interest. However, challenges associated with them have limited their use for a range of ailments, including the limited options available for local controlled delivery. To address this challenge, degradable hydrogel microparticles, or microgels, loaded with model biocargoes were created with tunable release profiles or triggered burst release using chemistries responsive to endogenous or exogeneous stimuli, respectively. Specifically, microfluidic flow-focusing was utilized to form homogenous microgels with different spontaneous click chemistries that afforded degradation either in response to redox environments for sustained cargo release or light for on-demand cargo release. The resulting microgels were an appropriate size to remain localized within tissues upon injection and were easily passed through a needle relevant for injection, providing means for localized delivery. Release of a model biopolymer was observed over the course of several weeks for redox-responsive formulations or triggered for immediate release from the light-responsive formulation. Overall, we demonstrate the ability of microgels to be formulated with different materials chemistries to achieve various therapeutic release modalities, providing new tools for creation of more complex protein release profiles to improve therapeutic regimens.

Scaling-up social needs screening in practice: a retrospective, cross-sectional analysis of data from electronic health records from Bronx county, New York, USA.

OBJECTIVES: There has been renewed focus on health systems integrating social care to improve health outcomes with relatively less related research focusing on 'real-world' practice. This study describes a health system's experience from 2018 to 2020, following the successful pilot in 2017, to scale social needs screening of patients within a large urban primary care ambulatory network. SETTING: Academic medical centre with an ambulatory network of 18 primary care practices located in an urban county in New York City (USA). PARTICIPANTS: This retrospective, cross-sectional study used electronic health records of 244 764 patients who had a clinical visit between 10 April 2018 and 8 December 2019 across any one of 18 primary care practices. METHODS: We organised measures using the RE-AIM framework domains of reach and adoption to ascertain the number of patients who were screened and the number of providers who adopted screening and associated documentation, respectively. We used descriptive statistics to summarise factors comparing patients screened versus those not screened, the prevalence of social needs screening and adoption across 18 practices. RESULTS: Between April 2018 and December 2019, 53 093 patients were screened for social needs, representing approximately 21.7% of the patients seen. Almost one-fifth (19.6%) of patients reported at least one unmet social need. The percentage of screened patients varied by both practice location (range 1.6%-81.6%) and specialty within practices. 51.8% of providers (n=1316) screened at least one patient. CONCLUSIONS: These findings demonstrate both the potential and challenges of integrating social care in practice. We observed significant variability in uptake across the health system. More research is needed to better understand factors driving adoption and may include harmonising workflows, establishing unified targets and using data to drive improvement.

The association between social needs and chronic conditions in a large, urban primary care population.

There is consensus that social needs influence health outcomes, but less is known about the relationships between certain needs and chronic health conditions in large, diverse populations. This study sought to understand the association between social needs and specific chronic conditions using social needs screening and clinical data from Electronic Health Records. Between April 2018-December 2019, 33,550 adult (≥18y) patients completed a 10-item social needs screener during primary care visits in Bronx and Westchester counties, NY. Generalized linear models were used to estimate prevalence ratios for eight outcomes by number and type of needs with analyses completed in Summer 2020. There was a positive, cumulative association between social needs and each of the outcomes. The relationship was strongest for elevated PHQ-2, depression, alcohol/drug use disorder, and smoking. Those with ≥3 social needs were 3.90 times more likely to have an elevated PHQ-2 than those without needs (95% CI: 3.66, 4.16). Challenges with healthcare transportation was associated with each condition and was the most strongly associated need with half of conditions in the fully-adjusted models. For example, those with transportation needs were 84% more likely to have an alcohol/drug use disorder diagnosis (95% CI: 1.59, 2.13) and 41% more likely to smoke (95% CI: 1.25, 1.58). Specific social needs may influence clinical issues in distinct ways. These findings suggest that health systems need to develop strategies that address unmet social need in order to optimize health outcomes, particularly in communities with a dual burden of poverty and chronic disease.

Unmet Social Needs and No-Show Visits in Primary Care in a US Northeastern Urban Health System, 2018-2019.

Objectives. To characterize the association between social needs prevalence and no-show proportion and variation in these associations among specific social needs.Methods. In this study, we used results from a 10-item social needs screener conducted across 19 primary care practices in a large urban health system in Bronx County, New York, between April 2018 and July 2019. We estimated the association between unmet needs and 2-year history of missed appointments from 41 637 patients by using negative binomial regression models.Results. The overall no-show appointment proportion was 26.6%. Adjusted models suggest that patients with 1 or more social needs had a significantly higher no-show proportion (31.5%) than those without any social needs (26.3%), representing an 19.8% increase (P < .001). We observed a positive trend (P < .001) between the number of reported social needs and the no-show proportion-26.3% for those with no needs, 30.0% for 1 need, 32.1% for 2 needs, and 33.8% for 3 or more needs. The strongest association was for those with health care transportation need as compared with those without (36.0% vs 26.9%).Conclusions. We found unmet social needs to have a significant association with missed primary care appointments with potential implications on cost, quality, and access for health systems.

Integrating Social Needs Screening and Community Health Workers in Primary Care: The Community Linkage to Care Program.

Clinic-based social needs screening has been associated with increased access to social services and improved health outcomes. Using a pragmatic study design in an urban pediatric practice, we used logistic regression to identify factors associated with successful social service uptake. From December 2017 to November 2018, 4948 households were screened for social needs, and 20% self-reported at least one. Of the 287 households with unmet needs who were referred and interested in further assistance, 43% reported successful social service uptake. Greater than 4 outreach encounters (adjusted odds ratio = 1.92; 95% confidence interval = 1.06-3.49) and follow-up time >30 days (adjusted odds ratio = 0.43; 95% confidence interval = 0.25-0.73) were significantly associated with successful referrals. These findings have implementation implications for programs aiming to address social needs in practice. Less than half of households reported successful referrals, which suggests the need for additional research and an opportunity for further program optimization.

Social Risks Among Primary Care Patients in a Large Urban Health System.

INTRODUCTION: Health systems are increasingly interested in addressing the social determinants of health via social risk screening. The objective of this study is to understand the variability in the number and types of social risks overall and in population subgroups among primary care patients routinely screened in a large urban health system. METHODS: Between April and December 2018, a total of 24,633 primary care patients completed a 10-item screener across 19 ambulatory sites within a health system in the Bronx, NY. The prevalence of any social risk and specific social risks was estimated overall and for population subgroups. Wald tests were used to determine statistically significant differences by subgroup. Data were analyzed in winter/spring 2019. RESULTS: Twenty percent of patients presented with at least 1 social risk. The most frequently reported risks included housing quality (6.5%) and food insecurity (6.1%). Middle-aged (30-59 years) respondents (24.7%, 95% CI=23.6%, 25.7%) compared with those aged 18-29 years (17.7%, 95% CI=16.4%, 19.2%, p<0.001), and Medicaid patients (24.8%, 95% CI=24.0%, 25.5%) compared with commercially insured patients (11.8%, 95% CI=11.1%, 12.5%, p<0.001), were more likely to report social risks. The strongest predictor of housing quality risk was residing in public housing (15.1%, 95% CI=13.8%, 16.6%) compared with those not in public housing (5.6%, 95% CI=5.3%, 5.9%, p<0.001). Housing quality was the most frequently reported risk for children (aged <18 years) and older adults (aged ≥70 years), whereas, for middle-aged respondents (30-69 years), it was food insecurity. CONCLUSIONS: There are important differences in the prevalence of overall and individual social risks by subgroup. These findings should be considered to inform clinical care and social risk screening and interventions.

The Reach of an Urban Hospital System-Based Diabetes Prevention Program: Patient Engagement and Weight Loss Characteristics.

PURPOSE: The purpose of this study was to identify patient and program delivery characteristics associated with engagement and weight loss in a Diabetes Prevention Program (DPP) implemented in an urban hospital system. METHODS: Patient and program delivery data were collected between July 2015 and December 2017. DPP eligibility was determined based on age, body mass index (BMI), and hemoglobin A1C data via the electronic health record. Engagement was measured at 3 levels: ≤3 sessions, 4 to 8 sessions, and ≥9 sessions. Weight was measured at each DPP session. RESULTS: Among the eligible patients (N = 31 524), referrals and engagement were lower in men than women, in Spanish speakers than English speakers, in younger (18-34 years) and middle-aged (35-54 years) than older adults, and in patients receiving Medicaid than other patients. Referral and engagement were higher in patients with higher BMIs and those prescribed ≥5 medications. Current smokers were less frequently engaged. Prior health care provider contact was associated with higher engagement. Overall, 28% of DPP participants achieved ≥5% weight loss; younger and middle-aged patients and those who gained weight in the prior 2 years were less likely to lose weight. CONCLUSION: This assessment identified characteristics of patients with lower levels of referral and engagement. The DPP staff may need to increase outreach to address barriers to referral and during all points of engagement among men, younger patients, and Spanish speakers. Future research is needed to increase understanding with regard to why referrals and engagement are lower among these groups.

From Policy Statement to Practice: Integrating Social Needs Screening and Referral Assistance With Community Health Workers in an Urban Academic Health Center.

Purpose: Social and economic factors have been shown to affect health outcomes. In particular, social determinants of health (SDH) are linked to poor health outcomes in children. Research and some professional academies support routine social needs screening during primary care visits. Translating this recommendation into practice remains challenging due to the resources required and dearth of evidence-based research to guide health center level implementation. We describe our experience implementing a novel social needs screening program at an academic pediatric clinic. Methods: The Community Linkage to Care (CLC) pilot program integrates social needs screening and referral support using community health workers (CHWs) as part of routine primary care visits. Our multidisciplinary team performed process mapping, developed workflows, and led ongoing performance improvement activities. We established key elements of the CLC program through an iterative process We conducted social needs screens at 65% of eligible well-child visits from May 2017 to April 2018; 19.7% of screens had one or more positive responses. Childcare (48.8%), housing quality and/or availability (39.9%), and food insecurity (22.8%) were the most frequently reported needs. On average, 76% of providers had their patients screened on more than half of eligible well-child visits. Discussion: Our experience suggests that screening for social needs at well-child visits is feasible as part of routine primary care. We attribute progress to leveraging resources, obtaining provider buy-in, and defining program components to sustain activities.

Medicare underpayment for Diabetes Prevention Program: implications for DPP suppliers.

OBJECTIVES: To examine if Medicare reimbursements for the Diabetes Prevention Program (DPP) cover program costs. STUDY DESIGN: A retrospective modeling study. METHODS: A microcosting approach was used to calculate the costs of delivering DPP in 2016 to more than 300 patients from Montefiore Health System (MHS), a large healthcare system headquartered in Bronx, New York. Attendance and weight loss outcomes were used to estimate Medicare reimbursement. We also modeled revenue assuming that our program outcomes had been similar to those observed in national data. RESULTS: The 1-year cost of delivering DPP to 322 participants in 2016 was $177,976, or $553 per participant. The costliest components of delivery were direct instruction (28% of total cost) and patient outreach, enrollment, and eligibility confirmation (24%). Based on our program outcomes (14.3% lost ≥5% of their initial weight and 50% attended ≥4 sessions), MHS would be reimbursed $34,625 ($108/patient). If outcomes were in line with national CDC reports (eg, better attendance and weight loss outcomes), MHS would have been reimbursed $61,270 ($190/patient). CONCLUSIONS: In a large urban health system serving a diverse population, the costs of delivering DPP far outweighed Medicare reimbursement amounts. Analyzing and documenting the costs associated with delivering the evidence-based DPP may inform prospective suppliers and payers and aid in advocacy for adequate reimbursement.

Factors in Placement and Enrollment of Primary Care Patients in YMCA's Diabetes Prevention Program, Bronx, New York, 2010-2015.

INTRODUCTION: The reach of the New York State YMCA's Diabetes Prevention Program (DPP) to at-risk populations may be increased through integration with primary care settings. Although considerable effort has been made in the referral and retention of patients, little is known about the factors associated with the placement of potential participants into YMCA's DPP. METHODS: Among Montefiore Health System (MHS) patients referred to YMCA's DPP (n = 1,249) from July 10, 2010, through November 11, 2015, we identified demographic factors (eg, age, preferred language) and primary care practice-level factors (eg, time between referral and start of session, session season) associated with placement into a session and subsequent drop-out. We also evaluated factors associated with weight loss. RESULTS: Patients were predominantly female (71%) and aged 45 years or older (71%). Patients preferring sessions in Spanish were less often placed in sessions. Patients aged 18 to 44 years were less often placed (P = .01) and enrolled (P = .001) than patients aged 60 years or older. Sessions conducted in the summer and spring had higher enrollment than fall and winter months. Patients who started the YMCA's DPP within 2 months of their referral date were more often enrolled (54.4%) than patients who waited 4 or more months (21.6%) to start their sessions. Patients aged 45 to 59 years lost marginally less weight than those aged 60 years or older (-3.1% vs -3.8%; P = .07). CONCLUSION: Although this evaluation gives some insight into the barriers to placement and enrollment in YMCA's DPP, challenges remain. Efforts are under way to increase referral of patients to community-based DPPs.

Lessons from Launching the Diabetes Prevention Program in a Large Integrated Health Care Delivery System: A Case Study.

There is urgent need for health systems to prevent diabetes. To date, few health systems have implemented the evidence-based Diabetes Prevention Program (DPP), and the few that have mostly partnered with community-based organizations to implement the program. Given the recent decision by the Centers for Medicare & Medicaid Services to reimburse for diabetes prevention, there is likely much interest in how such programs can be implemented within large health systems or how community partnerships can be expanded to support DPP implementation. Beginning in 2010, Montefiore Health System (MHS), a large health care system in the Bronx, NY, partnered with the Young Men's Christian Association (YMCA) of Greater New York to deliver the YMCA's DPP. Over 4 years, 1390 referrals to YMCA's DPP were made; 287 participants attended ≥3 classes, and average weight loss was 3.4%. Because of increased patient demand and internal capacity, MHS assumed responsibility for DPP implementation in May 2015. Fully integrating the program within the health system took 5-6 months, including configuring electronic health record templates/reports, hiring a coordinator, and creating clinical referral workflows/training guides. Billing workflows were designed for risk-based contracts. In the first 11 months of implementation, 1277 referrals were made, and referrals increased over time. Twenty-four class cycles were initiated, and 282 patients began attending classes. Average weight loss among 61 graduates from the Summer/Fall 2015 wave of MDPP classes was 3.8%. Additional opportunities for expansion include training allied health staff, providing patient incentives, increasing master trainer capacity, offering DPP to employees, and securing reimbursement.

Meaningful Use of an Electronic Health Record in the New York City Jail System.

Use of electronic health records (EHRs) is an important innovation for patients in jails and prisons. Efforts to incentivize health information technology, including the Medicaid EHR Incentive Program, are generally aimed at community providers; however, recent regulation changes allow participation of jail health providers. In the New York City jail system, the Department of Health and Mental Hygiene oversees care delivery and was able to participate in and earn incentives through the Medicaid EHR Incentive Program. Despite the challenges of this program and other health information innovations, participation by correctional health services can generate financial assistance and useful frameworks to guide these efforts. Policymakers will need to consider the specific challenges of implementing these programs in correctional settings.

Quality measure performance in small practices before and after electronic health record adoption.

INTRODUCTION: To date, little research has been published on the impact that the transition from paper-based record keeping to the use of electronic health records (EHR) has on performance on clinical quality measures. This study examines whether small, independent medical practices improved in their performance on nine clinical quality measures soon after adopting EHRs. METHODS: Data abstracted by manual review of paper and electronic charts for 6,007 patients across 35 small, primary care practices were used to calculate rates of nine clinical quality measures two years before and up to two years after EHR adoption. RESULTS: For seven measures, population-level performance rates did not change before EHR adoption. Rates of antithrombotic therapy and smoking status recorded increased soon after EHR adoption; increases in blood pressure control occurred later. Rates of hemoglobin A1c testing, BMI recorded, and cholesterol testing decreased before rebounding; smoking cessation intervention, hemoglobin A1c control and cholesterol control did not significantly change. DISCUSSION: The effect of EHR adoption on performance on clinical quality measures is mixed. To improve performance, practices may need to develop new workflows and adapt to different documentation methods after EHR adoption. CONCLUSIONS: In the short term, EHRs may facilitate documentation of information needed for improving the delivery of clinical preventive services. Policies and incentive programs intended to drive improvement should include in their timelines consideration of the complexity of clinical tasks and documentation needed to capture performance on measures when developing timelines, and should also include assistance with workflow redesign to fully integrate EHRs into medical practice.

Data-driven human rights: using the electronic health record to promote human rights in jail.

The electronic health record (EHR) is a commonplace innovation designed to promote efficiency, quality, and continuity of health services. In the New York City jail system, we implemented an EHR across 12 jails between 2008 and 2011. During the same time, our work increasingly focused on the importance of human rights as an essential element to the provision of medical and mental health care for our patients. Consequently, we made major modifications to the EHR to allow for better surveillance of vulnerable populations and enable reporting and analysis of patterns of abuse, neglect, and other patient concerns related to human rights. These modifications have improved our ability to find and care for patients injured in jail and those with mental health exacerbations. More work is needed, however, to optimize the potential of the EHR as a tool to promote human rights among patients in jail.

Factors related to clinical quality improvement for small practices using an EHR.

OBJECTIVE: To analyze the impact of three primary care practice transformation program models on performance: Meaningful Use (MU), Patient-Centered Medical Home (PCMH), and a pay-for-performance program (eHearts). DATA SOURCES/STUDY SETTING: Data for seven quality measures (QM) were retrospectively collected from 192 small primary care practices between October 2009 and October 2012; practice demographics and program participation status were extracted from in-house data. STUDY DESIGN: Bivariate analyses were conducted to measure the impact of individual programs, and a Generalized Estimating Equation model was built to test the impact of each program alongside the others. DATA COLLECTION/EXTRACTION METHODS: Monthly data were extracted via a structured query data network and were compared to program participation status, adjusting for variables including practice size and patient volume. Seven QMs were analyzed related to smoking prevention, blood pressure control, BMI, diabetes, and antithrombotic therapy. PRINCIPAL FINDINGS: In bivariate analysis, MU practices tended to perform better on process measures, PCMH practices on more complex process measures, and eHearts practices on measures for which they were incentivized; in multivariate analysis, PCMH recognition was associated with better performance on more QMs than any other program. CONCLUSIONS: Results suggest each of the programs can positively impact performance. In our data, PCMH appears to have the most positive impact.

Patient-centered medical home and quality measurement in small practices.

OBJECTIVES: To assess performance on quality measures among small primary care practices that recently adopted an electronic health record (EHR), and how performance differs between practices that have achieved patient-centered medical home (PCMH) recognition and those that have not. STUDY DESIGN: Retrospective cohort study. METHODS: Comparison of practice characteristics and performance on quality measures across 150 independent practices from 2009 to 2011 by recognition status for Physician Practice Connections-PCMH. RESULTS: PCMH-recognized practices performed significantly better than nonrecognized practices on 5 out of 7 clinical quality measures at baseline, and the differences were maintained over the 2-year study period. Both groups improved on all clinical quality measures. Though the magnitude of differences was small, PCMHrecognized practices had a higher number of patients diagnosed with hypertension and proportionally more black patients. A significant difference in PCMH-recognized practices is that they received, on average, 4 additional quality improvement visits compared with nonrecognized practices. CONCLUSIONS: Among small practices that have adopted EHRs, practices with PCMH recognition consistently outperformed practices without recognition on most clinical quality measures. With adequate assistance, small, resource-strapped practices can continue to have higher performance on clinical quality measures.

Preventive home visits for mortality, morbidity, and institutionalization in older adults: a systematic review and meta-analysis.

BACKGROUND: Home visits for older adults aim to prevent cognitive and functional impairment, thus reducing institutionalization and mortality. Visitors may provide information, investigate untreated problems, encourage medication compliance, and provide referrals to services. DATA SOURCES: Ten databases including CENTRAL and Medline searched through December 2012. STUDY SELECTION: Randomized controlled trials enrolling community-dwelling persons without dementia aged over 65 years. Interventions included visits at home by a health or social care professional that were not related to hospital discharge. DATA EXTRACTION AND SYNTHESIS: Two authors independently extracted data. Outcomes were pooled using random effects. MAIN OUTCOMES AND MEASURES: Mortality, institutionalization, hospitalization, falls, injuries, physical functioning, cognitive functioning, quality of life, and psychiatric illness. RESULTS: Sixty-four studies with 28642 participants were included. Home visits were not associated with absolute reductions in mortality at longest follow-up, but some programs may have small relative effects (relative risk = 0.93 [0.87 to 0.99]; absolute risk = 0.00 [-0.01 to 0.00]). There was moderate quality evidence of no overall effect on the number of people institutionalized (RR = 1.02 [0.88 to 1.18]) or hospitalized (RR = 0.96 [0.91 to 1.01]). There was high quality evidence for number of people who fell, which is consistent with no effect or a small effect (odds ratio = 0.86 [0.73 to 1.01]), but there was no evidence that these interventions increased independent living. There was low and very low quality evidence of effects for quality of life (standardised mean difference = -0.06 [-0.11 to -0.01]) and physical functioning (SMD = -0.10 [-0.17 to -0.03]) respectively, but these may not be clinically important. CONCLUSIONS: Home visiting is not consistently associated with differences in mortality or independent living, and investigations of heterogeneity did not identify any programs that are associated with consistent benefits. Due to poor reporting of intervention components and delivery, we cannot exclude the possibility that some programs may be effective.