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.

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.

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.

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.

Solitary confinement and risk of self-harm among jail inmates.

OBJECTIVES: We sought to better understand acts of self-harm among inmates in correctional institutions. METHODS: We analyzed data from medical records on 244 699 incarcerations in the New York City jail system from January 1, 2010, through January 31, 2013. RESULTS: In 1303 (0.05%) of these incarcerations, 2182 acts of self-harm were committed, (103 potentially fatal and 7 fatal). Although only 7.3% of admissions included any solitary confinement, 53.3% of acts of self-harm and 45.0% of acts of potentially fatal self-harm occurred within this group. After we controlled for gender, age, race/ethnicity, serious mental illness, and length of stay, we found self-harm to be associated significantly with being in solitary confinement at least once, serious mental illness, being aged 18 years or younger, and being Latino or White, regardless of gender. CONCLUSIONS: These self-harm predictors are consistent with our clinical impressions as jail health service managers. Because of this concern, the New York City jail system has modified its practices to direct inmates with mental illness who violate jail rules to more clinical settings and eliminate solitary confinement for those with serious mental illness.

Sustained improvement in clinical preventive service delivery among independent primary care practices after implementing electronic health record systems.

INTRODUCTION: Studies showing sustained improvements in the delivery of clinical preventive services are limited. Fewer studies demonstrate sustained improvements among independent practices that are not affiliated with hospitals or integrated health systems. This study examines the continued improvement in clinical quality measures for a group of independent primary care practices using electronic health records (EHRs) and receiving technical support from a local public health agency. METHODS: We analyzed clinical quality measure performance data from a cohort of primary care practices that implemented an EHR at least 3 months before October 2009, the study baseline. We assessed trends for 4 key quality measures: antithrombotic therapy, blood pressure control, smoking cessation intervention, and hemoglobin A1c (HbA1c) testing based on monthly summary data transmitted by the practices. RESULTS: Of the 151 practices, 140 were small practices and 11 were community health centers; average time using an EHR was 13.7 months at baseline. From October 2009 through October 2011, average rates increased for antithrombotic therapy (from 58.4% to 74.8%), blood pressure control (from 55.3% to 64.1%), HbA1c testing (from 46.4% to 57.7%), and smoking cessation intervention (from 29.3% to 46.2%). All improvements were significant. CONCLUSION: During 2 years, practices showed significant improvement in the delivery of several key clinical preventive services after implementing EHRs and receiving support services from a public health agency.

Injury surveillance in New York City jails.

To characterize injuries occurring in jails, we analyzed injury report forms from the New York City jail system. We abstracted data from 4695 injury report forms representing 3863 patients. Of the injuries reported, 66% were classified as intentional. The 2 leading causes of injuries were inmate-on-inmate aggression (40%) and slips and falls (27%). Injuries place a considerable burden on jail health care systems, and there is a need for more studies on this problem and development of injury prevention programs.

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.

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 effect of Transtheoretical Model based interventions on smoking cessation.

The Transtheoretical Model (TTM) proposes that stage matching improves the effectiveness of behaviour change interventions, such as for smoking cessation. It also proposes that standard smoking cessation interventions are matched to the relatively few smokers in the preparation stage and will not assist the majority of smokers, who are in the precontemplation or contemplation stages. This study tested the hypothesis that stage-matched interventions increase movement through the stages relative to interventions not stage-matched. It also tested the hypothesis that the relative effectiveness of stage-matched interventions is greater for people in precontemplation or contemplation (stage-matched for TTM but not for control) than for people in preparation (where both intervention and control were stage-matched). A total of 2471 UK adult smokers were randomised to either control or TTM-based self-help intervention and followed up 12 months after beginning the programme. Content analysis of the intervention and control self-help interventions examined whether control interventions were action-oriented, meaning they emphasised the processes of change relevant for preparation and action. Participants in the TTM arm were slightly more likely to make a positive move in stage, but this was not significant. There was no evidence that the TTM-based intervention was more effective for participants in precontemplation or contemplation than for participants in preparation. There was no evidence that TTM-based interventions were effective in this trial. The control intervention advocated process use appropriate for all stages and was not action-orientated. Stage matching does not explain the modest effects of TTM-based interventions over control interventions observed in some trials. These effects may instead have occurred because TTM-based interventions were more intensive than control interventions.

Interventions for preventing weight gain after smoking cessation.

BACKGROUND: Most people who stop smoking gain weight, on average about 7 kg in the long term. There are some interventions that have been specifically designed to tackle smoking cessation whilst also limiting weight gain. Many smoking cessation pharmacotherapies and other interventions may also limit weight gain. OBJECTIVES: This review is divided into two parts. (1) Interventions designed specifically to aid smoking cessation and limit post-cessation weight gain (2) Interventions designed to aid smoking cessation that may also plausibly have an effect on weight SEARCH STRATEGY: Part 1: We searched the Cochrane Tobacco Addiction Group's Specialized Register which includes trials indexed in MEDLINE, EMBASE, SciSearch and PsycINFO, and other reviews and conference abstracts. Part 2: We searched the included studies of Cochrane smoking cessation reviews of nicotine replacement therapy, antidepressants, nicotine receptor partial agonists, cannabinoid type 1 receptor antagonists (rimonabant), and exercise interventions, published in Issue 4, 2008 of The Cochrane Library. SELECTION CRITERIA: Part 1: We included trials of interventions designed specifically to address both smoking cessation and post-cessation weight gain that had measured weight at any follow-up point and/or smoking six months or more after quitting.Part 2: We included trials from the selected Cochrane reviews that could plausibly modify post-cessation weight gain if they had reported weight gain by trial arm at end of treatment or later. DATA COLLECTION AND ANALYSIS: We extracted data in duplicate on smoking and weight for part 1 trials, and on weight only for part 2. Abstinence from smoking is expressed as a risk ratio (RR), using the most rigorous definition of abstinence available in each trial, and biochemically validated rates if available. The outcome is expressed as the difference in weight change between trial arms from baseline. Where appropriate, we performed meta-analysis using the Mantel-Haenszel method for smoking and inverse variance for weight using a fixed-effect model. MAIN RESULTS: We found evidence that pharmacological interventions aimed at reducing post-cessation weight gain resulted in a significant reduction in weight gain at the end of treatment (dexfenfluramine (-2.50kg [-2.98kg to -2.02kg], fluoxetine (-0.80kg [-1.27kg to -0.33kg], phenylpropanolamine (PPA) (-0.50kg [-0.80kg to -0.20kg], naltrexone (-0.76kg [-1.51kg to -0.01kg])). No evidence of maintenance of the treatment effect was found at six or 12 months.Among the behavioural interventions, only weight control advice was associated with no reduction in weight gain and with a possible reduction in abstinence. Individualized programmes were associated with reduced weight gain at end of treatment and at 12 months (-2.58kg [-5.11kg to -0.05kg]), and with no effect on abstinence (RR 0.74 [0.39 to 1.43]). Very low calorie diets (-1.30kg (-3.49kg to 0.89kg] at 12 months) and cognitive behavioural therapy (CBT) (-5.20kg (-9.28kg to -1.12kg] at 12 months) were both associated with improved abstinence and reduced weight gain at end of treatment and at long-term follow up.Both bupropion (300mg/day) and fluoxetine (30mg and 60mg/day combined) were found to limit post-cessation weight gain at the end of treatment (-0.76kg [-1.17kg to -0.35kg] I(2)=48%) and -1.30kg [-1.91kg to -0.69kg]) respectively. There was no evidence that the weight reducing effect of bupropion was dose-dependent. The effect of bupropion at one year was smaller and confidence intervals included no effect (-0.38kg [-2.001kg to 1.24kg]).We found no evidence that exercise interventions significantly reduced post-cessation weight gain at end of treatment but evidence for an effect at 12 months (-2.07kg [-3.78kg, -0.36kg]).Treatment with NRT resulted in attenuation of post-cessation weight gain (-0.45kg [-0.70kg, -0.20kg]) at the end of treatment, with no evidence that the effect differed for different forms of NRT. The estimated weight gain reduction was similar at 12 months (-0.42kg [-0.92kg, 0.08kg]) but the confidence intervals included no effect.There were no relevant data on the effect of rimonabant on weight gain.We found no evidence that varenicline significantly reduced post-cessation weight gain at end of treatment and no follow-up data are currently available. One study randomizing successful quitters to 12 more weeks of active treatment showed weight to be reduced by 0.71kg (-1.04kg to -0.38kg). In three studies, participants taking bupropion gained significantly less weight at the end of treatment than those on varenicline (-0.51kg [-0.93kg to -0.09kg]). AUTHORS' CONCLUSIONS: Behavioural interventions of general advice only are not effective and may reduce abstinence. Individualized interventions, very low calorie diets, and CBT may be effective and not reduce abstinence. Exercise interventions are not associated with reduced weight gain at end of treatment, but may be associated with worthwhile reductions in weight gain in the long term, Bupropion, fluoxetine, nicotine replacement therapy, and probably varenicline all reduced weight gain while being used. Although this effect was not maintained one year after quitting for bupropion, fluoxetine, and nicotine replacement, the evidence is insufficient to exclude a modest long-term effect. The data are not sufficient to make strong clinical recommendations for effective programmes.

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.

Sexually transmitted infections. Initiatives for prevention.

Sexually transmissible infections (STIs) are responsible for a significant burden of disease in both developed and developing countries and young people are disproportionately affected by STIs and their consequences. STI rates in young people are determined by a wide range of well documented influences. These include physiological, cognitive and behavioural factors, as well as environmental factors such as the social, and cultural context in which young people live. Despite the erecognition of these influences, their complex inter-relationships are less well documented and the evidence for interventions to reduce STIs in young people is similarly less clear. This paper explore tht most important factors that impact STI rates in young people in Australia and reviews interventions that have shown success, in Australia and elsewhere. In addition, promising strategies for the promotion of sexual health and reduction of STIs in young Australians, are discussed.