Coordinated Health Care Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) plan.

Background: Evidence-based strategies to improve outcomes in minority children with uncontrolled asthma discharged from the emergency department (ED) are needed. Objectives: This multicenter pragmatic clinical trial was designed to compare an ED-only intervention (decision support tool), an ED-only intervention and home visits by community health workers for 6 months (ED-plus-home), and enhanced usual care (UC). Methods: Children aged 5 to 11 years with uncontrolled asthma were enrolled. The change over 6 months in the Patient-Reported Outcomes Measurement Information System Asthma Impact Scale score in children and Satisfaction with Participation in Social Roles score in caregivers were the primary outcomes. The secondary outcomes included guideline-recommended ED discharge care and self-management. Results: Recruitment was significantly lower than expected (373 vs 640 expected). Of the 373 children (64% Black and 31% Latino children), only 63% completed the 6-month follow-up visit. In multivariable analyses that accounted for missing data, the adjusted odds ratios and 98% CIs for differences in Asthma Impact Scores or caregivers' Satisfaction with Participation in Social Roles scores were not significant. However, guideline-recommended ED discharge care was significantly improved in the intervention groups versus in the UC group, and self-management behaviors were significantly improved in the ED-plus-home group versus in the ED-only and UC groups. Conclusions: The ED-based interventions did not significantly improve the primary clinical outcomes, although the study was likely underpowered. Although guideline-recommended ED discharge care and self-management did improve, their effect on clinical outcomes needs further study.

Resident Versus Attending Prenatal Care Models: an Analysis of the Effects of Race and Insurance on Appointment Attendance.

OBJECTIVE: To describe patient differences by prenatal care (PNC) model and identify factors that interact with race to predict more attended prenatal appointments, a key component of PNC adherence. METHODS: This retrospective cohort study used administrative data targeting prenatal patient utilization from two OB clinics with different care models (resident vs. attending OB) from within one large midwestern healthcare system. All appointment data among patients receiving prenatal care at either clinic between September 2, 2020, and December 31, 2021, were extracted. Multivariable linear regression was performed to identify predictors of attended appointments within the resident clinic, as moderated by race (Black vs. White). RESULTS: A total of 1034 prenatal patients were included: 653 (63%) served by the resident clinic (appointments = 7822) and 381 (38%) by the attending clinic (appointments = 4627). Patients were significantly different across insurance, race/ethnicity, partner status, and age between clinics (p < 0.0001). Despite prenatal patients at both clinics being scheduled for approximately the same number of appointments, resident clinic patients attended 1.13 (0.51, 1.74) fewer appointments (p = 0.0004). The number of attended appointments was predicted by insurance in crude analysis (ß = 2.14, p < 0.0001), with effect modification by race (Black vs. White) in final fitted analysis. Black patients with public insurance attended 2.04 fewer appointments than White patients with public insurance (7.60 vs. 9.64) and Black non-Hispanic patients with private insurance attended 1.65 more appointments than White non-Hispanic or Latino patients with private insurance (7.21 vs. 5.56). CONCLUSION: Our study highlights the potential reality that the resident care model, with more care delivery challenges, may be underserving patients who are inherently more vulnerable to PNC non-adherence at care onset. Our findings show that patients attend more appointments at the resident clinic if publicly insured, but less so if they are Black than White.

The potential impact of introducing a cost tool to facilitate cost-of-care conversations in routine OB care: Lessons from the CONTINUE pilot study.

Objective: The objective of the CONTINUE study is to gather preliminary data on the potential impact of implementing a "Cost Tool" in routine obstetrics (OB) care. It is hypothesized that by providing prenatal patients with an ability to forecast their care plan, they would be better able to anticipate and plan for the costs associated with their prenatal care. Methods: Pilot data from interviews and surveys were collected from 71 prenatal patients across three clinics throughout Chicago, IL. Results: As compared to privately insured prenatal patients, prenatal patients with public insurance reported the most benefit in Cost Tool use. Specifically, that the Cost Tool helped to navigate insurance more effectively (OR 4.49, p=0.0254), see the "Big Picture" and link it to the family budget (OR 4.25, p=0.0099), and make the financial tradeoffs needed to get through pregnancy (OR 5.50, p=0.0305). Conclusion: The CONTINUE study provides preliminary signals of the Cost Tool's potential to help publicly insured prenatal patients better navigate the costs associated with their care plan. Innovations: The CONTINUE study contributes valuable preliminary data about the utility of a cost tool in routine OB care, especially as it may benefit low-income prenatal patients navigate prenatal care better.

The Benefits of Introducing a Pregnancy Support Tool for Low-Income Women During Routine Obstetrics Care.

The objective of the CONTINUE (conversations in routine OB care) pilot study was to gather preliminary data on the benefits of integrating a well-designed pregnancy support tool ("CONTINUE Tool") in low-income prenatal care. A total of 184 tools were distributed by 21 OB providers during the study implementation period. Follow-up data were collected from 71 (38.5%) prenatal patients across three community-based midwestern OB clinics serving a diverse prenatal patient population. Early-gestation prenatal patients received the strategically designed CONTINUE Tool during routine prenatal care and later completed a semi-structured interview or electronic survey to report pre-determined individual benefit items experienced due to tool usage. Factor analysis used individual benefit items to identify factors representing common underlying benefits ("factor benefits"). Logistic regression analyses were performed to describe the relative odds of participants with low income (public insurance) experiencing individual and factor benefits of tool use compared to participants of higher income (private insurance). Chi square tests (or Fisher's exact tests) were performed to generate P values reflecting statistically significant differences by income group. More low-income prenatal participants reported experiencing individual benefits as compared to higher-income participants. Among factor benefits, low-income participants were statistically more likely to report experiencing a time-related logistics benefit (OR = 4.00; 95% CI 1.02-15.73; P = .045). Low-income participants reported experiencing an overall logistics factor benefit (OR = 4.29; 95% CI 0.47-38.75), including a cost-related logistics benefit (OR = 3.08; CI 0.59-16.00), as well as an understanding benefit (OR = 1.90; 95% CI 0.72-5.04) and a self-efficacy benefit (OR = 1.30; 95% CI 0.44-3.87). While this study is limited by sample size due to being a pilot study, the findings suggest there may be tangible benefits to introducing the CONTINUE Tool among low-income prenatal patients. Given the staggering inequity in OB care and subsequent health outcomes, any preliminary findings on ways to help combat this are necessary and should lay the groundwork for subsequent randomized trials. Our preliminary findings show that supplementing routine OB care with the CONTINUE Tool can confer benefits to both providers and patients, but particularly for low-income prenatal patients who tend to have more structural barriers to adequate care in the first place.

The Precision Interventions for Severe and/or Exacerbation-Prone (PrecISE) Asthma Network: An overview of Network organization, procedures, and interventions.

Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.

Syringe service program-based telemedicine linkage to opioid use disorder treatment: protocol for the STAMINA randomized control trial.

BACKGROUND: A key strategy for mitigating the current opioid epidemic is expanded access to medications for treating opioid use disorder (MOUD). However, interventions developed to expand MOUD access have limited ability to engage opioid users at higher levels of overdose risk, such as those who inject opioids. This paper describes the study protocol for testing STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention through NAvigation), an intervention that engages high-risk opioid users at community-based syringe service programs (SSP) and quickly links them to MOUD using a telemedicine platform. METHODS: This randomized control trial will be conducted at three SSP sites in Chicago. All participants will complete an initial assessment with a provider from a Federally Qualified Health Center who can prescribe or refer MOUD services as appropriate. The control arm will receive standard referral to treatment and the intervention arm will receive immediate telemedicine linkage to the provider and (depending on the type of MOUD prescribed) provided transportation to pick up their induction prescription (for buprenorphine or naltrexone) or attend their intake appointment (for methadone). We aim to recruit a total of 273 participants over two years to provide enough power to detect a difference in our primary outcome of MOUD treatment linkage. Secondary outcomes include treatment engagement, treatment retention, and non-MOUD opioid use. Data will be collected using structured interviews and saliva drug tests delivered at baseline, three months, and six months. Fixed and mixed effects generalized linear regression analyses and survival analysis will be conducted to compare the probabilities of a successful treatment linkage between the two arms, days retained in treatment, and post-baseline opioid and other drug use. DISCUSSION: If successful, STAMINA's telemedicine approach will significantly reduce the amount of time between SSP clients' initial indication of interest in the medication and treatment initiation. Facilitating this process will likely lead to stronger additional treatment- and recovery-oriented outcomes. This study is also timely given the need for more rigorous testing of telemedicine interventions in light of temporary regulatory changes that have occurred during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov (Clinical Trials ID: NCT04575324 and Protocol Number: 1138-0420). Registered 29 September 2020. The study protocol is also registered on the Open Science Framework (DOI 10.17605/OSF.IO/4853 M).

Development of a Framework and Tool to Facilitate Cost-of-Care Conversations With Patients During Prenatal Care.

Background: Studies show that patients want to engage in cost-of-care conversations and factor costs into the formulation of care plans. Low-income patients are particularly likely to defer care because of costs, suggesting that cost-of-care conversations may be an important factor in health equity. Little guidance is available to clinicians and health systems for how to integrate effective cost-of-care conversations into clinical practice or to address specific cost needs of low-income patients. Objective: To develop a framework and tool to assist cost-of-care conversations with low-income patients during prenatal care. Design: A qualitative study using human-centered design methods. Setting: University medical center-based obstetrics-gynecology (ob-gyn) practice. Participants: 20 pregnant or recently postpartum women, 16 clinicians, and 8 support and executive staff. Results: Pregnant women accumulate substantial indirect costs that interfere with treatment adherence and stress patients and their relationships. Frequency and duration of appointments are primary drivers of indirect costs; the burden is exacerbated by not knowing these costs in advance and disproportionately affects low-income patients. Working with ob-gyn clinicians, staff, and patients, a paper-based tool was developed to help patients forecast treatment demands and indirect costs, and to help clinicians introduce and standardize cost conversations. Limitations: Data were collected from a small number of stakeholders in a single clinical setting that may not be generalizable to other settings. The tool has not been tested for effects on adherence or clinical outcomes. Conclusion: A communication tool that helps pregnant patients understand their care plan and anticipate indirect costs can promote cost-of-care conversations between clinicians and low-income patients. Primary Funding Source: Robert Wood Johnson Foundation.

A machine learning based model for Out of Hospital cardiac arrest outcome classification and sensitivity analysis.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) affects nearly 400,000 people each year in the United States of which only 10% survive. Using data from the Cardiac Arrest Registry to Enhance Survival (CARES), and machine learning (ML) techniques, we developed a model of neurological outcome prediction for OHCA in Chicago, Illinois. METHODS: Rescue workflow data of 2639 patients with witnessed OHCA were retrieved from Chicago's CARES. An Embedded Fully Convolutional Network (EFCN) classification model was selected to predict the patient outcome (survival with good neurological outcomes or not) based on 27 input features with the objective of maximizing the average class sensitivity. Using this model, sensitivity analysis of intervention variables such as bystander cardiopulmonary resuscitation (CPR), targeted temperature management, and coronary angiography was conducted. RESULTS: The EFCN classification model has an average class sensitivity of 0.825. Sensitivity analysis of patient outcome shows that an additional 33 patients would have survived with good neurological outcome if they had received lay person CPR in addition to CPR by emergency medical services and 88 additional patients would have survived if they had received the coronary angiography intervention. CONCLUSIONS: ML modeling of the complex Chicago OHCA rescue system can predict neurologic outcomes with a reasonable level of accuracy and can be used to support intervention decisions such as CPR or coronary angiography. The discriminative ability of this ML model requires validation in external cohorts to establish generalizability.

Student perspectives on asthma management in schools: a mixed-methods study examining experiences, facilitators, and barriers to care.

Objective: Children spend nearly a third of their day at school, making it a critical point of intervention for those with asthma. This study aimed to illuminate minority students' experiences with asthma at school and perceptions of facilitators and barriers to care. Methods: A mixed-methods study was conducted with elementary students with asthma. Participants completed a 24-question survey, drawing exercise to depict experiences caring for their asthma at school, and focus group discussion. Drawings were analyzed for narrative and pictorial themes. Discussions were audio-recorded, transcribed, and independently coded for themes. Results: Fifteen children with asthma (8-11 years) participated from two Chicago schools with predominately African-American populations. Most students (79%) indicated they had control of asthma at school, while 85% identified asthma as a problem when exercising. Half (53%) received help with asthma care at school. Drawings depicted cooperative management with adults or peers and the central role of inhalers as part of everyday asthma care in school. Finally, focus groups produced six key themes within the domains of facilitators: 1) support of others, 2) self-efficacy; 3) perception of being normal; and barriers: 4) lack of support from others; 5) difficulty accessing inhaler; 6) perception of being different. Conclusions: This study suggests asthma care plays an important role in students' school experiences. Stigma around inhaler use, lack of concern by school staff, and limited access to medications remain as barriers to school-based asthma management. Although facilitators, such as support from teachers and peers, do exist, future interventions must address existing barriers.

Childhood Asthma Disparities in Chicago: Developing Approaches to Health Inequities.

We conducted a needs assessment to develop an evidence-based, locally tailored asthma care implementation plan for high-risk children with asthma in Chicago. Our team of health policy experts, clinicians, researchers, and designers included extensive stakeholder engagement (N = 162) in a mixed-methods community needs assessment. Results showed the lines of communication and collaboration across sectors were weak; caregivers were the only consistent force and could not always manage this burden. A series of recommendations for interventions and how to implement and measure them were generated. Cooperative, multidisciplinary efforts grounded in the community can target wicked problems such as asthma.

Engaging end-users in intervention research study design.

OBJECTIVE: Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) Plan is a 3-arm multicenter pragmatic trial to evaluate asthma interventions in high-risk Chicago children presenting to emergency departments (ED) with asthma. A formative evaluation with end-users to provide input into the trial design and outcome instruments was conducted prior to trial initiation. METHODS: A multi-level data gathering framework from the field of design and standard qualitative methods was employed. This included one focus group with asthma Community Health Workers (N = 8), two focus groups with caregivers of children with asthma (N = 9), in-home interviews with caregivers (N = 9), key informant interviews at six EDs and outpatient clinical sites (N = 19), and ED tours and observations (N = 6). Data were presented, discussed, and organized into themes. RESULTS: Data indicated that changes to the study design and discharge tool were warranted. A key insight was that ED discharge protocols typically place patient education at a single inopportune time, as families are preparing to leave the ED. At this point in time, families are less receptive to education due to fatigue and a desire to expedite the discharge process. The trial design was modified to reposition the discharge asthma plan to occur at earlier "teachable moments." Delivery of the asthma discharge plan was assigned to study-employed ED coordinators instead of ED providers and staff. Other potential challenges to study recruitment and implementation were raised and addressed. CONCLUSIONS: Engagement of end-users in the design phase of implementation research is critical to improve research feasibility and relevance.

Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.

Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ED with uncontrolled asthma that compares: [1] an ED-focused intervention to improve the quality of care on discharge to home, [2] the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and [3] enhanced usual care. All children receive spacers for the metered dose inhaler and teaching about its use. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale and Satisfaction with Participation in Social Roles at 6months are the primary outcomes in children and in caregivers, respectively. Other patient-reported outcomes and indicators of healthcare utilization are assessed as secondary outcomes. Innovative features of the CHICAGO Plan include early and continuous engagement of children, caregivers, the Chicago Department of Public Health, and other stakeholders to inform the design and implementation of the study and a shared research infrastructure to coordinate study activities. The objective of this report is to describe the development of the CHICAGO Plan, including the methods and rationale for engaging stakeholders, the shared research infrastructure, and other features of the pragmatic clinical trial design.

Care transition interventions for children with asthma in the emergency department.

The emergency department (ED) is a critical point of identification and treatment for some of the most high-risk children with asthma. This review summarizes the evidence regarding care transition interventions originating in the ED for children with uncontrolled asthma, with a focus on care coordination and self-management education. Although many interventions on care transition for pediatric asthma have been tested, only a few were actually conducted in the ED setting. Most of these targeted both care coordination and self-management education but ultimately did not improve attendance at follow-up appointments with primary care providers, improve asthma control, or reduce health care utilization. Conducting any ED-based intervention in the current environment is challenging because of the many demands on ED providers and staff, poor communication within and outside of the medical sector, and caregiver/patient burden. The evidence to date suggests that ED care transition interventions should consider expanding beyond the ED to bridge the multiple sectors children with asthma navigate, including health care settings, homes, schools, and community spaces. Patient-centered approaches may also be important to ensure adequate intervention design, enrollment, retention, and evaluation of outcomes important to children and their families.

Using design methods to provide the care that people want and need.

Kim Erwin is an Assistant Professor at IIT Institute of Design and trained in user-centered design methods, which put people at the center of any problem space so as to develop solutions that better fit their everyday lives, activities and context. Her expertise is in making complex information easier to understand and use. Her research targets communication tools and methods for collaborative knowledge construction built through shared experiences. Her book, Communicating the New: Methods to shape and accelerate innovation focuses on helping teams explore, build and diffuse critical knowledge inside organizations. Jerry Krishnan is a Professor of Medicine and Public Health, and Associate Vice President for Population Health Sciences at the University of Illinois Hospital & Health Sciences System. He pioneered the use of Analytic Hierarchy Process to elicit the expressed needs of stakeholders for research. He previously served as Chair of the US FDA Pulmonary and Allergy Drugs Advisory Committee and is a Principal Investigator in NIH and Patient Centered Outcomes Research Institute (PCORI)-funded research consortia. He chairs the US National Heart, Lung, and Blood Institute (NHLBI) Clinical Trials review committee and the PCORI Improving Healthcare Systems merit review panel.

Engaging stakeholders to design a comparative effectiveness trial in children with uncontrolled asthma.

AIM: To present the methods and outcomes of stakeholder engagement in the development of interventions for children presenting to the emergency department (ED) for uncontrolled asthma. METHODS: We engaged stakeholders (caregivers, physicians, nurses, administrators) from six EDs in a three-phase process to: define design requirements; prototype and refine; and evaluate. RESULTS: Interviews among 28 stakeholders yielded themes regarding in-home asthma management practices and ED discharge experiences. Quantitative and qualitative evaluation showed strong preference for the new discharge tool over current tools. CONCLUSION: Engaging end-users in contextual inquiry resulted in CAPE (CHICAGO Action Plan after ED discharge), a new stakeholder-balanced discharge tool, which is being tested in a multicenter comparative effectiveness trial.