Faculty Bibliography

BACKGROUND:Low medication adherence is a common cause of high blood pressure but is often unrecognized in clinical practice. Electronic data linkages between electronic health records (EHRs) and pharmacies offer the opportunity to identify low medication adherence, which can be used for interventions at the point of care. We developed a multicomponent intervention that uses linked EHR and pharmacy data to automatically identify patients with elevated blood pressure and low medication adherence. The intervention then combines team-based care with EHR-based workflows to address medication nonadherence. OBJECTIVE:This study aims to describe the design of the Leveraging EHR Technology and Team Care to Address Medication Adherence (TEAMLET) trial, which tests the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence among patients with hypertension. METHODS:TEAMLET is a pragmatic, cluster randomized controlled trial in which 10 primary care practices will be randomized 1:1 to the multicomponent intervention or usual care. We will include all patients with hypertension and low medication adherence who are seen at enrolled practices. The primary outcome is medication adherence, as measured by the proportion of days covered, and the secondary outcome is clinic systolic blood pressure. We will also assess intervention implementation, including adoption, acceptability, fidelity, cost, and sustainability. RESULTS:As of May 2023, we have randomized 10 primary care practices into the study, with 5 practices assigned to each arm of the trial. The enrollment for the study commenced on October 5, 2022, and the trial is currently ongoing. We anticipate patient recruitment to go through the fall of 2023 and the primary outcomes to be assessed in the fall of 2024. CONCLUSIONS:The TEAMLET trial will evaluate the effectiveness of a multicomponent intervention that leverages EHR-based data and team-based care on medication adherence. If successful, the intervention could offer a scalable approach to address inadequate blood pressure control among millions of patients with hypertension. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05349422; https://clinicaltrials.gov/ct2/show/NCT05349422. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/47930.

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities. We offer recommendations for how to increase generalizability of ePCT results and begin to mitigate bias to promote health equity.

BACKGROUND:Diabetes mellitus is a common medical complication of pregnancy, and its treatment is complex. Recent years have seen an increase in the application of mobile health tools and advanced technologies, such as remote patient monitoring, with the aim of improving care for diabetes mellitus in pregnancy. Previous studies of these technologies for the treatment of diabetes in pregnancy have been small and have not clearly shown clinical benefit with implementation. OBJECTIVE:Remote patient monitoring allows clinicians to monitor patients' health data (such as glucose values) in near real-time, between office visits, to make timely adjustments to care. Our objective was to determine if using remote patient monitoring for the management of diabetes in pregnancy leads to an improvement in maternal and neonatal outcomes. STUDY DESIGN/METHODS:This was a retrospective cohort study of pregnant patients with diabetes mellitus managed by the maternal-fetal medicine practice at one academic institution between October 2019 and April 2021. This practice transitioned from paper-based blood glucose logs to remote patient monitoring in February 2020. Remote patient monitoring options included (1) device integration with Bluetooth glucometers that automatically uploaded measured glucose values to the patient's Epic MyChart application or (2) manual entry in which patients manually logged their glucose readings into their MyChart application. Values in the MyChart application directly transferred to the patient's electronic health record for review and management by clinicians. In total, 533 patients were studied. We compared 173 patients managed with paper logs to 360 patients managed with remote patient monitoring (176 device integration and 184 manual entry). Our primary outcomes were composite maternal morbidity (which included third- and fourth-degree lacerations, chorioamnionitis, postpartum hemorrhage requiring transfusion, postpartum hysterectomy, wound infection or separation, venous thromboembolism, and maternal admission to the intensive care unit) and composite neonatal morbidity (which included umbilical cord pH <7.00, 5 minute Apgar score <7, respiratory morbidity, hyperbilirubinemia, meconium aspiration, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, pneumonia, seizures, hypoxic ischemic encephalopathy, shoulder dystocia, trauma, brain or body cooling, and neonatal intensive care unit admission). Secondary outcomes were measures of glycemic control and the individual components of the primary composite outcomes. We also performed a secondary analysis in which the patients who used the two different remote patient monitoring options (device integration vs manual entry) were compared. Chi-square, Fisher's exact, 2-sample t, and Mann-Whitney tests were used to compare the groups. A result was considered statistically significant at P<.05. RESULTS:Maternal baseline characteristics were not significantly different between the remote patient monitoring and paper groups aside from a slightly higher baseline rate of chronic hypertension in the remote patient monitoring group (6.1% vs 1.2%; P=.011). The primary outcomes of composite maternal and composite neonatal morbidity were not significantly different between the groups. However, remote patient monitoring patients submitted more glucose values (177 vs 146; P=.008), were more likely to achieve glycemic control in target range (79.2% vs 52.0%; P<.0001), and achieved the target range sooner (median, 3.3 vs 4.1 weeks; P=.025) than patients managed with paper logs. This was achieved without increasing in-person visits. Remote patient monitoring patients had lower rates of preeclampsia (5.8% vs 15.0%; P=.0006) and their infants had lower rates of neonatal hypoglycemia in the first 24 hours of life (29.8% vs 51.7%; P<.0001). CONCLUSION/CONCLUSIONS:Remote patient monitoring for the management of diabetes mellitus in pregnancy is superior to a traditional paper-based approach in achieving glycemic control and is associated with improved maternal and neonatal outcomes.

BACKGROUND:The improvements in care resulting from clinical decision support (CDS) have been significantly limited by consistently low health care provider adoption. Health care provider attitudes toward CDS, specifically psychological and behavioral barriers, are not typically addressed during any stage of CDS development, although they represent an important barrier to adoption. Emerging evidence has shown the surprising power of using insights from the field of behavioral economics to address psychological and behavioral barriers. Nudges are formal applications of behavioral economics, defined as positive reinforcement and indirect suggestions that have a nonforced effect on decision-making. OBJECTIVE:Our goal is to employ a user-centered design process to develop a CDS tool-the pulmonary embolism (PE) risk calculator-for PE risk stratification in the emergency department that incorporates a behavior theory-informed nudge to address identified behavioral barriers to use. METHODS:All study activities took place at a large academic health system in the New York City metropolitan area. Our study used a user-centered and behavior theory-based approach to achieve the following two aims: (1) use mixed methods to identify health care provider barriers to the use of an active CDS tool for PE risk stratification and (2) develop a new CDS tool-the PE risk calculator-that addresses behavioral barriers to health care providers' adoption of CDS by incorporating nudges into the user interface. These aims were guided by the revised Observational Research Behavioral Information Technology model. A total of 50 clinicians who used the original version of the tool were surveyed with a quantitative instrument that we developed based on a behavior theory framework-the Capability-Opportunity-Motivation-Behavior framework. A semistructured interview guide was developed based on the survey responses. Inductive methods were used to analyze interview session notes and audio recordings from 12 interviews. Revised versions of the tool were developed that incorporated nudges. RESULTS:Functional prototypes were developed by using Axure PRO (Axure Software Solutions) software and usability tested with end users in an iterative agile process (n=10). The tool was redesigned to address 4 identified major barriers to tool use; we included 2 nudges and a default. The 6-month pilot trial for the tool was launched on October 1, 2021. CONCLUSIONS:Clinicians highlighted several important psychological and behavioral barriers to CDS use. Addressing these barriers, along with conducting traditional usability testing, facilitated the development of a tool with greater potential to transform clinical care. The tool will be tested in a prospective pilot trial. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/42653.

Background: Family support is important in assisting with diabetes self-management for individuals with cognitive impairment, but what types of family support are most effective remain unknown. Objectives: We aimed to examine the association between the types of family support in diabetes self-management with glycemic control in middle-aged and older adults with cognitive impairment. Methods: A total of 267 individuals were included with diabetes and cognitive impairment (27-point Telephone Interview for Cognitive Status score <12), using the data of 2003 Health and Retirement Study (HRS) Diabetes Study and 2004 wave of the HRS. Results: Most respondents were White (68.9%), followed by Black (25.8%). The mean age was 73.4±8.4 years. Adults with strong family support (as indicated by a "strongly agree" response) in testing sugar and in handling feelings about diabetes had significantly lower A1C compared with those with less family support (mean ± standard deviation: 7.08±1.39 vs. 7.51±1.42, P=.03; 6.79±0.87 vs. 7.57±1.53; P=.007 respectively). Conclusions: Our findings indicate that family members of individuals with cognitive impairment provide critical support to patients with diabetes and cognitive impairment, and may need additional intervention to assist with diabetes self-management tasks that require unique knowledge and skills.

Background: Remote patient monitoring (RPM) technologies can support patients living with chronic conditions through self-monitoring of physiological measures and enhance clinicians"™ diagnostic and treatment decisions. However, to date, large-scale pragmatic RPM implementation within health systems has been limited, and understanding of the impacts of RPM technologies on clinical workflows and care experience is lacking. Objective: In this study, we evaluate the early implementation of operational RPM initiatives for chronic disease management within the ambulatory network of an academic medical center in New York City, focusing on the experiences of "early adopter" clinicians and patients. Methods: Using a multimethod qualitative approach, we conducted (1) interviews with 13 clinicians across 9 specialties considered as early adopters and supporters of RPM and (2) speculative design sessions exploring the future of RPM in clinical care with 21 patients and patient representatives, to better understand experiences, preferences, and expectations of pragmatic RPM use for health care delivery. Results: We identified themes relevant to RPM implementation within the following areas: (1) data collection and practices, including impacts of taking real-world measures and issues of data sharing, security, and privacy; (2) proactive and preventive care, including proactive and preventive monitoring, and proactive interventions and support; and (3) health disparities and equity, including tailored and flexible care and implicit bias. We also identified evidence for mitigation and support to address challenges in each of these areas. Conclusions: This study highlights the unique contexts, perceptions, and challenges regarding the deployment of RPM in clinical practice, including its potential implications for clinical workflows and work experiences. Based on these findings, we offer implementation and design recommendations for health systems interested in deploying RPM-enabled health care.

Background: Through our work, we have demonstrated how clinical decision support (CDS) tools integrated into the electronic health record (EHR) assist providers in adopting evidence-based practices. This requires confronting technical challenges that result from relying on the EHR as the foundation for tool development; for example, the individual CDS tools need to be built independently for each different EHR. Objective: The objective of our research was to build and implement an EHR-agnostic platform for integrating CDS tools, which would remove the technical constraints inherent in relying on the EHR as the foundation and enable a single set of CDS tools that can work with any EHR. Methods: We developed EvidencePoint, a novel, cloud-based, EHR-agnostic CDS platform, and we will describe the development of EvidencePoint and the deployment of its initial CDS tools, which include EHR-integrated applications for clinical use cases such as prediction of hospitalization survival for patients with COVID-19, venous thromboembolism prophylaxis, and pulmonary embolism diagnosis. Results: The results below highlight the adoption of the CDS tools, the International Medical Prevention Registry on Venous Thromboembolism-D-Dimer, the Wells' criteria, and the Northwell COVID-19 Survival (NOCOS), following development, usability testing, and implementation. The International Medical Prevention Registry on Venous Thromboembolism-D-Dimer CDS was used in 5249 patients at the 2 clinical intervention sites. The intervention group tool adoption was 77.8% (4083/5249 possible uses). For the NOCOS tool, which was designed to assist with triaging patients with COVID-19 for hospital admission in the event of constrained hospital resources, the worst-case resourcing scenario never materialized and triaging was never required. As a result, the NOCOS tool was not frequently used, though the EvidencePoint platform's flexibility and customizability enabled the tool to be developed and deployed rapidly under the emergency conditions of the pandemic. Adoption rates for the Wells' criteria tool will be reported in a future publication. Conclusions: The EvidencePoint system successfully demonstrated that a flexible, user-friendly platform for hosting CDS tools outside of a specific EHR is feasible. The forthcoming results of our outcomes analyses will demonstrate the adoption rate of EvidencePoint tools as well as the impact of behavioral economics "nudges" on the adoption rate. Due to the EHR-agnostic nature of EvidencePoint, the development process for additional forms of CDS will be simpler than traditional and cumbersome IT integration approaches and will benefit from the capabilities provided by the core system of EvidencePoint.

BACKGROUND/UNASSIGNED:Family support is important in assisting with diabetes self-management for individuals with cognitive impairment, but what types of family support are most effective remain unknown. OBJECTIVES/UNASSIGNED:We aimed to examine the association between the types of family support in diabetes self-management with glycemic control in middle-aged and older adults with cognitive impairment. METHODS/UNASSIGNED:A total of 267 individuals were included with diabetes and cognitive impairment (27-point Telephone Interview for Cognitive Status score <12), using the data of 2003 Health and Retirement Study (HRS) Diabetes Study and 2004 wave of the HRS. RESULTS/UNASSIGNED:=.007 respectively). CONCLUSIONS/UNASSIGNED:Our findings indicate that family members of individuals with cognitive impairment provide critical support to patients with diabetes and cognitive impairment, and may need additional intervention to assist with diabetes self-management tasks that require unique knowledge and skills.