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Leveraging Electronic Health Record Technology and Team Care to Address Medication Adherence: Protocol for a Cluster Randomized Controlled Trial

Blecker, Saul; Schoenthaler, Antoinette; Martinez, Tiffany Rose; Belli, Hayley M; Zhao, Yunan; Wong, Christina; Fitchett, Cassidy; Bearnot, Harris R; Mann, Devin
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.
PMCID:10362494
PMID: 37418304
ISSN: 1929-0748
CID: 5539452

Comparison of Care Provided to Underserved Patients With Diabetes by a Telementoring Model of Care to Care Provided by a Specialty Clinic: Endo ECHO Versus an Academic Specialty Clinic

Berry, Carolyn A; Dávila Saad, Andrea; Blecker, Saul; Billings, John; Bouchonville, Matthew F; Arora, Sanjeev; Paul, Margaret M
PURPOSE:The purpose of the study was to examine differences among adult patients with diabetes who receive care through a telementoring model versus care at an academic specialty clinic on guideline-recommended diabetes care and self-management behaviors. METHODS:Endocrinology-focused Extension for Community Healthcare Outcomes (ECHO Endo) patients completed surveys assessing demographics, access to care, health care quality, and self-management behaviors at enrollment and 1 year after program enrollment. Diabetes Comprehensive Care Center (DCCC) patients completed surveys at comparable time points. RESULTS:At baseline, ECHO patients were less likely than DCCC patients to identify English as their primary language, have postsecondary education, and private insurance. One year postenrollment, ECHO patients visited their usual source of diabetic care more frequently. There were no differences in A1C testing or feet checking by health care professionals, but ECHO patients were less likely to report eye exams and smoking status assessment. ECHO and DCCC patients did not differ in consumption of high-fat foods and soda, physical activity, or home feet checks. ECHO patients were less likely to space carbohydrates evenly and test glucose levels and more likely to have smoked cigarettes. CONCLUSIONS:Endo ECHO is a suitable alternative to specialty care for patients in underserved communities with restricted access to specialty care. Results support the value of the Project ECHO telementoring model in addressing barriers to high-quality care for underserved communities.
PMID: 37129282
ISSN: 2635-0114
CID: 5502952

Interindividual Variability in Self-Monitoring of Blood Pressure Using Consumer-Purchased Wireless Devices

Zheng, Yaguang; Zhang, Yanfu; Huang, Heng; Tison, Geoffrey H; Burke, Lora E; Blecker, Saul; Dickson, Victoria Vaughan; Olgin, Jeffrey E; Marcus, Gregory M; Pletcher, Mark J
BACKGROUND:Engagement with self-monitoring of blood pressure (BP) declines, on average, over time but may vary substantially by individual. OBJECTIVES/OBJECTIVE:We aimed to describe different 1-year patterns (groups) of self-monitoring of BP behaviors, identify predictors of those groups, and examine the association of self-monitoring of BP groups with BP levels over time. METHODS:We analyzed device-recorded BP measurements collected by the Health eHeart Study-an ongoing prospective eCohort study-from participants with a wireless consumer-purchased device that transmitted date- and time-stamped BP data to the study through a full 12 months of observation starting from the first day they used the device. Participants received no instruction on device use. We applied clustering analysis to identify 1-year self-monitoring, of BP patterns. RESULTS:Participants had a mean age of 52 years and were male and White. Using clustering algorithms, we found that a model with three groups fit the data well: persistent daily use (9.1% of participants), persistent weekly use (21.2%), and sporadic use only (69.7%). Persistent daily use was more common among older participants who had higher Week 1 self-monitoring of BP frequency and was associated with lower BP levels than the persistent weekly use or sporadic use groups throughout the year. CONCLUSION/CONCLUSIONS:We identified three distinct self-monitoring of BP groups, with nearly 10% sustaining a daily use pattern associated with lower BP levels.
PMCID:10299813
PMID: 37350699
ISSN: 1538-9847
CID: 5738162

Refining Clinical Phenotypes to Improve Clinical Decision Support and Reduce Alert Fatigue: A Feasibility Study

Samal, Lipika; Wu, Edward; Aaron, Skye; Kilgallon, John L; Gannon, Michael; McCoy, Allison; Blecker, Saul; Dykes, Patricia C; Bates, David W; Lipsitz, Stuart; Wright, Adam
BACKGROUND: Chronic kidney disease (CKD) is common and associated with adverse clinical outcomes. Most care for early CKD is provided in primary care, including hypertension (HTN) management. Computerized clinical decision support (CDS) can improve the quality of care for CKD but can also cause alert fatigue for primary care physicians (PCPs). Computable phenotypes (CPs) are algorithms to identify disease populations using, for example, specific laboratory data criteria. OBJECTIVES/OBJECTIVE: Our objective was to determine the feasibility of implementation of CDS alerts by developing CPs and estimating potential alert burden. METHODS: We utilized clinical guidelines to develop a set of five CPs for patients with stage 3 to 4 CKD, uncontrolled HTN, and indications for initiation or titration of guideline-recommended antihypertensive agents. We then conducted an iterative data analytic process consisting of database queries, data validation, and subject matter expert discussion, to make iterative changes to the CPs. We estimated the potential alert burden to make final decisions about the scope of the CDS alerts. Specifically, the number of times that each alert could fire was limited to once per patient. RESULTS: In our primary care network, there were 239,339 encounters for 105,992 primary care patients between April 1, 2018 and April 1, 2019. Of these patients, 9,081 (8.6%) had stage 3 and 4 CKD. Almost half of the CKD patients, 4,191 patients, also had uncontrolled HTN. The majority of CKD patients were female, elderly, white, and English-speaking. We estimated that 5,369 alerts would fire if alerts were triggered multiple times per patient, with a mean number of alerts shown to each PCP ranging from 0.07-to 0.17 alerts per week. CONCLUSION/CONCLUSIONS: Development of CPs and estimation of alert burden allows researchers to iteratively fine-tune CDS prior to implementation. This method of assessment can help organizations balance the tradeoff between standardization of care and alert fatigue.
PMCID:10338104
PMID: 37437601
ISSN: 1869-0327
CID: 5537092

Self-reported adherence and reasons for nonadherence among patients with low proportion of days covered for antihypertension medications

Kharmats, Anna Y; Martinez, Tiffany R; Belli, Hayley; Zhao, Yunan; Mann, Devin M; Schoenthaler, Antoinette M; Voils, Corrine I; Blecker, Saul
PMID: 37121253
ISSN: 2376-1032
CID: 5502912

Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care

Mukhopadhyay, Amrita; Reynolds, Harmony R; Phillips, Lawrence M; Nagler, Arielle R; King, William C; Szerencsy, Adam; Saxena, Archana; Aminian, Rod; Klapheke, Nathan; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Mineralocorticoid receptor antagonists (MRA) are under-prescribed for patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVE:To compare effectiveness of two automated, electronic health record (EHR)-embedded tools vs. usual care on MRA prescribing in eligible patients with HFrEF. METHODS:BETTER CARE-HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) was a three-arm, pragmatic, cluster-randomized trial comparing the effectiveness of an alert during individual patient encounters vs. a message about multiple patients between encounters vs. usual care on MRA prescribing. We included adult patients with HFrEF, no active MRA prescription, no contraindication to MRA, and an outpatient cardiologist in a large health system. Patients were cluster-randomized by cardiologist (60 per arm). RESULTS:The study included 2,211 patients (alert: 755, message: 812, usual care [control]: 644), with average age 72.2 years, average EF 33%, who were predominantly male (71.4%) and White (68.9%). New MRA prescribing occurred in 29.6% of patients in the alert arm, 15.6% in the message arm, and 11.7% in the control arm. The alert more than doubled MRA prescribing compared to control (RR: 2.53, 95% CI: 1.77-3.62, p<0.0001), and improved MRA prescribing compared to the message (RR: 1.67, 95% CI: 1.21-2.29, p=0.002). The number of patients with alert needed to result in an additional MRA prescription was 5.6. CONCLUSIONS:An automated, patient-specific, EHR-embedded alert increased MRA prescribing compared to both a message and usual care. Our findings highlight the potential for EHR-embedded tools to substantially increase prescription of life-saving therapies for HFrEF. (NCT05275920).
PMID: 36882134
ISSN: 1558-3597
CID: 5430312

Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial

Blecker, Saul; Gannon, Matthew; De Leon, Samantha; Shelley, Donna; Wu, Winfred Y; Tabaei, Bahman; Magno, Janice; Pham-Singer, Hang
BACKGROUND:Only half of patients with hypertension have adequately controlled blood pressure. Clinical decision support (CDS) has the potential to overcome barriers to delivering guideline-recommended care and improve hypertension management. However, optimal strategies for scaling CDS have not been well established, particularly in small, independent primary care practices which often lack the resources to effectively change practice routines. Practice facilitation is an implementation strategy that has been shown to support process changes. Our objective is to evaluate whether practice facilitation provided with hypertension-focused CDS can lead to improvements in blood pressure control for patients seen in small primary care practices. METHODS/DESIGN/METHODS:We will conduct a cluster randomized control trial to compare the effect of hypertension-focused CDS plus practice facilitation on BP control, as compared to CDS alone. The practice facilitation intervention will include an initial training in the CDS and a review of current guidelines along with follow-up for coaching and integration support. We will randomize 46 small primary care practices in New York City who use the same electronic health record vendor to intervention or control. All patients with hypertension seen at these practices will be included in the evaluation. We will also assess implementation of CDS in all practices and practice facilitation in the intervention group. DISCUSSION/CONCLUSIONS:The results of this study will inform optimal implementation of CDS into small primary care practices, where much of care delivery occurs in the U.S. Additionally, our assessment of barriers and facilitators to implementation will support future scaling of the intervention. CLINICALTRIALS/RESULTS:gov Identifier: NCT05588466.
PMID: 37037392
ISSN: 1559-2030
CID: 5464072

Design and pilot implementation for the BETTER CARE-HF trial: A pragmatic cluster-randomized controlled trial comparing two targeted approaches to ambulatory clinical decision support for cardiologists

Mukhopadhyay, Amrita; Reynolds, Harmony R; Xia, Yuhe; Phillips, Lawrence M; Aminian, Rod; Diah, Ruth-Ann; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Beart failure with reduced ejection fraction (HFrEF) is a leading cause of morbidity and mortality. However, shortfalls in prescribing of proven therapies, particularly mineralocorticoid receptor antagonist (MRA) therapy, account for several thousand preventable deaths per year nationwide. Electronic clinical decision support (CDS) is a potential low-cost and scalable solution to improve prescribing of therapies. However, the optimal timing and format of CDS tools is unknown. METHODS AND RESULTS/RESULTS:We developed two targeted CDS tools to inform cardiologists of gaps in MRA therapy for patients with HFrEF and without contraindication to MRA therapy: (1) an alert that notifies cardiologists at the time of patient visit, and (2) an automated electronic message that allows for review between visits. We designed these tools using an established CDS framework and findings from semistructured interviews with cardiologists. We then pilot tested both CDS tools (n = 596 patients) and further enhanced them based on additional semistructured interviews (n = 11 cardiologists). The message was modified to reduce the number of patients listed, include future visits, and list date of next visit. The alert was modified to improve noticeability, reduce extraneous information on guidelines, and include key information on contraindications. CONCLUSIONS:The BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) trial aims to compare the effectiveness of the alert vs. the automated message vs. usual care on the primary outcome of MRA prescribing. To our knowledge, no study has directly compared the efficacy of these two different types of electronic CDS interventions. If effective, our findings can be rapidly disseminated to improve morbidity and mortality for patients with HFrEF, and can also inform the development of future CDS interventions for other disease states. (Trial registration: Clinicaltrials.gov NCT05275920).
PMID: 36640860
ISSN: 1097-6744
CID: 5403312

Association Between Copayment Amount and Filling of Medications for Angiotensin Receptor Neprilysin Inhibitors in Patients With Heart Failure

Mukhopadhyay, Amrita; Adhikari, Samrachana; Li, Xiyue; Dodson, John A; Kronish, Ian M; Shah, Binita; Ramatowski, Maggie; Chunara, Rumi; Kozloff, Sam; Blecker, Saul
Background Angiotensin receptor neprilysin inhibitors (ARNI) reduce mortality and hospitalization for patients with heart failure. However, relatively high copayments for ARNI may contribute to suboptimal adherence, thus potentially limiting their benefits. Methods and Results We conducted a retrospective cohort study within a large, multi-site health system. We included patients with: ARNI prescription between November 20, 2020 and June 30, 2021; diagnosis of heart failure or left ventricular ejection fraction ≤40%; and available pharmacy or pharmacy benefit manager copayment data. The primary exposure was copayment, categorized as $0, $0.01 to $10, $10.01 to $100, and >$100. The primary outcome was prescription fill nonadherence, defined as the proportion of days covered <80% over 6 months. We assessed the association between copayment and nonadherence using multivariable logistic regression, and nonbinarized proportion of days covered using multivariable Poisson regression, adjusting for demographic, clinical, and neighborhood-level covariates. A total of 921 patients met inclusion criteria, with 192 (20.8%) having $0 copayment, 228 (24.8%) with $0.01 to $10 copayment, 206 (22.4%) with $10.01 to $100, and 295 (32.0%) with >$100. Patients with higher copayments had higher rates of nonadherence, ranging from 17.2% for $0 copayment to 34.2% for copayment >$100 (P<0.001). After multivariable adjustment, odds of nonadherence were significantly higher for copayment of $10.01 to $100 (odds ratio [OR], 1.93 [95% CI, 1.15-3.27], P=0.01) or >$100 (OR, 2.58 [95% CI, 1.63-4.18], P<0.001), as compared with $0 copayment. Similar associations were seen when assessing proportion of days covered as a proportion. Conclusions We found higher rates of not filling ARNI prescriptions among patients with higher copayments, which persisted after multivariable adjustment. Our findings support future studies to assess whether reducing copayments can increase adherence to ARNI and improve outcomes for heart failure.
PMID: 36453634
ISSN: 2047-9980
CID: 5374072

The reduction in non-COVID-19 hospitalizations during the pandemic: Problematic or beneficial? [Editorial]

Blecker, Saul B; Horwitz, Leora I
PMID: 36213943
ISSN: 1553-5606
CID: 5351882