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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

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: NCT05275920).
PMID: 36640860
ISSN: 1097-6744
CID: 5403312

Effects of Real-time Prescription Benefit Recommendations on Patient Out-of-Pocket Costs: A Cluster Randomized Clinical Trial

Desai, Sunita M; Chen, Alan Z; Wang, Jiejie; Chung, Wei-Yi; Stadelman, Jay; Mahoney, Chris; Szerencsy, Adam; Anzisi, Lisa; Mehrotra, Ateev; Horwitz, Leora I
Importance/UNASSIGNED:Rising drug costs contribute to medication nonadherence and adverse health outcomes. Real-time prescription benefit (RTPB) systems present prescribers with patient-specific out-of-pocket cost estimates and recommend lower-cost, clinically appropriate alternatives at the point of prescribing. Objective/UNASSIGNED:To investigate whether RTPB recommendations lead to reduced patient out-of-pocket costs for medications. Design, Setting, and Participants/UNASSIGNED:In this cluster randomized trial, medical practices in a large, urban academic health system were randomly assigned to RTPB recommendations from January 13 to July 31, 2021. Participants were adult patients receiving outpatient prescriptions during the study period. The analysis was limited to prescriptions for which RTPB could recommend an available alternative. Electronic health record data were used to analyze the intervention's effects on prescribing. Data analyses were performed from August 20, 2021, to June 8, 2022. Interventions/UNASSIGNED:When a prescription was initiated in the electronic health record, the RTPB system recommended available lower-cost, clinically appropriate alternatives for a different medication, length of prescription, and/or choice of pharmacy. The prescriber could select either the initiated order or one of the recommended options. Main Outcomes and Measures/UNASSIGNED:Patient out-of-pocket cost for a prescription. Secondary outcomes were whether a mail-order prescription and a 90-day supply were ordered. Results/UNASSIGNED:Of 867 757 outpatient prescriptions at randomized practices, 36 419 (4.2%) met the inclusion criteria of having an available alternative. Out-of-pocket costs were $39.90 for a 30-day supply in the intervention group and $67.80 for a 30-day supply in the control group. The intervention led to an adjusted 11.2%; (95% CI, -15.7% to -6.4%) reduction in out-of-pocket costs. Mail-order pharmacy use was 9.6% and 7.6% in the intervention and control groups, respectively (adjusted 1.9 percentage point increase; 95% CI, 0.9 to 3.0). Rates of 90-day supply were not different. In high-cost drug classes, the intervention reduced out-of-pocket costs by 38.9%; 95% CI, -47.6% to -28.7%. Conclusions and Relevance/UNASSIGNED:This cluster randomized clinical trial showed that RTPB recommendations led to lower patient out-of-pocket costs, with the largest savings occurring for high-cost medications. However, RTPB recommendations were made for only a small percentage of prescriptions. Trial Registration/ Identifier: NCT04940988; American Economic Association Registry: AEARCTR-0006909.
PMID: 36094537
ISSN: 2168-6114
CID: 5332742

Implementing the physical activity vital sign in an academic preventive cardiology clinic

McCarthy, Margaret M; Fletcher, Jason; Heffron, Sean; Szerencsy, Adam; Mann, Devin; Vorderstrasse, Allison
The aims were to implement physical activity (PA) screening as part of the electronic kiosk check-in process in an adult preventive cardiology clinic and assess factors related to patients' self-reported PA. The 3-question physical activity vital sign (PAVS) was embedded in the Epic electronic medical record and included how many days, minutes and intensity (light, moderate, vigorous) of PA patients conducted on average. This is a data analysis of PAVS data over a 60-day period. We conducted multivariable logistic regression to identify factors associated with not meeting current PA recommendations. Over 60 days, a total of 1322 patients checked into the clinic using the kiosk and 72% (n = 951) completed the PAVS at the kiosk. The majority of those patients were male (58%) and White (71%) with a mean age of 64 ± 15 years. Of the 951 patients completing the PAVS, 10% reported no PA, 55% reported some PA, and 35% reported achieving at least 150 min moderate or 75 min vigorous PA/week. In the logistic model, females (AOR = 1.4, 95%CI: 1.002-1.8, p = .049) vs. males, being Black (AOR = 2.0, 95%CI: 1.04-3.7, p = .038) or 'Other' race (AOR = 1.5, 95%CI: 1.02-2.3, p = .035) vs. White, unknown or other types of relationships (AOR = 0.0.26, 95%CI: 0.10-0.68, p = .006) vs. being married/partnered, and those who were retired (AOR = 1.9, 95% CI: 1.4-2.8, p < .001) or unemployed (AOR = 2.2, 95%CI: 1.3-3.7, p = .002) vs. full-time workers were associated with not achieving recommended levels of PA. The PAVS is a feasible electronic tool for quickly assessing PA and may prompt providers to counsel on this CVD risk factor.
PMID: 34150483
ISSN: 2211-3355
CID: 4936852

Applying A/B Testing to Clinical Decision Support: Rapid Randomized Controlled Trials

Austrian, Jonathan; Mendoza, Felicia; Szerencsy, Adam; Fenelon, Lucille; Horwitz, Leora I; Jones, Simon; Kuznetsova, Masha; Mann, Devin M
BACKGROUND:Clinical decision support (CDS) is a valuable feature of electronic health records (EHRs) designed to improve quality and safety. However, due to the complexities of system design and inconsistent results, CDS tools may inadvertently increase alert fatigue and contribute to physician burnout. A/B testing, or rapid-cycle randomized tests, is a useful method that can be applied to the EHR in order to rapidly understand and iteratively improve design choices embedded within CDS tools. OBJECTIVE:This paper describes how rapid randomized controlled trials (RCTs) embedded within EHRs can be used to quickly ascertain the superiority of potential CDS design changes to improve their usability, reduce alert fatigue, and promote quality of care. METHODS:A multistep process combining tools from user-centered design, A/B testing, and implementation science was used to understand, ideate, prototype, test, analyze, and improve each candidate CDS. CDS engagement metrics (alert views, acceptance rates) were used to evaluate which CDS version is superior. RESULTS:To demonstrate the impact of the process, 2 experiments are highlighted. First, after multiple rounds of usability testing, a revised CDS influenza alert was tested against usual care CDS in a rapid (~6 weeks) RCT. The new alert text resulted in minimal impact on reducing firings per patients per day, but this failure triggered another round of review that identified key technical improvements (ie, removal of dismissal button and firings in procedural areas) that led to a dramatic decrease in firings per patient per day (23.1 to 7.3). In the second experiment, the process was used to test 3 versions (financial, quality, regulatory) of text supporting tobacco cessation alerts as well as 3 supporting images. Based on 3 rounds of RCTs, there was no significant difference in acceptance rates based on the framing of the messages or addition of images. CONCLUSIONS:These experiments support the potential for this new process to rapidly develop, deploy, and rigorously evaluate CDS within an EHR. We also identified important considerations in applying these methods. This approach may be an important tool for improving the impact of and experience with CDS. TRIAL REGISTRATION/BACKGROUND:Flu alert trial: NCT03415425; Tobacco alert trial: NCT03714191;
PMID: 33835035
ISSN: 1438-8871
CID: 4840962

Giving Your Electronic Health Record a Checkup After COVID-19: A Practical Framework for Reviewing Clinical Decision Support in Light of the Telemedicine Expansion

Feldman, Jonah; Szerencsy, Adam; Mann, Devin; Austrian, Jonathan; Kothari, Ulka; Heo, Hye; Barzideh, Sam; Hickey, Maureen; Snapp, Catherine; Aminian, Rod; Jones, Lauren; Testa, Paul
BACKGROUND:The transformation of health care during COVID-19, with the rapid expansion of telemedicine visits, presents new challenges to chronic care and preventive health providers. Clinical decision support (CDS) is critically important to chronic care providers, and CDS malfunction is common during times of change. It is essential to regularly reassess an organization's ambulatory CDS program to maintain care quality. This is especially true after an immense change, like the COVID-19 telemedicine expansion. OBJECTIVE:Our objective is to reassess the ambulatory CDS program at a large academic medical center in light of telemedicine's expansion in response to the COVID-19 pandemic. METHODS:Our clinical informatics team devised a practical framework for an intrapandemic ambulatory CDS assessment focused on the impact of the telemedicine expansion. This assessment began with a quantitative analysis comparing CDS alert performance in the context of in-person and telemedicine visits. Board-certified physician informaticists then completed a formal workflow review of alerts with inferior performance in telemedicine visits. Informaticists then reported on themes and optimization opportunities through the existing CDS governance structure. RESULTS:Our assessment revealed that 10 of our top 40 alerts by volume were not firing as expected in telemedicine visits. In 3 of the top 5 alerts, providers were significantly less likely to take action in telemedicine when compared to office visits. Cumulatively, alerts in telemedicine encounters had an action taken rate of 5.3% (3257/64,938) compared to 8.3% (19,427/233,636) for office visits. Observations from a clinical informaticist workflow review included the following: (1) Telemedicine visits have different workflows than office visits. Some alerts developed for the office were not appearing at the optimal time in the telemedicine workflow. (2) Missing clinical data is a common reason for the decreased alert firing seen in telemedicine visits. (3) Remote patient monitoring and patient-reported clinical data entered through the portal could replace data collection usually completed in the office by a medical assistant or registered nurse. CONCLUSIONS:In a large academic medical center at the pandemic epicenter, an intrapandemic ambulatory CDS assessment revealed clinically significant CDS malfunctions that highlight the importance of reassessing ambulatory CDS performance after the telemedicine expansion.
PMID: 33400683
ISSN: 2291-9694
CID: 4767802

Patient Experience With Notification of Radiology Results: A Comparison of Direct Communication and Patient Portal Use

Garry, Kira; Blecker, Saul; Saag, Harry; Szerencsy, Adam; Jones, Simon A; Testa, Paul; Kang, Stella
OBJECTIVE:Patients increasingly access radiology results through digital portals. We compared patient satisfaction and understanding of radiology results when received through an electronic patient portal versus direct communication from providers. METHODS:tests and logistic regression. RESULTS:Of 1,005 survey respondents, 87.8% (882 of 1,005) reported having received their imaging test results, with 486 (48.4%) first being notified through the patient portal and 396 (39.4%) via direct provider communication. Patients reported high levels of satisfaction with timing regardless of whether they first received the results through the patient portal or through direct provider communication (88.8%-89.9%). Patients who first received their results through the patient portal reported a lesser degree of perceived understanding than those who first received their results through direct provider communication (26.7% versus 47.8%; P < .001). Patients were less likely to report clear understanding for advanced imaging (CT or MRI) than ultrasound or x-rays (29.3% versus 40.3% versus 38.2%, respectively; P = .02). Patient characteristics showed no association with understanding in multivariable analysis. CONCLUSION/CONCLUSIONS:As online portal release of radiology results to patients becomes commonplace, efforts may be warranted to improve patient experience when first receiving their radiology results online.
PMID: 32289281
ISSN: 1558-349x
CID: 4401322

Implementing the Physical Activity Vital Sign in an Academic Preventive Cardiology Clinic [Meeting Abstract]

McCarthy, Margaret M.; Heffron, Sean; Fletcher, Jason; Szerencsy, Adam; Mann, Devin; Vorderstrasse, Allison
ISSN: 0009-7322
CID: 4688862

User-Centered Development of a Behavioral Economics Inspired Electronic Health Record Clinical Decision Support Module

Chokshi, Sara Kuppin; Troxel, Andrea; Belli, Hayley; Schwartz, Jessica; Blecker, Saul; Blaum, Caroline; Szerencsy, Adam; Testa, Paul; Mann, Devin
Changing physician behaviors is difficult. Electronic health record (EHR) clinical decision support (CDS) offers an opportunity to promote guideline adherence. Behavioral economics (BE) has shown success as an approach to supporting evidence-based decision-making with little additional cognitive burden. We applied a user-centered approach to incorporate BE "nudges" into a CDS module in two "vanguard" sites utilizing: (1) semi-structured interviews with key informants (n = 8); (2) a design thinking workshop; and (3) semi-structured group interviews with clinicians. In the 133 day development phase at two clinics, the navigator section fired 299 times for 27 unique clinicians. The inbasket refill alert fired 124 times for 22 clinicians. Fifteen prescriptions for metformin were written by 11 clinicians. Our user-centered approach yielded a BE-driven CDS module with relatively high utilization by clinicians. Next steps include the addition of two modules and continued tracking of utilization, and assessment of clinical impact of the module.
PMID: 31438106
ISSN: 1879-8365
CID: 4046992


Chokshi, Sara; Troxel, Andrea B.; Belli, Hayley; Schwartz, Jessica; Blecker, Saul; Blaum, Caroline; Szerencsy, Adam; Testa, Paul; Mann, Devin
ISSN: 0883-6612
CID: 4181082