Lung Cancer Screening Before and After a Multifaceted Electronic Health Record Intervention: A Nonrandomized Controlled Trial.

Importance: Lung cancer is the deadliest cancer in the US. Early-stage lung cancer detection with lung cancer screening (LCS) through low-dose computed tomography (LDCT) improves outcomes. Objective: To assess the association of a multifaceted clinical decision support intervention with rates of identification and completion of recommended LCS-related services. Design, Setting, and Participants: This nonrandomized controlled trial used an interrupted time series design, including 3 study periods from August 24, 2019, to April 27, 2022: baseline (12 months), period 1 (11 months), and period 2 (9 months). Outcome changes were reported as shifts in the outcome level at the beginning of each period and changes in monthly trend (ie, slope). The study was conducted at primary care and pulmonary clinics at a health care system headquartered in Salt Lake City, Utah, among patients aged 55 to 80 years who had smoked 30 pack-years or more and were current smokers or had quit smoking in the past 15 years. Data were analyzed from September 2023 through February 2024. Interventions: Interventions in period 1 included clinician-facing preventive care reminders, an electronic health record-integrated shared decision-making tool, and narrative LCS guidance provided in the LDCT ordering screen. Interventions in period 2 included the same clinician-facing interventions and patient-facing reminders for LCS discussion and LCS. Main Outcome and Measure: The primary outcome was LCS care gap closure, defined as the identification and completion of recommended care services. LCS care gap closure could be achieved through LDCT completion, other chest CT completion, or LCS shared decision-making. Results: The study included 1865 patients (median [IQR] age, 64 [60-70] years; 759 female [40.7%]). The clinician-facing intervention (period 1) was not associated with changes in level but was associated with an increase in slope of 2.6 percentage points (95% CI, 2.4-2.7 percentage points) per month in care gap closure through any means and 1.6 percentage points (95% CI, 1.4-1.8 percentage points) per month in closure through LDCT. In period 2, introduction of patient-facing reminders was associated with an immediate increase in care gap closure (2.3 percentage points; 95% CI, 1.0-3.6 percentage points) and closure through LDCT (2.4 percentage points; 95% CI, 0.9-3.9 percentage points) but was not associated with an increase in slope. The overall care gap closure rate was 175 of 1104 patients (15.9%) at the end of the baseline period vs 588 of 1255 patients (46.9%) at the end of period 2. Conclusions and Relevance: In this study, a multifaceted intervention was associated with an improvement in LCS care gap closure. Trial Registration: ClinicalTrials.gov Identifier: NCT04498052.

Shape Expressions (ShEx) schemas for the FHIR R5 specification.

This work continues along a visionary path of using Semantic Web standards such as RDF and ShEx to make healthcare data easier to integrate for research and leading-edge patient care. The work extends the ability to use ShEx schemas to validate FHIR RDF data, thereby enhancing the semantic web ecosystem for working with FHIR and non-FHIR data using the same ShEx validation framework. It updates FHIR's ShEx schemas to fix outstanding issues and reflect changes in the definition of FHIR RDF. In addition, it experiments with expressing FHIRPath constraints (which are not captured in the XML or JSON schemas) in ShEx schemas. These extended ShEx schemas were incorporated into the FHIR R5 specification and used to successfully validate FHIR R5 examples that are included with the FHIR specification, revealing several errors in the examples.

GARDE: a standards-based clinical decision support platform for identifying population health management cohorts.

Population health management (PHM) is an important approach to promote wellness and deliver health care to targeted individuals who meet criteria for preventive measures or treatment. A critical component for any PHM program is a data analytics platform that can target those eligible individuals. OBJECTIVE: The aim of this study was to design and implement a scalable standards-based clinical decision support (CDS) approach to identify patient cohorts for PHM and maximize opportunities for multi-site dissemination. MATERIALS AND METHODS: An architecture was established to support bidirectional data exchanges between heterogeneous electronic health record (EHR) data sources, PHM systems, and CDS components. HL7 Fast Healthcare Interoperability Resources and CDS Hooks were used to facilitate interoperability and dissemination. The approach was validated by deploying the platform at multiple sites to identify patients who meet the criteria for genetic evaluation of familial cancer. RESULTS: The Genetic Cancer Risk Detector (GARDE) platform was created and is comprised of four components: (1) an open-source CDS Hooks server for computing patient eligibility for PHM cohorts, (2) an open-source Population Coordinator that processes GARDE requests and communicates results to a PHM system, (3) an EHR Patient Data Repository, and (4) EHR PHM Tools to manage patients and perform outreach functions. Site-specific deployments were performed on onsite virtual machines and cloud-based Amazon Web Services. DISCUSSION: GARDE's component architecture establishes generalizable standards-based methods for computing PHM cohorts. Replicating deployments using one of the established deployment methods requires minimal local customization. Most of the deployment effort was related to obtaining site-specific information technology governance approvals.

Evaluation in Life Cycle of Information Technology (ELICIT) framework: Supporting the innovation life cycle from business case assessment to summative evaluation.

OBJECTIVE: Our objective was to develop an evaluation framework for electronic health record (EHR)-integrated innovations to support evaluation activities at each of four information technology (IT) life cycle phases: planning, development, implementation, and operation. METHODS: The evaluation framework was developed based on a review of existing evaluation frameworks from health informatics and other domains (human factors engineering, software engineering, and social sciences); expert consensus; and real-world testing in multiple EHR-integrated innovation studies. RESULTS: The resulting Evaluation in Life Cycle of IT (ELICIT) framework covers four IT life cycle phases and three measure levels (society, user, and IT). The ELICIT framework recommends 12 evaluation steps: (1) business case assessment; (2) stakeholder requirements gathering; (3) technical requirements gathering; (4) technical acceptability assessment; (5) user acceptability assessment; (6) social acceptability assessment; (7) social implementation assessment; (8) initial user satisfaction assessment; (9) technical implementation assessment; (10) technical portability assessment; (11) long-term user satisfaction assessment; and (12) social outcomes assessment. DISCUSSION: Effective evaluation requires a shared understanding and collaboration across disciplines throughout the entire IT life cycle. In contrast with previous evaluation frameworks, the ELICIT framework focuses on all phases of the IT life cycle across the society, user, and IT levels. Institutions seeking to establish evaluation programs for EHR-integrated innovations could use our framework to create such shared understanding and justify the need to invest in evaluation. CONCLUSION: As health care undergoes a digital transformation, it will be critical for EHR-integrated innovations to be systematically evaluated. The ELICIT framework can facilitate these evaluations.

Establishing a multidisciplinary initiative for interoperable electronic health record innovations at an academic medical center.

OBJECTIVE: To establish an enterprise initiative for improving health and health care through interoperable electronic health record (EHR) innovations. MATERIALS AND METHODS: We developed a unifying mission and vision, established multidisciplinary governance, and formulated a strategic plan. Key elements of our strategy include establishing a world-class team; creating shared infrastructure to support individual innovations; developing and implementing innovations with high anticipated impact and a clear path to adoption; incorporating best practices such as the use of Fast Healthcare Interoperability Resources (FHIR) and related interoperability standards; and maximizing synergies across research and operations and with partner organizations. RESULTS: University of Utah Health launched the ReImagine EHR initiative in 2016. Supportive infrastructure developed by the initiative include various FHIR-related tooling and a systematic evaluation framework. More than 10 EHR-integrated digital innovations have been implemented to support preventive care, shared decision-making, chronic disease management, and acute clinical care. Initial evaluations of these innovations have demonstrated positive impact on user satisfaction, provider efficiency, and compliance with evidence-based guidelines. Return on investment has included improvements in care; over $35 million in external grant funding; commercial opportunities; and increased ability to adapt to a changing healthcare landscape. DISCUSSION: Key lessons learned include the value of investing in digital innovation initiatives leveraging FHIR; the importance of supportive infrastructure for accelerating innovation; and the critical role of user-centered design, implementation science, and evaluation. CONCLUSION: EHR-integrated digital innovation initiatives can be key assets for enhancing the EHR user experience, improving patient care, and reducing provider burnout.

Integrated displays to improve chronic disease management in ambulatory care: A SMART on FHIR application informed by mixed-methods user testing.

OBJECTIVE: The study sought to evaluate a novel electronic health record (EHR) add-on application for chronic disease management that uses an integrated display to decrease user cognitive load, improve efficiency, and support clinical decision making. MATERIALS AND METHODS: We designed a chronic disease management application using the technology framework known as SMART on FHIR (Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources). We used mixed methods to obtain user feedback on a prototype to support ambulatory providers managing chronic obstructive pulmonary disease. Each participant managed 2 patient scenarios using the regular EHR with and without access to our prototype in block-randomized order. The primary outcome was the percentage of expert-recommended ideal care tasks completed. Timing, keyboard and mouse use, and participant surveys were also collected. User experiences were captured using a retrospective think-aloud interview analyzed by concept coding. RESULTS: With our prototype, the 13 participants completed more recommended care (81% vs 48%; P < .001) and recommended tasks per minute (0.8 vs 0.6; P = .03) over longer sessions (7.0 minutes vs 5.4 minutes; P = .006). Keystrokes per task were lower with the prototype (6 vs 18; P < .001). Qualitative themes elicited included the desire for reliable presentation of information which matches participants' mental models of disease and for intuitive navigation in order to decrease cognitive load. DISCUSSION: Participants completed more recommended care by taking more time when using our prototype. Interviews identified a tension between using the inefficient but familiar EHR vs learning to use our novel prototype. Concept coding of user feedback generated actionable insights. CONCLUSIONS: Mixed methods can support the design and evaluation of SMART on FHIR EHR add-on applications by enhancing understanding of the user experience.

Standards-Based Clinical Decision Support Platform to Manage Patients Who Meet Guideline-Based Criteria for Genetic Evaluation of Familial Cancer.

PURPOSE: The ubiquitous adoption of electronic health records (EHRs) with family health history (FHH) data provides opportunities for tailoring cancer screening strategies to individuals. We aimed to enable a standards-based clinical decision support (CDS) platform for identifying and managing patients who meet guidelines for genetic evaluation of hereditary cancer. METHODS: The CDS platform (www.opencds.org) was used to implement algorithms based on the 2018 National Comprehensive Cancer Network guidelines for genetic evaluation of hereditary breast/ovarian and colorectal cancer. The platform was designed to be interfaced with different EHR systems via the Health Level Seven International Fast Healthcare Interoperability Resources standard. The platform was integrated with the Epic EHR and evaluated in a pilot study at an academic health care system. RESULTS: The CDS platform was executed against a target population of 143,012 patients; 5,245 (3.7%) met criteria for genetic evaluation based on the FHH recorded in the EHR. In a clinical pilot study, genetic counselors attempted to reach out to 71 of the patients. Of those patients, 25 (35%) scheduled an appointment, 10 (14%) declined, 2 (3%) did not need genetic counseling, 7 (10%) said they would consider it in the future, and 27 (38%) were unreachable. To date, 13 (52%) of the scheduled patients completed visits, and 2 (15%) of those were found to have pathogenic variants in cancer predisposition genes. CONCLUSION: A standards-based CDS platform integrated with EHR systems is a promising population-based approach to identify patients who are appropriate candidates for genetic evaluation of hereditary cancers.

Balancing Functionality versus Portability for SMART on FHIR Applications: Case Study for a Neonatal Bilirubin Management Application.

SMART on FHIR applications are standards-based tools integrated with electronic health record (EHR) systems and intended for dissemination across EHR platforms. A key challenge for disseminating many apps is that EHR vendors provide different levels of support for FHIR. Thus, app developers must balance functionality versus portability. In this case study, a feature-rich app for neonatal bilirubin management was developed prioritizing physician-requested functionality, with custom FHIR interfaces implemented within the EHR as needed. Following wide intra-institutional use, several approaches are being pursued for adapting the app for cross-institutional dissemination: user surveys and interviews to identify least-valued app features which could potentially be omitted; enabling the application to provide differential features depending on available EHR FHIR capabilities; replacing custom FHIR interfaces with native EHR FHIR interfaces as they became available; and using a canonical logical data model known as QUICK that can be mapped to different FHIR versions and profiles.