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.

Translating Social Determinants of Health into Standardized Clinical Entities.

Social determinants of health (SDH) are a valuable source of health information which still are not fully utilized in the clinical space. Knowing that a certain patient has trouble finding transportation, has a potentially hazardous relationship with a family member or close relative, is currently unemployed, or various other social factors would allow providers to tailor treatment plans in a way to best help that patient. However, these SDH must be gathered, represented, and stored in a standardized way before they can be leveraged by informatics tools designed for health providers. This process of translating SDH to standardized clinical entities includes two main steps. The first is a collaborative effort to establish an ontology of medical terminology codes (i.e., ICD, SNOMED, LOINC, etc.) which can be used to uniformly represent SDH as coded concepts. The second is a collaborative effort to use the FHIR standard to create profiles and extensions which will allow FHIR resources to be used to store the coded SDH as clinical entities. Each of these steps has their own complexities that must be considered and accounted for in future efforts to create interoperable clinical informatics solutions which utilize SDH.

QuitSMART Utah: an implementation study protocol for a cluster-randomized, multi-level Sequential Multiple Assignment Randomized Trial to increase Reach and Impact of tobacco cessation treatment in Community Health Centers.

BACKGROUND: Tobacco use remains the leading cause of death and disability in the USA and is disproportionately concentrated among low socioeconomic status (SES) populations. Community Health Centers (CHCs) are a key venue for reaching low SES populations with evidence-based tobacco cessation treatment such as Quitlines. Electronic health record (EHR)-based interventions at the point-of-care, text messaging (TM), and phone counseling have the potential to increase Quitline reach and are feasible to implement within CHCs. However, there is a lack of data to inform how, when, and in what combination these strategies should be implemented. The aims of this cluster-randomized trial are to evaluate multi-level implementation strategies to increase the Reach (i.e., proportion of tobacco-using patients who enroll in the Quitline) and Impact (i.e., Reach × Efficacy [efficacy is defined as the proportion of tobacco-using patients who enroll in Quitline treatment that successfully quit]) and to evaluate characteristics of healthcare system, providers, and patients that may influence tobacco-use outcomes. METHODS: This study is a multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART), conducted in CHCs (N = 33 clinics; N = 6000 patients). In the first phase, clinics will be randomized to two different EHR conditions. The second and third phases are patient-level randomizations based on prior treatment response. Patients who enroll in the Quitline receive no further interventions. In phase two, patients who are non-responders (i.e., patients who do not enroll in Quitline) will be randomized to receive either TM or continued-EHR. In phase three, patients in the TM condition who are non-responders will be randomized to receive either continued-TM or TM + phone coaching. DISCUSSION: This project will evaluate scalable, multi-level interventions to directly address strategic national priorities for reducing tobacco use and related disparities by increasing the Reach and Impact of evidence-based tobacco cessation interventions in low SES populations. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT03900767) on April 4th, 2019.

[Legal framework for electronic medical records in the Region of the Americas: definition of domains to legislate and situation analysisEnquadramento legal para os registros eletrônicos em saúde na Região das Américas: definição de domínios para regulamentação e análise da situação]. / Marco legal para registros médicos electrónicos en la Región de las Américas: definición de dominios a legislar y análisis de situación.

OBJECTIVES: Define a legal framework for electronic medical records (EMRs) and determine the degree to which the countries of the Region of the Americas are prepared in this regard. METHODS: The methodology consisted of two phases. In the first, a Delphi methodology was used to develop a questionnaire and define the framework and legal domains applicable to EMRs. In the second, the questionnaire was completed in each country. This included identifying national experts and the data collection process. RESULTS: Information was collected from a total of 21 countries regarding their situation with respect to legislation on EMRs in the following domains: 1) specific legislation on EMRs; 2) protection of patients' data and secondary use of the data; 3) legislation related to the actions of health professionals; 4) regulation on EMRs and the role of patients; and 5) health standards and EMR promotion programs. CONCLUSIONS: There has been progress in the Region with respect to new legislation covering the main areas related to EMRs (for example, protection of sensitive data and use of digital signatures). However, it is necessary to continue to address issues such as access to and updating of information in EMRs. This study contributes information on the essential components of legislation on EMRs, and reports on the situation in the Region of the Americas.

OBJETIVOS: Definir um enquadramento legal para os registros eletrônicos em saúde (RES) e identificar o grau de preparação dos países da Região das Américas neste sentido. MÉTODOS: A metodologia do estudo foi dividida em duas fases. Na primeira fase, foi usado o método Delphi para elaborar o questionário e definir o enquadramento e os domínios legais para RES. Na segunda fase, foi realizada a pesquisa por país, com a identificação de dados referentes nacionais e processo de coleta de dados. RESULTADOS: Ao todo, foram obtidos dados de 21 países sobre os aspectos legais e RES distribuídos nos seguintes domínios: 1) legislação específica para RES, 2) proteção dos dados dos pacientes e uso secundário da informação, 3) legislação relacionada à atuação dos profissionais da saúde, 4) regulamentação dos RES e papel dos pacientes e 5) padrões em saúde e programas de promoção dos RES. CONCLUSÕES: Houve progresso na Região quanto à promulgação de leis que abrangem os principais domínios dos RES (p. ex., proteção de dados sensíveis ou o uso de assinatura digital). Porém, alguns aspectos precisam ser reforçados, como o acesso e a atualização das informações nos registros. Este estudo contribui ao descrever os aspectos básicos da regulamentação e informar a situação dos RES na Região das Américas.

Understanding Primary Care Providers' Information Gathering Strategies in the Care of Children and Youth with Special Health Care Needs.

Background: Effective care coordination of children and youth with special health care needs (CYSHCN) is critical but challenging. Objective: To investigate clinicians' information-gathering strategies while preparing for visits with CYSHCN. Methods: Critical incident interviews with primary care physicians and care coordinators. Results: Six themes emerged indicating 1) substantial reliance on the electronic health record; 2) a central role of the problem list in organizing and summarizing information; 3) Medical Home's central role in organizing clinical documentation; 4) universal need to integrate information from external records; 5) lack of well-organized and labeled encounter documentation; and 6) lack of tools reconcile medication lists. Conclusion: Our findings have important implications to the design of informatics tools to support information-gathering in the care of CYSHCN.

Information needs of physicians, care coordinators, and families to support care coordination of children and youth with special health care needs (CYSHCN).

OBJECTIVES: Identify and describe information needs and associated goals of physicians, care coordinators, and families related to coordinating care for medically complex children and youth with special health care needs (CYSHCN). MATERIALS AND METHODS: We conducted 19 in-depth interviews with physicians, care coordinators, and parents of CYSHCN following the Critical Decision Method technique. We analyzed the interviews for information needs posed as questions using a systematic content analysis approach and categorized the questions into information need goal types and subtypes. RESULTS: The Critical Decision Method interviews resulted in an average of 80 information needs per interview. We categorized them into 6 information need goal types: (1) situation understanding, (2) care networking, (3) planning, (4) tracking/monitoring, (5) navigating the health care system, and (6) learning, and 32 subtypes. DISCUSSION AND CONCLUSION: Caring for CYSHCN generates a large amount of information needs that require significant effort from physicians, care coordinators, parents, and various other individuals. CYSHCN are often chronically ill and face developmental challenges that translate into intense demands on time, effort, and resources. Care coordination for CYCHSN involves multiple information systems, specialized resources, and complex decision-making. Solutions currently offered by health information technology fall short in providing support to meet the information needs to perform the complex care coordination tasks. Our findings present significant opportunities to improve coordination of care through multifaceted and fully integrated informatics solutions.

Problem list completeness in electronic health records: A multi-site study and assessment of success factors.

OBJECTIVE: To assess problem list completeness using an objective measure across a range of sites, and to identify success factors for problem list completeness. METHODS: We conducted a retrospective analysis of electronic health record data and interviews at ten healthcare organizations within the United States, United Kingdom, and Argentina who use a variety of electronic health record systems: four self-developed and six commercial. At each site, we assessed the proportion of patients who have diabetes recorded on their problem list out of all patients with a hemoglobin A1c elevation>=7.0%, which is diagnostic of diabetes. We then conducted interviews with informatics leaders at the four highest performing sites to determine factors associated with success. Finally, we surveyed all the sites about common practices implemented at the top performing sites to determine whether there was an association between problem list management practices and problem list completeness. RESULTS: Problem list completeness across the ten sites ranged from 60.2% to 99.4%, with a mean of 78.2%. Financial incentives, problem-oriented charting, gap reporting, shared responsibility, links to billing codes, and organizational culture were identified as success factors at the four hospitals with problem list completeness at or near 90.0%. DISCUSSION: Incomplete problem lists represent a global data integrity problem that could compromise quality of care and put patients at risk. There was a wide range of problem list completeness across the healthcare facilities. Nevertheless, some facilities have achieved high levels of problem list completeness, and it is important to better understand the factors that contribute to success to improve patient safety. CONCLUSION: Problem list completeness varies substantially across healthcare facilities. In our review of EHR systems at ten healthcare facilities, we identified six success factors which may be useful for healthcare organizations seeking to improve the quality of their problem list documentation: financial incentives, problem oriented charting, gap reporting, shared responsibility, links to billing codes, and organizational culture.