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Patient-centered care promotes the involvement of patients in decision-making related to their health care. The adoption and implementation of shared decision-making (SDM) into routine care are constrained by several obstacles, including technical and time constraints, clinician and patient attitudes and perceptions, and processes that exist outside the standardized clinical workflow. We aimed to understand the integration and implementation characteristics of reported SDM interventions integrated into an electronic health record (EHR) system. We conducted a scoping review using the methodological framework by Arksey and O'Malley with guidance from the Joanna Briggs Institute. Eligibility criteria included original research and reviews focusing on SDM situations in a real-world clinical setting and EHR integration of SDM tools and processes. We excluded retrospective studies, conference abstracts, simulation studies, user design studies, opinion pieces, and editorials. To identify eligible studies, we searched the following databases on January 11, 2021: MEDLINE, Embase, CINAHL Complete, Cochrane Library including CENTRAL, PsycINFO, Scopus, and Web of Science Core Collection. We systematically categorized descriptive data and key findings in a tabular format using predetermined data charting forms. Results were summarized using tables and associated narratives related to the review questions. Of the 2153 studies, 18 (0.84%) were included in the final review. There was a high degree of variation across studies, including SDM definitions, standardized measures, technical integration, and implementation strategies. SDM tools that targeted established health care processes promoted their use. Integrating SDM templates and tools into an EHR appeared to improve the targeted outcomes of most (17/18, 94%) studies. Most SDM interventions were designed for clinicians. Patient-specific goals and values were included in 56% (10/18) of studies. The 2 most common study outcome measures were SDM-related measures and SDM tool use. Understanding how to integrate SDM tools directly into a clinician's workflow within the EHR is a logical approach to promoting SDM into routine clinical practice. This review contributes to the literature by illuminating features of SDM tools that have been integrated into an EHR system. Standardization of SDM tools and processes, including the use of patient decision aids, is needed for consistency across SDM studies. The implementation approaches for SDM applications showed varying levels of planning and effort to promote SDM intervention awareness. Targeting accepted and established clinical processes may enhance the adoption and use of SDM tools. Future studies designed as randomized controlled trials are needed to expand the quality of the evidence base. This includes the study of integration methods into EHR systems as well as implementation methods and strategies deployed to operationalize the uptake of the SDM-integrated tools. Emphasizing patients' goals and values is another key area for future studies.

Background Individuals with high risk for lung cancer may benefit from lung cancer screening, but there are associated risks as well as benefits. Shared decision‐making (SDM) tools with personalized information may provide key support for patients. Understanding patient perspectives on educational tools to facilitate SDM for lung cancer screening may support tool development. Aim This study aimed to explore patient perspectives related to a SDM tool for lung cancer screening using a qualitative approach. Methods We elicited patient perspectives by showing a provider‐facing SDM tool. Focus group interviews that ranged in duration from 1.5 to 2 h were conducted with 23 individuals with high risk for lung cancer. Data were interpreted inductively using thematic analysis to identify patients' thoughts on and desires for a patient‐facing SDM tool. Results The findings highlight that patients would like to have educational information related to lung cancer screening. We identified several key themes to be considered in the future development of patient‐facing tools: barriers to acceptance, preference against screening and seeking empowerment. One further theme illustrated effects of patient–provider relationship as a limitation to meeting lung cancer screening information needs. Participants also noted several suggestions for the design of technology decision aids. Conclusion These findings suggest that patients desire additional information on lung cancer screening in advance of clinical visits. However, there are several issues that must be considered in the design and development of technology to meet the information needs of patients for lung cancer screening decisions. Patient or Public Contribution Patients, service users, caregivers or members of the public were not involved in the study design, conduct, analysis or interpretation of the data. However, clinical experts in health communication provided detailed feedback on the study protocol, including the focus group approach. The study findings contribute to a better understanding of patient expectations for lung cancer screening decisions and may inform future development of tools for SDM.

Background Recruitment of sufficient participants for clinical trials remains challenging. Primary care is an important avenue for patient recruitment but is underutilized. We developed and pilot tested a questionnaire to measure relevant barriers and facilitators to primary care providers’ involvement in recruiting patients for clinical trials. Methods Prior research informed the development of the questionnaire. The initial instrument was revised using feedback obtained from cognitive interviews. We invited all primary care providers practicing within the University of Utah Health system to complete the revised questionnaire. We used a mixed-mode design to collect paper responses via in-person recruitment and email contacts to collect responses online. Descriptive statistics, exploratory factor analysis, Cronbach’s alpha, and multivariable regression analyses were conducted. Results Sixty-seven primary care providers participated in the survey. Exploratory factor analysis suggested retaining five factors, representing the importance of clinical trial recruitment in providers’ professional identity, clinic-level interventions to facilitate referral, patient-related barriers, concerns about patient health management, and knowledge gaps. The five factors exhibited good or high internal consistency reliability. Professional identity and clinic-level intervention factors were significant predictors of providers’ intention to participate in clinical trial recruitment activities. Conclusions Results of this exploratory analysis provide preliminary evidence of the internal structure, internal consistency reliability, and predictive validity of the questionnaire to measure factors relevant to primary care providers’ involvement in clinical trial recruitment.

Poor clinical trial (CT) recruitment is a significant barrier to translating basic science discoveries into medical practice. Improving support for primary care provider (PCP) referral of patients to CTs may be an important part of the solution. However, implementing CT referral support in primary care is not only technically challenging, but also presents challenges at the person and organization levels. The objectives of this study were (1) to characterize provider and clinical supervisor attitudes and perceptions regarding CT research, recruitment, and referrals in primary care and (2) to identify perceived workflow strategies and facilitators relevant to designing a technology-supported primary care CT referral program. Focus groups were conducted with PCPs, directors, and supervisors. Analysis indicated widespread support for the intrinsic scientific value of CTs, while at the same time deep concerns regarding protecting patient well-being, perceived loss of control when patients participate in trials, concern about the impact of point-of-care referrals on clinic workflow, the need for standard processes, and the need for CT information that enables referring providers to quickly confirm that the burdens are justified by the benefits at both patient and provider levels. PCP suggestions pertinent to implementing a CT referral decision support system are reported. The results from this work contribute to developing an implementation approach to support increased referral of patients to CTs.

OBJECTIVES/SPECIFIC AIMS: Electronic health records have become the fulcrum for efforts by institutions to reduce errors, improve safety, reduce cost, and improve compliance with recommended guidelines. In recent times they are also being considered as a potential game changer for improving patient recruitment for clinical trials (CT). Although the use of CDS for clinical care is partially understood, its use for CT patient identification and recruitment is young and a great deal of experimental and theoretical research is needed in this area to optimize the use of CDS tools that personalize patient care by identifying relevant clinical trials and other research interventions. The use of CDS tools for CT recruitment offers a great deal of possibilities, but some initial usage has been disappointing. This may not be surprising because, while the implementation of these interventions is somewhat simple, ensuring that they are embedded into the right point of the care providers workflow is highly complex and may affect many actors in a clinical care setting, including patients, nurses, physicians, clinical coordinators, and investigators. Overcoming the challenges of alerting providers regarding their patient’s eligibility for clinical trials is an important and difficult challenge. Translating that effort into effective recruitment will require understanding of the psychological and workflow barriers and facilitators for how providers respond to automated alerts requesting patient referrals. Evidence from using CDS for clinical care that shows alerts become increasingly ignored over time or with more exposure (1, 2). The features, timing, and method of these alerts are important usability factors that may influence effectiveness of the referral process. Focus group methods capture the shared perspectives of a phenomenon and have been shown to be an effective method for identifying perceptions, attitudes, information needs, and other human factors effecting workflow (3, 4). Our objective was to develop a generalizable method for measuring physician and clinic level factors defining a successful point of care recruitment program in an outpatient care setting. To achieve this we attempted to (a) Characterize provider’s attitudes regarding CTs referrals and research. (b) Identify perceived workflow strategies and facilitators relevant to CT recruitment in primary care. (c) Develop and test a pilot instrument. METHODS/STUDY POPULATION: The methods had 3 phases: focus groups, development of item pool, and tool development. Focus group topics were developed by 4 experienced investigators, with training in biomedical informatics, cognitive psychology, human factors, and workflow analysis, based upon a knowledge of the literature. A script was developed and the methods were piloted with a group of 4 clinicians. In all, 16 primary care providers, 5 clinic directors, and 6 staff supervisors participated in 6 focus groups, with an average of 5 participants each, to discuss clinical trial recruitment at the point of care. Focus groups were conducted by the development team. Audio recording were content coded and analyzed to identify themes by consensus of 3 authors. Item Pool generation involved extracting items identified in the focus group analysis, selecting a subset deemed most interesting based on knowledge of the recruitment literature and iteratively writing and refining questions. Instrument development consisted of piloting an initial 7-item questionnaire with a local primary provider sample. Questions were correlated with the item pool and limited to reduce provider burden, based on those that the study team deemed most applicable to information technology supported recruitment. Descriptive statistical analysis was performed on the pilot survey results. An online survey was developed based on the findings of the focus groups and emailed to 127 primary care providers who were invited to participate. In total, 36 questionnaires were completed. This study was approved by the University of Utah Institutional Review Board. RESULTS/ANTICIPATED RESULTS: The results section is organized into 3 sections: (a) Focus groups, (b) Item generation; and (c) Questionnaire pilot. (I) (1) Focus Groups. Themes identified through a qualitative review are presented below with illustrative comments of participants. The diversity of attitudes and willingness to support clinical trial recruitment varied so substantially that no single pattern emerged. Attitudes ranged from enthusiastic support, to interest in some trials to disinterest or distrust in trials in general. Compensation for time spent, which could be monetary, informational, or through professional recognition; and provider relationship with the study team or pre-selection of specific trials by a clinic oversight committee, and importance to providers practice positively affected willingness to help recruit. “I would love to get people into clinical trials as much as possible... If it works for them you are going to help a whole lot of other people.” If we felt like we have done every possible thing that was already established as evidence-based and it didn’t work out, then we would consider the trials. I think that studies are more beneficial for specific specialists... There might be a whole slew of things that I never deal with or don’t care about because it’s not prevalent for my patient population. Local and reputable... A long distance someone asking to do something is just not the same as someone in the trenches with you. The bottom line is how much work is involved at our end and if there is going to be any compensation for that. I think also the providers would like have feedback on what they referred them to. And how did it go? So did we pick the right patient? ... It helps us to know, did they even sign up for the study? Getting your name on a research paper would be nice too. Lack of information regarding trials reduced support for recruitment of patients. Providers stated that they do not know how to quickly find information about studies, nor do they have time to find the information, and therefore cannot efficiently council patients regarding trial participation. Notifications regarding clinical trials that were deemed to be important included: Trial coordinator intention to recruit patients, enrollment of a patient in a clinical drug trial, trial progress and result updates, and reports of effectiveness of provider recruitment efforts. Perceived information needs regarding trials that providers are referring patients to included: trial purpose, design, benefits and risks, potential side effects, intervention details, medication class (mechanism of action), drug interactions with study drug, study timeline, coordinator contact information, link to print off patient handouts, enrollment instructions, and a link to study website. (2) It’s just we don’t know any of the information ... and it can’t take any of our time. ... I don’t have time to research it. Sometimes the patients ask me questions about it and I would like to be in a position where I have some information about it before I am asked. It would be nice to be notified if they [my patients] are enrolled in the trial, when it turns into actual recruitment. I do like to know if they’re in [a trial] so that when they come in for problems, I at least know that they might be on a study medication so I can be safe. I’ll get an ER message, “The patient got admitted. There blood pressure’s, you know, tanked, because they’re on a study drug I didn’t know anything about.” if there’s certain side effects that I need to be watching out for. It would also be good to have a contact person from the study in case we need to notify them of. “this person’s possible having an adverse event. Look into it more.” (3) Provider burden associated with patient recruitment appeared to be a deterrent. These burdens included adding to the providers task list, increasing the time required to complete a visit, and usurpation of control over the patients care plan with the associated effect on provider quality scores. We don’t have time. I mean, we don’t even take a lunch break. I have 15 minutes and now this is taking this many minutes away from my 15 minutes. I am just sick of extra work. We already have so much extra work. It’s just more stuff to do. We are maxed out on stuff to do. Right now, part of our compensation depends on having our patients A1Cs controlled. And so if we’re taking a chance that maybe they’re getting a medicine, maybe they’re not, maybe it’ll help, maybe it won’t, its gonna further delay our ability to get paid. Cause they’re like “I’m not going to let you go mess up my patient and I’m going to have to deal with the consequences is kind of the way they think. If you’re going to put the patient in a study, being able drop them from our registry so we don’t get penalized for a negative outcome [is important]. (4) Patient’s needs were a priority among factors influencing likelihood to help recruitment patients. Providers considered perceived benefit or risk to the patient, such as additional healthcare services, increased monitoring, financial assistance, or access to new treatments when other options have been ineffective, important; as well as continuance of established care that has proven effective, and ethical recruitment that addresses language and mental health to ensure that patients can make decisions regarding study participation. If there’s something great that’s gonna benefit a patient, I would definitely wanna know about it to give them that option. You know that’s what we wanna try to do is make our patients better. Someone who is really well controlled and doing well, I would not tend to put them toward the study. Just keep going with what’s working right now. Sometimes there’s financial incentives for them to participate, so you know, if its a good fit its easy to at least offer that to the patient

Abstract Lung cancer screening with low-dose computed tomography (CT) could help avert thousands of deaths each year. Since the implementation of screening is complex and underspecified, there is a need for systematic and theory-based strategies. Explore the implementation of lung cancer screening in primary care, in the context of integrating a decision aid into the electronic health record. Design implementation strategies that target hypothesized mechanisms of change and context-specific barriers. The study had two phases. The Qualitative Analysis phase included semi-structured interviews with primary care physicians to elicit key task behaviors (e.g., ordering a low-dose CT) and understand the underlying behavioral determinants (e.g., social influence). The Implementation Strategy Design phase consisted of defining implementation strategies and hypothesizing causal pathways to improve screening with a decision aid. Three key task behaviors and four behavioral determinants emerged from 14 interviews. Implementation strategies were designed to target multiple levels of influence. Strategies included increasing provider self-efficacy toward performing shared decision making and using the decision aid, improving provider performance expectancy toward ordering a low-dose CT, increasing social influence toward performing shared decision making and using the decision aid, and addressing key facilitators to using the decision aid. This study contributes knowledge about theoretical determinants of key task behaviors associated with lung cancer screening. We designed implementation strategies according to causal pathways that can be replicated and tested at other institutions. Future research is needed to evaluate the effectiveness of these strategies and to determine the contexts in which they can be effectively applied. Designing strategies and tools for implementing lung cancer screening can be informed by primary care physicians.

Electronic health records (EHRs) have been widely implemented in hospitals and outpatient settings and hold many promises for improved health outcomes. However, physicians have complained that the EHR has negative and unintended consequences, including interference with their relationship with the patient, high cognitive burden, low usability, and poor support for the medical decision-making process. In this dissertation, 4 studies were conducted to explore system features contributing to physician dissatisfaction and the EHR’s impact on cognitive tasks. A problem-focused data display, designed to support clinical decision-making, was developed and evaluated. The first study addresses physicians’ ability to manage the complex cognitive task of communicating with their patients during clinical exams, while accessing an EHR compared with use of a similar paper record. Communication skills were observed and evaluated in specific areas of clinical importance. Analysis shows that the simple transition from paper to computer does not appear to reduce physician’s ability to communicate with their patients. Rather, use of the computer trended toward slight improvement of communication skills. Second, an ineffective active clinical decision support (CDS) tool-set was evaluated. A heuristic evaluation was conducted followed by a user study to identify problems that might be corrected. These problems were mapped to dual cognitive processes and a set of CDS-specific design guidelines was developed. In the third study, a complex medical condition, delirium, was identified as an important target for CDS development and critical incident interviews were conducted to discover information needs of physicians caring for patients with delirium. Uncertainty and high effort in obtaining needed information were among the important themes identified. Fourth, information from decision theory and prior studies was leveraged in developing a CDS tool to support rapid awareness and analytical investigation for physicians managing the care of patients at high risk of developing delirium. The tool received positive usefulness ratings from physicians and, in a randomized controlled trial, resulted in ordering of more delirium prevention strategies and an increase in confidence in delirium risk management. This work expands methods of CDS design and evaluation to support physician cognition by grouping and summarizing problem-focused patient data.

The usefulness of electronic health record (EHR) systems could be significantly enhanced by innovative, third-party EHR add-on apps. To evaluate whether an EHR add-on app for neonatal bilirubin management can save clinicians time and improve patient care. This quality improvement study was conducted at the University of Utah Health Well Baby nursery and outpatient clinics and consisted of 4 substudies: (1) time savings were estimated in an experimental task-timing study comparing the time required for physicians to manage newborns' bilirubin levels with and without the add-on app, (2) app use was estimated from app logs, (3) health care use measures and guideline compliance were compared retrospectively before and after the intervention, and (4) clinician-perceived usability was measured through System Usability Scale surveys. The study took place between April 1, 2016, and September 3, 2019. Data analyses were conducted from October 30, 2018, to September 23, 2019. At baseline, clinicians used a manual approach to ensure compliance with an evidence-based clinical guideline for neonatal bilirubin management. To facilitate guideline compliance, an EHR add-on app that automatically retrieves, organizes, and visualizes relevant patient data was developed. The app provides patient-specific assessments and recommendations, including the risk of rebound hyperbilirubinemia following phototherapy based on a predictive model. The add-on app was integrated with the University of Utah Health EHR on April 12, 2017. Clinician time savings, app use, health care use measures, guideline-compliant phototherapy ordering, and perceived usability as measured by the System Usability Scale survey. The survey is composed of 10 statements with responses ranging from 1 (strongly disagree) to 5 (strongly agree). The survey results in a single score ranging from 0 to 100, with ratings described as worst imaginable (mean System Usability Scale score, 12.5), awful (20.3), poor (35.7), okay (50.9), good (71.4), excellent (85.5), and best imaginable (90.9). In 2018, the application was used 20 516 times by clinicians for 91.84% of eligible newborns. Use of the app saved 66 seconds for bilirubin management tasks compared with a commonly used tool (95% CI, 53-79 seconds; P < .001). Following the intervention, health care use rates remained stable, while orders for clinically appropriate phototherapy during hospitalization increased for newborns with bilirubin levels above the guideline-recommended threshold (odds ratio, 1.84; 95% CI, 1.16-2.90; P = .009). Surveys indicated excellent usability (System Usability Scale score, 83.90; 95% CI, 81.49-86.31). Well-designed EHR add-on apps may save clinicians time and improve patient care. If time-saving apps, such as the bilirubin app, were implemented widely across institutions and care domains, the potential association with improved patient care and clinician efficiency could be significant. The University of Utah Health bilirubin app is being prepared for release into EHR app stores as free-to-use software.

Objectives This paper reports on a mixed methods formative evaluation to support the design and implementation of information technology (IT) tools for a primary care weight management intervention delivered through the patient portal using primary care staff as coaches. Methods We performed a qualitative needs assessment, designed the IT tools to support the weight management program, and developed implementation tracking metrics. Implementation tracking metrics were designed to use real world electronic health record (EHR) data. Results The needs assessment revealed IT requirements as well as barriers and facilitators to implementation of EHR-based weight management interventions in primary care. We developed implementation metrics for the IT tools. These metrics were used in weekly project team calls to make sure that project resources were allocated to areas of need. Conclusion This study identifies the important role of IT in supporting weight management through patient identification, weight and activity tracking in the patient portal, and the use of the EHR as a population management tool. An intensive multi-level implementation approach is required for successful primary care-based weight management interventions including well-designed IT tools, comprehensive involvement of clinic leadership, and implementation tracking metrics to guide the process of workflow integration. This study helps to bridge the gap between informatics and implementation by using socio-technical formative evaluation methods early in order to support the implementation of IT tools. Trial registration clinicaltrials.gov, NCT04420936. Registered June 9, 2020. Lay Summary This study outlines the use of information technology (IT) tools to support weight management in primary care. The focus was on a program called MAINTAIN PRIME, which aims to help patients maintain healthy weight loss through education, self-monitoring, and coaching from primary care staff. The IT tools were designed to facilitate patient identification, engagement, and tracking of weight and activity via the patient portal. The study used a formative evaluation approach to adapt and refine these tools, considering factors such as workflow, staff and patient needs, and implementation barriers. The results highlighted the vital role of IT in managing weight through patient portals and electronic health records, emphasizing the need for comprehensive IT tools, clinic leadership involvement, and continuous implementation tracking. The study also points out the increasing need for effective IT-enabled strategies in clinical settings, especially considering the ongoing shortage of clinical staff in the United States. It is a step towards more informed, technology-assisted healthcare, aiming to make weight management interventions more accessible and sustainable in primary care. This research contributes to the integration of informatics and implementation science, offering insights into the design and application of IT solutions for health interventions.

Germline mutations in the ubiquitously expressed ACTB , which encodes β-cytoplasmic actin (CYA), are almost exclusively associated with Baraitser-Winter Cerebrofrontofacial syndrome (BWCFF). Here, we report six patients with previously undescribed heterozygous variants clustered in the 3′-coding region of ACTB . Patients present with clinical features distinct from BWCFF, including mild developmental disability, microcephaly, and thrombocytopenia with platelet anisotropy. Using patient-derived fibroblasts, we demonstrate cohort specific changes to β-CYA filament populations, which include the enhanced recruitment of thrombocytopenia-associated actin binding proteins (ABPs). These perturbed interactions are supported by in silico modeling and are validated in disease-relevant thrombocytes. Co-examination of actin and microtubule cytoskeleton constituents in patient-derived megakaryocytes and thrombocytes indicates that these β-CYA mutations inhibit the final stages of platelet maturation by compromising microtubule organization. Our results define an ACTB -associated clinical syndrome with a distinct genotype-phenotype correlation and delineate molecular mechanisms underlying thrombocytopenia in this patient cohort. Genetic variants in ACTB and ACTG1 have been associated with Baraitser-Winter Cerebrofrontofacial syndrome. Here, the authors report of a syndromic thrombocytopenia caused by variants in ACTB exons 5 or 6 that compromise the organization and coupling of the cytoskeleton, leading to impaired platelet maturation.