Browsing by Subject "Clinical decision support"
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Item A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury(Springer Nature, 2024-08-05) Tignanelli, Christopher J.; Shah, Surbhi; Vock, David; Siegel, Lianne; Serrano, Carlos; Haut, Elliott; Switzer, Sean; Martin, Christie L.; Rizvi, Rubina; Peta, Vincent; Jenkins, Peter C.; Lemke, Nicholas; Thyvalikakath, Thankam; Osheroff, Jerome A.; Torres, Denise; Vawdrey, David; Callcut, Rachael A.; Butler, Mary; Melton, Genevieve B.; Surgery, School of MedicineBackground: Venous thromboembolism (VTE) is a preventable medical condition which has substantial impact on patient morbidity, mortality, and disability. Unfortunately, adherence to the published best practices for VTE prevention, based on patient centered outcomes research (PCOR), is highly variable across U.S. hospitals, which represents a gap between current evidence and clinical practice leading to adverse patient outcomes. This gap is especially large in the case of traumatic brain injury (TBI), where reluctance to initiate VTE prevention due to concerns for potentially increasing the rates of intracranial bleeding drives poor rates of VTE prophylaxis. This is despite research which has shown early initiation of VTE prophylaxis to be safe in TBI without increased risk of delayed neurosurgical intervention or death. Clinical decision support (CDS) is an indispensable solution to close this practice gap; however, design and implementation barriers hinder CDS adoption and successful scaling across health systems. Clinical practice guidelines (CPGs) informed by PCOR evidence can be deployed using CDS systems to improve the evidence to practice gap. In the Scaling AcceptabLE cDs (SCALED) study, we will implement a VTE prevention CPG within an interoperable CDS system and evaluate both CPG effectiveness (improved clinical outcomes) and CDS implementation. Methods: The SCALED trial is a hybrid type 2 randomized stepped wedge effectiveness-implementation trial to scale the CDS across 4 heterogeneous healthcare systems. Trial outcomes will be assessed using the RE2-AIM planning and evaluation framework. Efforts will be made to ensure implementation consistency. Nonetheless, it is expected that CDS adoption will vary across each site. To assess these differences, we will evaluate implementation processes across trial sites using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation framework (a determinant framework) using mixed-methods. Finally, it is critical that PCOR CPGs are maintained as evidence evolves. To date, an accepted process for evidence maintenance does not exist. We will pilot a "Living Guideline" process model for the VTE prevention CDS system. Discussion: The stepped wedge hybrid type 2 trial will provide evidence regarding the effectiveness of CDS based on the Berne-Norwood criteria for VTE prevention in patients with TBI. Additionally, it will provide evidence regarding a successful strategy to scale interoperable CDS systems across U.S. healthcare systems, advancing both the fields of implementation science and health informatics.Item Actionable recommendations in the Bright Futures child health supervision guidelines(Schattauer, 2014) Finnell, S.M.E.; Stanton, J.L.; Downs, S.M.; Department of Pediatrics, IU School of MedicineBACKGROUND: With the growing use of electronic health record systems, there is a demand for an electronic version of the leading American pediatric preventive care guideline, Bright Futures. As computer implementation requires actionable recommendations, it is important to assess to what degree Bright Futures meets criteria for actionability. OBJECTIVES: We aimed to 1) determine the number of actionable recommendations in the current edition of Bright Futures and 2) to recommend a specific format for representing an important class of guidelines in a way that better facilitates computer implementation. METHODS: We consolidated all action statements in Bright Futures into recommendations. We then used two dimensions (decidability and executability) in the Guideline Implementability Appraisal v 2.0 (GLIA) to determine the actionability of the recommendations. Decidability means the recommendation states precisely under what conditions to perform those actions. Executability means actions are stated specifically, unambiguously and in sufficient detail. The results were presented in a figure titled Service Interval Diagram (SID), describing actionable recommendations, age intervals during which they are applicable, and how frequently they should occur in that interval. RESULTS: We consolidated 2161 action items into 245 recommendations and identified 52 that were actionable (21%). Almost exclusively, these recommendations addressed screening, such as newborn metabolic screening, or child safety, such as car seat use. A limited number (n=13) of recommendations for other areas of anticipatory guidance were also actionable. No recommendations on child discipline, family function or mental health met our criteria for actionability. The SID representing these recommendations is presented in a figure. CONCLUSION: Only a portion of the Bright Futures Guidelines meets criteria for actionability. Substantial work lies ahead to develop most recommendations for anticipatory guidance into a computer implementable format.Item AcumenTM hypotension prediction index guidance for prevention and treatment of hypotension in noncardiac surgery: a prospective, single-arm, multicenter trial(Springer Nature, 2024-03-04) Bao, Xiaodong; Kumar, Sathish S.; Shah, Nirav J.; Penning, Donald; Weinstein, Mitchell; Malhotra, Gaurav; Rose, Sydney; Drover, David; Pennington, Matthew W.; Domino, Karen; Meng, Lingzhong; Treggiari, Mariam; Clavijo, Claudia; Wagener, Gebhard; Chitilian, Hovig; Maheshwari, Kamal; HPI Study Team; Anesthesia, School of MedicineBackground: Intraoperative hypotension is common during noncardiac surgery and is associated with postoperative myocardial infarction, acute kidney injury, stroke, and severe infection. The Hypotension Prediction Index software is an algorithm based on arterial waveform analysis that alerts clinicians of the patient's likelihood of experiencing a future hypotensive event, defined as mean arterial pressure < 65 mmHg for at least 1 min. Methods: Two analyses included (1) a prospective, single-arm trial, with continuous blood pressure measurements from study monitors, compared to a historical comparison cohort. (2) A post hoc analysis of a subset of trial participants versus a propensity score-weighted contemporaneous comparison group, using external data from the Multicenter Perioperative Outcomes Group (MPOG). The trial included 485 subjects in 11 sites; 406 were in the final effectiveness analysis. The post hoc analysis included 457 trial participants and 15,796 comparison patients. Patients were eligible if aged 18 years or older, American Society of Anesthesiologists (ASA) physical status 3 or 4, and scheduled for moderate- to high-risk noncardiac surgery expected to last at least 3 h. Measurements: minutes of mean arterial pressure (MAP) below 65 mmHg and area under MAP < 65 mmHg. Results: Analysis 1: Trial subjects (n = 406) experienced a mean of 9 ± 13 min of MAP below 65 mmHg, compared with the MPOG historical control mean of 25 ± 41 min, a 65% reduction (p < 0.001). Subjects with at least one episode of hypotension (n = 293) had a mean of 12 ± 14 min of MAP below 65 mmHg compared with the MPOG historical control mean of 28 ± 43 min, a 58% reduction (p< 0.001). Analysis 2: In the post hoc inverse probability treatment weighting model, patients in the trial demonstrated a 35% reduction in minutes of hypotension compared to a contemporaneous comparison group [exponentiated coefficient: - 0.35 (95%CI - 0.43, - 0.27); p < 0.001]. Conclusions: The use of prediction software for blood pressure management was associated with a clinically meaningful reduction in the duration of intraoperative hypotension. Further studies must investigate whether predictive algorithms to prevent hypotension can reduce adverse outcomes.Item Clinician Perceptions of a Computerized Decision Support System for Pediatric Type 2 Diabetes Screening(Thieme, 2020-03) El Mikati, Hala K.; Yazel-Smith, Lisa; Grout, Randall W.; Downs, Stephen M.; Carroll, Aaron E.; Hannon, Tamara S.; Pediatrics, School of MedicineObjective: With the increasing prevalence of type 2 diabetes (T2D) in youth, primary care providers must identify patients at high risk and implement evidence-based screening promptly. Clinical decision support systems (CDSSs) provide clinicians with personalized reminders according to best evidence. One example is the Child Health Improvement through Computer Automation (CHICA) system, which, as we have previously shown, significantly improves screening for T2D. Given that the long-term success of any CDSS depends on its acceptability and its users' perceptions, we examined what clinicians think of the CHICA diabetes module. Methods: CHICA users completed an annual quality improvement and satisfaction questionnaire. Between May and August of 2015 and 2016, the survey included two statements related to the T2D-module: (1) "CHICA improves my ability to identify patients who might benefit from screening for T2D" and (2) "CHICA makes it easier to get the lab tests necessary to identify patients who have diabetes or prediabetes." Answers were scored using a 5-point Likert scale and were later converted to a 2-point scale: agree and disagree. The Pearson chi-square test was used to assess the relationship between responses and the respondents. Answers per cohort were compared using the Mann-Whitney U-test. Results: The majority of respondents (N = 60) agreed that CHICA improved their ability to identify patients who might benefit from screening but disagreed as to whether it helped them get the necessary laboratories. Scores were comparable across both years. Conclusion: CHICA was endorsed as being effective for T2D screening. Research is needed to improve satisfaction for getting laboratories with CHICA.Item Comparison of Antibiotic Dosing Before and After Implementation of an Electronic Order Set(Thieme, 2019-03) Nichols, Kristen R.; Petschke, Allison L.; Webber, Emily C.; Knoderer, Chad A.; Pediatrics, School of MedicineBackground: To maximize resources, the antimicrobial stewardship program at a pediatric tertiary care hospital made pediatric dosing specific guidance within the electronic health record available to all hospitals within the health system. Objective: The objective of this study was to compare the appropriateness of antibiotic dosing before and after the implementation of an electronic intravenous (IV) antibiotic order set. Methods: This was a retrospective cohort study evaluating orders from patients younger than 18 years who received cefepime, piperacillin-tazobactam, tobramycin, or gentamicin at 12 health-system hospitals. Antibiotic dosing regimens and order set use were evaluated in patients who received the specified antibiotics during the 6-month time frame prior to and following electronic order set availability at each hospital. Results: In the before and after implementation periods, 360 and 387 total antibiotic orders were included, respectively. Most orders were gentamicin (55.8% in the before implementation period and 54.5% in the after implementation period) followed by piperacillin-tazobactam (22.5% in the before period and 22.2% in the after period). Overall, 663 orders were classified as appropriate (88.8%). Appropriateness was similar in the before or after implementation periods (87.8 vs. 89.7%, p = 0.415). There was a significant difference in appropriateness if a blank order versus the electronic IV antibiotic order set was used (82.8 vs. 90.5%; p = 0.024). Conclusion: No difference in antibiotic appropriateness overall was found in the before and after implementation periods. However, when specifically compared with the appropriateness of dosing when blank order forms were used, dosing was more appropriate when electronic antibiotic order sets were used.Item Digital detection of dementia (D3): a study protocol for a pragmatic cluster-randomized trial examining the application of patient-reported outcomes and passive clinical decision support systems(MDPI, 2022-10-11) Kleiman, Michael J.; Plewes, Abbi D.; Owora, Arthur; Grout, Randall W.; Dexter, Paul Richard; Fowler, Nicole R.; Galvin, James E.; Ben Miled, Zina; Boustani, Malaz; Medicine, School of MedicineBackground: Early detection of Alzheimer's disease and related dementias (ADRD) in a primary care setting is challenging due to time constraints and stigma. The implementation of scalable, sustainable, and patient-driven processes may improve early detection of ADRD; however, there are competing approaches; information may be obtained either directly from a patient (e.g., through a questionnaire) or passively using electronic health record (EHR) data. In this study, we aim to identify the benefit of a combined approach using a pragmatic cluster-randomized clinical trial. Methods: We have developed a Passive Digital Marker (PDM), based on machine learning algorithms applied to EHR data, and paired it with a patient-reported outcome (the Quick Dementia Rating Scale or QDRS) to rapidly share an identified risk of impairment to a patient's physician. Clinics in both south Florida and Indiana will be randomly assigned to one of three study arms: 1200 patients in each of the two populations will be administered either the PDM, the PDM with the QDRS, or neither, for a total of 7200 patients across all clinics and populations. Both incidence of ADRD diagnosis and acceptance into ADRD diagnostic work-up regimens is hypothesized to increase when patients are administered both the PDM and QDRS. Physicians performing the work-up regimens will be blind to the study arm of the patient. Discussion: This study aims to test the accuracy and effectiveness of the two scalable approaches (PDM and QDRS) for the early detection of ADRD among older adults attending primary care practices. The data obtained in this study may lead to national early detection and management program for ADRD as an efficient and beneficial method of reducing the current and future burden of ADRD, as well as improving the annual rate of newly documented ADRD in primary care practices.Item Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults? Study protocol for a randomized controlled trial(BioMed Central, 2015-04-09) Green, Eric P.; Catalani, Caricia; Diero, Lameck; Carter, E. Jane; Gardner, Adrian; Ndwiga, Charity; Keny, Aggrey; Owiti, Philip; Israelski, Dennis; Biondich, Paul; Department of Medicine, IU School of MedicineBACKGROUND: This document describes a research protocol for a study designed to estimate the impact of implementing a reminder system for medical providers on the use of isoniazid preventative therapy (IPT) for adults living with HIV in western Kenya. People living with HIV have a 5% to 10% annual risk of developing active tuberculosis (TB) once infected with TB bacilli, compared to a 5% lifetime risk in HIV-negative people with latent TB infection. Moreover, people living with HIV have a 20-fold higher risk of dying from TB. A growing body of literature suggests that IPT reduces overall TB incidence and is therefore of considerable benefit to patients and the larger community. However, in 2009, of the estimated 33 million people living with HIV, only 1.7 million (5%) were screened for TB, and about 85,000 (0.2%) were offered IPT. METHODS/DESIGN: This study will examine the use of clinical decision-support reminders to improve rates of initiation of preventative treatment in a TB/HIV co-morbid population living in a TB endemic area. This will be a pragmatic, parallel-group, cluster-randomized superiority trial with a 1:1 allocation to treatment ratio. For the trial, 20 public medical facilities that use clinical summary sheets generated from an electronic medical records system will participate as clusters. All HIV-positive adult patients who complete an initial encounter at a study cluster and at least one return encounter during the study period will be included in the study cohort. The primary endpoint will be IPT prescription at 3 months post the initial encounter. We will conduct both individual-level and cluster-level analyses. Due to the nature of the intervention, the trial will not be blinded. This study will contribute to the growing evidence base for the use of electronic health interventions in low-resource settings to promote high-quality clinical care, health system optimization and positive patient outcomes. Trial registration ClinicalTrials.gov NCT01934309, registered 29 August 2013.Item Essential Care for Every Baby: Neonatal Clinical Decision Support Tool(Springer, 2020-07) Rajapuri, Anushri Singh; Ravindran, Radhika; Horan, Kevin; Bucher, Sherri; Purkayastha, Saptarshi; Medicine, School of MedicineUnacceptably high rates of neonatal mortality are an urgent global health challenge. Consistent application of Essential Newborn Care (ENC) interventions reduce newborn mortality. However, ENC has failed to scale-up in low-middle income countries, where the bulk of neonatal deaths occur. The American Academy of Pediatrics designed an evidence-based, simplified training and educational curriculum called Essential Care for Every Baby (ECEB), which includes a clinical practice guideline for the time of delivery through 24 h after birth. However, the scale-up of ECEB has been hampered by the need to provide a wide variety of time-sensitive ECEB interventions to numerous mother-baby pairs. This incurs significant cognitive load among providers who perform varied tasks every few minutes for each baby. In this high-load, stressful situation, there are often profound gaps in the delivery of crucial ECEB strategies. We propose an innovative, scalable, clinical decision support mobile app which prioritizes recognition over recall and addresses existing challenges.Item Evaluating a Prototype Clinical Decision Support Tool for Chronic Pain Treatment in Primary Care(Thieme, 2022) Allen, Katie S.; Danielson, Elizabeth C.; Downs, Sarah M.; Mazurenko, Olena; Diiulio, Julie; Salloum, Ramzi G.; Mamlin, Burke W.; Harle, Christopher A.; Health Policy and Management, School of Public HealthObjectives: The Chronic Pain Treatment Tracker (Tx Tracker) is a prototype decision support tool to aid primary care clinicians when caring for patients with chronic noncancer pain. This study evaluated clinicians' perceived utility of Tx Tracker in meeting information needs and identifying treatment options, and preferences for visual design. Methods: We conducted 12 semi-structured interviews with primary care clinicians from four health systems in Indiana. The interviews were conducted in two waves, with prototype and interview guide revisions after the first six interviews. The interviews included exploration of Tx Tracker using a think-aloud approach and a clinical scenario. Clinicians were presented with a patient scenario and asked to use Tx Tracker to make a treatment recommendation. Last, participants answered several evaluation questions. Detailed field notes were collected, coded, and thematically analyzed by four analysts. Results: We identified several themes: the need for clinicians to be presented with a comprehensive patient history, the usefulness of Tx Tracker in patient discussions about treatment planning, potential usefulness of Tx Tracker for patients with high uncertainty or risk, potential usefulness of Tx Tracker in aggregating scattered information, variability in expectations about workflows, skepticism about underlying electronic health record data quality, interest in using Tx Tracker to annotate or update information, interest in using Tx Tracker to translate information to clinical action, desire for interface with visual cues for risks, warnings, or treatment options, and desire for interactive functionality. Conclusion: Tools like Tx Tracker, by aggregating key information about past, current, and potential future treatments, may help clinicians collaborate with their patients in choosing the best pain treatments. Still, the use and usefulness of Tx Tracker likely relies on continued improvement of its functionality, accurate and complete underlying data, and tailored integration with varying workflows, care team roles, and user preferences.Item Evaluation of electronic recruitment efforts of primary care providers as research subjects during the COVID-19 pandemic(BMC, 2022-04-28) Mazurenko, Olena; Sanner, Lindsey; Apathy, Nate C.; Mamlin, Burke W.; Menachemi, Nir; Adams, Meredith C.B.; Hurley, Robert W.; Fortin Erazo, Saura; Harle, Christopher A.; Medicine, School of MedicineBackground: Recruiting healthcare providers as research subjects often rely on in-person recruitment strategies. Little is known about recruiting provider participants via electronic recruitment methods. In this study, conducted during the COVID-19 pandemic, we describe and evaluate a primarily electronic approach to recruiting primary care providers (PCPs) as subjects in a pragmatic randomized controlled trial (RCT) of a decision support intervention. Methods: We adapted an existing framework for healthcare provider research recruitment, employing an electronic consent form and a mix of brief synchronous video presentations, email, and phone calls to recruit PCPs into the RCT. To evaluate the success of each electronic strategy, we estimated the number of consented PCPs associated with each strategy, the number of days to recruit each PCP and recruitment costs. Results: We recruited 45 of 63 eligible PCPs practicing at ten primary care clinic locations over 55 days. On average, it took 17 business days to recruit a PCP (range 0-48) and required three attempts (range 1-7). Email communication from the clinic leaders led to the most successful recruitments, followed by brief synchronous video presentations at regularly scheduled clinic meetings. We spent approximately $89 per recruited PCP. We faced challenges of low email responsiveness and limited opportunities to forge relationships. Conclusion: PCPs can be efficiently recruited at low costs as research subjects using primarily electronic communications, even during a time of high workload and stress. Electronic peer leader outreach and synchronous video presentations may be particularly useful recruitment strategies.