Sundas Khan

Usability Testing of a Complex Clinical Decision Support Tool in the Emergency Department: Lessons Learned

Background As the electronic health record (EHR) becomes the preferred documentation tool across medical practices, health care organizations are pushing for clinical decision support systems (CDSS) to help bring clinical decision support (CDS) tools to the forefront of patient-physician interactions. A CDSS is integrated into the EHR and allows physicians to easily utilize CDS tools. However, often CDSS are integrated into the EHR without an initial phase of usability testing, resulting in poor adoption rates. Usability testing is important because it evaluates a CDSS by testing it on actual users. This paper outlines the usability phase of a study, which will test the impact of integration of the Wells CDSS for pulmonary embolism (PE) diagnosis into a large urban emergency department, where workflow is often chaotic and high stakes decisions are frequently made. We hypothesize that conducting usability testing prior to integration of the Wells score into an emergency room EHR will result in increased adoption rates by physicians. Objective The objective of the study was to conduct usability testing for the integration of the Wells clinical prediction rule into a tertiary care center’s emergency department EHR. Methods We conducted usability testing of a CDS tool in the emergency department EHR. The CDS tool consisted of the Wells rule for PE in the form of a calculator and was triggered off computed tomography (CT) orders or patients’ chief complaint. The study was conducted at a tertiary hospital in Queens, New York. There were seven residents that were recruited and participated in two phases of usability testing. The usability testing employed a “think aloud” method and “near-live” clinical simulation, where care providers interacted with standardized patients enacting a clinical scenario. Both phases were audiotaped, video-taped, and had screen-capture software activated for onscreen recordings. Results Phase I: Data from the “think-aloud” phase of the study showed an overall positive outlook on the Wells tool in assessing a patient for a PE diagnosis. Subjects described the tool as “well-organized” and “better than clinical judgment”. Changes were made to improve tool placement into the EHR to make it optimal for decision-making, auto-populating boxes, and minimizing click fatigue. Phase II: After incorporating the changes noted in Phase 1, the participants noted tool improvements. There was less toggling between screens, they had all the clinical information required to complete the tool, and were able to complete the patient visit efficiently. However, an optimal location for triggering the tool remained controversial. Conclusions This study successfully combined “think-aloud” protocol analysis with “near-live” clinical simulations in a usability evaluation of a CDS tool that will be implemented into the emergency room environment. Both methods proved useful in the assessment of the CDS tool and allowed us to refine tool usability and workflow.

Combination therapy for inflammatory bowel disease

Biologic therapies such as infliximab and adalimumab have become mainstays of treatment for inflammatory bowel disease. Early studies suggested that combination therapy (CT) with infliximab and an immunomodulator drug such as azathioprine may help optimize biologic pharmacokinetics, minimize immunogenicity, and improve outcomes. The landmark SONIC trial in Crohn’s disease and the UC SUCCESS trial in ulcerative colitis demonstrated CT with infliximab and azathioprine to be superior to monotherapy with either agent alone at inducing clinical remission in treatment naïve patients with moderate to severe disease. However, many unanswered questions linger. The role of CT in non-naive patients as well as the optimal duration of CT remains unknown. The effectiveness of CT with alternate biologics and/or alternate immunomodulators is not as clear, and it is unknown whether SONIC’s conclusions can be extrapolated beyond infliximab and azathioprine. Also looming are the risks of CT including opportunistic infection and malignancy; specifically, lymphoma. This review lays out the evidence as it pertains to the risks and benefits of CT as well as the areas that require further research. With this information in hand, the practitioner may develop a treatment strategy that best suits each individual patient.

Formative assessment and design of a complex clinical decision support tool for pulmonary embolism

Electronic health record (EHR)-based clinical decision support (CDS) tools are rolled out with the urgency to meet federal requirements without time for usability testing and refinement of the user interface. As part of a larger project to design, develop and integrate a pulmonary embolism CDS tool for emergency physicians, we conducted a formative assessment to determine providers’ level of interest and input on designs and content. This was a study to conduct a formative assessment of emergency medicine (EM) physicians that included focus groups and key informant interviews. The focus of this study was twofold, to determine the general attitude towards CDS tool integration and the ideal integration point into the clinical workflow. To accomplish this, we first approached EM physicians in a focus group, then, during key informant interviews, we presented workflow designs and gave a scenario to help the providers visualise how the CDS tool works. Participants were asked questions regarding the trigger location, trigger words, integration into their workflow, perceived utility and heuristic of the tool. Results from the participants’ survey responses to trigger location, perceived utility and efficiency, indicated that the providers felt the tool would be more of a hindrance than an aid. However, some providers commented that they had not had exposure to CDS tools but had used online calculators, and thought the tools would be helpful at the point-of-care if integrated into the EHR. Furthermore, there was a preference for an order entry wireframe. This study highlights several factors to consider when designing CDS tools: (1) formative assessment of EHR functionality and clinical environment workflow, (2) focus groups and key informative interviews to incorporate providers’ perceptions of CDS and workflow integration and/or (3) the demonstration of proposed workflows through wireframes to help providers visualise design concepts.

Clinical Markers of Crohn’s Disease Severity and Their Association With Opiate Use

Background The safety of opiate use for patients with Crohn’s disease (CD) has long been a concern. The recent Crohn’s therapy, resource, evaluation, and assessment tool (TREAT) registry update has added to these concerns by demonstrating an association of opiate use with an increased risk of infection and death in CD. While the association is clear, the relationship of opiates to these negative outcomes is not. It is unknown whether opiates are a contributing factor to these negative outcomes or if their use is merely a marker of more severe disease. We hypothesized that opiate use is not harmful in CD but is a marker of disease severity and would be associated with commonly accepted clinical markers of severe CD such as early age at CD onset, disease duration, small intestinal involvement, a history of fistula or stricture, and lower quality of life (QOL) scores. Methods Data on CD history including pain medication usage were obtained from an interviewer directed survey of patients admitted to two tertiary care hospitals over a 2-year period. CD as the primary admitting diagnosis was not required. Active opiate use was defined by usage within the past month prior to admission. Results A total of 133 patients were approached to participate, of whom 108 consented to the survey, and 51 were active opiate users. Opiate using CD patients were more commonly smokers (22% vs. 3.45%, P < 0.010), had fistulas (40% vs. 22.4%, P < 0.048) and had a poorer quality of life score by short form inflammatory bowel disease questionnaire (mean 3.80 vs. 4.34, P < 0.036) than non-opiate users. No difference was found between opiate users and non-users for age of diagnosis, disease duration, or a history of strictures. Conclusions The study findings demonstrate that opiate use in CD is associated with markers of disease severity including fistulas, smoking, and lower QOL scores. The findings suggest that opiates may not be directly harmful to patients with CD, but may merely be another marker of disease severity. However, given opiates unproven benefits for long term CD pain control and risk of dependence, caution should still be exercised in their use.

Healthcare provider perceptions of clinical prediction rules.

Objectives To examine internal medicine and emergency medicine healthcare provider perceptions of usefulness of specific clinical prediction rules. Setting The study took place in two academic medical centres. A web-based survey was distributed and completed by participants between 1 January and 31 May 2013. Participants Medical doctors, doctors of osteopathy or nurse practitioners employed in the internal medicine or emergency medicine departments at either institution. Primary and secondary outcome measures The primary outcome was to identify the clinical prediction rules perceived as most useful by healthcare providers specialising in internal medicine and emergency medicine. Secondary outcomes included comparing usefulness scores of specific clinical prediction rules based on provider specialty, and evaluating associations between usefulness scores and perceived characteristics of these clinical prediction rules. Results Of the 401 healthcare providers asked to participate, a total of 263 (66%), completed the survey. The CHADS2 score was chosen by most internal medicine providers (72%), and Pulmonary Embolism Rule-Out Criteria (PERC) score by most emergency medicine providers (45%), as one of the top three most useful from a list of 24 clinical prediction rules. Emergency medicine providers rated their top three significantly more positively, compared with internal medicine providers, as having a better fit into their workflow (p=0.004), helping more with decision-making (p=0.037), better fitting into their thought process when diagnosing patients (p=0.001) and overall, on a 10-point scale, more useful (p=0.009). For all providers, the perceived qualities of useful at point of care, helps with decision making, saves time diagnosing, fits into thought process, and should be the standard of clinical care correlated highly (≥0.65) with overall 10-point usefulness scores. Conclusions Healthcare providers describe clear preferences for certain clinical prediction rules, based on medical specialty.

Avoiding alert fatigue in pulmonary embolism decision support: a new method to examine ‘trigger rates’

A clinical decision support system (CDSS) is integrated into the electronic health record (EHR) and allows physicians to easily use a clinical decision support (CDS) tool. However, often CDSSs are integrated into the EHR with poor adoption rates. One reason for this is secondary to ‘trigger fatigue’. Therefore, we developed a new and innovative usability process named ‘sensitivity and specificity trigger analysis’ (SSTA) as part of our larger project around a pulmonary embolism decision support tool. SSTA will enable programmers to examine optimal trigger rates prior to the integration of a CDS tool into the EHR, by using a formal method of analysis. We performed a retrospective chart review. The outcome of interest was physician ordering of a CT angiography (CTA). Phrases that signify common symptoms associated with pulmonary embolism were assessed as possible triggers for the CDSS tool. We then analysed each triggers ability to predict physician ordering of a CTA. We found that the most sensitive way to trigger the Pulmonary Embolism CDS tool while still maintaining a high specificity was by combining 1 or more pertinent symptoms with 1 or more elements of the Wells criteria. This study explored a unique methodology, SSTA, used to limit inaccurate triggering of a CDS tool prior to integration into the EHR. This methodology can be applied to other studies aiming to decrease triggering rates and increase adoption rates of previously validated CDSS tools.

Declining use of combination infliximab and immunomodulator for inflammatory bowel disease in the community setting

AIM To describe trends of combination therapy (CT) of infliximab (IFX) and immunomodulator (IMM) for inflammatory bowel disease (IBD) in the community setting. METHODS A retrospective study was conducted of all IBD patients referred for IFX infusion to our community infusion center between 04/01/01 and 12/31/14. CT was defined as use of IFX with either azathioprine, 6-mercaptopurine, or methotrexate. We analyzed trends of CT usage overall, for Crohn’s disease (CD) and ulcerative colitis (UC), and for the subgroups of induction patients. We also analyzed the trends of CT use in these groups over the study period, and compared the rates of CT use prior to and after publication of the landmark SONIC trial. RESULTS Of 258 IBD patients identified during the 12 year study period, 60 (23.3%) received CT, including 35 of 133 (26.3%) induction patients. Based on the Cochran-Armitage trend test, we observed decreasing CT use for IBD patients overall (P < 0.0001) and IBD induction patients, (P = 0.0024). Of 154 CD patients, 37 (24.68%) had CT, including 20 of 77 (26%) induction patients. The Cochran Armitage test showed a trend towards decreasing CT use for CD overall (P < 0.0001) and CD induction, (P = 0.0024). Overall, 43.8% of CD patients received CT pre-SONIC vs 7.4% post-SONIC (P < 0.0001). For CD induction, 40.0% received CT pre-SONIC vs 10.8% post-SONIC (P = 0.0035). Among the 93 patients with UC, 19 (20.4%) received CT. Of 50 induction patients, 14 (28.0%) received CT. The trend test of the 49 patients with a known year of induction again failed to demonstrate any significant trends in the use of CT (P = 0.6). CONCLUSION We observed a trend away from CT use in IBD. A disconnect appears to exist between expert opinion and evidence favoring CT with IFX and IMM, and evolving community practice.

A Computerized Method for Measuring Computed Tomography Pulmonary Angiography Yield in the Emergency Department: Validation Study

Background Use of computed tomography pulmonary angiography (CTPA) in the assessment of pulmonary embolism (PE) has markedly increased over the past two decades. While this technology has improved the accuracy of radiological testing for PE, CTPA also carries the risk of substantial iatrogenic harm. Each CTPA carries a 14% risk of contrast-induced nephropathy and a lifetime malignancy risk that can be as high as 2.76%. The appropriate use of CTPA can be estimated by monitoring the CTPA yield, the percentage of tests positive for PE. This is the first study to propose and validate a computerized method for measuring the CTPA yield in the emergency department (ED). Objective The objective of our study was to assess the validity of a novel computerized method of calculating the CTPA yield in the ED. Methods The electronic health record databases at two tertiary care academic hospitals were queried for CTPA orders completed in the ED over 1-month periods. These visits were linked with an inpatient admission with a discharge diagnosis of PE based on the International Classification of Diseases codes. The computerized the CTPA yield was calculated as the number of CTPA orders with an associated inpatient discharge diagnosis of PE divided by the total number of orders for completed CTPA. This computerized method was then validated by 2 independent reviewers performing a manual chart review, which included reading the free-text radiology reports for each CTPA. Results A total of 349 CTPA orders were completed during the 1-month periods at the two institutions. Of them, acute PE was diagnosed on CTPA in 28 studies, with a CTPA yield of 7.7%. The computerized method correctly identified 27 of 28 scans positive for PE. The one discordant scan was tied to a patient who was discharged directly from the ED and, as a result, never received an inpatient discharge diagnosis. Conclusions This is the first successful validation study of a computerized method for calculating the CTPA yield in the ED. This method for data extraction allows for an accurate determination of the CTPA yield and is more efficient than manual chart review. With this ability, health care systems can monitor the appropriate use of CTPA and the effect of interventions to reduce overuse and decrease preventable iatrogenic harm.

Correlation of abnormal histology with endoscopic findings among mycophenolate mofetil treated patients

AIM To describe all abnormal histological findings and their associated endoscopic presentation in patients using mycophenolate mofetil (MMF). METHODS A retrospective review of all individuals prescribed MMF within 6 mo of a colonoscopy or flexible sigmoidoscopy between 07/2009 and 09/2015 was performed within Northwell Health system. Records were analyzed for age, gender, procedure indication, MMF indication, and both gross and microscopic findings. Only reports with abnormal histology were included. RESULTS One hundred and eighty-four procedures from 170 patients were found, of which 39 met inclusion criteria. Fifty-one point three percent were female. MMF was used for solid organ transplant in 71.8%. Diarrhea was the indication for 71.8% of colonoscopies. Fifty-nine percent of reports revealed gross and microscopic abnormalities while 41.0% had only microscopic findings. Only 11 patients’ reports (28.2%) indicated a specific histopathology of MMF colitis. Among the entire group, only 23.1% of abnormal histology was isolated proximal to the splenic flexure. CONCLUSION Our results demonstrate a high rate of left sided disease and microscopic findings without gross mucosal abnormalities among patients using MMF. Also, a broader definition of MMF-colonopathy may be appropriate, with a majority of our abnormal histology falling outside of the more narrowly defined MMF-colitis category. Given the high frequency of isolated microscopic abnormalities and distal disease, sigmoidoscopy with random biopsies may be an appropriate, less invasive initial endoscopic examination in selected MMF patients.

Effectiveness of montelukast in overweight and obese atopic asthmatics

Among the 2 obese-asthma phenotypes (early-onset/atopic and late-onset/nonatopic), patients have increased asthma severity,1 decreased asthma control,1,2 and decreased response to inhaled corticosteroids (ICSs),3e6 the first-line treatment for all patients with persistent asthma. In vitro studies of rat alveolar macrophages have found that leptin enhances cysteinyl leukotriene production.7 In obese patients with asthma, body mass index (BMI) correlated with leukotriene synthesis,8 suggesting that leptin perpetuates cysteinyl leukotrieneemediated inflammation in obese patients with asthma. A post hoc analysis of 4 double-blind, placebocontrolled studies noted that with increasing BMI, asthma control decreased in patients using ICSs but remained stable in those using leukotriene antagonists.3 Because ICSs are not as effective in treating obese patients with asthma, and leukotrienes may be an effective target in obese asthma, there is a need to determine whether montelukast may be more useful in obtaining asthma control among obese patients with asthma. The primary objective of this study was to determine whether montelukast is more effective in obtaining asthma control among overweight or obese patients with early-onset asthma than in normal weight patients with asthma. We conducted a prospective, randomized, double-blind controlled study in which patients with mild to moderate, persistent, early-onset/atopic asthma received montelukast (5 mg: age, 7e14 years; 10 mg: age, 15 years) or placebo for 24 weeks, in addition to their background ICSs. Patients were characterized as being overweight/obese or normal weight based on Centers for Disease Control and Prevention guidelines. At baseline and weeks 4, 8, 16, and 24 after randomization, the following end points were assessed: Asthma Control Test (ACT) scores, exhaled nitric oxide, spirometry measurements, asthma control, exacerbations, and total ICS dose. ICS doses were stepped down if patients had achieved adequate asthma control, according to the National Heart, Lung, and Blood Institute guidelines. Baseline, midpoint, and final fasting serum and urine studies were obtained to measure leptin, adiponectin, and urinary leukotriene E4. Serum and urine samples were stored at 80 C. After defrosting to room temperature, serum leptin and adiponectin were measured by enzyme immunoassay (SPI Bio, Montigny le Brettoneux, France). After defrosting urine to room temperature, an aliquot was purified using cysteinyl leukotriene affinity sorbent (Cayman Chemical, Ann Arbor, Michigan). Urinary leukotriene E4 levels were measured by enzyme