Notification of abnormal lab test results in an electronic medical record: do any safety concerns remain?

BACKGROUND: Follow-up of abnormal outpatient laboratory test results is a major patient safety concern. Electronic medical records can potentially address this concern through automated notification. We examined whether automated notifications of abnormal laboratory results (alerts) in an integrated electronic medical record resulted in timely follow-up actions. METHODS: We studied 4 alerts: hemoglobin A1c > or =15%, positive hepatitis C antibody, prostate-specific antigen > or =15 ng/mL, and thyroid-stimulating hormone > or =15 mIU/L. An alert tracking system determined whether the alert was acknowledged (ie, provider clicked on and opened the message) within 2 weeks of transmission; acknowledged alerts were considered read. Within 30 days of result transmission, record review and provider contact determined follow-up actions (eg, patient contact, treatment). Multivariable logistic regression models analyzed predictors for lack of timely follow-up. RESULTS: Between May and December 2008, 78,158 tests (hemoglobin A1c, hepatitis C antibody, thyroid-stimulating hormone, and prostate-specific antigen) were performed, of which 1163 (1.48%) were transmitted as alerts; 10.2% of these (119/1163) were unacknowledged. Timely follow-up was lacking in 79 (6.8%), and was statistically not different for acknowledged and unacknowledged alerts (6.4% vs 10.1%; P =.13). Of 1163 alerts, 202 (17.4%) arose from unnecessarily ordered (redundant) tests. Alerts for a new versus known diagnosis were more likely to lack timely follow-up (odds ratio 7.35; 95% confidence interval, 4.16-12.97), whereas alerts related to redundant tests were less likely to lack timely follow-up (odds ratio 0.24; 95% confidence interval, 0.07-0.84). CONCLUSIONS: Safety concerns related to timely patient follow-up remain despite automated notification of non-life-threatening abnormal laboratory results in the outpatient setting.

Assessing the impact of electronic health record technology adoption on hospital labor efficiency

Information technology (IT) in the hospital organization is fast becoming a key asset, particularly in light of recent reform legislation in the United States calling for expanding the role of IT in our health care system. Future payment reductions to hospitals included in current health reform are based on expected improvements in hospital operating efficiency. Since over half of hospital expenses are for labor, improved efficiency in use of labor resources can be critical in meeting this challenge. Policy makers have touted the value of IT investments to improve efficiency in response to payment reductions. ^ This study was the first to directly examine the relationship between electronic health record (EHR) technology and staffing efficiency in hospitals. As the hospital has a myriad of outputs for inpatient and outpatient care, efficiency was measured using an industry standard performance metric – full time equivalent employees per adjusted occupied bed (FTE/AOB). Three hypotheses were tested in this study.^ To operationalize EHR technology adoption, we developed three constructs to model adoption, each of which was tested by separate hypotheses. The first hypothesis that a larger number of EHR applications used by a hospital would be associated with greater staffing efficiency (or lower values of FTE/AOB) was not accepted. Association between staffing efficiency and specific EHR applications was the second hypothesis tested and accepted with some applications showing significant impacts on observed values for FTE/AOB. Finally, the hypothesis that the longer an EHR application was used in a hospital would be associated with greater labor efficiency was not accepted as the model showed few statistically significant relationships to FTE/AOB performance. Generally, there does not appear a strong relationship between EHR usage and improved labor efficiency in hospitals.^ While returns on investment from EHR usage may not come from labor efficiencies, they may be better sought using measures of quality, contribution to an efficient and effective local health care system, and improved customer satisfaction through greater patient throughput.^

Improving follow-up of abnormal cancer screens using electronic health records: trust but verify test result communication.

BACKGROUND: Early detection of colorectal cancer through timely follow-up of positive Fecal Occult Blood Tests (FOBTs) remains a challenge. In our previous work, we found 40% of positive FOBT results eligible for colonoscopy had no documented response by a treating clinician at two weeks despite procedures for electronic result notification. We determined if technical and/or workflow-related aspects of automated communication in the electronic health record could lead to the lack of response. METHODS: Using both qualitative and quantitative methods, we evaluated positive FOBT communication in the electronic health record of a large, urban facility between May 2008 and March 2009. We identified the source of test result communication breakdown, and developed an intervention to fix the problem. Explicit medical record reviews measured timely follow-up (defined as response within 30 days of positive FOBT) pre- and post-intervention. RESULTS: Data from 11 interviews and tracking information from 490 FOBT alerts revealed that the software intended to alert primary care practitioners (PCPs) of positive FOBT results was not configured correctly and over a third of positive FOBTs were not transmitted to PCPs. Upon correction of the technical problem, lack of timely follow-up decreased immediately from 29.9% to 5.4% (p<0.01) and was sustained at month 4 following the intervention. CONCLUSION: Electronic communication of positive FOBT results should be monitored to avoid limiting colorectal cancer screening benefits. Robust quality assurance and oversight systems are needed to achieve this. Our methods may be useful for others seeking to improve follow-up of FOBTs in their systems.

Timely follow-up of abnormal diagnostic imaging test results in an outpatient setting: are electronic medical records achieving their potential?

BACKGROUND: Given the fragmentation of outpatient care, timely follow-up of abnormal diagnostic imaging results remains a challenge. We hypothesized that an electronic medical record (EMR) that facilitates the transmission and availability of critical imaging results through either automated notification (alerting) or direct access to the primary report would eliminate this problem. METHODS: We studied critical imaging alert notifications in the outpatient setting of a tertiary care Department of Veterans Affairs facility from November 2007 to June 2008. Tracking software determined whether the alert was acknowledged (ie, health care practitioner/provider [HCP] opened the message for viewing) within 2 weeks of transmission; acknowledged alerts were considered read. We reviewed medical records and contacted HCPs to determine timely follow-up actions (eg, ordering a follow-up test or consultation) within 4 weeks of transmission. Multivariable logistic regression models accounting for clustering effect by HCPs analyzed predictors for 2 outcomes: lack of acknowledgment and lack of timely follow-up. RESULTS: Of 123 638 studies (including radiographs, computed tomographic scans, ultrasonograms, magnetic resonance images, and mammograms), 1196 images (0.97%) generated alerts; 217 (18.1%) of these were unacknowledged. Alerts had a higher risk of being unacknowledged when the ordering HCPs were trainees (odds ratio [OR], 5.58; 95% confidence interval [CI], 2.86-10.89) and when dual-alert (>1 HCP alerted) as opposed to single-alert communication was used (OR, 2.02; 95% CI, 1.22-3.36). Timely follow-up was lacking in 92 (7.7% of all alerts) and was similar for acknowledged and unacknowledged alerts (7.3% vs 9.7%; P = .22). Risk for lack of timely follow-up was higher with dual-alert communication (OR, 1.99; 95% CI, 1.06-3.48) but lower when additional verbal communication was used by the radiologist (OR, 0.12; 95% CI, 0.04-0.38). Nearly all abnormal results lacking timely follow-up at 4 weeks were eventually found to have measurable clinical impact in terms of further diagnostic testing or treatment. CONCLUSIONS: Critical imaging results may not receive timely follow-up actions even when HCPs receive and read results in an advanced, integrated electronic medical record system. A multidisciplinary approach is needed to improve patient safety in this area.

Cognitive Differences in Chart Reading: A Comparison of Nurses and Physicians

This pilot study compares the mental models of a patient constructed by nurses and physicians while reading an electronic medical record. Preliminary results suggest that the participants' summaries were both quantitatively and qualitatively different. The physician made more inferences and focused on deeper relationships in the record, whereas the nurse focused on the descriptive surface structure of the record.

DEVELOPING A METHOD FOR IDENTIFYING AND REDUCING FUNCTIONAL DISCREPANCIES OF INFORMATION SYSTEMS

Currently more than half of Electronic Health Record (EHR) projects fail. Most of these failures are not due to flawed technology, but rather due to the lack of systematic considerations of human issues. Among the barriers for EHR adoption, function mismatching among users, activities, and systems is a major area that has not been systematically addressed from a human-centered perspective. A theoretical framework called Functional Framework was developed for identifying and reducing functional discrepancies among users, activities, and systems. The Functional Framework is composed of three models – the User Model, the Designer Model, and the Activity Model. The User Model was developed by conducting a survey (N = 32) that identified the functions needed and desired from the user’s perspective. The Designer Model was developed by conducting a systemic review of an Electronic Dental Record (EDR) and its functions. The Activity Model was developed using an ethnographic method called shadowing where EDR users (5 dentists, 5 dental assistants, 5 administrative personnel) were followed quietly and observed for their activities. These three models were combined to form a unified model. From the unified model the work domain ontology was developed by asking users to rate the functions (a total of 190 functions) in the unified model along the dimensions of frequency and criticality in a survey. The functional discrepancies, as indicated by the regions of the Venn diagrams formed by the three models, were consistent with the survey results, especially with user satisfaction. The survey for the Functional Framework indicated the preference of one system over the other (R=0.895). The results of this project showed that the Functional Framework provides a systematic method for identifying, evaluating, and reducing functional discrepancies among users, systems, and activities. Limitations and generalizability of the Functional Framework were discussed.

Clinical decision support capabilities of commercially-available clinical information systems.

BACKGROUND: The most effective decision support systems are integrated with clinical information systems, such as inpatient and outpatient electronic health records (EHRs) and computerized provider order entry (CPOE) systems. Purpose The goal of this project was to describe and quantify the results of a study of decision support capabilities in Certification Commission for Health Information Technology (CCHIT) certified electronic health record systems. METHODS: The authors conducted a series of interviews with representatives of nine commercially available clinical information systems, evaluating their capabilities against 42 different clinical decision support features. RESULTS: Six of the nine reviewed systems offered all the applicable event-driven, action-oriented, real-time clinical decision support triggers required for initiating clinical decision support interventions. Five of the nine systems could access all the patient-specific data items identified as necessary. Six of the nine systems supported all the intervention types identified as necessary to allow clinical information systems to tailor their interventions based on the severity of the clinical situation and the user's workflow. Only one system supported all the offered choices identified as key to allowing physicians to take action directly from within the alert. Discussion The principal finding relates to system-by-system variability. The best system in our analysis had only a single missing feature (from 42 total) while the worst had eighteen.This dramatic variability in CDS capability among commercially available systems was unexpected and is a cause for concern. CONCLUSIONS: These findings have implications for four distinct constituencies: purchasers of clinical information systems, developers of clinical decision support, vendors of clinical information systems and certification bodies.

Standardization of data collection for the Lifetime Surveillance of Astronaut Health (LSAH)

Problems due to the lack of data standardization and data management have lead to work inefficiencies for the staff working with the vision data for the Lifetime Surveillance of Astronaut Health. Data has been collected over 50 years in a variety of manners and then entered into a software. The lack of communication between the electronic health record (EHR) form designer, epidemiologists, and optometrists has led to some level to confusion on the capability of the EHR system and how its forms can be designed to fit all the needs of the relevant parties. EHR form customizations or form redesigns were found to be critical for using NASA's EHR system in the most beneficial way for its patients, optometrists, and epidemiologists. In order to implement a protocol, data being collected was examined to find the differences in data collection methods. Changes were implemented through the establishment of a process improvement team (PIT). Based on the findings of the PIT, suggestions have been made to improve the current EHR system. If the suggestions are implemented correctly, this will not only improve efficiency of the staff at NASA and its contractors, but set guidelines for changes in other forms such as the vision exam forms. Because NASA is at the forefront of such research and health surveillance the impact of this management change could have a drastic improvement on the collection of and adaptability of the EHR. Accurate data collection from this 50+ year study is ongoing and is going to help current and future generations understand the implications of space flight on human health. It is imperative that the vast amount of information is documented correctly.^

Global practice experience: A useful lens for understanding patient and staff perceptions of successful integration of health information technology in primary care

Making healthcare comprehensive and more efficient remains a complex challenge. Health Information Technology (HIT) is recognized as an important component of this transformation but few studies describe HIT adoption and it's effect on the bedside experience by physicians, staff and patients. This study applied descriptive statistics and correlation analysis to data from the Patient-Centered Medical Home National Demonstration Project (NDP) of the American Academy of Family Physicians. Thirty-six clinics were followed for 26 months by clinician/staff questionnaires and patient surveys. This study characterizes those clinics as well as staff and patient perspectives on HIT usefulness, the doctor-patient relationship, electronic medical record (EMR) implementation, and computer connections in the practice throughout the study. The Global Practice Experience factor, a composite score related to key components of primary care, was then correlated to clinician and patient perspectives. This study found wide adoption of HIT among NDP practices. Patient perspectives on HIT helpfulness on the doctor-patient showed a suggestive trend that approached statistical significance (p = 0.172). Clinicians and staff noted successful integration of EMR into clinic workflow and their perception of helpfulness to the doctor-patient relationship show a suggestive increase also approaching statistical significance (p=0.06). GPE was correlated with clinician/staff assessment of a helpful doctor-patient relationship midway through the study (R 0.460, p = 0.021) with the remaining time points nearing statistical significance. GPE was also correlated to both patient perspectives of EMR helpfulness in the doctor-patient relationship (R 0.601, p = 0.001) and computer connections (R 0.618, p = 0.0001) at the start of the study. ^

Patient-centered medical home technology effects on hypertension and diabetes control

Background: Hypertension and Diabetes is a public health and economic concern in the United States. The utilization of medical home concepts increases the receipt of preventive services, however, do they also increase adherence to treatments? This study examined the effect of patient-centered medical home technologies such as the electronic health record, clinical support system, and web-based care management in improving health outcomes related to hypertension and diabetes. Methods: A systematic review of the literature used a best evidence synthesis approach to address the general question " Do patient-centered medical home technologies have an effect of diabetes and hypertension treatment?" This was followed by an evaluation of specific examples of the technologies utilized such as computer-assisted recommendations and web-based care management provided by the patient's electronic health record. Ebsco host, Ovid host, and Google Scholar were the databases used to conduct the literature search. Results: The initial search identified over 25 studies based on content and quality that implemented technology interventions to improve communication between provider and patient. After further assessing the articles for risk of bias and study design, 13 randomized controlled studies were chosen. All of the studies chosen were conducted in various primary care settings in both private practices and hospitals between the years 2000 and 2007. The sample sizes of the studies ranged from 42 to 2924 participants. The mean age for all of the studies ranged from 56 to 71 years. The percent women in the studies ranged from one to 78 percent. Over one-third of the studies did not provide the racial composition of the participants. For the seven studies that did provide information about the ethnic composition, 64% of the intervention participants were White. All of the studies utilized some type of web-based or computer-based communication to manage hypertension or diabetes care. Findings on outcomes were mixed, with nine out of 13 studies showing no significant effect on outcomes examined, and four of the studies showing significant and positive impact on health outcomes related to hypertension or diabetes Conclusion: Although the technologies improved patient and provider satisfaction, the outcomes measures such as blood pressure control and glucose control were inconclusive. Further research is needed with diverse ethnic and SES population to investigate the role of patient-centered technologies on hypertension and diabetes control. Also, further research is needed to investigate the effects of innovative medical home technologies that can be used by both patients and providers to increase quality of communication concerning adherence to treatments.^

Evaluating the Utility of Clinical Criteria for the Identification of Lynch Syndrome among Endometrial Cancer Patients

Background: Lynch Syndrome (LS) is a familial cancer syndrome with a high prevalence of colorectal and endometrial carcinomas among affected family members. Clinical criteria, developed from information obtained from familial colorectal cancer registries, have been generated to identify individuals at elevated risk for having LS. In 2007, the Society of Gynecologic Oncology (SGO) codified criteria to assist in identifying women presenting with gynecologic cancers at elevated risk for having LS. These criteria have not been validated in a population-based setting. Materials and Methods: We retrospectively identified 412, unselected endometrial cancer cases. Clinical and pathologic information were obtained from the electronic medical record, and all tumors were tested for expression of the DNA mismatch repair proteins through immunohistochemistry. Tumors exhibiting loss of MSH2, MSH6 and PMS2 were designated as probable Lynch Syndrome (PLS). For tumors exhibiting immunohistochemical loss of MLH1, we used the PCR-based MLH1 methylation assay to delineate PLS tumors from sporadic tumors. Samples lacking methylation of the MLH1 promoter were also designated as PLS. The sensitivity and specificity for SGO criteria for detecting PLS tumors was calculated. We compared clinical and pathologic features of sporadic tumors and PLS tumors. A simplified cost-effectiveness analysis was also performed comparing the direct costs of utilizing SGO criteria vs. universal tumor testing. Results: In our cohort, 43/408 (10.5%) of endometrial carcinomas were designated as PLS. The sensitivity and specificity of SGO criteria to identify PLS cases were 32.7 and 77%, respectively. Multivariate analysis of clinical and pathologic parameters failed to identify statistically significant differences between sporadic and PLS tumors with the exception of tumors arising from the lower uterine segment. These tumors were more likely to occur in PLS tumors. Cost-effectiveness analysis showed clinical criteria and universal testing strategies cost $6,235.27/PLS case identified and $5,970.38/PLS case identified, respectively. Conclusions: SGO 5-10% criteria successfully identify PLS cases among women who are young or have significant family history of LS related tumors. However, a larger proportion of PLS cases occurring at older ages with less significant family history are not detected by this screening strategy. Compared to SGO clinical criteria, universal tumor testing is a cost effective strategy to identify women presenting with endometrial cancer who are at elevated risk for having LS.

Costs and quality of medication reconciliation practice in primary care clinics

Medication reconciliation, with the aim to resolve medication discrepancy, is one of the Joint Commission patient safety goals. Medication errors and adverse drug events that could result from medication discrepancy affect a large population. At least 1.5 million adverse drug events and $3.5 billion of financial burden yearly associated with medication errors could be prevented by interventions such as medication reconciliation. This research was conducted to answer the following research questions: (1a) What are the frequency range and type of measures used to report outpatient medication discrepancy? (1b) Which effective and efficient strategies for medication reconciliation in the outpatient setting have been reported? (2) What are the costs associated with medication reconciliation practice in primary care clinics? (3) What is the quality of medication reconciliation practice in primary care clinics? (4) Is medication reconciliation practice in primary care clinics cost-effective from the clinic perspective? Study designs used to answer these questions included a systematic review, cost analysis, quality assessments, and cost-effectiveness analysis. Data sources were published articles in the medical literature and data from a prospective workflow study, which included 150 patients and 1,238 medications. The systematic review confirmed that the prevalence of medication discrepancy was high in ambulatory care and higher in primary care settings. Effective strategies for medication reconciliation included the use of pharmacists, letters, a standardized practice approach, and partnership between providers and patients. Our cost analysis showed that costs associated with medication reconciliation practice were not substantially different between primary care clinics using or not using electronic medical records (EMR) ($0.95 per patient per medication in EMR clinics vs. $0.96 per patient per medication in non-EMR clinics, p=0.78). Even though medication reconciliation was frequently practiced (97-98%), the quality of such practice was poor (0-33% of process completeness measured by concordance of medication numbers and 29-33% of accuracy measured by concordance of medication names) and negatively (though not significantly) associated with medication regimen complexity. The incremental cost-effectiveness ratios for concordance of medication number per patient per medication and concordance of medication names per patient per medication were both 0.08, favoring EMR. Future studies including potential cost-savings from medication features of the EMR and potential benefits to minimize severity of harm to patients from medication discrepancy are warranted. ^

Data Accuracy in Medical Record Abstraction

Clinical Research Data Quality Literature Review and Pooled Analysis We present a literature review and secondary analysis of data accuracy in clinical research and related secondary data uses. A total of 93 papers meeting our inclusion criteria were categorized according to the data processing methods. Quantitative data accuracy information was abstracted from the articles and pooled. Our analysis demonstrates that the accuracy associated with data processing methods varies widely, with error rates ranging from 2 errors per 10,000 files to 5019 errors per 10,000 fields. Medical record abstraction was associated with the highest error rates (70–5019 errors per 10,000 fields). Data entered and processed at healthcare facilities had comparable error rates to data processed at central data processing centers. Error rates for data processed with single entry in the presence of on-screen checks were comparable to double entered data. While data processing and cleaning methods may explain a significant amount of the variability in data accuracy, additional factors not resolvable here likely exist. Defining Data Quality for Clinical Research: A Concept Analysis Despite notable previous attempts by experts to define data quality, the concept remains ambiguous and subject to the vagaries of natural language. This current lack of clarity continues to hamper research related to data quality issues. We present a formal concept analysis of data quality, which builds on and synthesizes previously published work. We further posit that discipline-level specificity may be required to achieve the desired definitional clarity. To this end, we combine work from the clinical research domain with findings from the general data quality literature to produce a discipline-specific definition and operationalization for data quality in clinical research. While the results are helpful to clinical research, the methodology of concept analysis may be useful in other fields to clarify data quality attributes and to achieve operational definitions. Medical Record Abstractor’s Perceptions of Factors Impacting the Accuracy of Abstracted Data Medical record abstraction (MRA) is known to be a significant source of data errors in secondary data uses. Factors impacting the accuracy of abstracted data are not reported consistently in the literature. Two Delphi processes were conducted with experienced medical record abstractors to assess abstractor’s perceptions about the factors. The Delphi process identified 9 factors that were not found in the literature, and differed with the literature by 5 factors in the top 25%. The Delphi results refuted seven factors reported in the literature as impacting the quality of abstracted data. The results provide insight into and indicate content validity of a significant number of the factors reported in the literature. Further, the results indicate general consistency between the perceptions of clinical research medical record abstractors and registry and quality improvement abstractors. Distributed Cognition Artifacts on Clinical Research Data Collection Forms Medical record abstraction, a primary mode of data collection in secondary data use, is associated with high error rates. Distributed cognition in medical record abstraction has not been studied as a possible explanation for abstraction errors. We employed the theory of distributed representation and representational analysis to systematically evaluate cognitive demands in medical record abstraction and the extent of external cognitive support employed in a sample of clinical research data collection forms. We show that the cognitive load required for abstraction in 61% of the sampled data elements was high, exceedingly so in 9%. Further, the data collection forms did not support external cognition for the most complex data elements. High working memory demands are a possible explanation for the association of data errors with data elements requiring abstractor interpretation, comparison, mapping or calculation. The representational analysis used here can be used to identify data elements with high cognitive demands.