The Safety of Outpatient Health Care : Review of Electronic Health Records.

BACKGROUND: Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. OBJECTIVE: To measure AEs in the outpatient setting. DESIGN: Retrospective review of the electronic health record (EHR). SETTING: 11 outpatient sites in Massachusetts in 2018. PATIENTS: 3103 patients who received outpatient care. MEASUREMENTS: Using a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites. RESULTS: The 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care-associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, -0.05 [CI, -0.09 to -0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially. LIMITATION: Retrospective EHR review may miss AEs. CONCLUSION: Outpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed. PRIMARY FUNDING SOURCE: Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.

Assessment of Claimant, Clinical, and Financial Characteristics of Teleradiology Medical Malpractice Cases.

Background The increasing use of teleradiology has been accompanied by concerns relating to risk management and patient safety. Purpose To compare characteristics of teleradiology and nonteleradiology radiology malpractice cases and identify contributing factors underlying these cases. Materials and Methods In this retrospective analysis, a national database of medical malpractice cases was queried to identify cases involving telemedicine that closed between January 2010 and March 2022. Teleradiology malpractice cases were identified based on manual review of cases in which telemedicine was coded as one of the contributing factors. These cases were compared with nonteleradiology cases that closed during the same time period in which radiology had been determined to be the primary responsible clinical service. Claimant, clinical, and financial characteristics of the cases were recorded, and continuous or categorical data were compared using the Wilcoxon rank-sum test or Fisher exact test, respectively. Results This study included 135 teleradiology and 3474 radiology malpractices cases. The death of a patient occurred more frequently in teleradiology cases (48 of 135 [35.6%]) than in radiology cases (685 of 3474 [19.7%]; P < .001). Cerebrovascular disease was a more common final diagnosis in the teleradiology cases (13 of 135 [9.6%]) compared with the radiology cases (124 of 3474 [3.6%]; P = .002). Problems with communication among providers was a more frequent contributing factor in the teleradiology cases (35 of 135 [25.9%]) than in the radiology cases (439 of 3474 [12.6%]; P < .001). Teleradiology cases were more likely to close with indemnity payment (79 of 135 [58.5%]) than the radiology cases (1416 of 3474 [40.8%]; P < .001) and had a higher median indemnity payment than the radiology cases ($339 230 [IQR, $120 790-$731 615] vs $214 063 [IQR, $66 620-$585 424]; P = .01). Conclusion Compared with radiology cases, teleradiology cases had higher clinical and financial severity and were more likely to involve issues with communication. © RSNA, 2024 See also the editorial by Mezrich in this issue.

The Safety of Inpatient Health Care.

BACKGROUND: Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. METHODS: We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. RESULTS: In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). CONCLUSIONS: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Association of Simulation Training With Rates of Medical Malpractice Claims Among Obstetrician-Gynecologists.

OBJECTIVE: To compare malpractice claim rates before and after participation in simulation training, which focused on team training during a high-acuity clinical case. METHODS: We performed a retrospective analysis comparing the claim rates before and after simulation training among 292 obstetrician-gynecologists, all of whom were insured by the same malpractice insurer, who attended one or more simulation training sessions from 2002 to 2019. The insurer provided malpractice claims data involving study physicians, along with durations of coverage, which we used to calculate claim rates, expressed as claims per 100 physician coverage years. We used three different time periods in our presimulation and postsimulation training claim rates comparisons: the entire study period, 2 years presimulation and postsimulation training, and 1 year presimulation and postsimulation training. Secondary outcomes included indemnity payment amounts, percent of claims paid, and injury severity. RESULTS: Compared with presimulation training, malpractice claim rates were significantly lower postsimulation training for the full study period (11.2 vs 5.7 claims per 100 physician coverage years; P<.001) and the 2 years presimulation and postsimulation training (9.2 vs 5.4 claims per 100 physician coverage years; P=.043). For the 1 year presimulation and postsimulation training comparison, the decrease in claim rates was nonsignificant (8.8 vs 5.3 claims per 100 physician coverage years; P=.162). Attending more than one simulation session was associated with a greater reduction in claim rates. Postsimulation claim rates for physicians who attended one, two, or three or more simulation sessions were 6.3, 2.1, and 1.3 claims per 100 physician coverage years, respectively (P<.001). Compared with presimulation training, there was no significant difference in the median or mean indemnity paid, percent of claims on which an indemnity payment was made, or median severity of injury after simulation training. CONCLUSION: We observed a significant reduction in malpractice claim rates after simulation training. Wider use of simulation training within obstetrics and gynecology should be considered.

Rates and Characteristics of Medical Malpractice Claims Against Hospitalists.

BACKGROUND: Hospitalists practice in high-stakes and litigious settings. However, little data exist about the malpractice claims risk faced by hospitalists. OBJECTIVE: To characterize the rates and characteristics of malpractice claims against hospitalists. DESIGN, SETTING, AND PARTICIPANTS: An analysis was performed of malpractice claims against hospitalists, as well as against select other specialties, using data from a malpractice claims database that includes approximately 31% of US malpractice claims. MAIN OUTCOMES AND MEASURES: For malpractice claims against hospitalists (n = 1,216) and comparator specialties (n = 18,644): claims rates (using a data subset), percentage of claims paid, median indemnity payment amounts, allegation types, and injury severity. RESULTS: Hospitalists had an annual malpractice claims rate of 1.95 claims per 100 physician-years, similar to that of nonhospitalist general internal medicine physicians (1.92 claims per 100 physician-years), and significantly greater than that of internal medicine subspecialists (1.30 claims per 100 physician-years) (P < .001). Claims rates for hospitalists nonsignificantly increased during the study period (2009-2018), whereas claims rates for four of the five other specialties examined significantly decreased over this period. The median indemnity payment for hospitalist claims was $231,454 (interquartile range, $100,000-$503,015), significantly higher than the amounts for all the other specialties except neurosurgery. The greatest predictor of a hospitalist case closing with payment (compared with no payment) was an error in clinical judgment as a contributing factor, with an adjusted odds ratio of 5.01 (95% CI, 3.37-7.45). CONCLUSION: During the study period, hospitalist claims rates did not drop, whereas they fell for other specialties. Hospitalists' claims had relatively high injury severity and median indemnity payment amounts. The malpractice environment for hospitalists is becoming less favorable.

The Effect of Clinical Volume on Annual and Per-Patient Encounter Medical Malpractice Claims Risk.

OBJECTIVES: The relationship between medical malpractice risk and one of the fundamental characteristics of physician practice, clinical volume, remains undefined. This study examined how the annual and per-patient encounter medical malpractice claims risk varies with clinical volume. METHODS: Clinical volume was determined using health insurance charges and was linked at the physician level to malpractice claims data from a malpractice insurer. The annual medical malpractice claims risk was expressed as the percent of physicians with a malpractice claim, and the per-encounter medical malpractice claims risk was expressed as malpractice claims per 1000 patient encounters. Both of these malpractice claims risk metrics were analyzed as a function of clinical volume, using linear and spline regression. RESULTS: As clinical volume increased, the percent of physicians with a malpractice claim increased linearly. Among all physicians studied, for each decile increase in clinical volume, there was a 0.373% increase in physicians with a malpractice claim (95% confidence interval, 0.301%-0.446%; P < 0.0001). As clinical volume increased, the rate of malpractice claims per 1000 patient encounters decreased. This relationship between clinical volume and per-encounter claims risk was nonlinear. There was a clinical volume threshold, below which decreasing clinical volume was associated with increasing per-encounter claims risk, and above which claims risk no longer significantly varied with increases in clinical volume. CONCLUSIONS: Clinical volume is a crucial determinant of physician malpractice risk, with higher-volume physicians having higher annual risk but lower per-encounter risk. Clinical volume data should be incorporated into analyses of malpractice risk.

Healthcare system effects of pay-for-performance for smoking status documentation.

OBJECTIVES: To evaluate the impact on smoking status documentation of a payer-sponsored pay-for-performance (P4P) incentive that targeted a minority of an integrated healthcare delivery system's patients. STUDY DESIGN: Three commercial insurers simultaneously adopted P4P incentives to document smoking status of their members with 3 chronic diseases. The healthcare system responded by adding a smoking status reminder to all patients' electronic health records (EHRs). We measured change in smoking status documentation before (2008-2009) and after (2010-2011) P4P implementation by patient P4P eligibility. METHODS: The P4P-eligible patients were compared primarily with a subset of non-P4P-eligible patients who resembled P4P-eligible patients and also with all non-P4P-eligible patients. Multivariate models adjusted for patient and provider characteristics and accounted for provider-level clustering and preimplementation trends. RESULTS: Documentation increased from 48% of 207,471 patients before P4P to 71% of 227,574 patients after P4P. Improvement from 56% to 83% occurred among P4P-eligible patients (adjusted odds ratio [AOR], 3.6; 95% confidence interval [CI], 2.9-4.5) and from 56% to 80% among the comparable subset of non-P4P-eligible patients (AOR, 3.0; 95% CI, 2.3-3.9). The difference in improvement between groups was significant (AOR, 1.3; 95% CI, 1.1-1.4; P = .009). CONCLUSIONS: A P4P incentive targeting a minority of a healthcare system's patients stimulated adoption of a system wide EHR reminder and improved smoking status documentation overall. Combining a P4P incentive with an EHR reminder might help healthcare systems improve treatment delivery for smokers and meet "meaningful use" standards for EHRs.

Lexical concept distribution reflects clinical practice.

It is not known whether narrative medical text directly reflects clinical reality. We have tested the hypothesis that the pattern of distribution of lexical concept of medication intensification in narrative provider notes correlates with clinical practice as reflected in electronic medication records. Over 29,000 medication intensifications identified in narrative provider notes and 444,000 electronic medication records for 82 anti-hypertensive, anti-hyperlipidemic and anti-hyperglycemic medications were analyzed. Pearson correlation coefficient between the fraction of dose increases among all medication intensifications and therapeutic range calculated from EMR medication records was 0.39 (p = 0.0003). Correlations with therapeutic ranges obtained from two medication dictionaries, used as a negative control, were not significant. These findings provide evidence that narrative medical documents directly reflect clinical practice and constitute a valid source of medical data.

An unintended consequence of electronic prescriptions: prevalence and impact of internal discrepancies.

Many e-prescribing systems allow for both structured and free-text fields in prescriptions, making possible internal discrepancies. This study reviewed 2914 electronic prescriptions that contained free-text fields. Internal discrepancies were found in 16.1% of the prescriptions. Most (83.8%) of the discrepancies could potentially lead to adverse events and many (16.8%) to severe adverse events, involving a hospital admission or death. Discrepancies in doses, routes or complex regimens were most likely to have a potential for a severe event (p=0.0001). Discrepancies between structured and free-text fields in electronic prescriptions are common and can cause patient harm. Improvements in electronic medical record design are necessary to minimize the risk of discrepancies and resulting adverse events.

Prevalence and factors affecting home blood pressure documentation in routine clinical care: a retrospective study.

BACKGROUND: Home blood pressure (BP) is closely linked to patient outcomes. However, the prevalence of its documentation has not been examined. The objective of this study was to analyze the prevalence and factors affecting documentation of home BP in routine clinical care. METHODS: A retrospective study of 142,973 encounters of 9,840 hypertensive patients with diabetes from 2000 to 2005 was performed. The prevalence of recorded home BP and the factors associated with its documentation were analyzed. We assessed validity of home BP information by comparing the difference between home and office BP to previously published prospective studies. RESULTS: Home BP was documented in narrative notes for 2.08% of encounters where any blood pressure was recorded and negligibly in structured data (EMR flowsheets). Systolic and diastolic home BP in narrative notes were lower than office BP readings by 9.6 and 2.5 mm Hg, respectively (p < 0.0001 for both), consistent with prospective data. Probability of home BP documentation increased by 23.0% for each 10 mm Hg of office systolic BP (p < 0.0001), by 6.2% for each $10,000 in median income of zip code (p = 0.0055), and by 17.7% for each decade in the patient's age (p < 0.0001). CONCLUSIONS: Home BP readings provide a valid representation of the patient's condition, yet are seldom documented despite their potential utility in both patient care and research. Strong association between higher patient income and home BP documentation suggests that the cost of the monitors may be a limiting factor; reimbursement of home BP monitoring expenses should be pursued.

Encounter frequency and blood pressure in hypertensive patients with diabetes mellitus.

The relationship between encounter frequency (average number of provider-patient encounters over a period of time) and blood pressure for hypertensive patients is unknown. We tested the hypothesis that shorter encounter intervals are associated with faster blood pressure normalization. We performed a retrospective cohort study of 5042 hypertensive patients with diabetes mellitus treated at primary care practices affiliated with 2 academic hospitals between 2000 and 2005. Distinct periods of continuously elevated blood pressure (>or=130/85 mm Hg) were studied. We evaluated the association of the average encounter interval with time to blood pressure normalization and rate of blood pressure decrease. Blood pressure of the patients with the average interval between encounters 1 month (P<0.0001 for all). Median time to blood pressure normalization was 0.7 versus 1.9 months for the average encounter interval

Effects of documentation-based decision support on chronic disease management.

OBJECTIVE: To evaluate whether a new documentation-based clinical decision support system (CDSS) is effective in addressing deficiencies in the care of patients with coronary artery disease (CAD) and diabetes mellitus (DM). STUDY DESIGN: Controlled trial randomized by physician. METHODS: We assigned primary care physicians (PCPs) in 10 ambulatory practices to usual care or the CAD/DM Smart Form for 9 months. The primary outcome was the proportion of deficiencies in care that were addressed within 30 days after a patient visit. RESULTS: The Smart Form was used for 5.6% of eligible patients. In the intention-to-treat analysis, patients of intervention PCPs had a greater proportion of deficiencies addressed within 30 days of a visit compared with controls (11.4% vs 10.1%, adjusted and clustered odds ratio =1.14; 95% confidence interval, 1.02-1.28; P = .02). Differences were more pronounced in the "on-treatment" analysis: 17.0% of deficiencies were addressed after visits in which the Smart Form was used compared with 10.6% of deficiencies after visits in which it was not used (P <.001). Measures that improved included documentation of smoking status and prescription of antiplatelet agents when appropriate. CONCLUSIONS: Overall use of the CAD/DM Smart Form was low, and improvements in management were modest. When used, documentation-based decision support shows promise, and future studies should focus on refining such tools, integrating them into current electronic health record platforms, and promoting their use, perhaps through organizational changes to primary care practices.

Comparison of information content of structured and narrative text data sources on the example of medication intensification.

OBJECTIVE To compare information obtained from narrative and structured electronic sources using anti-hypertensive medication intensification as an example clinical issue of interest. DESIGN A retrospective cohort study of 5,634 hypertensive patients with diabetes from 2000 to 2005. MEASUREMENTS The authors determined the fraction of medication intensification events documented in both narrative and structured data in the electronic medical record. The authors analyzed the relationship between provider characteristics and concordance between intensifications in narrative and structured data. As there is no gold standard data source for medication information, the authors clinically validated medication intensification information by assessing the relationship between documented medication intensification and the patients' blood pressure in univariate and multivariate models. RESULTS Overall, 5,627 (30.9%) of 18,185 medication intensification events were documented in both sources. For a medication intensification event documented in narrative notes the probability of a concordant entry in structured records increased by 11% for each study year (p < 0.0001) and decreased by 19% for each decade of provider age (p = 0.035). In a multivariate model that adjusted for patient demographics and intraphysician correlations, an increase of one medication intensification per month documented in either narrative or structured data were associated with a 5-8 mm Hg monthly decrease in systolic and 1.5-4 mm Hg decrease in diastolic blood pressure (p < 0.0001 for all). CONCLUSION Narrative and structured electronic data sources provide complementary information on anti-hypertensive medication intensification. Clinical validity of information in both sources was demonstrated by correlation with changes in blood pressure.

Improving physician note entry rates through an incentive program.

The Massachusetts General Hospital Physicians Organization (MGPO) has implemented physician incentives to drive timely entry of notes into the outpatient electronic health record. Data from the Partners Quality Data Warehouse (QDW) were used to refine and produce a note completion metric and to create reports. This initiative has led to a decrease in the average time to complete a note from 197 to 90 hours, in less than a year.

Linking test ordering with order tracking: closing the loop in ambulatory care.

Test non-completion decreases quality of care and accounts for many diagnosis-related malpractice claims. Currently, clinicians using Partners' electronic Longitudinal Medical Record (LMR) can track results but lack a mechanism for tracking non-completed tests. This pilot intervention will study an "order tracking" functionality that flags newly-ordered tests and will lead to generation of written patient reminders if tests are not completed within pre-specified timeframes. If test completion rates improve, we will pursue development of a dedicated LMR application.

Identification of documented medication non-adherence in physician notes.

Medication non-adherence is common and the physicians awareness of it may be an important factor in clinical decision making. Few sources of data on physician awareness of medication non-adherence are available. We have designed an algorithm to identify documentation of medication non-adherence in the text of physician notes. The algorithm recognizes eight semantic classes of documentation of medication non-adherence. We evaluated the algorithm against manual ratings of 200 randomly selected notes of hypertensive patients. The algorithm detected 89% of the notes with documented medication non-adherence with specificity of 84.7% and positive predictive value of 80.2%. In a larger dataset of 1,000 documents, notes that documented medication non-adherence were more likely to report significantly elevated systolic (15.3% vs. 9.0%; p = 0.002) and diastolic (4.1% vs. 1.9%; p = 0.03) blood pressure. This novel clinically validated tool expands the range of information on medication non-adherence available to researchers.

Modeling pediatric vaccination guidelines in a data warehouse.

Frequent updates and complexity of vaccination schedules can make it difficult for pediatric practices to ensure adherence to immunization guidelines. To address this problem, Partners HealthCare System (PHS) has created a quality reporting utility to manage pediatric immunizations and to support quality improvement initiatives. The rules-based solution uses reference database tables to model the logic for each vaccine.

"Smart Forms" in an Electronic Medical Record: documentation-based clinical decision support to improve disease management.

Clinical decision support systems (CDSS) integrated within Electronic Medical Records (EMR) hold the promise of improving healthcare quality. To date the effectiveness of CDSS has been less than expected, especially concerning the ambulatory management of chronic diseases. This is due, in part, to the fact that clinicians do not use CDSS fully. Barriers to clinicians' use of CDSS have included lack of integration into workflow, software usability issues, and relevance of the content to the patient at hand. At Partners HealthCare, we are developing "Smart Forms" to facilitate documentation-based clinical decision support. Rather than being interruptive in nature, the Smart Form enables writing a multi-problem visit note while capturing coded information and providing sophisticated decision support in the form of tailored recommendations for care. The current version of the Smart Form is designed around two chronic diseases: coronary artery disease and diabetes mellitus. The Smart Form has potential to improve the care of patients with both acute and chronic conditions.