Establishing a regional registry for neonatal encephalopathy: impact on identification of gaps in practice.

BACKGROUND: Neonatal encephalopathy (NE) continues to be a significant risk for death and disability. To address this risk, regional guidelines were developed with the support of a malpractice insurance patient safety organization. A NE registry was also established to include 14 centers representing around 50% of deliveries in the state of Massachusetts. The aim of this study was to identify areas of variation in practice that could benefit from quality improvement projects. METHODS: This manuscript reports on the establishment of the registry and the primary findings to date. RESULTS: From 2018 to 2020, 502 newborns with NE were evaluated for Therapeutic Hypothermia (TH), of which 246 (49%) received TH, representing a mean of 2.91 per 1000 live births. The study reports on prenatal characteristics, delivery room resuscitation, TH eligibility screening, and post-natal management of newborns with NE who did and did not receive TH. CONCLUSIONS: The registry has allowed for the identification of areas of variation in clinical practices, which have guided ongoing quality improvement projects. The authors advocate for the establishment of local and regional registries to standardize and improve NE patient care. They have made the registry data collection tools freely available for other centers to replicate this work. IMPACT: Malpractice insurance companies can take an active role in supporting clinicians in establishing clinical practice guidelines and regional registries. Establishing a collaborative regional neonatal encephalopathy (NE) registry is feasible. Data Collection tools for a NE registry have been made publicly available to be adopted and replicated by other groups. Establishing a regional NE registry allowed for the identification of gaps in knowledge, variations in practice, and the opportunity to advance care through quality improvement projects.

Partnering With a Medical Malpractice Insurer to Improve Patient Safety and Decrease Risk.

Implementing evolving science into clinical practice remains challenging. Assimilating new scientific evidence into clinical protocols and best practice recommendations, in a timely manner, can be difficult. In this article, we examine the value of partnering with a captive medical malpractice insurance company and its Patient Safety Organization to use data and convening opportunities to build upon the principles of implementation science and foster efficient and widespread adoption of the most current evidence-based interventions. Analyses of medical malpractice and root-cause analysis data set the context for this partnership and acted as a catalyst for creating best practice guidelines for adopting therapeutic hypothermia in the treatment of neonatal encephalopathy. What follows is a powerful example of successfully leveraging the collective wisdom of healthcare providers across specialties and institutional lines to move patient safety forward while managing risk.

Changes in medical errors after implementation of a handoff program.

BACKGROUND: Miscommunications are a leading cause of serious medical errors. Data from multicenter studies assessing programs designed to improve handoff of information about patient care are lacking. METHODS: We conducted a prospective intervention study of a resident handoff-improvement program in nine hospitals, measuring rates of medical errors, preventable adverse events, and miscommunications, as well as resident workflow. The intervention included a mnemonic to standardize oral and written handoffs, handoff and communication training, a faculty development and observation program, and a sustainability campaign. Error rates were measured through active surveillance. Handoffs were assessed by means of evaluation of printed handoff documents and audio recordings. Workflow was assessed through time-motion observations. The primary outcome had two components: medical errors and preventable adverse events. RESULTS: In 10,740 patient admissions, the medical-error rate decreased by 23% from the preintervention period to the postintervention period (24.5 vs. 18.8 per 100 admissions, P<0.001), and the rate of preventable adverse events decreased by 30% (4.7 vs. 3.3 events per 100 admissions, P<0.001). The rate of nonpreventable adverse events did not change significantly (3.0 and 2.8 events per 100 admissions, P=0.79). Site-level analyses showed significant error reductions at six of nine sites. Across sites, significant increases were observed in the inclusion of all prespecified key elements in written documents and oral communication during handoff (nine written and five oral elements; P<0.001 for all 14 comparisons). There were no significant changes from the preintervention period to the postintervention period in the duration of oral handoffs (2.4 and 2.5 minutes per patient, respectively; P=0.55) or in resident workflow, including patient-family contact and computer time. CONCLUSIONS: Implementation of the handoff program was associated with reductions in medical errors and in preventable adverse events and with improvements in communication, without a negative effect on workflow. (Funded by the Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, and others.).

Randomized Trial of Reducing Ambulatory Malpractice and Safety Risk: Results of the Massachusetts PROMISES Project.

OBJECTIVE: Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. STUDY SETTING: In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. STUDY DESIGN: Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools. DATA COLLECTION METHODS: Chart reviews conducted at baseline and postintervention for intervention sites. Staff and patient survey data collected at baseline and postintervention for intervention and control sites. PRINCIPAL FINDINGS: Chart reviews demonstrated significant improvements in documentation of abnormal results, patient notification, documentation of an action or treatment plan, and evidence of a completed plan (all P<0.001). Mean days between laboratory test date and evidence of completed action/treatment plan decreased by 19.4 days (P<0.001). Staff surveys showed modest but nonsignificant improvement for intervention practices relative to controls overall and for the 3 high-risk domains that were the focus of PROMISES. CONCLUSIONS: A consortium of stakeholders, quality improvement tools, coaches, and learning network decreased selected ambulatory safety risks often seen in malpractice claims.

Missed Diagnosis of Cardiovascular Disease in Outpatient General Medicine: Insights from Malpractice Claims Data.

BACKGROUND: Diagnostic errors are an underrecognized source of patient harm, and cardiovascular disease can be challenging to diagnose in the ambulatory setting. Although malpractice data can inform diagnostic error reduction efforts, no studies have examined outpatient cardiovascular malpractice cases in depth. A study was conducted to examine the characteristics of outpatient cardiovascular malpractice cases brought against general medicine practitioners. METHODS: Some 3,407 closed malpractice claims were analyzed in outpatient general medicine from CRICO Strategies' Comparative Benchmarking System database-the largest detailed database of paid and unpaid malpractice in the world-and multivariate models were created to determine the factors that predicted case outcomes. RESULTS: Among the 153 patients in cardiovascular malpractice cases for whom patient comorbidities were coded, the majority (63%) had at least one traditional cardiac risk factor, such as diabetes, tobacco use, or previous cardiovascular disease. Cardiovascular malpractice cases were more likely to involve an allegation of error in diagnosis (75% vs. 47%, p <0.0001), have high clinical severity (86% vs. 49%, p <0.0001) and result in death (75% vs. 27%, p <0.0001), as compared to noncardiovascular cases. Initial diagnoses of nonspecific chest pain and mimics of cardiovascular pain (for example, esophageal disease) were common and independently increased the likelihood of a claim resulting in a payment (p <0.01). CONCLUSION: Cardiovascular malpractice cases against outpatient general medicine physicians mostly occur in patients with conventional risk factors for coronary artery disease and are often diagnosed with common mimics of cardiovascular pain. These findings suggest that these patients may be high-yield targets for preventing diagnostic errors in the ambulatory setting.

Effect of bar-code technology on the safety of medication administration.

BACKGROUND: Serious medication errors are common in hospitals and often occur during order transcription or administration of medication. To help prevent such errors, technology has been developed to verify medications by incorporating bar-code verification technology within an electronic medication-administration system (bar-code eMAR). METHODS: We conducted a before-and-after, quasi-experimental study in an academic medical center that was implementing the bar-code eMAR. We assessed rates of errors in order transcription and medication administration on units before and after implementation of the bar-code eMAR. Errors that involved early or late administration of medications were classified as timing errors and all others as nontiming errors. Two clinicians reviewed the errors to determine their potential to harm patients and classified those that could be harmful as potential adverse drug events. RESULTS: We observed 14,041 medication administrations and reviewed 3082 order transcriptions. Observers noted 776 nontiming errors in medication administration on units that did not use the bar-code eMAR (an 11.5% error rate) versus 495 such errors on units that did use it (a 6.8% error rate)--a 41.4% relative reduction in errors (P<0.001). The rate of potential adverse drug events (other than those associated with timing errors) fell from 3.1% without the use of the bar-code eMAR to 1.6% with its use, representing a 50.8% relative reduction (P<0.001). The rate of timing errors in medication administration fell by 27.3% (P<0.001), but the rate of potential adverse drug events associated with timing errors did not change significantly. Transcription errors occurred at a rate of 6.1% on units that did not use the bar-code eMAR but were completely eliminated on units that did use it. CONCLUSIONS: Use of the bar-code eMAR substantially reduced the rate of errors in order transcription and in medication administration as well as potential adverse drug events, although it did not eliminate such errors. Our data show that the bar-code eMAR is an important intervention to improve medication safety. (ClinicalTrials.gov number, NCT00243373.)

Return on investment for vendor computerized physician order entry in four community hospitals: the importance of decision support.

BACKGROUND: In-hospital adverse events are a major cause of morbidity and mortality and represent a major cost burden to health care systems. A study was conducted to evaluate the return on investment (ROI) for the adoption of vendor-developed computerized physician oder entry (CPOE) systems in four community hospitals in Massachusetts. METHODS: Of the four hospitals, two were under one management structure and implemented the same vendor-developed CPOE system (Hospital Group A), while the other two were under a second management structure and implemented another vendor-developed CPOE system (Hospital Group B). Cost savings were calculated on the basis of reduction in preventable adverse drug event (ADE) rates as measured previously. ROI, net cash flow, and the breakeven point during a 10-year cost-and-benefit model were calculated. At the time of the study, none of the participating hospitals had implemented more than a rudimentary decision support system together with CPOE. RESULTS: Implementation costs were lower for Hospital Group A than B ($7,130,894 total or $83/admission versus $19,293,379 total or $113/admission, respectively), as were preventable ADE-related avoided costs ($7,937,651 and $16,557,056, respectively). A cost-benefit analysis demonstrated that Hospital Group A had an ROI of 11.3%, breaking even on the investment eight years following implementation. Hospital Group B showed a negative return, with an ROI of -3.1%. CONCLUSIONS: Adoption of vendor CPOE systems in community hospitals was associated with a modest ROI at best when applying cost savings attributable to prevention of ADEs only. The modest financial returns can beattributed to the lack of clinical decision support tools.

Lessons learned from implementation of computerized provider order entry in 5 community hospitals: a qualitative study.

BACKGROUND: Computerized Provider Order Entry (CPOE) can improve patient safety, quality and efficiency, but hospitals face a host of barriers to adopting CPOE, ranging from resistance among physicians to the cost of the systems. In response to the incentives for meaningful use of health information technology and other market forces, hospitals in the United States are increasingly moving toward the adoption of CPOE. The purpose of this study was to characterize the experiences of hospitals that have successfully implemented CPOE. METHODS: We used a qualitative approach to observe clinical activities and capture the experiences of physicians, nurses, pharmacists and administrators at five community hospitals in Massachusetts (USA) that adopted CPOE in the past few years. We conducted formal, structured observations of care processes in diverse inpatient settings within each of the hospitals and completed in-depth, semi-structured interviews with clinicians and staff by telephone. After transcribing the audiorecorded interviews, we analyzed the content of the transcripts iteratively, guided by principles of the Immersion and Crystallization analytic approach. Our objective was to identify attitudes, behaviors and experiences that would constitute useful lessons for other hospitals embarking on CPOE implementation. RESULTS: Analysis of observations and interviews resulted in findings about the CPOE implementation process in five domains: governance, preparation, support, perceptions and consequences. Successful institutions implemented clear organizational decision-making mechanisms that involved clinicians (governance). They anticipated the need for education and training of a wide range of users (preparation). These hospitals deployed ample human resources for live, in-person training and support during implementation. Successful implementation hinged on the ability of clinical leaders to address and manage perceptions and the fear of change. Implementation proceeded smoothly when institutions identified and anticipated the consequences of the change. CONCLUSIONS: The lessons learned in the five domains identified in this study may be useful for other community hospitals embarking on CPOE adoption.

Rates of medical errors and preventable adverse events among hospitalized children following implementation of a resident handoff bundle.

IMPORTANCE: Handoff miscommunications are a leading cause of medical errors. Studies comprehensively assessing handoff improvement programs are lacking. OBJECTIVE: To determine whether introduction of a multifaceted handoff program was associated with reduced rates of medical errors and preventable adverse events, fewer omissions of key data in written handoffs, improved verbal handoffs, and changes in resident-physician workflow. DESIGN, SETTING, AND PARTICIPANTS: Prospective intervention study of 1255 patient admissions (642 before and 613 after the intervention) involving 84 resident physicians (42 before and 42 after the intervention) from July-September 2009 and November 2009-January 2010 on 2 inpatient units at Boston Children's Hospital. INTERVENTIONS: Resident handoff bundle, consisting of standardized communication and handoff training, a verbal mnemonic, and a new team handoff structure. On one unit, a computerized handoff tool linked to the electronic medical record was introduced. MAIN OUTCOMES AND MEASURES: The primary outcomes were the rates of medical errors and preventable adverse events measured by daily systematic surveillance. The secondary outcomes were omissions in the printed handoff document and resident time-motion activity. RESULTS: Medical errors decreased from 33.8 per 100 admissions (95% CI, 27.3-40.3) to 18.3 per 100 admissions (95% CI, 14.7-21.9; P < .001), and preventable adverse events decreased from 3.3 per 100 admissions (95% CI, 1.7-4.8) to 1.5 (95% CI, 0.51-2.4) per 100 admissions (P = .04) following the intervention. There were fewer omissions of key handoff elements on printed handoff documents, especially on the unit that received the computerized handoff tool (significant reductions of omissions in 11 of 14 categories with computerized tool; significant reductions in 2 of 14 categories without computerized tool). Physicians spent a greater percentage of time in a 24-hour period at the patient bedside after the intervention (8.3%; 95% CI 7.1%-9.8%) vs 10.6% (95% CI, 9.2%-12.2%; P = .03). The average duration of verbal handoffs per patient did not change. Verbal handoffs were more likely to occur in a quiet location (33.3%; 95% CI, 14.5%-52.2% vs 67.9%; 95% CI, 50.6%-85.2%; P = .03) and private location (50.0%; 95% CI, 30%-70% vs 85.7%; 95% CI, 72.8%-98.7%; P = .007) after the intervention. CONCLUSIONS AND RELEVANCE: Implementation of a handoff bundle was associated with a significant reduction in medical errors and preventable adverse events among hospitalized children. Improvements in verbal and written handoff processes occurred, and resident workflow did not change adversely.

Electronic risk alerts to improve primary care management of chest pain: a randomized, controlled trial.

BACKGROUND: The primary care evaluation of chest pain represents a significant diagnostic challenge. OBJECTIVE: To determine if electronic alerts to physicians can improve the quality and safety of chest pain evaluations. DESIGN AND PARTICIPANTS: Randomized, controlled trial conducted between November 2008 and January 2010 among 292 primary care clinicians caring for 7,083 adult patients with chest pain and no history of cardiovascular disease. INTERVENTION: Clinicians received alerts within the electronic health record during office visits for chest pain. One alert recommended performance of an electrocardiogram and administration of aspirin for high risk patients (Framingham Risk Score (FRS) ≥ 10%), and a second alert recommended against performance of cardiac stress testing for low risk patients (FRS < 10%). MAIN MEASURES: The primary outcomes included performance of an electrocardiogram and administration of aspirin therapy for high risk patients; and avoidance of cardiac stress testing for low risk patients. KEY RESULTS: The majority (81%) of patients with chest pain were classified as low risk. High risk patients were more likely than low risk patients to be evaluated in the emergency department (11% versus 5%, p < 0.01) and to be hospitalized (7% versus 3%, p < 0.01). Acute myocardial infarction occurred among 26 (0.4%) patients, more commonly among high risk compared to low risk patients (1.1% versus 0.2%, p < 0.01). Among high risk patients, there was no difference between the intervention and control groups in rates of performing electrocardiograms (51% versus 48%, p = 0.33) or administering aspirin (20% versus 18%, p = 0.43). Among low risk patients, there was no difference between intervention and control groups in rates of cardiac stress testing (10% versus 9%, p = 0.40). CONCLUSIONS: Primary care management of chest pain is suboptimal for both high and low risk patients. Electronic alerts do not increase risk-appropriate care for these patients.

Impact of vendor computerized physician order entry in community hospitals.

BACKGROUND: It is uncertain if computerized physician order entry (CPOE) systems are effective at reducing adverse drug event (ADE) rates in community hospitals, where mainly vendor-developed applications are used. OBJECTIVE: To evaluate the impact of vendor CPOE systems on the frequency of ADEs. DESIGN AND PATIENTS: Prospective before-and-after study conducted from January 2005 to September 2010 at five Massachusetts community hospitals. Participants were adults admitted during the study period. A total of 2,000 charts were reviewed for orders, medication lists, laboratory reports, admission histories, notes, discharge summaries, and flow sheets. MAIN MEASURES: The primary outcome measure was the rate of preventable ADEs. Rates of potential ADEs and overall ADEs were secondary outcomes. KEY RESULTS: The rate of preventable ADEs decreased following implementation (10.6/100 vs. 7.0/100 admissions; p = 0.007) with a similar effect observed at each site. However, the associated decrease in preventable ADEs was balanced against an increase in potential ADEs (44.4/100 vs. 57.5/100 admissions; p < 0.001). We observed a reduction of 34.0% for preventable ADEs, but an increase of 29.5% in potential ADEs following implementation. The overall rate of ADEs increased (14.6/100 vs. 18.7/100 admissions; p = 0.03), which was driven by non-preventable events (4.0/100 vs. 11.7/100 admissions; p < 0.001). CONCLUSIONS: Adoption of vendor CPOE systems was associated with a decrease in the preventable ADE rate by a third, although the rates of potential ADEs and overall ADEs increased. Our findings support the use of vendor CPOE systems as a means to reduce drug-related injury and harm. The potential ADE rate could be reduced by making refinements to the vendor applications and their associated decision support.

Off the hamster wheel? Qualitative evaluation of a payment-linked patient-centered medical home (PCMH) pilot.

CONTEXT: Many primary care practices are moving toward the patient-centered medical home (PCMH) model and increasingly are offering payment incentives linked to PCMH changes. Despite widespread acceptance of general PCMH concepts, there is still a pressing need to examine carefully and critically what transformation means for primary care practices and their patients and the experience of undergoing such change in a practice. METHODS: We used a qualitative case study approach to explore the underlying dynamics of change at five practices participating in PCMH transformation efforts linked to payment reform. The evaluation consisted of structured site visits, interviews, observations, and artifact reviews followed by a structured review of transcripts and documents for patterns, themes, and insights related to PCMH implementation. FINDINGS: We describe both the detailed components of each practice's transformation efforts and a grounded taxonomy of eight insights stemming from the experiences of these medical homes. We identified specific contextual factors related to wide variations in change tactics. We also observed widely varying approaches to catalyzing change using (or not) external consultants, specific challenges regarding health information technology implementation, team and staff role restructuring, compensation, and change fatigue, and several unexpected potential confounders or alternative explanations for practice success. CONCLUSIONS: Our evaluation affirms the value and necessity of qualitative methods for understanding primary care practice transformation, and it should encourage ongoing and future pilots to include assessments of the PCMH change process beyond clinical markers and claims data. The results raise insights into the heterogeneity of medical home transformation, the central but complex role of payment reform in creating a space for change, the ability of small practices to achieve substantial change in a short time period, and the challenges of sustaining it.

The costs of adverse drug events in community hospitals.

BACKGROUND: Adverse drug events (ADEs) occur often in hospitals, causing high morbidity and a longer length of stay (LOS), and are costly. However, most studies on the impact of ADEs have been conducted in tertiary referral centers, which are systematically different than community hospitals, where the bulk of care is delivered, and most available data about ADE costs in any setting are dated. Costs in community settings are generally lower than in academic hospitals, and the costs of ADEs might be as well. To assess the additional costs and LOS associated with patients with ADEs, a multicenter retrospective cohort study was conducted in six community hospitals with 100 to 300 beds in Massachusetts during a 20-month observation period (January 2005-August 2006). METHODS: A random sample of 2,100 patients (350 patients per study site) was drawn from a pool of 109,641 patients treated within the 20-month observation period. Unadjusted and adjusted cost of ADEs as well as LOS were calculated. RESULTS: ADEs were associated with an increased adjusted cost of $3,420 and an adjusted increase in length of stay (LOS) of 3.15 days. For preventable ADEs, the respective figures were +$3,511 and +3.37 days. The severity of the ADE was also associated with higher costs--the costs were +$2,852 for significant ADEs (LOS +2.77 days), +$3,650 for serious ADEs (LOS +3.47 days), and +$8,116 for life-threatening ADEs (LOS +5.54 days, all p < .001). CONCLUSIONS: ADEs in community hospitals cost more than $3,000 dollars on average and an average increase of LOS of 3.1 days--increments that were similar to previous estimates from academic institutions. The LOS increase was actually greater. A number of approaches, including computerized provider order entry and bar coding, have the potential to improve medication safety.

Tradeoffs of using administrative claims and medical records to identify the use of personalized medicine for patients with breast cancer.

BACKGROUND: Administrative claims and medical records are important data sources to examine healthcare utilization and outcomes. Little is known about identifying personalized medicine technologies in these sources. OBJECTIVES: To describe agreement, sensitivity, and specificity of administrative claims compared with medical records for 2 pairs of targeted tests and treatments for breast cancer. RESEARCH DESIGN: Retrospective analysis of medical records linked to administrative claims from a large health plan. We examined whether agreement varied by factors that facilitate tracking in claims (coding and cost) and that enhance medical record completeness (records from multiple providers). SUBJECTS: Women (35 to 65 y of age) with incident breast cancer diagnosed in 2006 to 2007 (n=775). MEASURES: Use of human epidermal growth factor receptor 2 (HER2) and gene expression profiling (GEP) testing, trastuzumab, and adjuvant chemotherapy in claims and medical records. RESULTS: Agreement between claims and records was substantial for GEP, trastuzumab, and chemotherapy, and lowest for HER2 tests. GEP, an expensive test with unique billing codes, had higher agreement (91.6% vs. 75.2%), sensitivity (94.9% vs. 76.7%), and specificity (90.1% vs. 29.2%) than HER2, a test without unique billing codes. Trastuzumab, a treatment with unique billing codes, had slightly higher agreement (95.1% vs. 90%) and sensitivity (98.1% vs. 87.9%) than adjuvant chemotherapy. CONCLUSIONS: Higher agreement and specificity were associated with services that had unique billing codes and high cost. Administrative claims may be sufficient for examining services with unique billing codes. Medical records provide better data for identifying tests lacking specific codes and for research requiring detailed clinical information.

Patient Engagement Activities and Patient Experience: Are Patients With a History of Depression the Canary in the Coal Mine?

Little is known about the effectiveness of primary care practices' efforts to engage patients in their health and health care. We examine the association between patient engagement efforts and patients' experiences of care. We found no association between an unweighted count of patient engagement activities and patient experience. Compared with the bottom quartile of practices, however, the top quartile had better performance on patient experience domains of communication, front-office staff, and organizational access (out of nine domains). Furthermore, patients reporting a diagnosis of depression have higher ratings across five domains of patient experience when in practices with higher levels of patient engagement activities measured using an unweighted scale. Future research is needed to understand how the benefits of patient engagement activities can accrue to more patient subgroups. These promising results suggest that payers and policy makers should continue to support implementation and benchmarking of patient engagement efforts across practices.

Expert Consensus on Currently Accepted Measures of Harm.

BACKGROUND: Twenty-five years after the seminal work of the Harvard Medical Practice Study, the numbers and specific types of health care measures of harm have evolved and expanded. Using the World Café method to derive expert consensus, we sought to generate a contemporary list of triggers and adverse event measures that could be used for chart review to determine the current incidence of inpatient and outpatient adverse events. METHODS: We held a modified World Café event in March 2018, during which content experts were divided into 10 tables by clinical domain. After a focused discussion of a prepopulated list of literature-based triggers and measures relevant to that domain, they were asked to rate each measure on clinical importance and suitability for chart review and electronic extraction (very low, low, medium, high, very high). RESULTS: Seventy-one experts from 9 diverse institutions attended (primary acceptance rate, 72%). Of 525 total triggers and measures, 67% of 391 measures and 46% of 134 triggers were deemed to have high or very high clinical importance. For those triggers and measures with high or very high clinical importance, 218 overall were deemed to be highly amenable to chart review and 198 overall were deemed to be suitable for electronic surveillance. CONCLUSIONS: The World Café method effectively prioritized measures/triggers of high clinical importance including those that can be used in chart review, which is considered the gold standard. A future goal is to validate these measures using electronic surveillance mechanisms to decrease the need for chart review.

Adverse drug event rates in six community hospitals and the potential impact of computerized physician order entry for prevention.

CONTEXT: Medications represent a major cause of harm and are costly for hospitalized patients, but more is known about these issues in large academic hospitals than in smaller hospitals. OBJECTIVE: To assess the incidence of adverse drug events (ADEs) in six community hospitals. DESIGN: Multicenter, retrospective cohort study. SETTING: Six Massachusetts community hospitals with 100 to 300 beds. PATIENTS: From 109,641 adult patients hospitalized from January 2005 through August 2006, a random sample of 1,200 patients was drawn, 200 per site. MAIN OUTCOME MEASURES: ADEs and preventable ADEs. METHODS: Presence of an ADE was evaluated using an adaptation of a trigger instrument developed by the Institute for Health Care Improvement. Independent reviewers classified events by preventability, severity, and potential for preventability by computerized physician order entry (CPOE). RESULTS: A total of 180 ADEs occurred in 141 patients (rate, 15.0/100 admissions). Overall, 75% were preventable. ADEs were rated as serious in 49.4% and life threatening in 11.7%. Patients with ADEs were older (mean age, 74.6 years, p < 0.001), more often female (60.3%, p = 0.61), and more often Caucasian (96.5%, p < 0.001) than patients without ADEs. Of the preventable ADEs, 81.5% were judged potentially preventable by CPOE. CONCLUSIONS: The incidence of ADEs in these community hospital admissions was high, and most ADEs were preventable, mostly through CPOE. These data suggest that CPOE may be beneficial in this setting.

Integrating incident data from five reporting systems to assess patient safety: making sense of the elephant.

BACKGROUND: A study was conducted to examine and compare information gleaned from five different reporting systems within one institution: incident reporting, patient complaints, risk management, medical malpractice claims, and executive walk rounds. These data sources vary in the timing of the reporting (retrospective or prospective), severity of the events, and profession of the reporters. METHODS: A common methodology was developed for classifying incidents. Data specific to each incident were abstracted from each system and then categorized using the same framework into one of 23 categories. RESULTS: Overall, there was little overlap, although each reporting system identified important safety issues. Communication problems were common among patient complaints and malpractice claims; malpractice claims' leading category was clinical judgement. Walk rounds identified issues with equipment and supplies. Adverse event reporting systems highlighted identification issues, especially mislabelled specimens. The frequency of contributions of reports by provider group varied substantially by system. Physicians accounted for 50% of risk management reports, but in adverse event reporting, where nurses were the main reporters, physicians accounted for only 2.5% of reports. Complaints and malpractice claims come primarily from patients. CONCLUSIONS: The five reporting systems each identified different yet complementary patient safety issues. To obtain a comprehensive picture of their patient safety problems and to develop priorities for improving safety, hospitals should use a broad portfolio of approaches and then synthesize the messages from all individual approaches into a collated and cohesive whole.

Occurrence of adverse, often preventable, events in community hospitals involving nephrotoxic drugs or those excreted by the kidney.

Medication errors in patients with reduced creatinine clearance are harmful and costly; however, most studies have been conducted in large academic hospitals. As there are few studies regarding this issue in smaller community hospitals, we conducted a multicenter, retrospective cohort study in six community hospitals (100 to 300 beds) to assess the incidence and severity of adverse drug events (ADEs) in patients with reduced creatinine clearance. A chart review was performed on adult patients hospitalized during a 20-month study period with serum creatinine over 1.5 mg/dl who were exposed to drugs that are nephrotoxic or cleared by the kidney. Among 109,641 patients, 17,614 had reduced creatinine clearance, and in a random sample of 900 of these patients, there were 498 potential ADEs and 90 ADEs. Among these ADEs, 91% were preventable, 51% were serious, 44% were significant, and 4.5% were life threatening. Of the potential ADEs, 54% were serious, 44% were significant, 1.6% were life threatening, and 96.6% were not intercepted. All 82 preventable events could have been intercepted by renal dose checking. Our study shows that ADEs were common in patients with impaired kidney function in community hospitals, and many appear potentially preventable with renal dose checking.

Risks of complications by attending physicians after performing nighttime procedures.

CONTEXT: Few data exist on the relationships between experienced physicians' work hours and sleep, and patient safety. OBJECTIVE: To determine if sleep opportunities for attending surgeons and obstetricians/gynecologists are associated with the risk of complications. DESIGN, SETTING, AND PATIENTS: Matched retrospective cohort study of procedures performed from January 1999 through June 2008 by attending physicians (86 surgeons and 134 obstetricians/gynecologists) who had been in the hospital performing another procedure involving adult patients for at least part of the preceding night (12 am-6 am, postnighttime procedures). Sleep opportunity was calculated as the time between end of the overnight procedure and start of the first procedure the following day. Matched control procedures included as many as 5 procedures of the same type performed by the same physician on days without preceding overnight procedures. Complications were identified and classified by a blinded 3-step process that included administrative screening, medical record reviews, and clinician ratings. MAIN OUTCOME MEASURES: Rates of complications in postnighttime procedures as compared with controls; rates of complications in postnighttime procedures among physicians with more than 6-hour sleep opportunities vs those with sleep opportunities of 6 hours or less. RESULTS: A total of 919 surgical and 957 obstetrical postnighttime procedures were matched with 3552 and 3945 control procedures, respectively. Complications occurred in 101 postnighttime procedures (5.4%) and 365 control procedures (4.9%) (odds ratio, 1.09; 95% confidence interval [CI], 0.84-1.41). Complications occurred in 82 of 1317 postnighttime procedures with sleep opportunities of 6 hours or less (6.2%) vs 19 of 559 postnighttime procedures with sleep opportunities of more than 6 hours (3.4%) (odds ratio, 1.72; 95% CI, 1.02-2.89). Postnighttime procedures completed after working more than 12 hours (n = 958) compared with 12 hours or less (n = 918) had nonsignificantly higher complication rates (6.5% vs 4.3%; odds ratio, 1.47; 95% CI, 0.96-2.27). CONCLUSION: Overall, procedures performed the day after attending physicians worked overnight were not associated with significantly increased complication rates, although there was an increased rate of complications among postnighttime surgical procedures performed by physicians with sleep opportunities of less than 6 hours.