Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population.

OBJECTIVE: There is a lack of research on adverse event (AE) detection in oncology patients, despite the propensity for iatrogenic harm. Two common methods include voluntary safety reporting (VSR) and chart review tools, such as the Institute for Healthcare Improvement's Global Trigger Tool (GTT). Our objective was to compare frequency and type of AEs detected by a modified GTT compared with VSR for identifying AEs in oncology patients in a larger clinical trial. METHODS: Patients across 6 oncology units (from July 1, 2013, through May 29, 2015) were randomly selected. Retrospective chart reviews were conducted by a team of nurses and physicians to identify AEs using the GTT. The VSR system was queried by the department of quality and safety of the hospital. Adverse event frequencies, type, and harm code for both methods were compared. RESULTS: The modified GTT detected 0.90 AEs per patient (79 AEs in 88 patients; 95% [0.71-1.12] AEs per patient) that were predominantly medication AEs (53/79); more than half of the AEs caused harm to the patients (41/79, 52%), but only one quarter were preventable (21/79; 27%). The VSR detected 0.24 AEs per patient (21 AEs in 88 patients; 95% [0.15-0.37] AEs per patient), a large plurality of which were medication/intravenous related (8/21); more than half did not cause harm (70%). Only 2% of the AEs (2/100) were detected by both methods. CONCLUSIONS: Neither the modified GTT nor the VSR system alone is sufficient for detecting AEs in oncology patient populations. Further studies exploring methods such as automated AE detection from electronic health records and leveraging patient-reported AEs are needed.

Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study

OBJECTIVE: To determine whether medical errors, family experience, and communication processes improved after implementation of an intervention to standardize the structure of healthcare provider-family communication on family centered rounds. DESIGN: Prospective, multicenter before and after intervention study. SETTING: Pediatric inpatient units in seven North American hospitals, 17 December 2014 to 3 January 2017. PARTICIPANTS: All patients admitted to study units (3106 admissions, 13171 patient days); 2148 parents or caregivers, 435 nurses, 203 medical students, and 586 residents. INTERVENTION: Families, nurses, and physicians coproduced an intervention to standardize healthcare provider-family communication on ward rounds ("family centered rounds"), which included structured, high reliability communication on bedside rounds emphasizing health literacy, family engagement, and bidirectional communication; structured, written real-time summaries of rounds; a formal training programme for healthcare providers; and strategies to support teamwork, implementation, and process improvement. MAIN OUTCOME MEASURES: Medical errors (primary outcome), including harmful errors (preventable adverse events) and non-harmful errors, modeled using Poisson regression and generalized estimating equations clustered by site; family experience; and communication processes (eg, family engagement on rounds). Errors were measured via an established systematic surveillance methodology including family safety reporting. RESULTS: The overall rate of medical errors (per 1000 patient days) was unchanged (41.2 (95% confidence interval 31.2 to 54.5) pre-intervention v 35.8 (26.9 to 47.7) post-intervention, P=0.21), but harmful errors (preventable adverse events) decreased by 37.9% (20.7 (15.3 to 28.1) v 12.9 (8.9 to 18.6), P=0.01) post-intervention. Non-preventable adverse events also decreased (12.6 (8.9 to 17.9) v 5.2 (3.1 to 8.8), P=0.003). Top box (eg, "excellent") ratings for six of 25 components of family reported experience improved; none worsened. Family centered rounds occurred more frequently (72.2% (53.5% to 85.4%) v 82.8% (64.9% to 92.6%), P=0.02). Family engagement 55.6% (32.9% to 76.2%) v 66.7% (43.0% to 84.1%), P=0.04) and nurse engagement (20.4% (7.0% to 46.6%) v 35.5% (17.0% to 59.6%), P=0.03) on rounds improved. Families expressing concerns at the start of rounds (18.2% (5.6% to 45.3%) v 37.7% (17.6% to 63.3%), P=0.03) and reading back plans (4.7% (0.7% to 25.2%) v 26.5% (12.7% to 7.3%), P=0.02) increased. Trainee teaching and the duration of rounds did not change significantly. CONCLUSIONS: Although overall errors were unchanged, harmful medical errors decreased and family experience and communication processes improved after implementation of a structured communication intervention for family centered rounds coproduced by families, nurses, and physicians. Family centered care processes may improve safety and quality of care without negatively impacting teaching or duration of rounds. TRIAL REGISTRATION: ClinicalTrials.gov NCT02320175.

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.

Families as Partners in Hospital Error and Adverse Event Surveillance.

Importance: Medical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection. Objective: To compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports. Design, Setting, and Participants: We conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%-90%; κ, 0.50-0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient. Main Outcomes and Measures: Error and AE rates. Results: Overall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26-40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95% CI, 1.1-1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95% CI, 1.0-1.2; P = .006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95% CI, .5-1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95% CI, 0.8-2.2). Family-reported error rates were 5.0-fold (95% CI, 1.9-13.0) higher and AE rates 2.9-fold (95% CI, 1.2-6.7) higher than hospital incident report rates. Conclusions and Relevance: Families provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better design and assessment of interventions to improve safety.

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.).

Errors associated with outpatient computerized prescribing systems.

OBJECTIVE: To report the frequency, types, and causes of errors associated with outpatient computer-generated prescriptions, and to develop a framework to classify these errors to determine which strategies have greatest potential for preventing them. MATERIALS AND METHODS: This is a retrospective cohort study of 3850 computer-generated prescriptions received by a commercial outpatient pharmacy chain across three states over 4 weeks in 2008. A clinician panel reviewed the prescriptions using a previously described method to identify and classify medication errors. Primary outcomes were the incidence of medication errors; potential adverse drug events, defined as errors with potential for harm; and rate of prescribing errors by error type and by prescribing system. RESULTS: Of 3850 prescriptions, 452 (11.7%) contained 466 total errors, of which 163 (35.0%) were considered potential adverse drug events. Error rates varied by computerized prescribing system, from 5.1% to 37.5%. The most common error was omitted information (60.7% of all errors). DISCUSSION: About one in 10 computer-generated prescriptions included at least one error, of which a third had potential for harm. This is consistent with the literature on manual handwritten prescription error rates. The number, type, and severity of errors varied by computerized prescribing system, suggesting that some systems may be better at preventing errors than others. CONCLUSIONS: Implementing a computerized prescribing system without comprehensive functionality and processes in place to ensure meaningful system use does not decrease medication errors. The authors offer targeted recommendations on improving computerized prescribing systems to prevent errors.

Medication errors in paediatric outpatients.

BACKGROUND: Medication errors are common in many settings and have important ramifications. Although there is growing research on rates and characteristics of medication errors in adult ambulatory settings, less is known about the paediatric ambulatory setting. OBJECTIVE: To assess medication error rates in paediatric patients in ambulatory settings. METHODS: The authors conducted a prospective cohort study of paediatric patients in six outpatient offices in Massachusetts. Data were collected using duplicate prescription review, two parental surveys and chart review. A research nurse classified all medication errors by stage and type of error. RESULTS: The authors identified 1205 medication errors with minimal potential for harm (rate: 68% of patients, 95% CI 64 to 72%; 53% of Rx, 95% CI 50 to 56%) and 464 potentially harmful medication errors (ie, near misses) (rate: 26% of patients, 95% CI 24 to 28%; 21% of Rx, 95% CI 19 to 22%). Overall, 94% of the medication errors with minimal potential for harm and 60% of the near misses occurred at the prescribing stage. The most common types of errors were inappropriate abbreviations followed by dosing errors. The most frequent cause of errors was illegibility. CONCLUSION: With paper prescribing, half the prescriptions had medication errors, and one in five had a potentially harmful error. These rates are very high. Interventions targeting the ordering and administration stages have the greatest potential benefit.

Adverse drug events in pediatric outpatients.

OBJECTIVE: To determine rates and types of adverse drug events (ADEs) in the pediatric ambulatory setting. METHODS: A prospective cohort study at 6 office practices in the greater Boston area was conducted over 2-month periods. Duplicate prescription review, telephone surveys 10 days and 2 months after visit, and chart reviews were done. A 2-physician panel classified the severity, preventability, and ability to ameliorate (ie, if the severity or duration of the side effect could have been mitigated by improved communication) ADEs. RESULTS: We identified 57 preventable ADEs (rate 3%; 95% confidence intervals [CI], 3%-4%) and 226 nonpreventable ADEs (rate 13%; 95% CI, 11%-15%) in the medical care of 1788 patients. Of the ADEs, 152 (54%) were able to be ameliorated. None of the preventable ADEs were life threatening, although 8 (14%) were serious. Forty (70%) of the preventable ADEs were related to parent drug administration. Improved communication between health care providers and parents and improved communication between pharmacists and parents, whether in the office or in the pharmacy, were judged to be the prevention strategies with greatest potential. CONCLUSIONS: Patient harm from medication use was common in the pediatric ambulatory setting. Errors in home medication administration resulted in the majority of preventable ADEs. Approximately one fifth of ADEs were potentially preventable and many more were potentially able to be ameliorated. Rates of ADEs due to errors are comparable in children and adults despite less medication utilization in children.