Preventing lost-to-follow up diagnostic imaging in ambulatory care: evaluation of an electronic notification tool.

OBJECTIVE: Missed or cancelled imaging tests may be invisible to the ordering clinician and result in diagnostic delay. We developed an outpatient results notification tool (ORNT) to alert physicians of patients' missed radiology studies. DESIGN: Randomised controlled evaluation of a quality improvement intervention. SETTING: 23 primary care and subspecialty ambulatory clinics at an urban academic medical centre. PARTICIPANTS: 276 physicians randomised to intervention or usual care. MAIN OUTCOME MEASURE: 90-day test completion of missed imaging tests. RESULTS: We included 3675 radiology tests in our analysis: 1769 ordered in the intervention group and 1906 in the usual care group. A higher per cent of studies were completed for intervention compared with usual care groups in CT (20.7% vs 15.3%, p=0.06), general radiology (19.6% vs 12.0%, p=0.02) and, in aggregate, across all modalities (18.1% vs 16.1%, p=0.03). In the multivariable regression model adjusting for sex, age and insurance type and accounting for clustering with random effects at the level of the physician, the intervention group had a 36% greater odds of test completion than the usual care group (OR: 1.36 (1.097-1.682), p=0.005). In the Cox regression model, patients in the intervention group were 1.32 times more likely to complete their test in a timely fashion (HR: 1.32 (1.10-1.58), p=0.003). CONCLUSIONS: An electronic alert that notified the responsible clinician of a missed imaging test ordered in an ambulatory clinic reduced the number of incomplete tests at 90 days. Further study of the obstacles to completing recommended diagnostic testing may allow for the development of better tools to support busy clinicians and their patients and reduce the risk of diagnostic delays.

Clinical value of second opinions in oncology: A retrospective review of changes in diagnosis and treatment recommendations.

BACKGROUND: Data on the clinical value of second opinions in oncology are limited. We examined diagnostic and treatment changes resulting from second opinions and the expected impact on morbidity and prognosis. METHODS: This retrospective cohort study included patients presenting in 2018 to a high-volume cancer center for second opinions about newly diagnosed colorectal, head and neck, lung, and myeloma cancers or abnormal results. Two sub-specialty physicians from each cancer type reviewed 30 medical records (120 total) using a process and detailed data collection guide meant to mitigate institutional bias. The primary outcome measure was the rate of treatment changes that were "clinically meaningful", i.e., expected to impact morbidity and/or prognosis. Among those with treatment changes, another outcome measure was the rate of clinically meaningful diagnostic changes that led to treatment change. RESULTS: Of 120 cases, forty-two had clinically meaningful changes in treatment with positive expected outcomes (7 colorectal, 17 head and neck, 11 lung, 7 myeloma; 23-57%). Two patients had negative expected outcomes from having sought a second opinion, with worse short-term morbidity and unchanged long-term morbidity and prognosis. All those with positive expected outcomes had improved expected morbidity (short- and/or long-term); 11 (0-23%) also had improved expected prognosis. Nine involved a shift from treatment to observation; 21 involved eliminating or reducing the extent of surgery, compared to 6 adding surgery or increasing its extent. Of the 42 with treatment changes, 13 were due to clinically meaningful diagnostic changes (1 colorectal, 5 head and neck, 3 lung, 4 myeloma; 3%-17%) . CONCLUSIONS: Second-opinion consultations sometimes add clinical value by improving expected prognoses; more often, they offer treatment de-escalations, with corresponding reductions in expected short- and/or long-term morbidity. Future research could identify subgroups of patients most likely to benefit from second opinions.

Implementation of a Patient-Provider Agreement to Improve Healthcare Delivery for Patients With Substance Use Disorder in the Inpatient Setting.

OBJECTIVES: Inpatient healthcare delivery to people who use drugs is an opportunity to provide acute medical stabilization and offer treatment for underlying substance use disorder (SUD). The process of delivering quality healthcare to people with SUD can present challenges. METHODS: We convened a group of stakeholders to discuss challenges and opportunities for improving healthcare safety and employee satisfaction when providing inpatient care to people with SUD. RESULTS: We developed, implemented, and evaluated a "Pain and Addiction Agreement" tool, a document to guide discussions between providers and patients about expectations and policies for inpatient care. CONCLUSIONS: In this article, we share our experience of working closely with stakeholders. We hope that our project can serve as a blueprint motivating other centers to pursue quality improvement initiatives to improve healthcare for people with SUD and support the people who take care of them in the hospital.

Risk Factors for Adverse Events in Patients With Breast, Colorectal, and Lung Cancer.

OBJECTIVE: The aim of the study was to identify risk factors associated with medical errors and iatrogenic injuries during an initial course of cancer-directed treatment. METHODS: In this retrospective cohort study of 400 patients 18 years or older undergoing an initial course of treatment for breast, colorectal, or lung cancer at a comprehensive cancer center, we abstracted patient, disease, and treatment-related variables from the electronic medical record. We examined adverse events (AEs) and preventable AEs by risk factor using the χ2 or Fisher exact tests. We estimated the association between risk factors and the relative risk of an additional AE or preventable AE in multivariable negative binomial regression models with backwards selection (P < 0.1). RESULTS: There were 304 AEs affecting 136 patients (34%) and 97 preventable AEs affecting 53 patients (13%). In multivariable analyses, AEs were overrepresented in those with lung cancer compared with patients with breast cancer (incident rate ratio = 1.9, 95% confidence interval = 1.1-3.2). Nonwhite race (1.6, 1.0-2.6), Hispanic or Latino ethnicity (2.0, 0.9-4.1), advanced disease (1.7, 1.1-2.6), use of each additional class of high-risk nonchemotherapy medication (1.6, 1.3-1.9), and chemotherapy (2.1, 1.3-3.3) were all associated with risk of an additional AE. Preventable AEs were associated with lung cancer (7.4, 2.4-23.2), Hispanic or Latino ethnicity (5.5, 1.7-17.9), and high-risk nonchemotherapy medications (1.5, 1.2-2.0). CONCLUSIONS: Risk factors for AEs among patients with cancer reflected patients' underlying disease, cancer-directed therapy, and high-risk noncancer medications. The association of AEs with ethnicity merits further research. Risk factor models could be used prospectively to identify patients with cancer at increased risk of harm.

Teamwork Among Medicine House Staff During Work Rounds: Development of a Direct Observation Tool.

OBJECTIVE: Teamwork is integral to effective health care but difficult to evaluate. Few tools have been tested outside of classroom or medical simulation settings. Accordingly, we aimed to develop and pilot test an easy-to-use direct observation instrument for measuring teamwork among medical house staff. METHODS: We performed direct observations of 18 inpatient medicine house staff teams at a teaching hospital using an instrument constructed from existing teamwork tools, expert panel review, and pilot testing. We examined differences across teams using the Kruskal-Wallis statistic. We examined interrater reliability with the κ statistic, domain scales using Cronbach α, and construct validity using correlation and multivariable regression analyses of quality and utilization metrics. Observers rated team performance before and after providing feedback to 12 of the 18 team leaders and assessed changes in team performance using paired two-tailed t tests. RESULTS: We found variation in team performance in the situation monitoring, mutual support, and communication domains. The instrument evidenced good interrater reliability among concurrent, independent observers (κ = 0.7, P < 0.001). It had satisfactory face validity based on expert panel review and the assessments of resident team leaders. Construct validity was supported by a positive correlation between team performance and the Hospital Consumer Assessment of Healthcare Providers and Systems physician communication score (r = 0.6, P = 0.03). Providing resident physicians with information about their teams' performance was associated with improved mean performance in follow-up observations (3.6-3.8/4.0, P = 0.001). CONCLUSIONS: Direct observation of teamwork behaviors by medicine house staff on ward rounds is feasible and feedback may improve performance.

Association between cancer-specific adverse event triggers and mortality: A validation study.

BACKGROUND: As there are few validated measures of patient safety in clinical oncology, creating an efficient measurement instrument would create significant value. Accordingly, we sought to assess the validity of a novel patient safety measure by examining the association of oncology-specific triggers and mortality using administrative claims data. METHODS: We examined a retrospective cohort of 322 887 adult cancer patients enrolled in commercial or Medicare Advantage products for one year after an initial diagnosis of breast, colorectal, lung, or prostate cancer in 2008-2014. We used diagnosis and procedure codes to calculate the prevalence of 16 cancer-specific "triggers"-events that signify a potential adverse event. We compared one-year mortality rates among patients with and without triggers by cancer type and metastatic status using logistic regression models. RESULTS: Trigger events affected 19% of patients and were most common among patients with metastatic colorectal (41%) and lung (50%) cancers. There was increased one-year mortality among patients with triggers compared to patients without triggers across all cancer types in unadjusted and multivariate analyses. The increased mortality rate among patients with trigger events was particularly striking for nonmetastatic prostate cancer (1.3% vs 7.5%, adjusted odds ratio 1.96 [95% CI 1.49-2.57]) and nonmetastatic colorectal cancer (4.1% vs 11.7%, 1.44 [1.19-1.75]). CONCLUSIONS: The association between adverse event triggers and poor survival among a cohort of cancer patients supports the validity of a cancer-specific, administrative claims-based trigger tool.

Preventing Diagnostic Errors in Ambulatory Care: An Electronic Notification Tool for Incomplete Radiology Tests.

BACKGROUND: Failure to complete recommended diagnostic tests may increase the risk of diagnostic errors. OBJECTIVES: The aim of this study is to develop and evaluate an electronic monitoring tool that notifies the responsible clinician of incomplete imaging tests for their ambulatory patients. METHODS: A results notification workflow engine was created at an academic medical center. It identified future appointments for imaging studies and notified the ordering physician of incomplete tests by secure email. To assess the impact of the intervention, the project team surveyed participating physicians and measured test completion rates within 90 days of the scheduled appointment. Analyses compared test completion rates among patients of intervention and usual care clinicians at baseline and follow-up. A multivariate logistic regression model was used to control for secular trends and differences between cohorts. RESULTS: A total of 725 patients of 16 intervention physicians had 1,016 delayed imaging studies; 2,023 patients of 42 usual care clinicians had 2,697 delayed studies. In the first month, physicians indicated in 23/30 cases that they were unaware of the missed test prior to notification. The 90-day test completion rate was lower in the usual care than intervention group in the 6-month baseline period (18.8 vs. 22.1%, p = 0.119). During the 12-month follow-up period, there was a significant improvement favoring the intervention group (20.9 vs. 25.5%, p = 0.027). The change was driven by improved completion rates among patients referred for mammography (21.0 vs. 30.1%, p = 0.003). Multivariate analyses showed no significant impact of the intervention. CONCLUSION: There was a temporal association between email alerts to physicians about missed imaging tests and improved test completion at 90 days, although baseline differences in intervention and usual care groups limited the ability to draw definitive conclusions. Research is needed to understand the potential benefits and limitations of missed test notifications to reduce the risk of delayed diagnoses, particularly in vulnerable patient populations.

Association of open communication and the emotional and behavioural impact of medical error on patients and families: state-wide cross-sectional survey.

BACKGROUND: How openly healthcare providers communicate after a medical error may influence long-term impacts. We sought to understand whether greater open communication is associated with fewer persisting emotional impacts, healthcare avoidance and loss of trust. METHODS: Cross-sectional 2018 recontact survey assessing experience with medical error in a 2017 random digit dial survey of Massachusetts residents. Two hundred and fifty-three respondents self-reported medical error. Respondents were similar to non-respondents in sociodemographics confirming minimal response bias. Time since error was categorised as <1, 1-2 or 3-6 years before interview. Open communication was measured with six questions assessing different communication elements. Persistent impacts included emotional (eg, sadness, anger), healthcare avoidance (specific providers or all medical care) and loss of trust in healthcare. Logistic regressions examined the association between open communication and long-term impacts. RESULTS: Of respondents self-reporting a medical error 3-6 years ago, 51% reported at least one current emotional impact; 57% reported avoiding doctor/facilities involved in error; 67% reported loss of trust. Open communication varied: 34% reported no communication and 24% reported ≥5 elements. Controlling for error severity, respondents reporting the most open communication had significantly lower odds of persisting sadness (OR=0.17, 95% CI 0.05 to 0.60, p=0.006), depression (OR=0.16, 95% CI 0.03 to 0.77, p=0.022) or feeling abandoned/betrayed (OR=0.10, 95% CI 0.02 to 0.48, p=0.004) compared with respondents reporting no communication. Open communication significantly predicted less doctor/facility avoidance, but was not associated with medical care avoidance or healthcare trust. CONCLUSIONS: Negative emotional impacts from medical error can persist for years. Open communication is associated with reduced emotional impacts and decreased avoidance of doctors/facilities involved in the error. Communication and resolution programmes could facilitate transparent conversations and reduce some of the negative impacts of medical error.

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data.

BACKGROUND: As there are few validated tools to identify treatment-related adverse events across cancer care settings, we sought to develop oncology-specific "triggers" to flag potential adverse events among cancer patients using claims data. METHODS: 322 887 adult patients undergoing an initial course of cancer-directed therapy for breast, colorectal, lung, or prostate cancer from 2008 to 2014 were drawn from a large commercial claims database. We defined 16 oncology-specific triggers using diagnosis and procedure codes. To distinguish treatment-related complications from comorbidities, we required a logical and temporal relationship between a treatment and the associated trigger. We tabulated the prevalence of triggers by cancer type and metastatic status during 1-year of follow-up, and examined cancer trigger risk factors. RESULTS: Cancer-specific trigger events affected 19% of patients over the initial treatment year. The trigger burden varied by disease and metastatic status, from 6% of patients with nonmetastatic prostate cancer to 41% and 50% of those with metastatic colorectal and lung cancers, respectively. The most prevalent triggers were abnormal serum bicarbonate, blood transfusion, non-contrast chest CT scan following radiation therapy, and hypoxemia. Among patients with metastatic disease, 10% had one trigger event and 29% had two or more. Triggers were more common among older patients, women, non-whites, patients with low family incomes, and those without a college education. CONCLUSIONS: Oncology-specific triggers offer a promising method for identifying potential patient safety events among patients across cancer care settings.

Computerized Physician Order Entry in the Neonatal Intensive Care Unit: A Narrative Review.

BACKGROUND: Computerized physician order entry (CPOE) has grown since the early 1990s. While many systems serve adult patients, systems for pediatric and neonatal populations have lagged. Adapting adult CPOE systems for pediatric use may require significant modifications to address complexities associated with pediatric care such as daily weight changes and small medication doses. OBJECTIVE: This article aims to review the neonatal intensive care unit (NICU) CPOE literature to characterize trends in the introduction of this technology and to identify potential areas for further research. METHODS: Articles pertaining to NICU CPOE were identified in MEDLINE using MeSH terms "medical order entry systems," "drug therapy," "intensive care unit, neonatal," "infant, newborn," etc. Two physician reviewers evaluated each article for inclusion and exclusion criteria. Consensus judgments were used to classify the articles into five categories: medication safety, usability/alerts, clinical practice, clinical decision Support (CDS), and implementation. Articles addressing pediatric (nonneonatal) CPOE were included if they were applicable to the NICU setting. RESULTS: Sixty-nine articles were identified using MeSH search criteria. Twenty-two additional articles were identified by hand-searching bibliographies and 6 articles were added after the review process. Fifty-five articles met exclusion criteria, for a final set of 42 articles. Medication safety was the focus of 22 articles, followed by clinical practice (10), CDS (10), implementation (11), and usability/alerts (4). Several addressed more than one category. No study showed a decrease in medication safety post-CPOE implementation. Within clinical practice articles, CPOE implementation showed no effect on blood glucose levels or time to antibiotic administration but showed conflicting results on mortality rates. Implementation studies were largely descriptive of single-hospital experiences. CONCLUSION: CPOE implementation within the NICU has demonstrated improvement in medication safety, with the most consistent benefit involving a reduction in medication errors and wrong-time administration errors. Additional research is needed to understand the potential limitations of CPOE systems in neonatal intensive care and how CPOE affects mortality.

Patients' Perspectives on Reasons for Unplanned Readmissions.

Massachusetts has one of the highest rates of 30-day readmissions in the country. To identify patient-reported factors that may contribute to readmissions, we conducted semi-structured interviews with patients with unplanned readmissions within 30 days of inpatient discharge from the medicine services at an urban medical center between June and August 2016. Interviews with patients and/or proxies were conducted in English, Spanish, Mandarin, or Cantonese, then translated to English if necessary, transcribed verbatim, and deidentified. A team of four coders conducted the thematic analysis. Most patients did not identify factors associated with readmission beyond their underlying illness; however, a mismatch between the patient's clinical care needs and services available at postacute facilities, as well as poor communication between providers, facilities, and patients/proxies, were identified as contributing factors to readmissions. Non-English speaking patients and their families reported confusion with written discharge instructions, even if an interpreter provided verbal instructions. Patients will benefit from future interventions that aim to improve transfers to postacute care facilities, develop written materials in languages prevalent in the local population, and improve communication among providers, facilities, and patients and their families.

Going Mobile: Resident Physicians' Assessment of the Impact of Tablet Computers on Clinical Tasks, Job Satisfaction, and Quality of Care.

BACKGROUND: There are few published studies of the use of portable or handheld computers in health care, but these devices have the potential to transform multiple aspects of clinical teaching and practice. OBJECTIVE: This article assesses resident physicians' perceptions and experiences with tablet computers before and after the introduction of these devices. METHODS: We surveyed 49 resident physicians from 8 neurology, surgery, and internal medicine clinical services before and after the introduction of tablet computers at a 415-bed Boston teaching hospital. The surveys queried respondents about their assessment of tablet computers, including the perceived impact of tablets on clinical tasks, job satisfaction, time spent at work, and quality of patient care. RESULTS: Respondents reported that it was easier (73%) and faster (70%) to use a tablet computer than to search for an available desktop. Tablets were useful for reviewing data, writing notes, and entering orders. Respondents indicated that tablet computers increased their job satisfaction (84%), reduced the amount of time spent in the hospital (51%), and improved the quality of care (65%). CONCLUSION: The introduction of tablet computers enhanced resident physicians' perceptions of efficiency, effectiveness, and job satisfaction. Investments in this technology are warranted.

Measuring Medical Housestaff Teamwork Performance Using Multiple Direct Observation Instruments: Comparing Apples and Apples.

PURPOSE: To examine the composition and concordance of existing instruments used to assess medical teams' performance. METHOD: A trained observer joined 20 internal medicine housestaff teams for morning work rounds at Tufts Medical Center, a 415-bed Boston teaching hospital, from October through December 2015. The observer rated each team's performance using nine teamwork observation instruments that examined domains including team structure, leadership, situation monitoring, mutual support, and communication. Observations recorded on paper forms were stored electronically. Scores were normalized from 1 (low) to 5 (high) to account for different rating scales. Overall mean scores were calculated and graphed; weighted scores adjusted for the number of items in each teamwork domain. Teamwork scores were analyzed using t tests, pairwise correlations, and the Kruskal-Wallis statistic, and team performance was compared across instruments by domain. RESULTS: The nine tools incorporated five major domains, with 5 to 35 items per instrument, for a total of 161 items per observation session. In weighted and unweighted analyses, the overall teamwork performance score for a given team on a given day varied by instrument. While all of the tools identified the same low outlier, high performers on some instruments were low performers on others. Inconsistent scores for a given team across instruments persisted in domain-level analyses. CONCLUSIONS: There was substantial variation in the rating of individual teams assessed concurrently by a single observer using multiple instruments. Because existing teamwork observation tools do not yield concordant assessments, researchers should create better tools for measuring teamwork performance.

Chemotherapy medication errors.

Although chemotherapy is a well established treatment modality, chemotherapy errors represent a potentially serious risk of patient harm. We reviewed published research from 1980 to 2017 to understand the extent and nature of medication errors in cancer chemotherapy, and to identify effective interventions to help prevent mistakes. Chemotherapy errors occur at a rate of about one to four per 1000 orders, affect at least 1-3% of adult and paediatric oncology patients, and occur at all stages of the medication use process. Oral chemotherapy use is a particular area of growing risk. Our knowledge of chemotherapy errors is drawn primarily from single-institution studies at university hospitals and referral centres, with a particular focus on prescription orders and pharmacy practices. Although the heterogeneity of research methods and measures used in these studies limits our understanding of this issue, the rate of chemotherapy error-related injuries is generally lower than those seen in comparable studies of general medical patients. Although many interventions show promise in reducing chemotherapy errors, most have little empirical support. Additional research is needed to understand and to mitigate the risk of chemotherapy medication errors.

Preventable and mitigable adverse events in cancer care: Measuring risk and harm across the continuum.

BACKGROUND: Patient safety is a critical concern in clinical oncology, but the ability to measure adverse events (AEs) across cancer care is limited by a narrow focus on treatment-related toxicities. The objective of this study was to assess the nature and extent of AEs among cancer patients across inpatient and outpatient settings. METHODS: This was a retrospective cohort study of 400 adult patients selected by stratified random sampling who had breast (n = 128), colorectal (n = 136), or lung cancer (n = 136) treated at a comprehensive cancer center in 2012. Candidate AEs, or injuries due to medical care, were identified by trained nurse reviewers over the course of 1 year from medical records and safety-reporting databases. Physicians determined the AE harm severity and the likelihood of preventability and harm mitigation. RESULTS: The 400-patient sample represented 133,358 days of follow-up. Three hundred four AEs were identified for an overall rate of 2.3 events per 1000 patient days (91.2 per 1000 inpatient days and 0.9 per 1000 outpatient days). Thirty-four percent of the patients had 1 or more AEs (95% confidence interval, 29%-39%), and 16% of the patients had 1 or more preventable or mitigable AEs (95% confidence interval, 13%-20%). The AE rate for patients with breast cancer was lower than the rate for patients with colorectal or lung cancer (P ≤ .001). The preventable or mitigable AE rate was 0.9 per 1000 patient days. Six percent of AEs and 4% of preventable AEs resulted in serious harm. Examples included lymphedema, abscess, and renal failure. CONCLUSIONS: A heavy burden of AEs, including preventable or mitigable events, has been identified. Future research should examine risk factors and improvement strategies for reducing their burden. Cancer 2017;123:4728-4736. © 2017 American Cancer Society.

Developing and Testing the Health Care Safety Hotline: A Prototype Consumer Reporting System for Patient Safety Events.

This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.

Peers without fears? Barriers to effective communication among primary care physicians and oncologists about diagnostic delays in cancer.

OBJECTIVE: Relatively little attention has been devoted to the role of communication between physicians as a mechanism for individual and organisational learning about diagnostic delays. This study's objective was to elicit physicians' perceptions about and experiences with communication among physicians regarding diagnostic delays in cancer. DESIGN, SETTING, PARTICIPANTS: Qualitative analysis based on seven focus groups. Fifty-one physicians affiliated with three New York-based academic medical centres participated, with six to nine subjects per group. We used content analysis to identify commonalities among primary care physicians and specialists (ie, medical and surgical oncologists). PRIMARY OUTCOME MEASURE: Perceptions and experiences with physician-to-physician communication about delays in cancer diagnosis. RESULTS: Our analysis identified five major themes: openness to communication, benefits of communication, fears about giving and receiving feedback, infrastructure barriers to communication and overcoming barriers to communication. Subjects valued communication about cancer diagnostic delays, but they had many concerns and fears about providing and receiving feedback in practice. Subjects expressed reluctance to communicate if there was insufficient information to attribute responsibility, if it would have no direct benefit or if it would jeopardise their existing relationships. They supported sensitive approaches to conveying information, as they feared eliciting or being subject to feelings of incompetence or shame. Subjects also cited organisational barriers. They offered suggestions that might facilitate communication about delays. CONCLUSIONS: Addressing the barriers to communication among physicians about diagnostic delays is needed to promote a culture of learning across specialties and institutions. Supporting open and honest discussions about diagnostic delays may help build safer health systems.

Implementation and evaluation of a prototype consumer reporting system for patient safety events.

OBJECTIVE: No methodologically robust system exists for capturing consumer-generated patient safety reports. To address this challenge, we developed and pilot-tested a prototype consumer reporting system for patient safety, the Health Care Safety Hotline. DESIGN: Mixed methods evaluation. SETTING: The Hotline was implemented in two US healthcare systems from 1 February 2014 through 30 June 2015. PARTICIPANTS: Patients, family members and caregivers associated with two US healthcare systems. INTERVENTION: A consumer-oriented incident reporting system for telephone or web-based administration was developed to elicit medical mistakes and care-related injuries. MAIN OUTCOMES MEASURES: Key informant interviews, measurement of website traffic and analysis of completed reports. RESULTS: Key informants indicated that Hotline participation was motivated by senior leaders' support and alignment with existing quality and safety initiatives. During the measurement period from 1 October 2014 through 30 June 2015, the home page had 1530 visitors with a unique IP address. During its 17 months of operation, the Hotline received 37 completed reports including 20 mistakes without harm and 15 mistakes with injury. The largest category of mistake concerned problems with diagnosis or advice from a health practitioner. Hotline reports prompted quality reviews, an education intervention, and patient follow-ups. CONCLUSION: While generating fewer reports than its capacity to manage, the Health Care Safety Hotline demonstrated the feasibility of consumer-oriented patient safety reporting. Further research is needed to understand how to increase consumers' use of these systems.