Association Between Parent Comfort With English and Adverse Events Among Hospitalized Children | Health Care Safety | JAMA Pediatrics | JAMA Network
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Table 1.  Patient and Parent Characteristics by Language-Comfort Status
Patient and Parent Characteristics by Language-Comfort Status
Table 2.  Patient and Parent Characteristics by Adverse Event Occurrence
Patient and Parent Characteristics by Adverse Event Occurrence
Table 3.  Multivariable Predictors of Adverse Eventsa
Multivariable Predictors of Adverse Eventsa
Table 4.  Multivariable Predictors of Preventable Adverse Eventsa
Multivariable Predictors of Preventable Adverse Eventsa
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    1 Comment for this article
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    Effect modification by the I-PASS intervention?
    Barry Saver, MD, MPH | Swedish Family Medicine Cherry Hill
    I read this article with interest and searched for a report of testing for effect modification by the I-PASS intervention on LCE was evaluated, since one would hope it would ameliorate or eliminate a causal association of LCE and adverse events. I finally found statements in the discussion that pre/post I-PASS status was adjusted for, but not analyzed/reported as a covariate and potential effect modifier. Was this evaluated or could the authors do so and add the findings here? That would help inform both interpretation of the findings and what, if anything, might be considered as an intervention to counteract this association if we think it is causal.
    CONFLICT OF INTEREST: None Reported
    READ MORE
    Original Investigation
    October 19, 2020

    Association Between Parent Comfort With English and Adverse Events Among Hospitalized Children

    Author Affiliations
    • 1Division of General Pediatrics, Department of Pediatrics, Boston Children’s Hospital, Boston, Massachusetts
    • 2Harvard Medical School, Boston, Massachusetts
    • 3Department of Pediatrics and Department of Population Health, New York University Langone Health/Hassenfeld Children’s Hospital, New York
    • 4Department of Pediatrics and Department of Population Health, New York University School of Medicine, New York
    • 5Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Rockville, Maryland
    • 6Program for Patient Safety and Quality, Boston Children’s Hospital, Boston, Massachusetts
    • 7Institutional Centers for Clinical and Translational Studies, Boston Children’s Hospital, Boston, Massachusetts
    • 8The Hedwig van Amerigen Executive Leadership in Academic Medicine (ELAM) Program, Philadelphia, Pennsylvania
    • 9Department of Pediatrics, Drexel University College of Medicine, Philadelphia, Pennsylvania
    • 10Division of Sleep Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
    • 11Division of Developmental-Behavioral Pediatrics, New York University Langone Health/Hassenfeld Children's Hospital, New York
    • 12Department of Pediatrics, New York University School of Medicine, New York
    JAMA Pediatr. 2020;174(12):e203215. doi:10.1001/jamapediatrics.2020.3215
    Key Points

    Question  Do hospitalized children of parents expressing limited comfort with English (LCE) have higher odds of adverse events than children of parents expressing comfort with English?

    Findings  In this cohort study of 1666 parents of hospitalized children, 147 parents (8.8%) expressed LCE. Using systematic safety surveillance (medical record review, clinician reports, hospital incident reports, and family safety reporting), children of parents expressing LCE had 2.1 higher odds of adverse events than children of parents who expressed comfort with English, after controlling for other factors.

    Meaning  Hospitalized children of parents expressing LCE were at higher risk for adverse events; dedicated interventions to improve communication and safety in this vulnerable population are needed.

    Abstract

    Importance  Children of parents expressing limited comfort with English (LCE) or limited English proficiency may be at increased risk of adverse events (harms due to medical care). No prior studies have examined, in a multicenter fashion, the association between language comfort or language proficiency and systematically, actively collected adverse events that include family safety reporting.

    Objective  To examine the association between parent LCE and adverse events in a cohort of hospitalized children.

    Design, Setting, and Participants  This multicenter prospective cohort study was conducted from December 2014 to January 2017, concurrent with data collection from the Patient and Family Centered I-PASS Study, a clinician-family communication and patient safety intervention study. The study included 1666 Arabic-, Chinese-, English-, and Spanish-speaking parents of general pediatric and subspecialty patients 17 years and younger in the pediatric units of 7 North American hospitals. Data were analyzed from January 2018 to May 2020.

    Exposures  Language-comfort data were collected through parent self-reporting. LCE was defined as reporting any language besides English as the language in which parents were most comfortable speaking to physicians or nurses.

    Main Outcomes and Measures  The primary outcome was adverse events; the secondary outcome was preventable adverse events. Adverse events were collected using a systematic 2-step methodology. First, clinician abstractors reviewed patient medical records, solicited clinician reports, hospital incident reports, and family safety interviews. Then, review and consensus classification were completed by physician pairs. To examine the association of LCE with adverse events, a multivariable logistic regression was conducted with random intercepts to adjust for clustering by site.

    Results  Of 1666 parents providing language-comfort data, 1341 (80.5%) were female, and the mean (SD) age of parents was 35.4 (10.0) years. A total of 147 parents (8.8%) expressed LCE, most of whom (105 [71.4%]) preferred Spanish. Children of parents who expressed LCE had higher odds of having 1 or more adverse events compared with children whose parents expressed comfort with English (26 of 147 [17.7%] vs 146 of 1519 [9.6%]; adjusted odds ratio, 2.1; 95% CI, 1.2-3.7), after adjustment for parent race and education, complex chronic conditions, length of stay, site, and the intervention period. Similarly, children whose parents expressed LCE were more likely to experience 1 or more preventable adverse events (adjusted odds ratio, 2.3; 95% CI, 1.2-4.2).

    Conclusions and Relevance  Hospitalized children of parents expressing LCE were twice as likely to experience harms due to medical care. Targeted strategies are needed to improve communication and safety for this vulnerable group of children.

    Introduction

    As many as 250 000 US patients may die annually due to medical errors, making medical error a leading cause of death.1-3 Hospitalized children have similar medical error rates compared with hospitalized adults but higher rates of potentially harmful errors.4 Communication failures frequently cause serious medical errors.5

    Communication failures are particularly likely when patients or their families have language barriers.6-8 Approximately 25 million people in the US (8.6% of the total population) have limited English proficiency.9 Patients with language barriers may be at increased risk of hospital adverse events (ie, harms due to medical care) resulting from interpretation and communication challenges.10-12 However, multicenter studies examining whether hospitalized children of parents with language barriers experience more adverse events are lacking, particularly studies that use state-of-the-art approaches to measuring and classifying adverse events.

    Therefore, we studied the association between parents’ limited comfort with English (LCE) and adverse events in a cohort of hospitalized children. We hypothesized that children whose parents expressed LCE would have higher risk of both overall and preventable adverse events.

    Methods
    Study Population

    This multicenter prospective cohort study was conducted from December 2014 to January 2017 in the pediatric inpatient units of 7 North American teaching hospitals. We collected data concurrent with data collection for the Patient and Family Centered I-PASS Study,13 a multicenter study of a structured communication intervention for family-centered rounds emphasizing family engagement, health literacy, and bidirectional communication. Boston Children’s Hospital’s Institutional Review Board provided human subjects approval, and all parents provided verbal informed consent.

    We included parents and caregivers (referred to as parents for simplicity) of children 17 years or younger hospitalized in the study units. Parents who primarily spoke Arabic, Chinese, English, or Spanish were included. These languages represent the most commonly spoken languages across study sites, according to interpreter services data. Language spoken was identified verbally by patients’ care teams to the research staff. An information sheet was translated into all study languages and provided to parents prior to consent. For families who had been identified as speaking Arabic, Chinese, or Spanish, consent was facilitated by interpreters. Participants received small incentives (eg, snacks) for participation. We obtained a waiver of consent to review patient medical records.

    Setting

    All 7 units were pediatric non–intensive care inpatient medical units in pediatric hospitals within larger hospital systems (n = 3), freestanding children’s hospitals (n = 3), or adult hospitals (n = 1). Unit daily patient censuses ranged from 10 to 30. Clinical services included general pediatrics and subspecialties (eg, pulmonary, hematology, surgical, complex care). In-person, telephonic, or video interpreters were available at all sites.

    Outcomes

    The primary outcome was having any hospital adverse event (harm due to medical care, such as a serious allergic reaction after receiving antibiotics). We also examined the subset of preventable adverse events (ie, adverse events due to medical error, also known as harmful errors, such as an allergic reaction after receiving an antibiotic to which the patient has a known allergy). These are distinct from nonpreventable adverse events (eg, an allergic reaction after the patient receives an antibiotic without having a known allergy).

    We measured adverse events through an established 2-step systematic safety surveillance methodology.4,14-18 First, every weekday, clinician abstractors reviewed patient medical records, solicited clinician reports (research staff administered outgoing nighttime resident safety surveys every morning), hospital incident reports, and family safety interviews for suspected errors and adverse events.19 Family safety interviews occurred prior to discharge and every 7 days, as detailed previously.19 Second, trained physician-reviewer pairs, blinded to parents’ language comfort and other variables, independently reviewed and categorized suspected errors and adverse events as adverse events, nonharmful errors (eg, dosing error with no clinical consequence), or exclusions (eg, quality issue without safety implications). They dichotomized adverse events as preventable (clearly caused by medical error) or nonpreventable. Consensus reconciliation of any discordant categorizations followed.

    Predictors and Covariates

    The primary predictor was whether parents were comfortable speaking English to their physicians or nurses. We used simple randomization to survey 6 to 8 parents per week per site approximately 24 hours prior to anticipated discharge regarding hospital experience, sociodemographic information (parent age, sex, race/ethnicity, education, and income), and language comfort. We defined LCE as reporting any language besides English in response to the item, “What language do you feel most comfortable speaking to your doctor or nurse in?” Taken from the Guide to Implementing the Health Literacy Universal Precautions Toolkit,20 this item is recommended for assessing language preference and assistance needs. Our survey was translated into Arabic, simplified Chinese, and Spanish. Families identified by clinical staff as primarily speaking these languages were approached by research assistants with the assistance of a qualified in-person or telephonic interpreter. Participants requiring translated surveys self-completed them on paper; others completed them electronically or on paper.

    Patient-level covariates obtained through hospital administrative data included patient age, sex, race, insurance status, and complex chronic conditions (CCCs, International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]–based and ICD-10-CM–based markers of medical complexity).21 Patient ethnicity was captured inconsistently or not at all in site hospital administrative data so only patient race was included. We measured unit length of stay by reviewing patient medical records.

    Statistical Analysis

    Our sample included all patients whose parents provided language-comfort data. We used descriptive statistics to present adverse event rates and compare patient and parent sociodemographic characteristics among parents with and without LCE. We analyzed means (SDs) for continuous variables and counts and percentages for categorical variables.

    To identify factors associated with adverse events, we dichotomized the sample into patients with 1 or more adverse events vs none. We examined bivariate associations between experiencing 1 or more adverse events and covariates of interest using χ2 tests and t tests for categorical and continuous variables, respectively.

    To examine associations between LCE and experiencing 1 or more adverse events, we conducted a multivariable logistic regression with random intercepts to adjust for clustering by site. We adjusted for a priori parent- and patient-level predictors deemed clinically significant, including parent race, parent education, length of stay, and CCCs. We also controlled for Patient and Family Centered I-PASS Study intervention period (preintervention vs postintervention), as adverse events and preventable adverse events decreased significantly postintervention.13 Multiple imputation adjusted for observations with missing parent race and/or education data (n = 96; 5.8%). We examined associations between LCE and preventable adverse events using the same variables as with overall adverse events. Significance was set at a 2-tailed P value of less than 0.05. We used REDCap (Vanderbilt University)22 to collect and manage study data and SAS version 9.4 (SAS Institute) for analyses.

    Results
    Sample Characteristics

    Of 3106 overall study unit patient admissions, 2570 (82.7%) met the eligibility criteria. Of these, 2148 parents (83.6%) provided consent for the Patient and Family Centered I-PASS Study and 1666 completed language-comfort items (77.6% response rate).13

    Patient mean (SD) age and unit length of stay were 6.0 (5.9) years and 4.7 (5.5) days, respectively. Patients were well balanced by sex and the most common race was White (716 of 1466 [48.8%]), followed by other (395 of 1466 [26.9%]), Black (278 of 1466 [19.0%]), and Asian (77 of 1466 [5.3%]). A total of 427 of 1666 (25.6%) had 1 or more CCCs and 1105 of 1636 (67.5%) had government insurance.

    Parent mean (SD) age was 35.4 (10.0) years and sex was predominantly female (1341 of 1659 [80.8%]). Parent race was predominantly White (939 of 1587 [59.2%]), followed by Black (287 of 1587 [18.1%]), other (249 of 1587 [15.7%]), and Asian (112 of 1587 [7.1%]). A total of 367 of 1640 (22.4%) were of Hispanic/Latino ethnicity. Most (1062 of 1640 [64.8%]) had attended some college or more, and 576 of 1651 (34.9%) reported an annual household income of less than $50 000.

    LCE

    Overall, 147 parents (8.8%) expressed LCE. Spanish (105 [71.4%]), French (9 [6.1%]), and Arabic (6 [4.1%]) were the languages most commonly spoken by these parents. In addition, 24 parents (16.3%) with LCE (ie, based on their survey responses to the language comfort item) spoke other languages. However, these parents were not initially identified as having LCE and therefore consented to the study and took the survey in English. Patients whose parents expressed LCE had similar age, sex, and length of stay but significantly different race, insurance, and CCC counts compared with patients whose parents expressed comfort with English (Table 1). Parents expressing LCE had similar age and sex but significantly different race, ethnicity, education, and income compared with patients whose parents expressed comfort with English.

    Adverse Events

    Overall, we identified 217 adverse events (13.0 per 100 admissions), including 142 preventable adverse events (8.5 per 100 admissions). In bivariate analyses, 26 of 147 children (17.7%) whose parents expressed LCE experienced an adverse event during hospitalization compared with 146 of 1519 (9.6%) of children whose parents expressed comfort with English (Table 2). Adverse events occurred more frequently in admissions of patients with 1 or more CCCs (18.3% [78 of 427] vs 7.6% [94 of 1239]), longer mean (SD) lengths of stay (10.7 [12.4] days vs 4.0 [3.5] days), and more educated parents (126 of 1062 [11.9%] some college or more vs 42 of 578 [7.3%] no college), as well as those who were hospitalized preintervention (110 of 871 [12.6%] vs 62 of 795 [7.8%]). Adverse events also varied by patient race. In multivariable analysis, children whose parents expressed LCE had higher odds of experiencing 1 or more adverse events (adjusted odds ratio [aOR], 2.1; 95% CI, 1.2-3.7) and experiencing 1 or more preventable adverse events (aOR, 2.3; 95% CI, 1.2-4.2) compared with children whose parents expressed comfort with English, after controlling for presence of CCCs, length of stay, parent race, parent education, intervention period, and site (Table 3 and Table 4).

    Prior research has shown that higher parent education is associated with greater family safety reporting.19 Therefore, we ran multivariable regressions removing adverse events and preventable adverse events that were uniquely reported by families (ie, were not detected through medical record review, clinician reports, or hospital incident reports) to further investigate the association of parent education with adverse events. Higher parent education remained associated with adverse events (aOR, 1.6; 95% CI, 1.0-2.6) but was not associated with preventable adverse events (aOR, 1.5; 95% CI, 0.8-2.6) (eTables 1 and 2 in the Supplement).

    Discussion

    In this multicenter study of pediatric units at 7 North American hospitals, 1 in 11 hospitalized children’s parents expressed LCE. These children had twice the odds of experiencing an adverse event compared with children of parents expressing comfort with English, despite the availability of interpreter services. This finding highlights the prevalence and vulnerability of children whose parents face language barriers and the need for targeted interventions to improve communication and safety in this vulnerable group.

    Few studies examine the link between language barriers and safety in pediatric inpatients. Prior studies on language barriers and safety focused on adults10,23 or outpatients,23-25 or used less rigorous safety surveillance methods, such as hospital incident reporting,11 which is prone to underreporting and typically includes only clinician input.10 These studies suggest that patients with language barriers are at higher risk of experiencing safety events and experience higher severity harm than their English-speaking counterparts.10

    To our knowledge, ours is the only study to examine adverse events in hospitalized children of parents with language barriers using rigorous, systematic, multicenter surveillance methods that include family safety reporting. By rigorously measuring adverse events, including those reported by families, in a multicenter fashion and examining the pediatric inpatient population, our study strengthens the evidence that pediatric inpatients with parents experiencing language barriers are particularly vulnerable to harm in hospital settings.

    Our LCE rate (8.8%) was similar to the limited English proficiency rates founds by the 2010 US Census (8.6%).9 However, our language distribution differed from US Census rates, given that French was the second most common language among parents expressing LCE in our study. This is likely because 1 study site was located in Canada, where French is a national language in addition to English (although medical care is still primarily provided in English at this site). Similar to other studies, we found that adverse events varied by CCC and length of stay.19,26

    Hospitalized children of parents who express LCE may have increased risk of adverse events for multiple reasons. Communication challenges may prevent families from identifying and pointing out errors that may result in adverse events (eg, speaking up when a medication dose seems excessive). Adverse events may also result from interpretation errors, which are common in outpatient and emergency settings and more likely of clinical consequence when ad hoc interpreters are used.24,27

    Interpretation errors may be even more prevalent in the inpatient setting, given inpatient plan complexity and the challenges of communicating when multiple individuals are speaking during rounds, often simultaneously. Moreover, inpatient communication occurs among patients, families, and multiple health care professionals (eg, nurses, clinical assistants, consultants) during multiple time points (eg, medication reconciliation, medication administration, procedures, discharge). Interpreters may not always be used, particularly when there are competing demands on clinicians’ and interpreters’ time. In a 2015 study,28 even after an intervention to improve interpreter use, families only received 1.5 interpretations per patient-day, suggesting that most clinical interactions occurred without an interpreter. Clinicians may opt not to interpret many clinical interactions, or they may use nonqualified clinicians as ad hoc interpreters. Such scenarios represent missed opportunities for families with LCE to alert staff to errors. Adolescent health brokering, where sick adolescents whose parents express LCE serve as ad hoc interpreters for their parents, is an additional risk unique to pediatrics.29

    Language barriers and health literacy limitations, which can be associated,6,25 may prevent parents from fully understanding diagnoses, treatment options, care plans, and follow-up recommendations.30 Families with language barriers may be less likely to report safety concerns due to communication, cultural, or other barriers.19,31 Cultural norms regarding how to communicate with healthcare professionals may affect the quality and frequency of interaction with inpatient staff, thereby contributing to a sense of disempowerment and impeding effective communication. Parents may assume medical staff know best and not question issues that could lead to adverse events, particularly when unable to access interpreters for all clinical interactions. Taken together, these barriers may prevent parents who express LCE from serving as effective partners in the care and safety of their children.

    Other factors contributing to increased adverse event risk in children whose parents express LCE may include systemic racism, implicit bias, microaggressions, immigration status, mistrust, and marginalization. In a 2013 study,32 51% of clinicians had moderate to strong implicit bias against Latino patients. Implicit bias can affect patient-clinician interactions,33,34 treatment decisions,32 and patient health outcomes35,36 and may have clinical implications.37-39 Immigration policies resulting in fear of deportation or law enforcement involvement and racial profiling are associated with reduced health care utilization and poorer health overall.40-42 Such factors may be present in the inpatient setting and increase the likelihood of adverse events if patients or their parents are reluctant to ask questions or alert staff to safety concerns, delay presentation to care in the first place, or withhold information because they mistrust the health care system.

    Based on our prior research,19,43 we were surprised that patients with more educated parents in this study were more likely to have adverse events, even when adverse events uniquely reported by families were excluded. We found that while excluding unique family reports reduced the power of education to predict preventable adverse events, education continued to predict overall adverse events. Unmeasured confounders may explain this result. Hospitalized children with more educated parents may have higher illness severity or acuity—which predisposes them to adverse events—if they have greater access to outpatient care and are thus less likely to be hospitalized for minor illnesses. Additionally, these children may come from wider catchment areas in academic centers that serve a dual role as local city hospitals and tertiary care referral hospitals. More educated parents may request additional testing or procedures, leading to higher adverse event risk. They may also be more likely to call attention to adverse events, making it more likely such events will be reported by staff or documented in the medical record. Further research is needed to explore these possibilities.

    Many interventions can address challenges faced by hospitalized children whose parents have language barriers.44 Hospitals can adopt best practices for identifying and communicating with these families. As language barriers are not always apparent, accurately and consistently identifying and documenting language assistance needs is important. Additionally, hospitals can develop standards around inpatient interpreter use, for example, requiring documentation and use of qualified interpreters in every clinical interaction with patients or parents expressing LCE. Hospitals can train interpreters and clinicians to work as teams and empower interpreters to speak up if they recognize safety issues.45 They can increase access to interpreter resources, ideally in person but also using telephonic or video relay interpreting services accessible via smart phones and tablets. One study found that developing a clear protocol for scheduling interpreters and tracking adherence dramatically increased interpreter presence on family-centered rounds for families with limited English proficiency.46 Payers can expand reimbursement for language services, which is also associated with increased interpreter use.47

    Early alerting of staff may prevent adverse events; therefore, staff can be trained to proactively encourage families with LCE to speak up about safety concerns. Additionally, hospitals can use electronic medical record triggers to obtain interpreter services in error-prone interactions (eg, admission, transfer, discharge, medication administration) and provide periodic training to remind clinicians when and how to obtain interpreters. Hospitals, medical schools, and residency training programs can also invest in anti-racism, implicit bias, cultural competency, and health literacy training48 to inculcate these principles throughout preclinical and postgraduate education.

    Limitations

    Our study has several limitations. As it was conducted at academic teaching centers, generalizability may be a concern. Availability of interpretation services and the population of parents with LCE may differ at other types of hospitals. In addition, interpreters were available at all of the study sites; adverse events may be even higher at hospitals with fewer interpreter resources. Languages spoken by parents expressing LCE were not representative of the national population with limited English proficiency. In particular, our study included a low number of Asian parents expressing LCE. Our results may not be applicable to other populations expressing LCE. Additionally, our sample size did not allow examination of whether the association of LCE with adverse event risk differed by language spoken. Although we measured education, we did not routinely assess health literacy, which may be an important unmeasured confounder. LCE could also have been associated with nonparticipation. We did not measure interpreter use or presence of bilingual staff, an important area for future study. Finally, we relied on self-reported language-comfort data, which is subject to reporting bias by parents who are overconfident in their English proficiency, are embarrassed, or wish to conceal that they used their children to interpret for them. Based on survey responses, we also found that at least 24 parents were identified as having LCE based on their survey responses but completed the consent process and survey in English rather than their primary language. This may have been because staff overestimated these parents’ English proficiency or because parents overstated their comfort level speaking English.

    Further study is needed to better understand factors that contribute to increased risk for children of parents expressing LCE, including language, culture, education, racism, implicit bias, and health literacy. Other areas of future research include the differential impact of communication and safety interventions on patients whose parents face language barriers, adverse events in English-proficient adolescents with parents who have limited English proficiency, and implementation strategies to improve communication and safety for patients and/or families with language barriers.

    Conclusions

    In this multicenter study of 7 North American hospitals with interpreter services, hospitalized children with parents who expressed LCE were twice as likely to experience harm due to medical care, including preventable harm. To achieve health equity, hospitals and physicians should implement targeted strategies to improve communication and safety for this vulnerable group of children.

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    Article Information

    Accepted for Publication: May 6, 2020.

    Corresponding Author: Alisa Khan, MD, MPH, Division of General Pediatrics, Boston Children’s Hospital, Harvard Medical School, 21 Autumn St, Room 200.2, Boston, MA 02115 (alisa.khan@childrens.harvard.edu).

    Published Online: October 19, 2020. doi:10.1001/jamapediatrics.2020.3215

    Author Contributions: Drs Khan and Graham had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Khan, Yin, Ramotar, Williams, Spector, Landrigan, Dreyer.

    Acquisition, analysis, or interpretation of data: All authors.

    Drafting of the manuscript: Khan, Graham.

    Critical revision of the manuscript for important intellectual content: Khan, Yin, Brach, Ramotar, Williams, Spector, Landrigan, Dreyer.

    Statistical analysis: Graham, Ramotar, Williams, Dreyer.

    Obtained funding: Khan, Landrigan.

    Administrative, technical, or material support: Ramotar, Spector, Landrigan.

    Supervision: Spector, Landrigan, Dreyer.

    Conflict of Interest Disclosures: Drs Spector and Landrigan hold equity in and have consulted with the I-PASS Patient Safety Institute. Dr Landrigan has received grant support from the Children’s Hospital Association for his work as an Executive Council member of the Pediatric Research in Inpatient Settings (PRIS) network; has received personal fees from the Missouri Hospital Association; and has served as an expert witness in cases regarding patient safety and sleep deprivation. No other disclosures were reported.

    Funding/Support: This project was supported by grant CDR-1306-03556 from the Patient-Centered Outcomes Research Institute (principal investigator: Dr Landrigan). Dr Khan’s time was supported by grant K12HS022986 from the Agency for Healthcare Research and Quality (principal investigator: Jonathan Finkelstein, MD; Boston Children’s Hospital, Boston, Massachusetts) and grant K08HS025781 from the Agency for Healthcare Research and Quality.

    Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    Group Information: The Patient and Family Centered I-PASS Health Literacy Subcommittee includes the following individuals, Wilma Alvarado-Little, MA, New York State Department of Health, Albany; Cindy Brach, MPP, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Rockville, Maryland; Bernard P. Dreyer, MD, Division of Developmental-Behavioral Pediatrics, New York University Langone Health/Hassenfeld Children’s Hospital, New York; Fernando Mendoza, MD, MPH, Lucile Packard Children’s Hospital, Stanford University, Stanford, California; Lee Sanders, MD, MPH, Lucile Packard Children’s Hospital, Stanford University; Theodore C. Sectish, MD, Boston Children’s Hospital, Harvard Medical School, Boston, Massachusetts; and H. Shonna Yin, MD, Department of Pediatrics and Department of Population Health, New York University Langone Health/Hassenfeld Children’s Hospital, New York.

    Disclaimer: The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of authors’ employers or funders, including the Agency for Healthcare Quality and Research and the Department of Health and Human Services.

    Meeting Presentations: Data from this article were presented at the 2018 Pediatric Academic Societies (PAS) meeting; May 6, 2018; Toronto, Ontario, Canada; and the 2018 Pediatric Hospital Medicine (PHM) meeting; July 20, 2018; Atlanta, Georgia.

    Additional Contributions: We thank the Patient and Family Centered I-PASS Study group, participating investigators at the Patient and Family Centered I-PASS Study sites, the data coordinating center, and the patients and families who participated in this study.

    Additional Information: The I-PASS Patient Safety Institute is a company that seeks to train institutions in best handoff practices and aid in their implementation. The I-PASS Patient Safety Institute was in no way involved in this study. Moreover, to ensure objectivity, all data were sent directly from the sites to the statistical team at the data coordinating center, who do not have any involvement with the I-PASS Patient Safety Institute. Analyses were conducted by a statistical team who do not have any involvement with the I-PASS Patient Safety Institute.

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