Assessing the Revised Safer Dx Instrument® in the understanding of ambulatory system design changes for type 1 diabetes and autism spectrum disorder in pediatrics.

OBJECTIVES: We sought within an ambulatory safety study to understand if the Revised Safer Dx instrument may be helpful in identification of diagnostic missed opportunities in care of children with type 1 diabetes (T1D) and autism spectrum disorder (ASD). METHODS: We reviewed two months of emergency department (ED) encounters for all patients at our tertiary care site with T1D and a sample of such encounters for patients with ASD over a 15-month period, and their pre-visit communication methods to better understand opportunities to improve diagnosis. We applied the Revised Safer Dx instrument to each diagnostic journey. We chose potentially preventable ED visits for hyperglycemia, diabetic ketoacidosis, and behavioral crises, and reviewed electronic health record data over the prior three months related to the illness that resulted in the ED visit. RESULTS: We identified 63 T1D and 27 ASD ED visits. Using the Revised Safer Dx instrument, we did not identify any potentially missed opportunities to improve diagnosis in T1D. We found two potential missed opportunities (Safer Dx overall score of 5) in ASD, related to potential for ambulatory medical management to be improved. Over this period, 40 % of T1D and 52 % of ASD patients used communication prior to the ED visit. CONCLUSIONS: Using the Revised Safer Dx instrument, we uncommonly identified missed opportunities to improve diagnosis in patients who presented to the ED with potentially preventable complications of their chronic diseases. Future researchers should consider prospectively collected data as well as development or adaptation of tools like the Safer Dx.

Risk of Anaphylaxis Among New Users of GLP-1 Receptor Agonists: A Cohort Study.

OBJECTIVE: To assess risk of anaphylaxis among patients with type 2 diabetes mellitus who are initiating therapy with a glucagon-like peptide 1 receptor agonist (GLP-1 RA), with a focus on those starting lixisenatide therapy. RESEARCH DESIGN AND METHODS: A cohort study was conducted in three large, U.S. claims databases (2017-2021). Adult (aged ≥18 years) new users of a GLP-1 RA who had type 2 diabetes mellitus and ≥6 months enrollment in the database before GLP-1 RA initiation (start of follow-up) were included. GLP-1 RAs evaluated were lixisenatide, an insulin glargine/lixisenatide fixed-ratio combination (FRC), exenatide, liraglutide or insulin degludec/liraglutide FRC, dulaglutide, and semaglutide (injectable and oral). The first anaphylaxis event during follow-up was identified using a validated algorithm. Incidence rates (IRs) and 95% CIs were calculated within each medication cohort. The unadjusted IR ratio (IRR) comparing anaphylaxis rates in the lixisenatide cohort with all other GLP-1 RAs combined was analyzed post hoc. RESULTS: There were 696,089 new users with 456,612 person-years of exposure to GLP-1 RAs. Baseline demographics, comorbidities, and use of other prescription medications in the 6 months before the index date were similar across medication cohorts. IRs (95% CIs) per 10,000 person-years were 1.0 (0.0-5.6) for lixisenatide, 6.0 (3.6-9.4) for exenatide, 5.1 (3.7-7.0) for liraglutide, 3.9 (3.1-4.8) for dulaglutide, and 3.6 (2.6-4.9) for semaglutide. The IRR (95% CI) for the anaphylaxis rate for the lixisenatide cohort compared with the pooled other GLP-1 RA cohort was 0.24 (0.01-1.35). CONCLUSIONS: Anaphylaxis is rare with GLP-1 RAs. Lixisenatide is unlikely to confer higher risk of anaphylaxis than other GLP-1 RAs.

Factors Associated With HIV Testing in Adolescent and Young Adult Females With a History of STI.

To determine the percentage of female adolescent patients (13-26 years old) who had HIV testing ordered within 90 days of incident sexually transmitted infection (STI) diagnosis during an outpatient clinic visit. This was a retrospective chart review study evaluating 830 visits among 589 female patients 13 to 26 years who had an incident STI diagnosed in outpatient Adolescent Medicine or Pediatric Practices in an urban, nonprofit, academic, free-standing children's hospital at the main campus and a community site in the Northeast United States. Odds of HIV screening was greater at the community-based adolescent medicine practice (odds ratio [OR] = 3.17; 95% confidence interval [CI]: [1.92, 5.24]) and when seen by an adolescent medicine provider (OR = 1.44; 95% CI: [1.02, 2.03]). Only 33.5% (n = 283) of 844 clinical encounters had HIV screening obtained within 90 days of incident STI diagnosis. Overall, HIV screening rates within 90 days of STI diagnosis was low, and there is much room for improvement.

Prospective Study of the Multisite Spread of a Medication Safety Intervention: Factors Common to Hospitals With Improved Outcomes.

Context and implementation approaches can impede the spread of patient safety interventions. The objective of this article is to characterize factors associated with improved outcomes among 9 hospitals implementing a medication safety intervention. Nephrotoxic Injury Negated by Just-in-Time Action (NINJA) is a pharmacist-driven intervention that led to a sustained reduction in nephrotoxic medication-associated acute kidney injury (NTMx-AKI) at 1 hospital. Using qualitative comparative analysis, the team prospectively assessed the association between context and implementation factors and NTMx-AKI reduction during NINJA spread to 9 hospitals. Five hospitals reduced NTMx-AKI. These 5 had either (1) a pharmacist champion and >2 pharmacists working on NINJA (Scon 1.0, Scov 0.8) or (2) a nephrologist-implementing NINJA with minimal competing organizational priorities (Scon 1.0, Scov 0.2). Interviews identified ways NINJA team leaders obtained pharmacist support or successfully implemented without that support. In conclusion, these findings have implications for future spread of NINJA and suggest an approach to study spread of safety interventions more broadly.

Measurement of Ambulatory Medication Errors in Children: A Scoping Review.

BACKGROUND AND OBJECTIVES: Children use most medications in the ambulatory setting where errors are infrequently intercepted. There is currently no established measure set for ambulatory pediatric medication errors. We have sought to identify the range of existing measures of ambulatory pediatric medication errors, describe the data sources for error measurement, and describe their reliability. METHODS: We performed a scoping review of the literature published since 1986 using PubMed, CINAHL, PsycINFO, Web of Science, Embase, and Cochrane and of grey literature. Studies were included if they measured ambulatory, including home, medication errors in children 0 to 26 years. Measures were grouped by phase of the medication use pathway and thematically by measure type. RESULTS: We included 138 published studies and 4 studies from the grey literature and identified 21 measures of medication errors along the medication use pathway. Most measures addressed errors in medication prescribing (n = 6), and administration at home (n = 4), often using prescription-level data and observation, respectively. Measures assessing errors at multiple phases of the medication use pathway (n = 3) frequently used error reporting databases and prospective measurement through direct in-home observation. We identified few measures of dispensing and monitoring errors. Only 31 studies used measurement methods that included an assessment of reliability. CONCLUSIONS: Although most available, reliable measures are too resource and time-intensive to assess errors at the health system or population level, we were able to identify some measures that may be adopted for continuous measurement and quality improvement.

Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: A multisite longitudinal assessment.

BACKGROUND: There is little longitudinal information about the type and frequency of harm resulting from medication errors among outpatient children with cancer. We aimed to characterize rates and types of medication errors and harm to outpatient children with leukemia and lymphoma over 7 months of treatment. METHODS: We recruited children taking medications at home for leukemia or lymphoma from three pediatric cancer centers. Errors were identified by chart review, in-home medication review, observation of administration, and interviews. Physician reviewers confirmed error (Fleiss' κ = 0.95), harm (Fleiss' κ = 0.82), and suggested interventions. Generalized linear mixed models with random effects were used to account for clustering by site. RESULTS: Among 131 children taking 1669 medications with 367 home visits, 408 errors were identified, including 242 with potential for harm and 39 with harm (1.0 harm per 1000 patient-days [95% CI, 0.1-9.8]). Ten percent of children were injured by errors and 42% had errors with potential for harm. Twenty-six percent of caregivers reported that miscommunication led to missed doses or overdoses at home. Children on >13 medications had significantly more serious medication errors than those on fewer medications (77% vs 61%; p = .05). Physician reviewers judged that improved communication among caregivers and between caregivers and clinicians may have prevented the most harm (66%). CONCLUSIONS: In this longitudinal study, 10% children with leukemia or lymphoma experienced adverse drug events because of outpatient medication errors. Improvements addressing communication with and among caregivers should be codeveloped with families and based on human-factors engineering. PLAIN LANGUAGE SUMMARY: In this longitudinal study, medication errors in the clinic, pharmacy, or at home among children with leukemia or lymphoma over a 7-month period were common, and 10% suffered harm because of errors. Children on >13 medications had significantly more serious medication errors than those on fewer medications (77% vs 61%; p = .05). Physician reviewers judged that improved communication among caregivers and between caregivers and clinicians may have prevented the most harm (66%). Improvements addressing communication with and among caregivers should be codeveloped with families and based on human-factors engineering.

Safer Type 1 Diabetes Care at Home: SEIPS-based Process Mapping with Parents and Clinicians.

Introduction: The limited data indicate that pediatric medical errors in the outpatient setting, including at home, are common. This study is the first step of our Ambulatory Pediatric Patient Safety Learning Lab to address medication errors and treatment delays among children with T1D in the outpatient setting. We aimed to identify failures and potential solutions associated with medication errors and treatment delays among outpatient children with T1D. Methods: A transdisciplinary team of parents, safety researchers, and clinicians used Systems Engineering Initiative for Patient Safety (SEIPS) based process mapping of data we collected through in-home medication review, observation of administration, chart reviews, parent surveys, and failure modes and effects analysis (FMEA). Results: Eight (57%) of the 14 children who had home visits experienced 18 errors (31 per 100 medications). Four errors in two children resulted in harm, and 13 had the potential for harm. Two injuries occurred when parents failed to treat severe hypoglycemia and lethargy, and two were due to repeated failures to administer insulin at home properly. In SEIPS-based process maps, high-risk errors occurred during communication between the clinic and home or in management at home. Two FMEAs identified interventions to better communicate with families and support home care, especially during evolving illness. Conclusion: Using SEIPS-based process maps informed by multimodal methods to identify medication errors and treatment delays, we found errors were common. Better support for managing acute illness at home and improved communication between the clinic and home are potentially high-yield interventions.

Context in Implementation Science.

Changing health care delivery systems and processes of care to improve health care quality is complex. What is done (intervention) is equally important as how it is done (implementation) and where it is done (context). Furthermore, it has been consistently observed that among groups participating in multisite quality improvement (QI) efforts and implementation studies, significant heterogeneity in the improvements is seen. Our objective is to provide a step-by-step guide to assist both researchers and groups practicing QI on the frontlines in addressing context in planning, implementing, and disseminating their QI and implementation interventions. We discuss in depth a sample of the >60 available dissemination and implementation frameworks that consider context. We then provide an approach to addressing context in QI and implementation initiatives and discuss an application of this approach, using a published study as an example. Finally, we discuss next steps for the field of context and implementation science. Data from networks of health systems working together on QI are needed on both network-wide rates of process and outcome measures. Also needed are segmented/stratified data that inform our understanding of the influence of context on successful implementation in subgroups. Finally, multisite prospective studies are needed to develop an in-depth understanding of how specific context and implementation factors affect the successful spread of proven interventions.

Professional stakeholders' perceptions of barriers to behavioral health care following pediatric traumatic brain injury.

OBJECTIVE: To examine professional stakeholders' perspectives of barriers to behavioral health care (BHC) follow-up and telepsychology after pediatric traumatic brain injury (TBI). METHODS: Twenty-nine professionals participated in a focus group (FG) or key informant interview (KII) between January and March 2020. Professionals answered questions about facilitators and barriers to BHC follow-up and telepsychology. Given widespread telepsychology implementation since COVID-19, a follow-up survey assessing telehealth perceptions since the pandemic was sent out in December 2020. Nineteen professionals completed the survey. RESULTS: Professionals identified individual (e.g., family factors, insurance coverage/finances, transportation/distance, availability, planning follow-up care) and system-level (e.g., lack of access to BHC providers) barriers to BHC post-injury. Possible solutions, like collaborative follow-up care, were also identified. Generally, clinical professionals have favorable impressions of telepsychology and utilized services as a delivery modality for clinical care. Though telepsychology could reduce barriers to care, professionals also expressed concerns (e.g., technology issues, security/safety) and challenges (e.g., funding, accessibility, training/licensure for clinicians) with implementing telepsychology. CONCLUSION: Barriers identified highlight the need for context-specific solutions to increase BHC access, with telepsychology generally recognized as a beneficial modality for BHC. Future work should continue to focus on understanding barriers to BHC and potential solutions after pediatric TBI.

Testing an Automated Approach to Identify Variation in Outcomes among Children with Type 1 Diabetes across Multiple Sites.

Introduction: Efficient methods to obtain and benchmark national data are needed to improve comparative quality assessment for children with type 1 diabetes (T1D). PCORnet is a network of clinical data research networks whose infrastructure includes standardization to a Common Data Model (CDM) incorporating electronic health record (EHR)-derived data across multiple clinical institutions. The study aimed to determine the feasibility of the automated use of EHR data to assess comparative quality for T1D. Methods: In two PCORnet networks, PEDSnet and OneFlorida, the study assessed measures of glycemic control, diabetic ketoacidosis admissions, and clinic visits in 2016-2018 among youth 0-20 years of age. The study team developed measure EHR-based specifications, identified institution-specific rates using data stored in the CDM, and assessed agreement with manual chart review. Results: Among 9,740 youth with T1D across 12 institutions, one quarter (26%) had two or more measures of A1c greater than 9% annually (min 5%, max 47%). The median A1c was 8.5% (min site 7.9, max site 10.2). Overall, 4% were hospitalized for diabetic ketoacidosis (min 2%, max 8%). The predictive value of the PCORnet CDM was >75% for all measures and >90% for three measures. Conclusions: Using EHR-derived data to assess comparative quality for T1D is a valid, efficient, and reliable data collection tool for measuring T1D care and outcomes. Wide variations across institutions were observed, and even the best-performing institutions often failed to achieve the American Diabetes Association HbA1C goals (<7.5%).

Testing the Use of Data Drawn from the Electronic Health Record to Compare Quality.

INTRODUCTION: Health systems spend $1.5 billion annually reporting data on quality, but efficacy and utility for benchmarking are limited due, in part, to limitations of data sources. Our objective was to implement and evaluate measures of pediatric quality for three conditions using electronic health record (EHR)-derived data. METHODS: PCORnet networks standardized EHR-derived data to a common data model. In 13 health systems from 2 networks for 2015, we implemented the National Quality Forum measures: % children with sickle cell anemia who received a transcranial Doppler; % children on antipsychotics who had metabolic screening; and % pediatric acute otitis media with amoxicillin prescribed. Manual chart review assessed measure accuracy. RESULTS: Only 39% (N = 2,923) of 7,278 children on antipsychotics received metabolic screening (range: 20%-54%). If the measure indicated screening was performed, the chart agreed 88% of the time [95% confidence interval (CI): 81%-94%]; if it indicated screening was not done, the chart agreed 86% (95% CI: 78%-93%). Only 69% (N = 793) of 1,144 children received transcranial Doppler screening (range across sites: 49%-88%). If the measure indicated screening was performed, the chart agreed 98% of the time (95% CI: 94%-100%); if it indicated screening was not performed, the chart agreed 89% (95% CI: 82%-95%). For acute otitis media, chart review identified many qualifying cases missed by the National Quality Forum measure, which excluded a common diagnostic code. CONCLUSIONS: Measures of healthcare quality developed using EHR-derived data were valid and identified wide variation among network sites. This data can facilitate the identification and spread of best practices.

Development and validation of a predictive model algorithm to identify anaphylaxis in adults with type 2 diabetes in U.S. administrative claims data.

PURPOSE: To use medical record adjudication and predictive modeling methods to develop and validate an algorithm to identify anaphylaxis among adults with type 2 diabetes (T2D) in administrative claims. METHODS: A conventional screening algorithm that prioritized sensitivity to identify potential anaphylaxis cases was developed and consisted of diagnosis codes for anaphylaxis or relevant signs and symptoms. This algorithm was applied to adults with T2D in the HealthCore Integrated Research Database (HIRD) from 2016 to 2018. Clinical experts adjudicated anaphylaxis case status from redacted medical records. We used confirmed case status as an outcome for predictive models developed using lasso regression with 10-fold cross-validation to identify predictors and estimate the probability of confirmed anaphylaxis. RESULTS: Clinical adjudicators reviewed medical records with sufficient information from 272 adults identified by the anaphylaxis screening algorithm, which had an estimated Positive Predictive Value (PPV) of 65% (95% confidence interval [CI]: 60%-71%). The predictive model algorithm had a c-statistic of 0.95. The model's probability threshold of 0.60 excluded 89% (84/94) of false positives identified by the screening algorithm, with a PPV of 94% (95% CI: 91%-98%). The model excluded very few true positives (15 of 178), and identified 92% (95% CI: 87%-96%) of the cases selected by the screening algorithm. CONCLUSIONS: Predictive modeling techniques yielded an accurate algorithm with high PPV and sensitivity for identifying anaphylaxis in administrative claims. This algorithm could be considered in future safety studies using similar claims data to reduce potential outcome misclassification.

Misuse of Pediatric Medications and Parent-Physician Communication: An Interactive Voice Response Intervention.

BACKGROUND: Children take 1 medication each week on average at home. Better communication between parents and providers could support safer home medication use and prevent misuse of pediatric medications, such as intentional underdosing or overdosing. Our primary objective was to assess the impact of an interactive voice response system on parent-provider communication about medications. METHODS: Parents of children 4 months to 11 years of age with upcoming well child visits were invited to call our interactive voice response system, called Personal Health Partner (PHP), which asked questions about the child's health and medication use. Responding parents were randomized to either PHP (interview and counseling) or control (injury prevention survey). Parents' responses were embedded in the electronic health record. After the physical visit, research assistants performed a phone follow-up survey. RESULTS: Of 475 parents, including 293 PHPs and 182 controls, 93% were women. We found a high prevalence of misuse of medications: 14% reported underdosing (n = 63) fever-reducer medications and 3% reported overdosing (n = 13). Twenty percent (n = 37) of the 190 children younger than 3 years had received cold medication. Thirty-three percent (n = 19) of 62 PHP parents of children on prescription medications reported nonadherence. Among children on prescription medications, PHP significantly increased discussion of medications at the physical, but not the number who brought medications to the visit; it had no impact on those not on prescription medications. CONCLUSIONS: Pediatric medication misuse was common in this study. Use of a previsit interactive voice response system increased medication-related communication during visits and supports the need for systems that better prepare patients for visits and improve medication-related patient-physician communication.

The Parent Role in Advocating for a Deteriorating Child: A Qualitative Study.

BACKGROUND AND OBJECTIVES: Families of children with medical complexity are experts on their child's baseline behavior and temperament and may recognize changes in their hospitalized child's health before clinicians. Our objective was to develop a comprehensive understanding of how families identify and communicate their child's deteriorating health with the hospital-based health care team. METHODS: In this qualitative study, our multidisciplinary team recruited family members of hospitalized children with neurologic impairment. Interviews, conducted in the hospital, were audio recorded, deidentified, and transcribed. By using inductive thematic analysis, each transcript was independently coded by 3 or 4 team members. Members met regularly to reach consensus on coding decisions. Patterns observed were organized into themes and subthemes. RESULTS: Participants included 28 family members of 26 hospitalized children 9 months to 17 years of age. Children had a mean of 9 hospitalizations in the previous 3 years. Analysis resulted in 6 themes. First, families often reported their child "writes his own book," meaning the child's illness narrative rarely conformed to textbooks. Second, families developed informal, learned pathways to navigate the inpatient system. Third, families stressed the importance of advocacy. Fourth, families self-identified as "not your typical parents" and discussed how they learned their roles as part of the care team. Fifth, medical culture often did not support partnership. Finally, families noted they are often "running on empty" from stress, fear, and lack of sleep. CONCLUSIONS: Families of children with medical complexity employ mature, experience-based pathways to identify deteriorating health. Existing communication structures in the hospital are poorly equipped to incorporate families' expertise.

Use of EHR-Based Pediatric Quality Measures: Views of Health System Leaders and Parents.

Measures of health care quality are produced from a variety of data sources, but often, physicians do not believe these measures reflect the quality of provided care. The aim was to assess the value to health system leaders (HSLs) and parents of benchmarking on health care quality measures using data mined from the electronic health record (EHR). Using in-context interviews with HSLs and parents, the authors investigated what new decisions and actions benchmarking using data mined from the EHR may enable and how benchmarking information should be presented to be most informative. Results demonstrate that although parents may have little experience using data on health care quality for decision making, they affirmed its potential value. HSLs expressed the need for high-confidence, validated metrics. They also perceived barriers to achieving meaningful metrics but recognized that mining data directly from the EHR could overcome those barriers. Parents and HSLs need high-confidence health care quality data to support decision making.

Barriers and Facilitators of Adverse Event Reporting by Adolescent Patients and Their Families.

OBJECTIVES: The objectives were (1) to describe barriers and facilitators of adverse event reporting by adolescent patients and parents in a pediatric hospital and (2) to identify characteristics the participants wished to have in a formal reporting system of adverse events. METHODS: We used a qualitative design in which 6 focus groups, 3 with parents and 3 with adolescents, were conducted. The transcripts of audio recordings, notes of team debriefings, and written field notes of group behaviors were analyzed using NVivo software for qualitative data analysis. RESULTS: Participants reported that the quality of the experience with the health care system, type of communication with health care providers, and degree of personal self-confidence in communication within the health care system were 3 interacting factors influencing willingness to report adverse events. Preferred reporting mechanisms were different for different participants and included face-to-face meetings with hospital representatives, Web sites, smart phone capability, phone calls from a human, and paper mail. Reporting systems should be easy to use, ensure confidentiality, and provide user feedback. CONCLUSIONS: Experience, communication, and confidence are 3 factors that can engage an adolescent patient and parents in their health care. Confident adolescent patients and parents in turn have a possibility of reporting an adverse safety event given an opportunity.