Colleen Mangeot

Efficacy, Dose Reduction, and Resistance to High-Dose Fluticasone in Patients With Eosinophilic Esophagitis

BACKGROUND & AIMS We evaluated the efficacy and safety of high-dose swallowed fluticasone propionate (FP) and dose reduction in patients with eosinophilic esophagitis (EoE) and analyzed esophageal transcriptomes to identify mechanisms. METHODS We conducted a randomized, multisite, double-blind, placebo-controlled trial of daily 1760 mcg FP in participants age 3-30 years with active EoE. Twenty-eight participants received FP, and 14 participants received placebo. After 3 months, participants given FP who were in complete remission (CR) received 880 mcg FP daily, and participants in the FP or placebo groups who were not in CR continued or started, respectively, 1760 mcg FP daily for 3 additional months. The primary end point was histologic evidence for CR. Secondary end points were partial remission (PR), symptoms, compliance, esophageal gene expression, esophageal eosinophil count, and the relationship between clinical features and FP responsiveness. RESULTS After 3 months, 65% of subjects given FP and no subjects given placebo were in CR (P = .0001); 12% of those given FP and 8% of those given placebo were in PR. In the FP group, 73% of subjects remained in CR, and 20% were in PR after the daily dose was reduced by 50%. Extending FP therapy in FP-resistant participants did not induce remission. FP decreased heartburn severity (P = .041). Compliance, age, sex, atopic status, or anthropomorphic features were not associated with response to FP. Gene expression patterns in esophageal tissues of FP responders were similar to those of patients without EoE; there was evidence for heterogeneous steroid signaling in subjects who did not respond to FP and preliminary evidence for transcripts predictive of FP responsiveness. CONCLUSIONS Daily administration of a high dose of FP induces histologic remission in 65%-77% of patients with EoE after 3 months. A 50% dose reduction remained effective in 73%-93% of patients who initially responded to FP. Nonresponders had evidence of steroid resistance; histologic and molecular markers may predict resistance. Clinicaltrials.gov number: NCT00426283.

Improvement in Interstage Survival in a National Pediatric Cardiology Learning Network

Infants with univentricular congenital heart disease (CHD), including those with hypoplastic left heart syndrome (HLHS), regularly pose dilemmas in decision-making because their anatomy and physiology are often unique and variable. The typical staged surgical course for infants with complex univentricular anatomy with systemic outflow obstruction begins with the Norwood (stage 1) operation or variant shortly after birth, followed several months later by superior cavopulmonary anastomosis (stage 2 palliation) with an ultimate goal of a Fontan-type operation several years later.1–3 Improvement in surgical and postoperative management has led to considerable improvement in early post-Norwood survival in the recent era.4–7 However, after the Norwood procedure and before stage 2 palliation, a high-risk time period termed interstage, mortality has been previously been reported at 10% to 15%.8–10 The rare nature of this disorder has limited robust learning about successful strategies to improve survival undertaken by single-surgical centers, and a gap exists in our ability to further improve mortality in this population. The National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC), the first multicenter learning network within pediatric cardiology,11 was established with the goal of improving care and outcomes for children with univentricular heart after the Norwood operation and specifically to (1) improve interstage mortality, (2) decrease interstage growth failure, and (3) reduce interstage hospital readmissions for major medical events. There were several perceived challenges to success in changing clinical outcomes before starting the NPC-QIC collaborative. A primary challenge in collaboration among multiple sites can be agreement on best practices that should be implemented. This is especially true for rare diseases, such as univentricular heart disease, where evidence-based clinical guidelines are not available to clinicians. As noted above, major variation persists in management practices among individuals and institutions caring for children with HLHS and other …

Digoxin Use Is Associated With Reduced Interstage Mortality in Patients With No History of Arrhythmia After Stage I Palliation for Single Ventricle Heart Disease

Background Interstage mortality (IM) remains significant after stage 1 palliation (S1P) for single‐ventricle heart disease (SVD), with many deaths sudden and unexpected. We sought to determine whether digoxin use post‐S1P is associated with reduced IM, utilizing the multicenter database of the National Pediatric Cardiology Quality Improvement Collaborative (NPCQIC). Methods and Results From June 2008 to July 2013, 816 infants discharged after S1P from 50 surgical sites completed the interstage to stage II palliation, transplant, or IM. Arrhythmia during S1P hospitalization or discharge on antiarrhythmic medications were exclusions (n=270); 2 patients were lost to follow‐up. Two analyses were performed: (1) propensity‐score adjusted logistic regression with IM as outcome and (2) retrospective cohort analysis for patients discharged on digoxin versus not, matched for surgical site and other established IM risk factors. Of 544 study patients, 119 (21.9%) were discharged on digoxin. Logistic regression analysis with propensity score, site‐size group, and digoxin use as predictor variables showed an increased risk of IM in those not discharged on digoxin (odds ratio, 8.6; lower confidence limit, 1.9; upper confidence limit, 38.3; P<0.01). The retrospective cohort analysis for 60 patients on digoxin (matched for site of care, type of S1P, post‐S1P ECMO use, genetic syndrome, discharge feeding route, ventricular function, tricuspid regurgitation, and aortic arch gradient) showed 0% IM in the digoxin at discharge group and an estimated IM difference between the 2 groups of 9% (P=0.04). Conclusions Among SVD infants in the NPCQIC database discharged post‐S1P with no history of arrhythmia, use of digoxin at discharge was associated with reduced IM.

Effects of a 1-Time Nurse-Led Telephone Call After Pediatric Discharge: The H2O II Randomized Clinical Trial

Importance Families often struggle after discharge of a child from the hospital. Postdischarge challenges can lead to increased use of urgent health care services. Objective To determine whether a single nurse-led telephone call after pediatric discharge decreased the 30-day reutilization rate for urgent care services and enhanced overall transition success. Design, Setting, and Participants This Hospital-to-Home Outcomes (H2O) randomized clinical trial included 966 children and adolescents younger than 18 years (hereinafter referred to as children) admitted to general medicine services at a free-standing tertiary care children’s hospital from May 11 through October 31, 2016. Data were analyzed as intention to treat and per protocol. Interventions A postdischarge telephone call within 4 days of discharge compared with standard discharge. Main Outcomes and Measures The primary outcome was the 30-day reutilization rate for urgent health care services (ie, unplanned readmission, emergency department visit, or urgent care visit). Secondary outcomes included additional utilization measures, as well as parent coping, return to normalcy, and understanding of clinical warning signs measured at 14 days. Results A total of 966 children were enrolled and randomized (52.3% boys; median age [interquartile range], 2.4 years [0.5-7.8 years]). Of 483 children randomized to the intervention, the nurse telephone call was completed for 442 (91.5%). Children in the intervention and control arms had similar reutilization rates for 30-day urgent health care services (intervention group, 77 [15.9%]; control group, 63 [13.1%]; P = .21). Parents of children in the intervention group recalled more clinical warning signs at 14 days (mean, 1.8 [95% CI, 1.7-2.0] in the intervention group; 1.5 [95% CI, 1.4-1.6] in the control group; ratio of intervention to control, 1.2 [95% CI, 1.1-1.3]). Conclusions and Relevance Although postdischarge nurse contact did not decrease the reutilization rate of postdischarge urgent health care services, this method shows promise to bolster postdischarge education. Trial Registration ClinicalTrials.gov Identifier: NCT02081846

Guideline Adoption for Community-Acquired Pneumonia in the Outpatient Setting

Adoption of pediatric pneumonia guidelines in the outpatient setting. BACKGROUND: The Pediatric Infectious Diseases Society and Infectious Diseases Society of America national childhood community-acquired pneumonia (CAP) guideline encouraged the standard evaluation and treatment of children who were managed as outpatients. Our objectives were to (1) increase adherence to guideline-recommended diagnostics and antibiotic treatment of CAP at 5 pediatric primary care practices (PPCPs) by using quality-improvement methods and (2) evaluate the association between guideline adherence and unscheduled follow-up visits. METHODS: Immunocompetent children >3 months of age with no complex chronic conditions and who were diagnosed with CAP were eligible for inclusion in this stepped-wedge study. Interventions were focused on education, knowledge of colleagues’ prescribing practices, and feedback sessions. Statistical process control charts were used to assess changes in recommendations and antibiotic treatment. Unscheduled follow-up visits were compared across time by using generalized estimating equations that were clustered by PPCP. RESULTS: CAP was diagnosed in 1906 children. Guideline recommended therapy and pulse oximetry use increased from a mean baseline of 24.9% to a mean of 68.0% and from 4.3% to 85.0%, respectively, over the study period. Among children >5 years of age, but not among those who were younger, the receipt of guideline recommended antibiotics, as compared with nonguideline therapy, was associated with the increased likelihood of unscheduled follow-up (adjusted odds ratio, 2.12; 95% confidence interval: 1.31–3.43). Chest radiographs and complete blood cell counts were rarely performed at baseline. CONCLUSIONS: Recommendations for limited use of chest radiographs and complete blood cell counts and standardized antibiotic therapy in children is supported at PPCPs. However, the guideline may need to include macrolide monotherapy as appropriate antibiotic therapy for older children.

Identification of hospitalized tracheostomy and ventilator dependent patients in administrative data

Patients with established tracheostomy and ventilator dependence are hospitalized more frequently and use more healthcare resources than other patients with complex chronic conditions. However, data to compare variation in hospitalization and resource use among patients in this population across the United States is deficient, partly due to the lack of structured methods to query national databases.

Piloting a Statewide Home Visiting Quality Improvement Learning Collaborative

Objective To pilot test a statewide quality improvement (QI) collaborative learning network of home visiting agencies. Methods Project timeline was June 2014–May 2015. Overall objectives of this 8-month initiative were to assess the use of collaborative QI to engage local home visiting agencies and to test the use of statewide home visiting data for QI. Outcome measures were mean time from referral to first home visit, percentage of families with at least three home visits per month, mean duration of participation, and exit rate among infants <6 months. Of 110 agencies, eight sites were selected based on volume, geography, and agency leadership. Our adapted Breakthrough Series model included monthly calls with performance feedback and cross-agency learning. A statewide data system was used to generate monthly run charts. Results Mean time from referral to first home visit was 16.7 days, and 9.4% of families received ≥3 visits per month. Mean participation was 11.7 months, and the exit rate among infants <6 months old was 6.1%. Agencies tested several strategies, including parent commitment agreements, expedited contact after referral, and Facebook forums. No shift in outcome measures was observed, but agencies tracked intermediate process changes using internal site-specific data. Agencies reported positive experiences from participation including more frequent and structured staff meetings. Conclusions for Practice Within a pilot QI learning network, agencies tested and measured changes using statewide and internal data. Potential next steps are to develop and test new metrics with current pilot sites and a larger collaborative.

Risk Factors for Unanticipated Readmissions During the Interstage: A Report From the National Pediatric Cardiology Quality Improvement Collaborative

This study describes unanticipated interstage readmissions in patients with hypoplastic left heart syndrome, identifies independent risk factors for unanticipated interstage readmissions, and evaluates variation in unanticipated readmission rates among collaborative centers. Retrospective data of patients enrolled in the National Pediatric Cardiology Quality Improvement Collaborative registry from July 2008 to July 2013 were analyzed. Risk factors present at the beginning of the interstage were captured. Competing risks time to event analyses determined the association between these factors and unanticipated interstage readmission. Readmission center variation was examined using funnel plots. Unanticipated interstage readmissions occurred in 66% of 815 patients at 50 centers. The median readmission length of stay was 2 days (interquartile range: 0-6) and median time to first readmission was 29 days (interquartile range: 9-63). Most readmissions were prompted by minor changes in clinical status (64%), whereas only 6% were major adverse event readmissions. Independent readmission risk factors included genetic syndrome (HR = 1.40, 95% CI: 1.05-1.88), center volume (small vs large HR = 1.32, CI: 1.04-1.66, medium vs large HR = 1.35, CI: 1.09-1.68), preoperative ventricular dysfunction (HR = 2.02, CI: 1.31-3.10), tricuspid regurgitation (HR = 1.36, CI: 1.08-1.72), duration of circulatory arrest (HR = 0.99, CI: 0.989-0.998), and undergoing Hybrid procedure relative to Norwood/right ventricle to pulmonary artery conduit (HR = 1.40, CI: 1.02-1.93). There was significant center variation in the number of readmissions and duration of readmissions. Unanticipated readmissions are common during the interstage period with notable center variation. However, these readmissions are short and are rarely in response to major adverse events.

Dissemination of a quality improvement intervention to reduce early term elective deliveries and improve birth registry accuracy at scale in Ohio

Methods Participating hospitals were exposed to an 8-month QI intervention to reduce non-medically indicated scheduled deliveries <39 weeks and reflect those improvements in accurate state vital statistics data. The intervention was implemented using a step-wedge design with hospitals divided into three balanced waves. Effectiveness was assessed using interrupted time-series analysis. Interviews with a sample of participants and project call recordings were analyzed using qualitative methods to understand implementation.