Reinventing the Clinical Audit in a Pediatric Oncology Network.

Providing equal access to pediatric cancer patients regardless of their geographic location is a major goal of the Affiliate Program at St. Jude Children's Research Hospital (St. Jude). Thirty-five percent of new cancer patients enrolled on St. Jude clinical trials reside in the communities of 1 of the 8 affiliate clinics, which serve 9 states in the Southeast and Midwest United States. The affiliate clinics support participant recruitment for clinical trials and the geographic extension of St. Jude clinical care. To ensure high-quality pediatric cancer care, we instituted on-site clinical audits, however, we did not see improvement in clinical outcomes including the time to antibiotics in febrile immunocompromised patients, consistent hand-off communication, consistent documentation of oral chemotherapy, and adherence to a central line bundle in the ambulatory setting. We then moved to a more comprehensive clinical audit which involved self-reflection of clinic staff members, transparent data sharing, development of local quality champions, and engagement of senior leaders. The comprehensive approach was more successful in improving clinical outcomes including the time to antibiotics, hand-off communication, documentation of oral chemotherapy administration, and adherence to a central line bundle in the ambulatory setting.

Health Equity in Pediatric Drug Development: Translating Aspiration into Operation.

The concept of health equity-the attainment of the highest possible level of health for all members of society-requires equitable access to all aspects of healthcare, including pediatric drug development. However, many communities are under-represented in pediatric drug development programs. Barriers to participation include geographic, economic, racial/ethnic bias, legal, cultural, linguistic, and other factors. While there is no "one size fits all" approach to addressing these barriers, community engagement and collaboration is recognized by the Centers for Disease Control, the World Health Organization, and other global health organizations as a cornerstone for building a more equitable healthcare system. In this article, we will present case studies of stakeholder and community engagement in clinical research for rare diseases and other areas of healthcare, as examples of strategies and practices for actively involving under-represented communities and fostering their participation in pediatric drug development programs. These studies may serve as templates for facilitating equity in pediatric drug development from aspiration into operation.

Reducing Morning Hypoglycemia Among Children Undergoing Treatment for Acute Lymphoblastic Leukemia.

PURPOSE: Hypoglycemia has been observed in children receiving acute lymphoblastic leukemia (ALL) therapy, and it can negatively affect patient outcomes. We documented a 4%-6% prevalence of hypoglycemia among patients in the two clinics in this study. We aim to reduce morning hypoglycemia in children on chemotherapy for ALL at two community pediatric oncology clinics (A and B) by 50% in 9 months. METHODS: We used the Institute for Healthcare Improvement (IHI) Model for Improvement as the framework. Prolonged hours of fasting for procedural sedation, gaps in the caregivers' knowledge of hypoglycemia risk, and a lack of awareness of the new mercaptopurine administration guidelines were the most likely contributing factors for hypoglycemia. We developed a hypoglycemia prevention educational program for staff and caregivers followed by a knowledge assessment tool. RESULTS: Each month, the average number of patients seen in both clinics was 43. The monthly average of blood glucose tests in these patients was 94. After implementing the intervention, the percentage of caregivers who received hypoglycemia education reached 88%. Of those, 78% scored ≥ 75% in the knowledge reassessment resurvey. The combined average hypoglycemic episodes in the two clinics decreased by 46%. A higher reduction in hypoglycemic episodes was observed in clinic A (75%) compared with clinic B (17%). CONCLUSION: Implementing hypoglycemia education led to a significant drop in hypoglycemic episodes among children on ALL therapy. Despite using a similar approach, one of the two clinics showed a more than fourfold improvement compared with the other.

Role of implicit bias in pediatric cancer clinical trials and enrollment recommendations among pediatric oncology providers.

BACKGROUND: Provider implicit bias can negatively affect clinician-patient communication. In the current study, the authors measured implicit bias training among pediatric oncology providers and exposure to implicit association tests (IATs). They then assessed associations between IATs for race and socioeconomic status (SES) and recommendations for clinical trial enrollment. METHODS: A prospective multisite study was performed to measure implicit bias among oncology providers at St. Jude Children's Research Hospital and affiliate clinics. An IAT was used to assess bias in the domains of race and SES. Case vignettes were used to determine an association between bias and provider recommendation for trial enrollment. Data were analyzed using Student t tests or Wilcoxon tests for comparisons and Jonckheere-Terpstra tests were used for association. RESULTS: Of the 105 total participants, 95 (90%) had not taken an IAT and 97 (92%) had no prior implicit bias training. A large effect was found for (bias toward) high SES (Cohen d, 1.93) and European American race (Cohen d, 0.96). The majority of participants (90%) had a vignette score of 3 or 4, indicating recommendation for trial enrollment for most or all vignettes. IAT and vignette scores did not significantly differ between providers at St. Jude Children's Research Hospital or affiliate clinics. No association was found between IAT and vignette scores for race (P = .58) or SES (P = .82). CONCLUSIONS: The authors noted a paucity of prior exposure to implicit bias self-assessments and training. Although these providers demonstrated preferences for high SES and European American race, this did not appear to affect recommendations for clinical trial enrollment as assessed by vignettes.

Multisite Quality Improvement Initiative to Repair Incomplete Electronic Medical Record Documentation As One of Many Causes of Provider Burnout.

PURPOSE: Provider burnout is a challenge adversely affecting the quality, safety, and cost of health care. We measured burnout among pediatric oncology providers in the St Jude Affiliate network and used a Plan-Do-Study-Act (PDSA) improvement cycle to address one of the factors contributing to burnout. METHODS: Within the framework of the ASCO Thematic Quality Training Program, we sent the Mini Z 2.0 Survey to 47 pediatric oncology providers. Applying a fishbone diagram and Pareto chart, we analyzed potential causes of provider burnout. On the basis of the analysis, we used a PDSA approach to address documentation of oral chemotherapy adherence for children with acute lymphoblastic leukemia to mitigate burnout among providers. RESULTS: The burnout survey response rate was 44.6%. Burnout was identified in 42.9% of providers. Documentation in the electronic medical record (EMR) was cited as the second most common contributor to burnout, and it was this issue we chose to address according to a priority matrix. We improved the completeness of oral chemotherapy documentation from a baseline of 13% compliance to 87% compliance within 3 months. The improved compliance was achieved by standardizing the documentation process in the EMR for content and location. CONCLUSION: The EMR was one of the contributing factors in the burnout survey of the pediatric oncology providers in the St Jude Affiliate network. A PDSA improvement model to improve clinical research documentation was successful in addressing one of several contributing factors to provider burnout.

Handoff Communication between Remote Healthcare Facilities.

INTRODUCTION: Handoffs and transitions of care are common weak points in healthcare provider communication as patients move between sites. With no consistent pattern of communication between St. Jude Children's Research Hospital (St. Jude) and its affiliated clinics, the Affiliate Program Office at St. Jude developed and implemented a standardized communication tool to facilitate patient transitions between different healthcare sites. METHODS: Each team of providers created flow diagrams to define the current state of communication when patients were transitioning between remote sites. Fishbone diagrams identified the common barriers to effective communication as a lack of consistent communication and ownership. We developed a communication tool to address these barriers, which was disseminated by secure email. We measured the percent usage of the completed hand-off tool before a patient transitioned, staff experience, and the number of errors. RESULTS: The time to send or receive the communication bundle was <10 minutes. Within 3 months of implementing the SMART bundle at 3 pilot sites, the bundle was used completely in 6 of 8 patient transitions and was associated with somewhat improved staff satisfaction. We identified no adverse events related to the communication bundle. CONCLUSIONS: In this small pilot study, we accomplished closed-loop communication between geographically remote healthcare sites by using an electronically transmitted standardized communication bundle.

Communication Regarding Therapeutic Clinical Trial Enrollment Between Oncologists and Adolescents and Young Adults with Cancer.

Adolescent and young adult (AYA) cancer patients enroll in therapeutic clinical trials at low rates. Prior study has focused on trial availability; this research attempts to elucidate the role of communication in individual decision-making. We surveyed 193 AYA patients and reviewed medical records of informed consent discussions. Twenty percent (38/193) of patients were offered trials, 58% (22/38) enrolled. Many were unable to correctly identify whether they were offered trials or enrolled, including 27% (6/22) of patients on clinical trials who believed that they were not. Efforts to improve communication have potential to enhance informed decision-making in this vulnerable population.

Chemotherapy Wait Times in a Network of Pediatric Oncology Clinics.

Patient satisfaction with medical care delivery is an important aspect of value-based health care. Providers strive to provide optimal patient satisfaction. Among a network of ambulatory pediatric oncology affiliate clinics, we conducted patient satisfaction surveys and found that the lowest scores were related to delays in the administration of chemotherapy. To address this shortcoming, we used continuous improvement methodologies to reduce the delay in chemotherapy administration in 3 affiliate clinics. To evaluate the efficacy of the quality improvement interventions implemented at each affiliate clinic, we measured the time from patient arrival to the start of chemotherapy administration over a 2-week period before and after the interventions. Wait times for chemotherapy administration were reduced in each clinic by 7% to 15%, exceeding the preestablished goal of a 5% reduction without affecting patient safety. Patient satisfaction for chemotherapy wait times was also marginally increased. In conclusion, implementation of quality improvement interventions across a clinical network can improve specific aspects of patient satisfaction, thereby improving the overall patient experience.

Barriers and facilitators of clinical trial enrollment in a network of community-based pediatric oncology clinics.

INTRODUCTION: Major advances in the field of pediatric oncology have resulted from rigorous, prospective clinical oncology research trials. Optimizing access for all children and adolescents to clinical research trials is an important goal. Barriers to clinical trial enrollment are numerous, involving the health care system, research infrastructure, access to care, providers, and participants. The perspectives of pediatric oncologists may provide insight into the barriers of clinical trial enrollment for this unique population. METHODS AND MATERIALS: We conducted qualitative structured interviews over two months of pediatric oncologists in a community-based clinical network as part of a quality improvement project aimed at increasing enrollment rates at St. Jude Affiliate Clinics. We assessed barriers and facilitators to clinical trial opportunities for racial and ethnic minority pediatric participants. In the same fiscal year of the interviews, we tracked clinical trial enrollment by race and ethnicity of the participant over 12 months. RESULTS: The major barriers to clinical trial enrollment for pediatric cancer minority participants included language discordance, travel difficulties, and complex trial designs. In contrast, the major facilitators included building trust with participants and their parents, and education on the merits of clinical research studies. We did not observe any disparities in clinical trial enrollment among the racial and ethnic minority participants of the clinical trials conducted across our network of pediatric oncology clinics. CONCLUSIONS: Identifying barriers and facilitators may improve clinical trial enrollment for underrepresented participant groups.

Quality Improvement Interventions across a Network of Pediatric Hematology-Oncology Clinics.

INTRODUCTION: Achieving improvement in quality among different institutions is challenging. Immunocompromised children with febrile neutropenia are at high risk of severe infection. Pediatric hematology-oncology patients frequently experience central line-associated bloodstream infections (CLABSIs) associated with implanted catheters. A network of 8 pediatric hematology-oncology clinics affiliated with St. Jude Children's Research Hospital launched 2 initiatives designed to reduce the incidence of infections and improve infection treatment. METHODS: We reviewed the timing of antibiotic administration for immunocompromised patients with a fever before and after a quality improvement intervention tailored to each affiliate clinic. We also reviewed the frequency of CLABSIs before and after implementing a central line care bundle for implanted catheters in ambulatory patients. RESULTS: Across the affiliate clinic network, the timing of antibiotic administration improved from the preintervention period (23% of patients received antibiotics within 60 min of registration) to 53% and 73%, in successive postintervention periods. Implementing a central line bundle for implanted catheters was associated with increased compliance and a trend toward increased time between CLABSIs. CONCLUSION: We describe an approach to quality improvement utilizing a system of monitoring with annual clinical audits, development of joint quality improvement initiatives, ongoing education, and focused training of staff for effecting change that improves patient healthcare across multiple institutions.

Vaccination history and risk of childhood leukaemia.

BACKGROUND: Previous studies on vaccination and childhood leukaemia generated inconsistent results. METHODS: In the Northern California Childhood Leukaemia Study, a case-control study with incident cases and matched birth certificate controls, detailed written vaccination records were collected. A total of 323 cases aged 0-14 years at diagnosis and 409 controls were included in this analysis. All vaccinations were censored on the reference date (date of diagnosis for cases and the corresponding date for matched controls). Conditional logistic regression analysis was conducted, adjusting for potential confounding factors. A primary variable of interest is the number of administrations (doses) of various types of vaccines. RESULTS: Vaccinations against diphtheria, pertussis, tetanus, poliomyelitis, measles, mumps, and rubella were not associated with the risk of leukaemia. The odds ratio for each dose of Haemophilus influenzae type b (Hib) vaccine was 0.81 (95% CI 0.68-0.96). Compared with children who received two or fewer doses of Hib vaccine, those who received three or more doses had a significantly reduced risk of childhood leukaemia (odds ratio = 0.55, 95% confidence interval 0.32-0.94). The number of doses of hepatitis B vaccine received was not associated with leukaemia risk. CONCLUSIONS: Hib vaccination is associated with a reduced risk of childhood leukaemia. Future studies with detailed exposure assessment and large sample sizes are needed to further address the role of vaccinations in the etiology of childhood leukaemia.

Apparent genotype-phenotype correlation in childhood, adolescent, and adult Chediak-Higashi syndrome.

Chediak-Higashi syndrome (CHS) is a rare autosomal recessive disorder characterized by severe immunologic defects, reduced pigmentation, bleeding tendency, and progressive neurological dysfunction. Most patients present in early childhood and die unless treated by bone marrow transplantation. About 10-15% of patients exhibit a much milder clinical phenotype and survive to adulthood, but develop progressive and often fatal neurological dysfunction. Very rare patients exhibit an intermediate adolescent CHS phenotype, presenting with severe infections in early childhood, but a milder course by adolescence, with no accelerated phase. Here, we describe the organization and genomic DNA sequence of the CHS1 gene and mutation analysis of 21 unrelated patients with the childhood, adolescent, and adult forms of CHS. In patients with severe childhood CHS, we found only functionally null mutant CHS1 alleles, whereas in patients with the adolescent and adult forms of CHS we also found missense mutant alleles that likely encode CHS1 polypeptides with partial function. Together, these results suggest an allelic genotype-phenotype relationship among the various clinical forms of CHS.