Deficiencies, variability, and missed opportunities in the delivery of medical care are well-described (1,2). Such deficiencies have led to an increased focus on quality improvement (QI) in clinical practice during the past 15 years. Practitioners have been challenged to improve the care that is delivered to our patients. Pediatric gastroenterology (GI) practitioners and researches have been early and current leaders in applying QI methods to improve the delivery of care (3,4). Initially improvement activities in pediatric GI were confined to multicenter collaborations or academic centers. More recently, practical applications of QI undertaken at the local level have begun to expand and QI is becoming ingrained in the expectations of many physicians’ and practitioners’ daily activities. Although still being met with resistance or skepticism by some, the value of QI is gaining acceptance and is now expected of all practitioners as demonstrated by the part IV requirements of the maintenance of certification process of the American Board of Pediatrics.
This review will describe examples of successful advances in QI and delivery of care in a variety of settings within pediatric GI. Acute and chronic conditions, inpatient, outpatient, and the endoscopy unit can each benefit from improvement projects. As illustrated below, simple QI interventions including use of checklists, bundles, and order sets can be effective methods of improvement. In addition, more advanced approaches such as process control charts or development of multicenter registries have been used. Barriers to effective use of QI continue to exist and resource limitations must be considered when planning interventions. This report is intended to encourage creativity in identifying opportunities to apply QI principles to routine daily clinical care in centers of all sizes.
STANDARDIZATION AND PATIENT REGISTRIES
Perhaps the most prominent example of the application of QI methodology to pediatric GI clinical care is the multicenter pediatric inflammatory bowel disease (IBD) collaborative, ImproveCareNow (ICN) (3,4). Developed in 2007, ICN is based largely upon the principles of the Model for Improvement emphasizing use of Plan-Do-Study-Act cycles, the Chronic Care Model, and with a focus upon measurement of both performance and outcomes (4–6). A systematic approach to reducing unwarranted variation and the consistent collection and measurement of data have resulted in improvements in both process and outcome measures. Examples include implementing process interventions when monitoring serum vitamin D levels or affecting outcome measures such as improving the percentages of patients in clinical remission (4,7). Furthermore, individual centers with ICN support have expanded patient and parent partnerships to improve communication and gain meaningful perspectives regarding family barriers to effective care. Integrating family input has allowed more comprehensive care delivery, a concept consistent with efforts to better understand patient-reported outcomes (8,9).
Standardization in IBD care can also affect escalating health care costs. The increasing cost of IBD care has been previously described (10) and reduction in unnecessary costs in the treatment of children with IBD, especially in those treated with costly anti–tumor necrosis factor (TNF) therapy, is of particular importance. ICN researchers proposed strategies to reduce costs for patients treated with anti-TNF therapy (11). Recommended interventions include elimination of episodic use of anti-TNF therapy and more objectively differentiating symptoms of active IBD through consistent testing (Clostridium difficile, serum markers of inflammation [C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin]) before adjustment of the anti-TNF dosing. Finally, once tolerance and safety of the infusions are established, use of shortened infusion times to reduce non–drug infliximab costs per infusion should be considered (11,12). Implementing these standardized interventions are not limited to academic centers leading ICN, but rather can each be implemented at the local level by divisions of all sizes.
Patient registries have been used to reduce variation in the delivery of care at the population level in a variety of clinical settings, including pediatric acute liver failure. A 2009 study completed by the Pediatric Acute Liver Failure (PALF) study group demonstrated the potential effect of more consistent diagnostic testing (13). Testing for the most common causes of PALF (infections, drug exposures, autoimmune, and metabolic diseases) was found to be highly variable among PALF sites. Of 329 patients described as having indeterminate PALF, <40% had urine toxicology or acetaminophen levels obtained, 45% had no testing for common metabolic diseases, and 20% had no testing for autoimmune disorders, highlighting potential missed treatment opportunities. Those patients without testing may have benefited from treatment including antiviral or steroid therapy, targeted metabolic therapy (tyrosinemia), or treatment of acetaminophen toxicity. Furthermore, more complete diagnostic testing could affect transplantation decisions, future discussion about genetic counseling, or considerations for subsequent pregnancies. Given the complexity and rarity of PALF, Narkewicz et al (13) concluded that a more standardized evaluation approach was needed. Although successful examples demonstrating the effectiveness of registries are well-established, one must remember that meaningful registries require consistent, accurate, and reliable data entry and monitoring to draw sound conclusions from the data output.
CONTROL CHARTS AND PROCESS EVALUATION
A common tool in QI projects, control charts allow centers to observe the effect of interventions over time as compared to prior baselines. For example, statistical process control has been used in the management of chronic immunosuppressive therapy in pediatric liver transplant. Bucuvalas et al (14) used statistical process control to increase the percentage of patients with calcineurin inhibitor (CNI) levels within a therapeutic target range through clearer definitions of CNI target ranges, protocolized medication management, and the display of results over time using control charts. After protocol implementation, the proportion of CNI levels within the target range improved from a baseline of 50% to 77% (P < 0.001). Division-wide application of the protocol promoted standardized dosing and reduced dose tampering by practitioners; interventions associated with reduced variation in drug levels. A subsequent study showed that patients with increased variation in tacrolimus levels had increased risk of allograft rejection and that those with more variable levels often related to variable medication adherence (15). The tracking of levels was used to improve the understanding of reasons for variation in levels and allowed more targeted approaches to improve adherence (15).
Careful process evaluation can also improve the quality of endoscopic care by safely streamlining throughput in the pediatric endoscopy suite. Tomer et al used tracking methods to establish the baseline process from endoscopy order to completion of outpatient procedures. Their improvement team identified common reasons for delays, successfully improved the efficiency of the endoscopy process, and was able to reduce delays in procedure start times by 65 minutes per day (P = 0.02) (16). Endoscopy in children remains an area in need of reduced variation. Identified improvement opportunities include time to procedure completion, consistent method of documentation, and bowel preparation for colonoscopies in children (17).
ORDERS SETS, CHECKLISTS, AND BUNDLING
The electronic medical record (EMR) provides a format to creatively improve consistent care delivery through the use of orders sets and checklists that can be applied to many clinical conditions. Marked variability exists in the treatment of mild acute pancreatitis (AP) with regards to use of intravenous fluid administration, the need for central venous access, and in the timing of reintroduction of enteral nutrition. This variation can exist between institutions, and also within institutions among practitioners and/or between inpatient services (GI vs surgery vs general medicine). Szabo et al developed an inpatient order set for patients admitted with mild AP to standardize the institutional approach to care. The order set included higher rates of intravenous fluid within 24 hours of admission and initiation of enteral nutrition within 48 hours. Reduction in length of hospital stay, admissions to the intensive care unit (ICU), and in the number of children progressing to severe AP all occurred after implementation of the order set (18).
Bundles packages and checklists have previously been shown to be effective in central line care in the ICU (19,20), but these QI tools need not be limited to the ICU setting. Central catheter–associated bloodstream infections (CCABSI) are a common complication in children with intestinal failure who are dependent on parenteral nutrition. Ardura et al described their improvement teams’ expansion of previously established central catheter–associated prevention bundles to include ethanol lock prophylaxis (ELP) in patients with intestinal failure. Integrating the routine use of ELP into central line care was associated with a significant and sustained reduction in CCABSI, and ELP was then safely incorporated into the best-practice CCABSI prevention bundle (21).
BARRIERS AND BALANCING
As demonstrated above, QI interventions have been successful in a wide variety of clinical settings. Barriers to implementing these improvements, however, continue to exist and can limit successful application. Infrastructure and cost are 2 prominent realities that can be challenging for many centers to overcome. Participation in multicenter collaboratives may require up front and ongoing costs to allow access to data output. Inadequate support may limit successful implementation of timely and accurate of data collection. Without reliable and consistent data capture, collaborative participation can be less productive for many centers and participation may be short lived. These barriers should be considered at the time of project implementation. In addition, QI efforts should consider the risk of unintended consequences. Balancing measures should be built into the project where possible. Teams should be asking themselves: How will these efforts affect cost, patient satisfaction, or possible secondary complications? Are too many EMR checklists creating fatigue and the content of EMR reminders is being overlooked or ignored? Inadequate consideration of these barriers can contribute to resistance, frustration, and an ability to sustain gains in the improvement efforts.
Deficiencies in the delivery of medical care continue to exist and all health care professionals are challenged to improve the care that we deliver. Application of QI to daily clinical care can be achieved in the context of both multicenter collaborative efforts and at the local level in a variety of clinical settings. Use of common QI techniques to assess the effect of interventions in real-time and establishing a method for tracking and measuring outcomes has repeatedly demonstrated success across a variety of clinical conditions. Although barriers continue to exist, creative use of the EMR, development of checklists, and careful review of inefficient processes can be used by centers and practitioners in most clinical settings. A tracking system and the ability to measure and monitor the effect of the interventions over time are critical for success in these endeavors. Practitioners within the pediatric GI community have demonstrated a willingness to accept this challenge and in so doing have become leaders in changing practice and improving outcomes.
1. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001.
2. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. N Engl J Med
3. Crandall W, Kappelman MD, Colletti RB, et al. ImproveCareNow: the development of a pediatric inflammatory bowel disease improvement network. Inflamm Bowel Dis
4. Crandall WV, Margolis PA, Kappelman MD, et al. Improved outcomes in a quality improvement
collaborative for pediatric inflammatory bowel disease. Pediatrics
5. Courtlandt CD, Noonan L, Feld LG. Model for improvement. Part 1: a framework for health care quality. Pediatr Clin North Am
6. Wagner EH, Austin BT, Davis C, et al. Improving chronic illness care: translating evidence into action. Health Aff (Millwood)
7. Samson CM, Morgan P, Williams E, et al. Improved outcomes with quality improvement
interventions in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr
8. Donegan A, Boyle B, Crandall W, et al. Connecting families: a pediatric IBD center's development and implementation of a volunteer parent mentor program. Inflamm Bowel Dis
9. Geisz M, Ha C, Kappelman MD, et al. Medication utilization and the impact of continued corticosteroid use on patient-reported outcomes in older patients with inflammatory bowel disease. Inflamm Bowel Dis
10. Kappelman MD, Rifas-Shiman SL, Porter CQ, et al. Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults. Gastroenterology
11. Park KT, Crandall W, Fridge J, et al. Implementable strategies and exploratory considerations to reduce costs associated with anti-TNF therapy in inflammatory bowel disease. Inflamm Bowel Dis
12. Neef HC, Riebschleger MP, Adler J. Meta-analysis: rapid infliximab infusions are safe. Aliment Pharmacol Ther
13. Narkewicz MR, Dell Olio D, Karpen S, et al. Pattern of diagnostic evaluation for the causes of pediatric acute liver failure: an opportunity for quality improvement
. J Pediatr
14. Bucuvalas J, Ryckman F, Arya G, et al. A novel approach to managing variation: outpatient therapeutic monitoring of calcineurin inhibitor blood levels in liver transplant recipients. J Pediatr
15. Venkat VL, Nick TG, Wang Y, et al. An objective measure to identify pediatric liver transplant recipients at risk for late allograft rejection related to non-adherence. Pediatr Transplant
16. Tomer G, Choi S, Montalvo A, et al. Improving the timeliness of procedures in a pediatric endoscopy suite. Pediatrics
17. Thakkar K, Holub JL, Gilger MA, et al. Quality indicators for pediatric colonoscopy: results from a multicenter consortium. Gastrointest Endosc
18. Szabo FK, Fei L, Cruz LA, et al. Early enteral nutrition and aggressive fluid resuscitation are associated with improved clinical outcomes in acute pancreatitis. J Pediatr
19. Quan K, Cousins S, Porter D, et al. Electronic health record solutions to reduce central line-associated bloodstream infections by enhancing documentation of central line insertion practices, line days, and daily line necessity. Am J Infect Control
20. Hermon A, Pain T, Beckett P, et al. Improving compliance with central venous catheter care bundles using electronic records. Nurs Crit Care
21. Ardura M, Lewis J, Tansmore J, et al. Central catheter-associated bloodstream infection reduction with ethanol lock prophylaxis in pediatric intestinal failure: broadening quality improvement
initiatives from hospital to home. JAMA Pediatr