Fig. 56.1
Variation in care. (a) Improving quality by decreasing variation. (b) Improving quality by shifting distribution
Variation in care has been demonstrated in pediatric IBD [10–12]. In one study, pediatric gastroenterologists enrolled patients with Crohn disease who were starting treatment with a thiopurine (6-mercaptopurine or azathioprine) or infliximab [11]. Data from 250 patients at 80 sites were examined for variation in diagnostic and therapeutic interventions. Diagnostic studies in which care was uniform included complete blood count, performed in 100% of patients, erythrocyte sedimentation rate and colonoscopy in 96%, and upper endoscopy in 89%. However, imaging of the small bowel had not been performed in 19%, and a stool test for pathogens had not been performed in 29%. Thiopurine methyltransferase (TPMT) had been measured in 61% of patients before treatment with a thiopurine; in 85%, TPMT was normal. Nonetheless, even when TPMT was normal, 40% of patients received an initial dose of thiopurine that was lower than recommended. Testing for tuberculosis before initiating treatment with infliximab was not documented in 30%. In addition, 36% of severely underweight patients were not receiving a multivitamin supplement, supplemental formula, or tube feeding [12]. Another study demonstrated widespread intercenter variation in the treatment of newly diagnosed children with Crohn disease, even after adjusting for possible differences in case mix between institutions [12]. Variation in the use of immunomodulators and infliximab in patients with Crohn disease has also been reported [10, 13]. Thus, there is clear documentation of considerable variation in diagnostic and therapeutic care in pediatric IBD, suggesting the presence of underuse, overuse, and potentially misuse of interventions that may lead to unintended differences in health-care costs and outcomes.
Documentation of variation in care has been important in efforts to standardize and improve care in other fields of medicine [3]. For example, the Epidemiologic Study of Cystic Fibrosis demonstrated large variations in practice patterns regarding the prescription of various therapies as well as the fact that a significant proportion of cystic fibrosis (CF) patients are not monitored as recommended by the Cystic Fibrosis Foundation (CFF) [14, 15]. In this study, only 58% of patients had quarterly visits to their CF Care Center, 76% had biannual spirometry, 79% had annual airway cultures, and 68% had annual chest radiographs [16]. CF Registry reports are now presented in such a way as to reveal practice variation among practice sites, partly in order to motivate an evaluation of this variation and to promote standardization where indicated.
The Chronic Illness Care Model
The chronic illness care model provides a useful framework for developing changes to the system of IBD care [17, 18]. Wagner and colleagues conducted an exhaustive literature review and program assessment to identify the key components of systems of health-care delivery that result in improved outcomes for patients with chronic illness. Wagner’s model includes the following components: family and patient self-management support, decision support, delivery system design, clinical information systems, community resources, and health-care organization (Fig. 56.2). Family and patient self-management support includes the methods used by the clinic to increase families’ participation in care. Decision support includes the use of care protocols that are integrated into practice systems. The delivery system design component includes the use of planned encounters, clarity in the roles and responsibilities of team members with appropriate training, and the use of regular meetings of the care team to review performance. The clinical information system refers to the ability of caregivers to access data and use registries for care and to provide regular feedback to the team and also information technology to facilitate scheduling and patient tracking. A prepared proactive practice team interacts with an informed activated patient to improve functional and clinical outcomes.
Fig. 56.2
The chronic illness care model (Adapted from EH Wagner, Joint Commission Journal on Quality Improvement 2001;27:65, by permission)
Improvement science is broadly defined as the science of implementing and testing change. There are many different ways in which improvement science is applied in practice. Each involves the common theme of methodically implementing and testing small changes and then adopting or rejecting the changes based on the findings of testing [19]. Improvement interventions can range from prospective randomized controlled trials to observational studies [20]. The application of improvement science has led to major advances in quality in the automobile, microchip, and other industries [21–23]. Does quality improvement work in health care? Quality improvement interventions utilizing the chronic care illness model have improved clinical outcomes, processes of care, and quality of life in asthma, congestive heart failure, depression, and diabetes [24]. Studies of controlled trials of interventions that contain at least one element of the chronic care illness model have demonstrated significant improvements in care [25]. In a cohort study to determine the effect of a specialist nurse on the outcome of 340 patients with IBD, intervention was associated with a 38% reduction in hospital visits, a 19% reduction in hospital length of stay, and a 10% increase in patients in remission and improvement in patient satisfaction [26]. A multicenter randomized controlled trial of a quality improvement project in IBD showed similar results [27]. In the UK, development of a pediatric IBD service has improved provision of services and access to care for patients [28]. In Australia, the implementation of a dedicated IBD service was associated with a reduction in the use of steroids and opiates as well as a reduction in hospitalizations for IBD [29].
The Need for Quality Improvement in IBD
Have Crohn disease outcomes improved during the last four decades? In a report published in 2004, a structured systematic literature review was performed to evaluate measurable outcomes in Crohn disease. Evaluation of mortality, cancer, disease recurrence, extraintestinal manifestations, and medication use failed to show hard evidence for the improvement in disease outcome in Crohn disease during the last four decades [30]. Despite advances in research and therapy, the application of knowledge to the improvement of health outcomes and quality of life has lagged. Hospitalization rates for IBD, particularly Crohn disease, increased from 1988–2011, incurring a substantial rise in inflation-adjusted economic burden [31, 32]. Further, even in the era of biologics, the proportion of patients with inflammatory bowel disease not entering remission remains high [33].
Are patients with IBD receiving optimal care? A study found that adults with IBD referred for a second opinion often were not receiving optimal medical therapy [34]. There was prolonged use of corticosteroids, failure to use steroid-sparing agents, suboptimal dosing of mesalamine and immunomodulatory medications, inadequate measures to prevent metabolic bone disease, and inadequate screening for colorectal cancer.
A study of the diagnostic evaluation of pediatric patients diagnosed with IBD also identified substantial gaps in small bowel imaging, though this was found to improve over the 5-year course of study [35]. Many pediatric patients diagnosed with Crohn disease had not been tested for intestinal pathogens, had not had imaging of the small intestine, were not receiving a multivitamin supplement, had not been tested for TPMT prior to treatment with a thiopurine, had not been tested for tuberculosis prior to treatment with infliximab, and were receiving suboptimal dosage of medications [11].
Quality improvement in adult gastroenterology has previously focused on endoscopic procedures [36–44]. More recently, there has been an emphasis on reducing venous thromboembolic events in hospitalized IBD patients [45, 46]. However, the American Gastroenterological Association (AGA) Task Force on Quality in Practice issued a report recommending the formation of an AGA Quality Center to assure uniform documentable excellence in quality of clinical care and GI practice, to support the aims for quality health care set forth by the Institute of Medicine, to identify key quality of care indicators in the treatment of digestive diseases and how they will be measured, to develop programs and tools to assist in implementing evidence-based guidelines and measuring and reporting adherence to quality indicators, and to develop patient education materials to ensure that patients have appropriate expectations regarding high-quality, patient-centered, evidence-based care [47]. In 2011 the AGA developed a set of IBD process measures, approved by the American Medical Association’s Physician Consortium for Performance Improvement, which focus on transitioning patients to corticosteroid-sparing therapy and preventive care. The AGA subsequently developed a series of quality improvement measures called the Physician Quality Reporting System (PQRS) [48]. The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) has also developed a set of process measures. In conjunction with measure development, the AGA has also developed the Digestive Health Outcome Registry (DHOR) to help practices develop benchmarking, outcomes measurement, and population management capabilities for patients with IBD [49].
The Improvement Model
The improvement model is the foundation of a system for innovation and a framework for developing, testing, and implementing incremental change [50]. The model is based on three questions (Fig. 56.3): What are we trying to accomplish? How will we know that a change is an improvement? What change can we make that will result in improvement? Any approach to improvement must be based on building and applying knowledge. Within the overall framework, the plan-do-study-act (PDSA) cycle is a structured application of the scientific method that provides a means to learn rapidly in complex organizational settings. The plan phase consists of stating the objective of the test, making predictions, and developing a plan to carry out the test. The do phase consists of carrying out the test, documenting problems and unexpected observations, and beginning an analysis of the data. The study phase consists of completing the analysis of the data, comparing the test data to predictions, and summarizing what was learned. The act phase consists of deciding upon and carrying out the changes to be made and considering what will be the objective of the next cycle. The improvement model means applying the principles of using data; developing, testing, and implementing changes; and working collaboratively to bring about improvement in the outcomes of health care (Fig. 56.4). The improvement model can be applied to any aspect of health care.
Fig. 56.3
The improvement model (Adapted from Langley, Nolan, Nolan, Norman and Provost [37], page 10, by permission of Jossey Bass)
Fig. 56.4
Repeated use of the plan-do-study-act cycle. (Adapted from Langley, Nolan, Nolan, Norman and Provost [37], page 9, by permission of Jossey Bass)
The Improvement Collaborative
An improvement collaborative is a sequential process in which a group of multidisciplinary teams from different practice sites work intensively together using the principals of improvement science to improve the delivery of care and the quality of life of patients [51, 52]. Improvements consist of redesigning delivery systems to ensure that patients receive recommended care and are not subject to underuse, overuse, or misuse. An improvement collaborative includes three main phases: (1) a design and development phase, in which the aim and measures for the project are developed (see Table 56.1) and changes to be tested are identified and summarized using formal methods for the design of new processes and systems; (2) an implementation phase, in which practice sites work together to test and adapt changes in care delivery; and (3) a dissemination phase, where, as changes in the processes of care delivery are tested and reliably achieve desired goals, they are disseminated to other and eventually all pediatric gastroenterology practice sites. Participating sites collect data about their patients’ care, share data about the outcomes of care with all of the other sites, identify sites that are performing better, examine reasons for the better performance, set benchmarks for outcomes, and share ideas to enable the other sites to improve their outcomes. Participating sites gather together for conferences to share data and ideas and then return to their sites to perform PDSA improvement projects there, gathering and sharing new data in an incremental process (Fig. 56.5).
Table 56.1
Measurable outcomes of treatment of pediatric IBD
Disease activity |
Remission rate |
Interval between relapses |
Complication rates (e.g., fistula) |
Nutritional status |
Growth, final adult height |
Days missed from school |
Emergency department visits |
Hospitalization rate |
Hospital length of stay |
Surgery |
Patient and family satisfaction |
Patient quality of life |
Adverse drug events (e.g., infusion reactions) |
Surgical complication rate |
Fig. 56.5
A schematic drawing of the sequence of events in an improvement collaborative. (Adapted from a presentation of the Institute for Healthcare Improvement)
An IBD improvement collaborative is intended to encourage practices to adopt a more organized approach to IBD care. It is based on models of behavior change and diffusion of innovations in medical practice including involvement of opinion leaders in the medical community, recognition of a performance gap, involving physicians and staff in developing a strategy to make changes to close the gap, compatibility of the intervention with current practice, and reinforcement of positive change [53]. It is designed to identify and address barriers in the way care is delivered in IBD clinics.
This type of systems intervention is especially important in pediatric IBD clinics because many pediatric IBD practice sites operate within large tertiary medical centers with relatively rigid infrastructures requiring significant and determined effort to change. IBD care is characterized by a complex mixture of preventive and chronic therapeutic interventions; distance and other factors make frequent return visits difficult for many patients, so accidental omission of services and other missed opportunities for care are difficult to recognize and are harder to correct. Also, the responsibility for care is shared by multidisciplinary teams and multiple physicians with diverse responsibilities who may overestimate the consistency with which they deliver specific services [54].
The ImproveCareNow Network
The first improvement collaborative in IBD, called ImproveCareNow, was established in early 2007; its global aim is to build a sustainable network of all pediatric gastroenterologists in the USA to improve the care and outcomes of children with Crohn disease and ulcerative colitis [55]. In its first five years, it grew from 8 to 34 centers, with approximately 300 pediatric gastroenterologists and 10,000 pediatric IBD patients. By 2015, the ImproveCareNow Network grew to 85 centers, across 36 states in the US and in England, which include approximately 750 pediatric gastroenterologists and 24,000 patients. The six primary drivers of the ImproveCareNow Network are (1) a prepared proactive practice team, (2) accurate diagnosis and disease classification, (3) appropriate drug selection and dosage, (4) adequate nutritional intake, (5) adequate growth monitoring, and (6) informed, activated, and engaged patients and families.
ImproveCareNow developed and implemented five major interventions: (1) enrollment and data quality, (2) consistent reliable care, (3) population management, (4) pre-visit planning, and (5) self-management support. The centers aimed to identify and enroll all of their IBD patient population, collect data from all visits using a standardized template for data elements, and provide complete and accurate data in a timely fashion. ImproveCareNow developed a Model IBD Care Guideline for Consistent Reliable Care, based on an integration of evidence and consensus, and key clinical measures, and process and outcome measures, to monitor the performance at each center and the collaborative as a whole [56]. In addition, an algorithm for nutrition and growth was developed.
A population management tool was developed and used to ensure patients were being seen regularly and to identify patients who were not receiving model IBD care and who could benefit from a proactive change in their management. A pre-visit planning checklist was developed and implemented at centers to review important clinical data, identify and highlight variables that fall outside of protocol guidelines (e.g., drug dosages and results of previous laboratory tests), identify and arrange for needed resources at the time of visit (e.g., preordering laboratory tests, scheduling a dietician), and assist the clinician in preparing an agenda of important issues requiring attention at the visit. In 2011, a systematic program was undertaken to develop tools for patient and family self-management support, including providing patient education, eliciting patient and family priorities for visits, confirming patient understanding of new information, setting and monitoring patient goals collaboratively, and improving adherence.
One of the primary strengths of ImproveCareNow is a focus on learning from data. Each participating center receives monthly reports with tables and longitudinal graphs of their performance on the key clinical and data quality measures and twice-monthly population management reports. These electronic reports provide both aggregate and individual patient- and visit-level data that can be used to monitor populations of patients and identify subgroups of patients in need of attention or intervention. The reports are used to identify subpopulations of patients with medical issues in need of attention, such as patients who are on systemic steroids or patients with suboptimal nutritional status. They also are used to identify patients who have outgrown the doses of their medications. The reports can also facilitate failure mode and effects analyses to study problems and gain insights to inform improvement efforts. The reports also include run charts and control charts to help identify special cause variation when a significant change from baseline has occurred. Centers also have the ability to compare their performance to that of other centers and of the entire network [57].
The data that inform these reports are collected from each patient at each outpatient visit. ImproveCareNow has developed processes by which automated data transfer can be done from electronic medical record systems to populate the data registry. This has reduced the burden of data collection and errors associated with duplicate data entry for many of the participating network sites. For sites without the capability of electronic data transfer, manual data entry is performed. There are numerous quality checks to minimize errors in manual data entry. Data collection includes all the data necessary for calculating the short pediatric Crohn disease activity index (sPCDAI) and the pediatric ulcerative colitis activity index (PUCAI) [58–60].
Related posts:
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
