Improving Quality in the Care of Patients with Inflammatory Bowel Diseases

Abstract

Efforts to improve healthcare quality were firmly established before the Institute of Medicine (IOM) historic 2000 and 2001 reports, To Err is Human Building a Safer Health System and Crossing the Quality Chasm: A New Health System for the 21st Century Despite the long-standing healthcare quality improvement (QI) efforts that date back to the turn of the 20^th century, the IOM reports significantly advanced the awareness of healthcare quality deficits and the resulting risk to patients from those gaps in care. Studies immediately following the IOM reports emphasized and verified the presence of detrimental care gaps and highlighted a myriad of contributing factors. Studies focused specifically on the inflammatory bowel diseases (IBD), Crohn's disease and ulcerative colitis , demonstrated suboptimal patient outcomes stemming from, in part, system and provider variation. In the years that have followed, research studies have shown the persistence of suboptimal outcomes in IBD despite an awareness of key drivers for poor care quality and concerted efforts in advancing QI initiatives. In 2017, IBD advocacy groups and provider networks have demonstrated progress in furthering both pediatric and adult IBD outcomes through the use of QI methods and tools including collaborative learning networks. A significant amount of work lies ahead, however, to build upon these advances and improve IBD outcomes further. This article reviews the history of quality initiatives in healthcare, identifies ongoing gaps in IBD care with a review of current IBD improvement efforts taking place, and identifies several targets for improving IBD care quality moving forward into the 21st century.

INTRODUCTION

The inflammatory bowel diseases (IBD) are chronic illnesses classically comprised of Crohn’s Disease (CD), ulcerative colitis (UC), and indeterminate colitis (IC). These diseases are characterized by a waxing and waning inflammatory course marked by signs and symptoms including diarrhea, weight loss, and debilitating abdominal pain with varying degrees of intestinal blood loss. The prevalence and incidence are increasing both in the United States (US) and worldwide.^1–4 In the US roughly 1.2 million individuals are affected by CD or UC.⁵ The estimated incidence rate in adults is 200 cases–240 cases per 100,000 persons and is rising.⁶

Uncontrolled disease is expensive to treat and leads to a significant reduction in quality of life, lost productivity in work or school, and escalation in care either in the acute setting of the emergency room or through prolonged hospitalization. In the early 2000s, the financial burden of IBD on the health care system was estimated at nearly $6.3 billion annually.⁷ Though treatment expenses are a large portion of IBD costs, inappropriate therapies, lack of adherence, and suboptimal care has led to estimates of the total IBD cost burden to reach between $14.6 billion and $31.6 billion in 2014.⁸

In addition to the direct impact of the IBD process, these diseases also carry with them modifiable yet persistent risks of serious infections,^9–11 invasive intestinal malignancies, ^{12, 13} extraintestinal malignancies,¹⁴ and thrombotic events.^15–17 IBD increases the immediate and lifelong risk of mortality when compared to matched controls¹⁸ emphasizing the importance of care targeting risk reduction whenever and wherever possible.

Despite recent improvements in healthcare quality, IBD patients continue to struggle with suboptimal disease control, preventable disease complications, and negative consequences of therapy including serious infections and cancer. Advancing the quality of IBD care is a critically important initiative. However, as the healthcare system evolves, so too should the approach to improvement efforts. To begin, understanding the current IBD quality landscape will better position care providers to maximize patient outcomes and remain engaged in producing high value, reliable health care for the future.

The aims of this article are to (1) discuss the history of quality initiatives in healthcare, (2) review the ongoing gaps in quality of care with a focus on IBD, (3) highlight the challenges for quality improvement work in IBD, (4) review the current IBD improvement efforts taking place and their impact on care and outcomes, and (5) discuss a future roadmap for IBD quality improvement.

QUALITY INITIATIVES IN HEALTHCARE: EARLY BEGINNINGS

In 2000, the Institute of Medicine (IOM) issued a report, To Err is Human: Building a Safer Health System, quantifying an alarming rate of medical errors contributing to an unacceptable number of hospital deaths. The focus of the report on patient safety shifted the spotlight away from individual providers contribution to medical errors and onto the “system of care.” In doing so, the IOM report challenged healthcare to design better processes of care that recognize and prevent medical errors.¹⁹ Accomplishing such a task would bring healthcare more in line with the IOM vision for quality healthcare defined as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge”.²⁰

In 2001 the IOM published a second report titled, Crossing the Quality Chasm: A New Health System for the 21^stCentury. This report famously identified that “between the health care we have and the care we could have lies not just a gap, but a chasm”, providing a sobering reminder to care providers and health system leaders that health care needed significant improvement. In that 2001 report, the IOM defined 6 key dimensions needed for a health care system designed to improve the quality of care it delivered. These dimensions include care that is Safe, Timely, Efficient, Equitable, Effective, and Patient-centered (STEEEP). These two historic reports were largely responsible for the “quality improvement” impetus that has advanced healthcare quality to where it is today.

However, attributing the current health care improvement’s sole impetus to the IOM To Err is Human and Crossing the Quality Chasm would be to overlook important improvement efforts that had long been in place before the IOM call to action. Over 100 years ago, health care improvement efforts were underway through the work of Boston surgeon Ernest Codman, MD, a strong proponent of hospital reform. His “end result system” is believed to have initiated outcome measurement in health care and, as a consequence, the study of quality measures in health care began.^{21, 22}

Around the same time on the other side of the world, Sakichi Toyoda was overseeing a textile company that would later give rise to the Toyota Motor Company. Taiichi Ohno and others helped take the company’s production process and codify it into what has come to be known as the Toyota Production System (TPS).^23–25 TPS is a model for manufacturing centered on achieving high value through efficient production methods and simultaneous reduction of waste. Many of the TPS methods (better known as Lean management) have been adapted by the health care industry in efforts to reach high levels of care quality while truncating ever-rising costs. One of the more popular concepts of the TPS approach to production is Kaizan or continuous improvement. Several healthcare organizations have adopted Kaizan and the TPS approach to pursue the IOM 6 domains of high-quality health care. Virginia Mason Medical Center is an example of cost saving in practice. Waste reduction efforts by the health system allowed for tremendous increases in care capacity while simultaneously saving millions of dollars of planned spending.²⁶

Lean methodology is not the only quality improvement framework that has evolved from decades of improvement efforts in production. During the 1950s, the work of W. Edwards Deming, Walter Shewhart, and Joseph Juran popularized the idea of production process measurement with a particular emphasis on reducing variation to provide greater efficiency and effectiveness in production. Each of these men was well respected for their individual contributions to process improvement, however, together they produced work that would later give rise to the modern day quality improvement platform, the Model for Improvement.²³ This model has proven to be extremely successful with a roster of achievements involving hundreds of health care organizations around the world.²⁷

In the late 1980s, Donald Berwick, a Boston pediatrician, (later the head of the Centers for Medicare and Medicaid Services (CMS) appointed by President Barack Obama) together with leaders from the Juran Institute created the National Demonstration Project on Quality Improvement in Health Care. The goal of this effort was to examine whether current quality improvement methods, successful in other business domains, could achieve similar success in the health care setting. In 1991, as a result of these efforts, the Institute for Healthcare Improvement (IHI) was created. Today, the IHI continues its mission of healthcare improvement with the Triple Aim, improving the experience of care, improving health of populations, and reducing per capita costs of health care.²⁸ These aims have been expanded to include a focus for the well-being of care providers in response to the escalating rate of physician burnout.^{29, 30} The evolution of healthcare improvement began over a century ago, and whereas the IOM papers reinvigorated efforts to provide higher quality healthcare in early 2000, disparities in care persist.

THE ONGOING GAP IN HEALTH CARE QUALITY

Despite the productive landscape in healthcare improvement over the past 2 decades, a gap persists between the goal of high-quality, reliable care and the everyday practice of today. Several studies immediately following the IOM’s reports solidified the presence of these disparities that have continued to the current day.

In 2003, McGlynn and colleagues demonstrated that just over half of adult patients in general medicine receive the recommended preventative care by their providers during health visits. A similar percentage was seen in the provision of recommended care for patients with chronic conditions including diabetes, asthma, and congestive heart failure among others.³¹ Subsequent evaluation of contributing factors failed to find meaningful contributions from race or socioeconomic status in explaining these deficiencies in the provision of recommended care.³² A study published 4 years later by Mangione-Smith and colleagues, randomly sampled pediatric patients from 12 metropolitan areas and demonstrated that children receive roughly 47% of the recommended care by their providers.³³ Variation in practice spans both outpatient and inpatient settings as demonstrated by Jha etal who showed significant deviation from recommended care delivered to hospitalized adult patients with acute myocardial infarction, congestive heart failure, or pneumonia using 10 widely accepted quality metrics.³⁴

Although the study of quality deficits in healthcare has been rigorous and efforts to close the gap persistent, recent studies continue to show a deficit in the provision of up-to-date care consistent with current professional knowledge. Recent examples of quality gaps in the care of IBD include a survey demonstrating that nearly 30% of gastroenterologists were unaware of guidelines recommending the use of thromboembolic prophylaxis in hospitalized IBD patients³⁵ ,and a survey of dermatologists and gastroenterologists demonstrated that only 46% of providers were aware of the association between nonmelanoma skin cancer and immunosuppressive agents 6-mercaptopurine and azathioprine.³⁶

Knowledge gaps are not the only deficits to persist in healthcare. Among the IOM 6 dimensions of care quality, timeliness of IBD care also demonstrates room for improvement. Dykes et al identified pediatric IBD patients who lacked timely follow-up after disease flare or medication change potentially exposing them to therapy complications and/or persistence of uncontrolled disease.³⁷ An inability to provide consistent and timely follow-up for patients with chronic illness serves as a direct threat to quality and optimal patient outcomes.

These studies demonstrate the present need for focused improvement initiatives targeted at the direct contributors to the suboptimal quality of health care. Persistence of practice variation, perpetuation of knowledge gaps, rising health care costs, provision of unnecessary care, underutilization of important preventative services, and preventable complications remain at the forefront of targets to improve the value of health care. A considerable amount of work lies ahead if we are to improve patient care when simultaneously constraining cost and improving value.²³

CHALLENGES FOR IMPROVING QUALITY IN IBD

Care Complexity

The provision of care for patients with chronic illnesses such as IBD is complex. Achieving excellence in this dynamic care scenario requires a strategic approach incorporating both patient and care team. The Chronic Care Model³⁸ is an approach to chronic disease management emphasizing collaboration between an engaged, knowledgeable patient and a prepared, proactive provider. The coordinated, multidisciplinary Chronic Care Model has proven successful in the approach to chronic disease management in both pediatric and adult populations^{39, 40}; however, this model has yet to be universally practiced by providers in all specialties at scale.⁴¹

Conflation of Quality Assurance with Quality Improvement

Quality assurance programs (QA) have steadily become a top priority in health care in recent years and play an instrumental role in the provision of high-quality and reliable care. QA programs pursue measurement and reporting of quality metrics often used by payers to incentivize the reporting of quality metrics, presumably as a way to demonstrate the quality of care provided.⁴² Although vital to ensuring the provision of high-quality care, QA differs from quality improvement (QI). In contrast to QA, QI initiatives are rooted in hypothesis-driven testing of novel ideas believed to advance the quality of a specific aspect of care. The improvement process involves generating a target aim, development and implementation of testing cycles with a defined sequence of steps, measurement protocols, and analysis of results.

Manifestation of this hypothesis-driven approach is the previously mentioned Model for Improvement. Refined through the work of Associates in Process Improvement, the Model for Improvement is comprised of several components beginning with 3 important questions to frame the improvement project: (1) What are we trying to accomplish?, (2) How will we know that a change is an improvement? ,and (3) What change can we make that will result in improvement? These questions are followed by the Plan-Do-Study-Act (PDSA) cycle(s), an iterative sequence of testing of process changes (“small tests of change”). The iterative PDSA cycles are designed to organize repeated efforts directed towards achievement of a well-defined improvement aim. Strategies that prove beneficial move on to subsequent steps of larger scale implementation, whereas changes not providing benefit are discarded.

Care providers and healthcare systems invest a great deal of time and energy into QA, however, doing so does not guarantee quality improvement. The pursuit of advancing quality in IBD should involve efforts in both QA and QI.

Variation

Variation in health care practice is a major driver for substandard IBD care and is often used as a surrogate marker to represent deficiencies in care delivery. Variation can signal underuse, overuse, or misuse of medical and/or surgical care.^{43, 44} Drivers for variation in IBD care may include the heterogeneity of IBD phenotypes, breadth of therapeutic strategies available, and/or the lack of practice guidelines that have been studied for their impact on patient outcomes. Practice variation has long persisted in the field of IBD medical care with little to no evidence to show an improving trend. In a 2007 study of treatment strategies in adult CD, health care providers from both community centers and specialty centers demonstrated high rates of variation in treatment strategies using 5-ASA, immunomodulators, and biologic therapies. Not only was this variation seen between provider groups but also within provider groups.⁴⁵ A similar study was conducted in the pediatric CD population that demonstrated high rates of variation in treatment strategies.⁴⁶ Variation in approaches to IBD management contributes to the heterogeneity in patient outcomes.

Overuse

Health care expenditures remain disproportionately high in the US compared to other Western countries, yet health outcomes are no better.⁴⁷ This imbalance has been attributed, in part, to health care service overuse.^{48, 49} Overuse represents excessive and unnecessary care that drives up health care cost without advancing levels of health.⁴⁹ In addition to the inefficiency overuse creates, it also places patients at higher risk for complications. This is particularly important in the care of patients with IBD. An area of overuse that has drawn recent attention is emergency department (ED) utilization. The ED is a high cost setting that is not designed for improving long-term outcomes. Between 1994 and 2005, the annual number of ED visits for IBD-related concerns rose from 28,000 to 76,000 visits.⁵⁰ In a multicenter pediatric study, close to 20% of ED visits by IBD patients were deemed unnecessary. In that study, drivers for ED visits included disease severity, time of day, and physician instruction.⁵¹ Although ED visits frequently involve important acute care needs, high utilization of the ED in nonacute scenarios of IBD signals an important area for improvement that has not yet been fully addressed.

Underuse

Although overuse is the predominant trend in health care, service underuse is equally detrimental to the provision of quality care. Health care underuse fails to provide services that keep patients healthy and subsequently eliminate the need for acute care or progression of disease activity often requiring escalation of therapy. IBD medication adherence and appropriate prescribing have long been a target for improving patient remission rates and reducing disease progression and complication. Underuse of prescribed therapy by patients continues to plague the field of IBD therapy. In a study conducted by Trindade et al, medication adherence by patients was overestimated by 67% of treating physicians potentially motivating unwarranted escalation of therapy and associated risks.⁵² In a recent study of elderly IBD patients, close to 97% of applicable patients eligible for steroid-sparing biologic therapy were not on anti-TNF alpha agents resulting in prolonged exposure to steroid-based immunosuppression.⁵³ Underuse of appropriate therapeutic agents contributes significantly to morbidity through disease progression and increase in potentially preventable disease complications.

Misuse

Within the spectrum of healthcare utilization, misuse is often considered a surrogate for medical errors, provision of the wrong care, or unwarranted exposure to risk (diagnostic or therapeutic). Management of patients with IBD requires interval assessments by objective measures. Endoscopy and colonoscopy have been the cornerstone of diagnostic evaluation in IBD. A study of lower endoscopy procedures in pediatrics found roughly 40% of procedures, driven by concerns for IBD, showed no pathologic abnormality. Among the results, authors concluded that a subset of normal colonoscopies could have been avoided.⁵⁴ It is important to note that normal studies often provide clinically relevant information and should not be discounted.⁵⁵ Endoscopic study of the intestinal track through its documentation of mucosal healing, or lack thereof, is an important source of information guiding therapeutic decision-making in IBD. However, invasive testing also represents significant risk exposure via sedation and procedural risk. Judicious use of such testing is important, because misuse of invasive interventions is a modifiable source of poor quality of care.

CURRENT INITIATIVES FOR IBD

Given the chronic nature of IBD and the high frequency of interactions with the health care system, patients with IBD stand to gain significant benefit from improved care quality. Several U.S. advocacy and provider groups have taken it upon themselves to advance IBD’s improvement efforts in hopes of making potential patient benefit a reality. These advocacy and provider groups include the ImproveCareNow collaborative network (ICN), the Crohn’s & Colitis Foundation, the American Gastroenterological Association (AGA), and the American College of Gastroenterology (ACG). These groups have made meaningful advances over the past several years with respect to defining, measuring, and enhancing the quality of care in IBD.

ICN

The (ICN) was established in 2007 as a consortium of 8 core centers, with the global objective of improving the care and health of all children and adolescents with CD and UC. The initial work of the collaborative focused on developing consensus guidelines for pediatric IBD diagnosis and management, creating an infrastructure for standardized data collection ,and tracking well-defined outcomes across centers. Over the past decade, ICN has grown into an international QI consortium comprised of 107 pediatric gastrointestinal (GI) centers, including 95 in United States, 2 in England, 1 in Qatar, and 9 in Belgium. Currently, 32,000 patients are registered in the network, and data from 215,000 visits have been collected and analyzed. As such, ICN is the largest and fastest growing pediatric IBD registry in the world.

Figure 1 shows the key driver diagram for ICN. As indicated, the primary measurable outcome is remission rate, which is defined by a physician global assessment of disease activity. The 7 key drivers for improving remission rates that have been identified by the consortium are: (1) optimal access to care; (2) a prepared and proactive practice team; (3) accurate diagnosis and disease classification; (4) appropriate drug selection and dosage; (5) optimal nutritional intake; (6) optimal psychosocial health; and (7) informed patients and families who can engage in self management.

FIGURE 1.

Key driver diagram for ICN.

Over the past decade, demonstrable improvements have been made for pediatric IBD patients within the ICN network. Remission rates have increased from 52% to 81%. Importantly, prednisone-free remission rates also have improved from 49% to 80%. Ninety-three percent of patients now have a satisfactory growth status, and 90% have a satisfactory nutritional status (up from 86% and 85%, respectively). Although the drivers of these improvements are clearly multifactorial (ie, new therapies, monitoring guidelines, etc.), the improvement model practiced by ICN is clearly enhancing the care of pediatric IBD patients within the network.

Crohn’s and Colitis Foundation

The Crohn’s & Colitis Foundation has developed a multicenter learning health system called “IBD Qorus”, which is comprised of 30 community-based and academic gastroenterology practices focused on IBD. This program is designed to facilitate interactions between patient/provider and providers with one another, to improve care. The specific aims of the project include defining the standards of care in IBD, developing an implementation program to deliver and measure the standards of care, conducting continuous evaluation and refinement of the process and measure, and improving the impact of standards of care on IBD patient outcomes.⁵⁶ IBD Qorus has developed initiatives that have focused on the standardization of care processes and a focus on patient outcomes. For example, a Qorus initiative to improve access to urgent care services has yielded several potential strategies shared by practices within the program to help identify and treat patients in need of urgent access to care. Qorus has also developed standardized Care Pathways for the identification, assessment, and management of anemia and malnutrition in IBD. The shared interests and team-based approaches of each individual site within the program facilitates rapid uptake, testing, and learning of each aspect of care improvement that has led to iterative changes in the pathways over time.

AGA

In 2011, the AGA released the adult IBD Physician Performance Measure Set that was the product of a multistakeholder work group with representation from the AGA, the American Society of Colon and Rectal Surgeons (ASCR), Crohn’s & Colitis Foundation, Physician Consortium for Performance Improvement (PCPI), and representatives from the family practice, research, patient, and payor communities.⁵⁷ The goal of this workgroup was to create a set of measures for accountability and performance measurement. This final AGA performance set included the measures listed in Table 1.

Table 1:

AGA IBD Clinical Performance Measures

Clinical Performance Measures
IBD: Type, anatomical location, and activity all assessed
IBD preventive care: Corticosteroid sparing therapy
IBD preventive care: Corticosteroid- related iatrogenic injury – bone loss assessment
IBD preventive care: Influenza immunization
IBD preventive care: Pneumococcal immunization
Testing for latent TB before initiating anti-TNF therapy
Assessment of hepatitis B virus before initiating anti-TNF therapy
Testing for Clostridium difficile – inpatient measure
Prophylaxis for venous thromboembolism – inpatient measure
IBD preventive care: Tobacco user – screening and cessation intervention

The AGA IBD measure set also included a measure for tobacco use screening and cessation, and 2 inpatient measures (Clostridium difficile infection and VTE prophylaxis) that were not included in the CMS IBD Measure group. This measure group was also used in a variety of accountability programs including Bridges to Excellence (BTE),⁵⁸ which is a program of the Health Care Incentives Improvement Institute that aimed to link demonstration of high-quality IBD care with incentives from health insurers.⁵⁹ Uptake of this program was minimal and was discontinued in 2015.

With the exception of removing the measure referencing documentation of IBD type and transitioning the influenza and pneumococcal measures from IBD-specific to broad based cross-cutting measures, the IBD measure group remained largely unchanged until the passage of the Medicare Access to Radiology Care Act legislation creating the Quality Payment Program (QPP). Only 2 of the original IBD measures are currently included for reporting in the QPP⁶⁰:

• - Preventive Care: Corticosteroid- Related Iatrogenic Injury – Bone Loss Assessment

• - Assessment of Hepatitis B Virus Status before Initiating Anti-TNF Therapy

Although CMS did not provide a rational for its rulemaking, the decision to limit these measures in the QPP was likely influenced by relatively high performance on all measures. These high levels of performance suggested that the measures may have been “topped out” and that opportunities for further improvement were limited. Additionally, the Core Quality Measures Collaborative that included private payers and CMS chose to include only these 2 IBD measures in its core gastroenterology set that preceded the finalization of the QPP.⁶¹

The challenge of relying on quality assurance measures, such as the original IBD measure set to improve quality, is that it narrowly focuses QI efforts around the specifications of these measures. This impact will be even more pronounced with the further narrowing of measures in the QPP. Furthermore, there is evidence to suggest that quality assurance measures do not improve quality, and in some cases, cause harm.^{62, 63} Similarly, the literature suggests that incentive programs such as pay for performance have limited to no impact on the quality of care.^{64, 65} These limitations offer an opportunity for the field to further embrace collaborative quality improvement initiatives such as those organized by the ICN and the Crohn’s & Colitis Foundation.

A second major effort of the AGA in advancing the quality of care in IBD has been the creation of several Clinical Care Pathways and Treatment Algorithms. Developed through a multistakeholder process, the Clinical Care Pathways incorporate expert consensus and meta-analytic methodology to produce current state-of-the-art algorithms rooted in the principles of evidence-based medicine. The pathways are further reinforced through the addition of clinical support tools and other quality products aimed at implementation of expert-derived care strategies for the practicing GI clinician. Current IBD topics include the Identification, Assessment, and Initial Medical Treatment in CD ,⁶⁶ the Identification, Assessment, and Initial Medical Treatment of UC,⁶⁷ Drug Therapy for CD,⁶⁸ Management of CD D after Surgical Resection,⁶⁹ and Therapeutic Drug Monitoring.⁷⁰ Clinical Care Pathways will be reviewed annually and assessed for ongoing relevance, specific major or minor revisions, and the overall need for update as other professional societies may have produced similar, more current guidelines negating the need for AGA updates.⁷¹ The prospective evaluation and validation of these pathways and clinical tools will play a critical role in ensuring relevance and ongoing impact on patient care.

ACG

A recent effort by the ACG to advance the quality of care delivered to patients with GI disease, and by extension IBD, is the Gastrointestinal Quality Improvement Consortium, LTD. (GIQuIC). This initiative is a collaborative effort along with the American Society for Gastrointestinal Endoscopy (ASGE) to develop a quality benchmarking registry aimed at providing “reliable and relevant” measures of endoscopic quality to empower physicians to improve patient care based on these metrics.⁷² The data collected for this registry is guided by a previous joint effort by the ACG and ASGE that identified procedural quality indicators focused on high-quality endoscopy ensuring that each patient receives the indicated procedure, yielding the correct diagnosis, and minimizing exposure to risk.⁷³ Implementation of this collaborative project integrates experience and know-how to improve procedural outcomes in GI disease workup and management, including IBD.

The ACG also has made contributions to clinical care pathways in IBD . Aimed at empowering collaboration between the gastroenterologist and primary care team, the ACG recently published guidelines regarding preventative care in IBD updating current management strategies for risks associated with the chronic diseases.⁷⁴

DRIVING IMPROVEMENT FORWARD: TARGETS FOR CONTINUING IMPROVEMENT

The work of groups like the ICN network, the Crohn’s & Colitis Foundation, the AGA, and the ACG advance the mission of improving care quality in IBD here in the USand abroad. Internationally, the United Kingdom (UK) has made significant advances in IBD care quality through the work of an IBD Standards group whose most recent 2013 update sought to “ensure that patients with IBD receive consistent, high quality care and that IBD services throughout the UK are knowledge-based, engaged in local and national networking, based on modern IT and meet specific minimum standards”.⁷⁵ The UK’s retooling of IBD clinical practice came in response to the variation in IBD care observed throughout the region and has brought success. Organizing bodies in the UK continue to review provider practice to ensure ongoing quality standards and performance measures are achieved.⁷⁶

Advancing IBD quality further will require sustaining current improvement efforts when focusing on the problems and challenges posed by an evolving disease process, evolving patient population, and evolving health care system.

Variation

Variation has proven to be a major driver of substandard care.^77–79 The ICN network in pediatric IBD has advanced the understanding of care standardization and the impact international collaboration can have on important pediatric health outcomes.⁸⁰ These outcomes are not limited to the field of pediatric IBD, as the increasing rates of disease remission in the face of reduced steroid exposure also can be transposed to adult IBD populations. Continued practice standardization can be achieved through high- quality comparative effectiveness research focused on high impact treatment decisions, dissemination of new evidence through rigorous development of practice guidelines, and careful measurement and analysis of resulting patient outcomes. Practice guidelines that have proven effective can then be shared among a network of providers and institutions, as demonstrated in the work of the ICN network. This approach to reducing practice variation through the spread of knowledge from learning networks will play an important role in IBD care moving forward.

Health Technology Platforms

Collaboration has been shown to influence and benefit the care of patients with IBD⁸⁰ and may be facilitated by health information technology and platforms that foster the sharing and spreading of relevant information. For example, the Crohn’s & Colitis QORUS project provides a platform to facilitate data gathering, display, and analysis in the care of IBD. The ICN network also has harnessed innovative information technology to measure and improve care in pediatric IBD. At participating practices, data collection is embedded in the process of clinical care delivery, and the transfer of clinical data to the registry is partially automated through electronic data transfer. Registry data are available in near real time to support performance measurement, population measurement, and previsit planning, allowing real-world comparative effectiveness research. Within ICN, an electronic “Exchange” and other technology and communication platforms have been developed to facilitate the sharing, scaling, and spreading of effective care practices.

System and Provider Alignment

Misalignment of care team and healthcare system often leads to a system of “work-arounds”.⁸¹ Work-arounds fuel practice variation that perpetuates suboptimal patient care.^81–83 Aligning care team and institutional visions for improvement will result in a care environment primed for innovation and collaboration. At the microsystems level, physicians, nurses, social workers, and other care team members work in concert using lessons from learning consortiums. These microsystems cannot scale to the macrosystem level without commitment and buy in from senior leadership. Together, a top-down and bottom-up approach efficiently drives improvement throughout the culture of a healthcare system producing supportive and motivating work environments. Such environments eliminate the need for provider work-arounds and play a role in reducing the escalating rate of provider burnout, another threat to the quality of care.^{84, 85}

Quality Metrics

In recent years, dozens of iterations on quality metrics have been produced.⁸⁶ Consensus regarding parsimonious yet thorough measurement sets remains difficult and may be the primary challenge for the implementation of quality metrics in IBD. Avendis Donabedian published an articulate and concise model for organizing quality measurement and improvement initiatives.⁸⁷ The model is comprised of 3 domains (Table 2): structural measures, process measures, and outcome measures. Studies have evaluated the strengths and weaknesses of each domain in developing innovative strategies to quality improvement in IBD.^88–90 Many of these studies highlight the difficulty in using outcome measures for IBD improvement initiatives citing challenges of time horizon, confounding, and limitations in the understanding of causal relationships between healthcare efforts and IBD outcomes.⁸⁸ These challenges have deterred improvement initiatives from including outcome measures, and as a result, there has been a failure to set meaningful care benchmarks in IBD.

Table 2:

Donabedian Model with Domain Descriptions from AHRQ^{93, 94} and Examples for the IBD Population

Domain	Description	IBD Examples
Structural	Structural measures are characteristics of the larger care setting including measures of the human and material resources available to the health care system and organizational factors	Electronic medical records, accreditation status, and nurse or medical assistant availability.
		Examination room number and turnover.
		Hospital volume, teaching status, staff deployment, and qualifications
Process	Process measures describe activities performed for, on behalf of, or by a patient. Process measures are often the first to benefit from evidence- based guidelines, however, are also often the first to suffer from provider practice variation. Process measures provide a better estimate and are more sensitive and responsive to change. These measures are easier to quantify and associate with outcomes.	Scheduling of surveillance colonoscopies, yearly influenza vaccination rates, and additional health maintenance items
		Controller medication (such as immune-modulators) refill rates.
Outcomes	Outcome measures describe what happens to patients as a result of the care received. Outcome measures are the best reflection of the impact care has on the patient; therefore, patients have a particularly vested interest in outcome measures as they closely reflect the individual’s health status.	Disease activity/remission, surgical interventions, steroid exposure rates, hospitalization rates, or admission lengths of stay.
		Patient Reported Outcomes (PROMs)

Most quality initiatives to date have focused primarily on process measures because they provide a feasible method for service accounting in the current pay-for-performance healthcare design.⁹¹ Process measures such as documentation of serologic titers, health maintenance efforts, and cancer surveillance all serve important roles within IBD care^{74, 92}; however, they do not advance the leading edge of patient outcomes further than where they are currently. Additional outcomes to strive for include metrics that capture expeditious return of quality of life, efficient induction and maintenance of disease remission, and/or longitudinal measures of mucosal healing.

As IBD care moves further into the 21^st century, patients and providers alike must be ambitious and nimble in defining meaningful outcomes for the changing future healthcare environment. To do so, we must begin by acknowledging several aspects of measurement sets. First, metrics encompass multiple aspects of care. No single metric can capture the breadth of IBD care nor can a single metric summarize each patient’s unique experience of reliable care and the impact such care has on the multiple facets of that patient’s life. Second, measurement sets need to be aligned to support one another across structure, process, and outcome without being too burdensome. Therefore, measurement sets should be parsimonious and scenario specific (new diagnosis vs established, inpatient vs outpatient, ED visit, etc.). Creating metrics that span the spectrum of care will identify gaps in systems-level provision of care and help unify a healthcare system that has become highly fragmented.

Lastly, outcome metrics should center on data-driven planning aimed at keeping healthy patients healthy, speeding recovery of patients amidst a disease flare, reducing ED visits, reduction of unwarranted invasive testing and/or radiation exposure, and emphasizing the unique aspects of health most important to individual patients. These are ambitious goals. However, small directed tests of change carried out on a consistent basis, in supportive healthcare settings, and shared over collaborative networks can lead to attainment of seemingly impossible goals.

CONCLUSION

The US healthcare quality improvement efforts had been in place long before the IOM papers, To Err is Human and Crossing the Quality Chasm. Although efforts were already well established, these landmark reports highlighted the persistent failing performance of the healthcare industry to provide safe, high-quality, and reliable care.

Despite the reinvigorated QI efforts seen at the turn of the 21^st century, healthcare quality continues to be lacking due in part to high care complexity; persistence of practice variation; and the overuse, underuse, and misuse of care.

IBD, like many chronic diseases, stands to benefit greatly from higher quality care due to the persistent need for disease maintenance, high frequency of interaction with the healthcare system, and the significant financial and patient cost when the therapeutic relationship between patient and healthcare system breaks down. Efforts such as those of the ICN network, Crohn’s & Colitis, AGA, and ACG will drive IBD care quality forward in the coming years. These efforts can be augmented exponentially through additional work in implementation of data-driven outcome measures tailored to patient and care scenario, reduction of practice variation, and facilitation and scale via health technology platforms. Microsystem functioning within the care team can only be scaled with buy in from senior leadership. Healthcare systems committed to production of high- quality and reliable care both from a bottom-up and top-down approach will prove to be most successful as the emphasis on quality of care continues to permeate throughout healthcare. Although these are difficult aims to achieve, improving outcomes will not only enhance the health of patients, but also the health of the US.healthcare system as well.

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Supported by: Dr. Egberg’s effort was supported in part by Harvard Pediatric Health Service Research Fellowship, grant number T32HS000063 from the Agency for Healthcare Research and Quality (AHRQ). The content is solely the responsibility of the authors and does not necessarily represent the official views of the AHRQ. 2. Dr. Gellad’s effort is funded by Veterans Affairs Health Services Research and Development Career Development Award (CDA 14–158). URL/Trial ID: None

Supported by: This article is the result of NIH funding (see above). No funding was received from the Wellcome Trust, Howard Hughes Medical Institute, or others.

Conflicts of Interest: There are no conflicts of interest to report for any of the listed authors.