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Quality Improvement Research in Pediatric Hospital Medicine and the Role of the Pediatric Research in Inpatient Settings (PRIS) Network Tamara D. Simon, MD, MSPH; Amy J. Starmer, MD, MPH; Patrick H. Conway, MD, MSc; Christopher P. Landrigan, MD, MPH; Samir S. Shah, MD, MSCE; Mark W. Shen, MD; Theodore C. Sectish, MD; Nancy D. Spector, MD; Joel S. Tieder, MD, MPH; Rajendu Srivastava, MD, FRCP(C), MPH; Leah E. Willis, MS; Karen M. Wilson, MD, MPH From the Department of Pediatrics, Division of Hospital Medicine, University of Washington School of Medicine, Seattle, Wash (Drs Simon and Tieder); Seattle Children’s Hospital, Seattle, Wash (Drs Simon and Tieder); Department of Pediatrics, Doernbecher Children’s Hospital (Dr Starmer), Oregon Health and Science University, Portland, Ore (Dr Starmer); Division of General Pediatrics, Department of Medicine, Boston Children’s Hospital, Boston, Mass (Drs Starmer, Landrigan, and Sectish); Centers for Medicare & Medicaid Services, Baltimore, Md (Dr Conway); Division of Sleep Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, Mass (Dr Landrigan); Harvard Medical School, Boston, Mass (Drs Landrigan and Sectish); Division of Hospital Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnato, Ohio (Drs Conway and Shah); Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio (Drs Conway and Shah); Division of Hospital Medicine, Dell Children’s Medical Center of Central Texas, Austin, Tex (Dr Shen); Department of Pediatrics, University of Texas Southwestern, Austin, Tex (Dr Shen); Section of General Pediatrics, St Christopher’s Hospital for Children, Philadelphia, Pa (Dr Spector); Department of Pediatrics, Drexel University College of Medicine, Philadelphia, Pa (Dr Spector); Primary Children’s Medical Center, Intermountain Health Care (Dr Srivastava and Ms Willis), Department of Pediatrics, University of Utah Health Sciences Center, Salt Lake City, Utah (Dr Srivastava and Ms Willis); Pediatric Hospital Medicine, Children’s Hospital Colorado, Aurora, Colo (Dr Wilson); and University of Colorado School of Medicine, Aurora, Colo (Dr Wilson) The views expressed in this report are those of the authors and do not necessarily represent those of the US Department of Health and Human Services, the Agency for Healthcare Research and Quality or the American Board of Pediatrics Foundation. The authors declare that they have no conflict of interest. Publication of this article was supported by the Agency for Healthcare Research and Quality and the American Board of Pediatrics Foundation. Address correspondence to Tamara D. Simon, MD, MSPH, M/S C-9S-9, 1900 Ninth Ave, Seattle, WA 98101 (e-mail: Tamara.Simon@ seattlechildrens.org). Received for publication November 1, 2012; accepted April 12, 2013.
ABSTRACT Pediatric hospitalists care for many hospitalized children in community and academic settings, and they must partner with administrators, other inpatient care providers, and researchers to assure the reliable delivery of high-quality, safe, evidence-based, and cost-effective care within the complex inpatient setting. Paralleling the growth of the field of pediatric hospital medicine is the realization that innovations are needed to address some of the most common clinical questions. Some of the unique challenges facing pediatric hospitalists include the lack of evidence for treating common conditions, children with chronic complex conditions, compressed time frame for admissions, and the variety of settings in which hospitalists practice. Most pediatric hospitalists are engaged in some kind of quality improvement (QI) work as hospitals provide many opportunities for QI activity and innovation. There are multiple national efforts in the pediatric hospital medicine community to improve quality, including the Children’s Hospital Association (CHA) collaboratives and the Value in Pediatrics Network (VIP). Pediatric hospitalists are also challenged by the differences between QI and QI research; understanding that while improving local care is important, to provide consistent
quality care to children we must study single-center and multicenter QI efforts by designing, developing, and evaluating interventions in a rigorous manner, and examine how systems variations impact implementation. The Pediatric Research in Inpatient Setting (PRIS) network is a leader in QI research and has several ongoing projects. The Prioritization project and Pediatric Health Information System Plus (PHISþ) have used administrative data to study variations in care, and the IIPE-PRIS Accelerating Safe Sign-outs (I-PASS) study highlights the potential for innovative QI research methods to improve care and clinical training. We address the importance, current state, accomplishments, and challenges of QI and QI research in pediatric hospital medicine; define the role of the PRIS Network in QI research; describe an exemplary QI research project, the I-PASS Study; address challenges for funding, training and mentorship, and publication; and identify future directions for QI research in pediatric hospital medicine.
WHY IS QUALITY IMPROVEMENT (QI) IMPORTANT TO INPATIENT PEDIATRIC CARE?
approximately 16% of all hospitalizations and 9% of total costs for all patients, representing a total yearly cost of about $34 billion.1 The most common pediatric discharge diagnoses are respiratory illnesses—pneumonia, asthma, and acute bronchitis—followed by mood disorders.1 Pediatric
KEYWORDS: hospital medicine; hospitalists; implementation; pediatric; quality improvement; research networks
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PEDIATRIC HOSPITALIZATIONS—DEFINED AS inpatient stays for children 17 years of age or younger—comprise ACADEMIC PEDIATRICS Copyright ª 2013 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.
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inpatients are cared for in a variety of settings including freestanding children’s hospitals, community hospitals with or without dedicated pediatric beds, and children’s hospitals within a larger adult hospital. Although some pediatricians have practiced inpatient care for many years, the field of pediatric hospital medicine has emerged in the last 15 years2 and is now the fastest growing pediatric subspecialty.3 Pediatric hospitals have many functions. In addition to providing inpatient medical care to children, they serve as educational institutions, research laboratories, health care safety nets, and sources of employment. These missions sometimes compete, and as the Institutes of Medicine report, To Err Is Human, suggests, at times we do not meet our obligation to provide the best-quality care to patients.4 Pediatric hospital medicine physicians partner with administrators, other inpatient care providers, and researchers to assure the reliable delivery of safe, evidence-based, and cost-effective care. QI programs are our primary means to facilitate change.
ities with patients waiting for beds. On the other hand, in some cases, a shorter length of stay may represent an appropriate reluctance to offer unnecessary interventions. Pediatric hospitalists must understand the difference. Finally, the wide variety of settings in which pediatric hospitalists practice provides diversity but also complexity. Teaching services in academic hospitals present challenges to communication and balancing the needs of the learners with the needs of the patients. Community sites have fewer resources available for consultation and overnight coverage, and many staff members may not have extensive experience with pediatric care. The complex environment of the hospital is filled with an array of patients, families, physicians, other care providers, payers, and organizational factors. Such contextual factors cannot be dismissed as confounders or noise and simply ignored. Rather, they should be captured and considered as we seek to improve delivery of care in the pediatric inpatient setting. Pediatric hospitalists must deliver high-quality care for hospitalized children regardless of the setting. QI is the primary method with which pediatric hospitalists can understand systems and processes, and therefore effect change.
WHAT IS THE ROLE OF PEDIATRIC HOSPITALISTS IN QI? Pediatric hospitalists are a consistent presence on pediatric floors, and they often engage in QI activities as a part of their clinical responsibilities. Many pediatric hospitalists play important roles in their institutions’ QI efforts, including authoring clinical practice guidelines, serving on committees, and taking on leadership positions in departments of quality and safety. Pediatric hospitalists face unique challenges as they work to improve the quality of care. Even for some common and straightforward pediatric inpatient diagnoses, we lack the evidence to know what quality care actually represents. For instance, the understanding of the management of bronchiolitis, despite being one of the most common reasons for hospitalization, has advanced little over the last 3 decades.5 However, even an intervention proven by traditional research methods, such as the randomized clinical trial, may not be successful in real-world practice. Innovation development and adoption are interdependent and must be addressed simultaneously rather than in tandem; QI methodology can give us the tools necessary to translate interventions into effective programs at a broad range of centers. We also need more rapid adoption of existing knowledge. In many cases, adherence to higher-quality, evidence-based care is the exception rather than the rule.6–10 Pediatric hospitalists see a wide range of diseases affecting multiple organ systems, and they are often responsible for coordinating the opinions of multiple subspecialists. This can make providing quality care especially difficult when the diagnosis is unclear or when the subspecialists disagree. Many of our patients have complex chronic conditions, and we must balance the benefits and harms of interventions that may affect already damaged organ systems. Children have an average length of stay of 3.8 days.1 This creates a compressed time frame that may create a tension between providing children with high-quality care and facilitating discharges in busy facil-
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CURRENT STATE OF QI IN PEDIATRIC HOSPITAL MEDICINE Hospitals have many opportunities for QI activity and innovation. As embedded hospital workers, hospitalists have a unique understanding of the hospital setting. Many pediatric hospitalists are engaged in QI activities either informally or on guideline committees, and some have developed skills to lead QI initiatives through official roles as quality and safety officers. The American Board of Pediatrics (ABP) Maintenance of Certification (MOC) Part 4 requirement provides yet another avenue for increasing participation in hospital-based QI. Mandated reporting of quality and safety measures will further drive the dissemination of recommended practices.6,11 Although large-scale QI collaboratives such as those within the Children’s Hospital Association (CHA) have increasingly been used to disseminate recommended practices among a wide range of specialties,12–14 pediatric hospitalists have begun their own independent efforts. A grassroots effort has arisen within the pediatric hospital medicine community to bring QI collaboratives to nonfreestanding pediatric units and hospitals, where the majority of children are hospitalized.15 Founded in 2008, the Value in Inpatient Pediatrics (VIP) Network has become an inclusive improvement organization for pediatric hospitalists seeking to learn, share, and change across the continuum, from small community hospitals to tertiarycare academic centers. VIP initially targeted the slow pace of implementation of evidence-based care for bronchiolitis with a primary benchmarking initiative and recently published demonstrations of decreased bronchodilator utilization across the network.16 Additional initiatives have also demonstrated improvement with reductions in patient identification band errors and improved timeliness of discharge communication across participating sites.17,18 These
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efforts have been unique in that they occurred without any significant source of funding, yet each initiative involved several thousand children. For example, the collaborative audited 11,377 patients for identification band errors between September 2009 and September 2010, and decreased the error rate from 17% to 4.1% (a 77% relative reduction).17 In 2011, VIP joined the American Academy of Pediatrics (AAP) and is now part of the Quality Improvement Innovation Networks (QuIIN), which has facilitated continued development of projects and which has MOC credit available to participants.
IS IT QI? OR QI RESEARCH? As pediatric hospitalists work to change and improve local practices and systems to provide better care for our inpatients, and as they join collaboratives such as the VIP Network to disseminate successful QI initiatives from single to many institutions, we (and others) are struggling with defining the differences between quality improvement and quality improvement research. The Hastings Center defines quality improvement as “systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of healthcare.”19 This definition clearly conveys that QI is not a study design or analytic approach but rather the desired goal or end point. QI methods focus on standardizing the delivery of care, learning throughout the implementation process, and testing theories about processes and systems.20 These are often done for the benefit of one institution, and they may easily be adapted to the specific microsystem cultures in which they are implemented. However, QI initiatives can produce generalizable knowledge about systems of care and how best to change those systems when they are designed, developed, and evaluated with this as the end goal20; this represents quality improvement research. QI research applies a broad range of experimental and quasi-experimental methods, several of which are described in this special issue, in evaluating the effectiveness of a QI intervention. Such studies can provide insight into the institutional factors that may influence the adoption and maintenance of care delivery processes.20 QI research studies do not attempt to eliminate variability; rather, they seek to understand it. QI research often requires alternative study designs that do not fit into the traditional randomized controlled trial model; these are covered elsewhere in this supplement in more detail. Attention to methodological rigor in QI will allow pediatric hospitalists to conduct QI that leads to meaningful and sustained changes to the system of health care. Although the challenges to conduct of QI research are numerous, there have been some early accomplishments in the field of pediatric hospital medicine. One major accomplishment has been in the coordination and conduct of collaborative research efforts across multiple hospitals by the Pediatric Research in Inpatient Settings (PRIS) network. ROLE OF THE PRIS NETWORK IN QI RESEARCH The mission of PRIS is to improve the health of and health care delivery to hospitalized children and their fami-
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lies by providing valuable insight for the selection and design of research projects that both answer important questions and close the quality gap through rapid implementation and dissemination. Started in 2001 as an open hospitalist research network, PRIS received joint support from the Academic Pediatric Association (APA), the AAP, and the Society of Hospital Medicine (SHM). Early successes included a period of rapid membership growth and studies identifying opportunities to improve the quality of inpatient care. In response to the growth of hospital medicine, PRIS underwent a redesign in 2009. PRIS asked leaders in QI and implementation science— engaging such institutions as the Institute for Healthcare Improvement, National Initiative for Children’s Healthcare and Quality, and the Institute for Healthcare Delivery Research at Intermountain Healthcare—to join the PRIS advisory board.21 PRIS’s agenda now includes the conduct of QI research. Although member hospitals already invest institutional resources to tackle locally prioritized conditions, the PRIS Network is working with and across hospitals to understand how to improve health care delivery and advance QI research. PRIS has created a network of hospitalists with engagement of multiple stakeholders in a refocused organizational structure, including implementation experts to advise on QI research projects, with experience developing and conducting large-scale implementation research studies.22 In several proposed grants, PRIS will continue to address gaps in inpatient settings in the dissemination and implementation of recommended care for the most prevalent and costly diseases affecting hospitalized children by studying strategies to test the most common dissemination and implementation training strategies in diverse inpatient settings. PRIS hopes to establish capacity within more of the network hospitals to continually improve best practices in the real-world setting; by partnering with established front-line networks such as VIP QuIIN, we can improve the delivery of quality care to children across all health care settings. Today, however, PRIS is completing 3 large multicenter studies, all of which were applied for and funded during the redesign period and have implications for QI research in pediatric hospital medicine. The first PRIS study, the Prioritization Project, is funded by the CHA. Although it is not QI research per se, it has been used to inform QI in the CHA member institutions. The first stage of the Prioritization Project identified the inpatient medical and surgical pediatric conditions with high prevalence, high cost, and/or substantial variation in resource utilization.23 This work provided 43 CHA hospitals with scientifically rigorous data to prioritize their QI resources, and it engaged the clinical leadership to improve care within their hospital. In its second stage, PRIS is identifying the sources of variation in resource utilization across hospitals and developing condition-specific quality measures for 4 inpatient pediatric conditions (diabetic ketoacidosis, tonsillectomy, appendicitis, and pneumonia). The results will be used by CHA hospitals to identify opportunities to reduce unnecessary variation in care and implement best practices.
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The second PRIS study, Pediatric Health Information System Plus (PHISþ), is funded by the Agency for Healthcare Research and Quality (AHRQ).24 The PHISþ project links the clinical data (including laboratory, microbiology, and radiology data) from 6 children’s hospitals that already submit administrative data to CHA’s PHIS database. The primary purpose of PHISþ is to conduct pediatric comparative effectiveness research studies using clinical data. However, the potential for QI research is equally relevant, as interventions that rely on aspects of a patient’s course will be able to incorporate relevant data. The third PRIS study, IIPE-PRIS Accelerating Safe Signouts (I-PASS), is primarily funded through the US Department of Health and Human Services and the National Institutes of Health (NIH).25,26 The extraordinary efforts by the I-PASS study and implementation teams has helped the PRIS Network understand the effort required to systematically disseminate and implement a rigorous complex intervention in varied settings and still ensure fidelity to a rigorous study design targeting patient outcomes.
The 11 institutions were selected to participate on the basis of a known balance of complementary talent and skill sets of coinvestigators, including expertise in health services research, QI methodologies, faculty development, medical simulation, curriculum development, and data management and analysis. Both junior and senior faculty were invited to participate as coinvestigators at each site, recognizing the important role that engaging faculty at all levels of training would be in order for the intervention to have maximal uptake and impact. PRIS provided a structure and set of processes to help the I-PASS study investigators; in addition, the I-PASS study group partnered with the Initiative for Innovation in Pediatric Education (IIPE). Achieving IIPE project status required high-level institutional educational support, including letters of support from each hospital chief executive officer, department chair, designated institutional official, and residency program director. The coupling of a study team of investigators, educators, and clinicians with the institutional leadership ensured that all participating sites were thoroughly invested in the project months before project funding was secured. The I-PASS Coordinating Council meets regularly and developed a comprehensive manual of operations that includes standard operating procedures that ensure all study coinvestigators are awarded appropriate academic credit for their contributions. The Scientific Oversight Committee developed the numerous outcome measures. The Educational Executive Committee of the I-PASS Study Group used a rigorous approach to develop the educational curriculum and associated campaign materials. At each participating site, the I-PASS study design consisted of a 6-month baseline data collection period, followed by a 6-month wash-in period to implement the I-PASS handoff bundle intervention, followed by an additional 6 months of postintervention data collection. Data collection times were staggered across sites over the 3-year grant period, both to allow later sites the opportunity to benefit from the experience of earlier sites and to allow study leaders and staff the opportunity to focus their attention on a more manageable number of sites at any one time. A pre–post design at each site (with pre and post periods matched by time of year at each site to prevent confounding by time of year or resident experience effects) was intentionally chosen over the possibility of randomizing sites to intervention or control groups because of a lack of equipoise. Dissemination efforts have been accomplished by multiple presentations at national meetings utilizing both junior and senior faculty facilitators. Additionally, the IPASS Study Group launched a project Web site (http:// www.ipasshandoffstudy.com) where all curricular materials can be downloaded, free of charge, by any institution or individual interested in improving communication between health care providers using the I-PASS methods. By bundling evidence-based handoff interventions together and disseminating them through a multicenter research and education network, the I-PASS Study Group will continue to accelerate their adoption by institutions and translate the I-PASS handoff into common practice.
I-PASS: AN EXAMPLE OF ONGOING QI RESEARCH IN PEDIATRIC HOSPITAL MEDICINE I-PASS is an ongoing collaboration involving eleven academic institutions that aims to determine the effectiveness of a group of interventions, the I-PASS Handoff Bundle, in standardizing and improving handoffs of care between residents. The specific aims and outcome measures being tested in the I-PASS Study are: 1) to test the hypotheses that rates of serious medical errors, as well as verbal and written miscommunications, time spent by residents gathering and signing out data, and resident dissatisfaction with sign out, will decrease after implementation of the I-PASS Handoff Bundle; and 2) to determine the manner in which the I-PASS Handoff Bundle’s adoption and effects on primary and secondary outcomes are modified by hospital-level factors, including institutional safety culture and information technology support, and patient-level factors, especially the presence of a chronic disease or disability. The rationale for the I-PASS study is based on the premise that communication and handoff failures are the leading root cause of sentinel events.27 Prior research on handoff tools and processes identified team training, verbal mnemonics, and the use of written or computerized tools as strategies to improve handoffs and reduce medical errors.28,29 In a pilot study that preceded the ongoing multisite I-PASS study, an intervention combining all 3 of these interventions together as a handoff bundle was associated with a 40% reduction in overall medical error rates and significant decreases in both verbal and written miscommunication rates.30 The I-PASS study refined the bundle and is now testing it rigorously at additional institutions to demonstrate its effectiveness in other settings. Operationalizing the I-PASS study required input and partnership from numerous stakeholder groups and a complex organizational structure that delegated leadership, oversight, and tasks to key coinvestigators (Figure).
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Figure. Current organizational structure of I-PASS study group.
CHALLENGES TO PEDIATRIC HOSPITAL MEDICINE QI: FUNDING, TRAINING AND MENTORSHIP, AND PUBLICATIONS FUNDING The successful applications for funding for Prioritization, PHISþ, and I-PASS highlight a recent increase in funding for QI and QI research, but the question remains whether the United States is investing sufficiently to drive transformation as quickly as needed to achieve better health and better care at lower costs.31 Specifically, the federal government, primarily via the AHRQ and the NIH, is funding hundreds of millions of dollars’ worth of QI and implementation research annually. The Centers for Medicare and Medicaid Services (CMS) via the Innovation Center, Quality Improvement Organizations, Children’s Health Insurance Program, and other quality programs is now funding hundreds of millions of dollars annually to improve quality and transform the system to deliver better value. The Patient Centered Outcomes Research Institute (PCORI) is funding comparative effectiveness research; in addition, it is also significantly supporting dissemination and implementation research with at least 20% of their funding, likely to exceed $100 million. In recognition that funding comparative effectiveness research is necessary but not sufficient to drive system
improvement and uptake of evidence-based treatments, funding from PCORI and others focuses both on producing evidence and testing how best to implement evidence into practice and improve quality and outcomes. Despite these investments, challenges remain. Many of the programs above focus resources on Medicare patient populations, and uncertainty over the fiscal health of the United States may limit the funding available to AHRQ and the NIH. Thus we will continue to depend on nonfederal sources as well. Fortunately, nonfederal sources of QI and implementation research funding are growing. Foundations such as the Robert Wood Johnson Foundation have funded major efforts, including Aligning Forces for Quality. Increasingly, as payment is based on quality and value, providers such as hospitals will need to further invest in improving quality and value. Associations such as the CHA have played a role in investing in QI research, and this role will likely need to increase to meet the needs of their constituent hospitals to demonstrate their ability to meet quality and cost targets. Nonprofit provider institutions have a responsibility to the communities they serve to invest in better health for the population in their community. Collaboration, including public–private partnerships, is essential to test improvement methods, learn in rapid cycle, and spread successful interventions. The
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Prioritization Project collaboration between the PRIS network and CHA is a successful example of working together to understand underlying issues in variation in quality and cost performance and then to begin to test methods to improve quality and lower costs.
Attention to methodological rigor in QI will allow the hospitalists to conduct QI that leads to meaningful and sustained changes to the system of health care. However, the SQUIRE guidelines do not address the publication of QI research; specific guidance could help pediatric hospitalists improve their projects, as well as the resulting publications.
TRAINING AND MENTORING Currently only 25% of pediatric hospitalists have an advanced degree (master’s or PhD), and only 15% have completed a fellowship.32 Although there are well over 1000 pediatric hospitalists and 82% of these are at academic institutions,32 there were only 22 pediatric hospital medicine fellowships in 2013, and the majority train only a single fellow per year. In order to develop the scholarship skills of fellows in research and QI methodology, our field needs to continue both to support the development of new fellowship programs with scholarly content and to foster additional training opportunities in QI and QI research methodology. The Pediatric Hospital Medicine Annual Meeting, sponsored jointly by the APA, AAP, and SHM, has taken on a significant responsibility for disseminating this content. In addition to a precourse on leadership by the APA, the meeting has also developed core workshop curricula in both QI and research and has encouraged additional content submissions from hospitalists with this expertise. The APA QI Special Interest Group has also seen this challenge and sponsors an annual precourse to the Pediatric Academic Societies meeting in QI research. Although these opportunities are all excellent, they do not meet the needs of all interested pediatric hospitalists. Because many pediatric hospitalists are relatively junior, it can be difficult to find appropriate mentorship for young hospitalists, especially those with an interest in making a career of QI and QI research. Particularly for those who are doing QI and QI research, the standard promotions paradigms may not adequately reward their scholarly and academic work, and we need to continue to advocate for alternative promotions criteria to reflect this.33 PUBLICATIONS Publication of QI and QI research has also been a challenge for pediatric hospitalists, both because many hospitalists who are writing projects for publication do not have formal training in manuscript preparation, and because traditional manuscript publication guidelines have not provided sufficient guidance on the design, types of interventions, data collection, and analysis for QI or QI research. The Standards for Quality Improvement Reporting Excellence (SQUIRE) Guidelines for Quality Improvement Reporting were developed to provide a framework for reporting of QI projects. The SQUIRE statement consists of a checklist of 19 items (http://www.squire-statement. org) that authors need to consider when writing articles that describe formal studies of QI. Many checklist items are common to all scientific reporting, but they have been modified to reflect the unique nature of QI work.
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THE FUTURE OF QI RESEARCH IN PEDIATRIC HOSPITAL MEDICINE As the field of pediatric hospital medicine begins to mature, with the implementation of several large funded studies, the work of PRIS and VIP, and the continued growth of pediatric hospital medicine fellowships, we are looking toward the future. Our priority conditions for study now are broad because evidence is lacking in many areas, but such priorities include the Prioritization project conditions (diabetic ketoacidosis, tonsillectomy, appendicitis, and pneumonia) and bronchiolitis as the current major focus of VIP. Aside from specific conditions, studying the optimal delivery of interventions such as intravenous fluid use and pain management should be another priority. Pediatric hospitalist QI research will need to focus both on generic processes of care that span many organ systems and the more traditional disease-specific approach to investigation. Pediatric hospitals are complex systems, and successful conduct of implementation research will require organization on the part of hospitalists and the organizations we represent. To keep pace with changes to payment incentives, hospitals will need to further invest in improving quality and value. To keep up with demand for QI activities, both academic medical centers and community hospitals will need to create infrastructure to support faculty and staff interested in QI and implementation science. The improvement-focused line of scientific inquiry and service should be rewarded and nurtured through training, mentorship, and promotions. Pediatric hospitalists and the systems in which they work need to continue to invest in testing new methods to rapidly learn and improve in order to remain at the forefront of this wave of change for hospitalized children.
ACKNOWLEDGMENTS The authors would like to acknowledge the PRIS Network, a collaborative hospitalist research network sponsored by the Children’s Hospital Association (CHA), Academic Pediatric Association (APA), American Academy of Pediatrics (AAP), and the Society of Hospital Medicine (SHM). Details are available online (http://www.prisnetwork.org). The Prioritization Project is funded by a grant from the CHA and from the Health Research Formula Grant 4100050891 from the Pennsylvania Department of Public Health Commonwealth Universal Research Enhancement Program. PHISþ is funded by grant 1R01HSO986201 from the Agency for the Health Care Research and Quality (AHRQ). The I-PASS Study is primarily funded through a grant from the US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, grant 1R18AE000023-01. Additional funding for I-PASS has been provided by the Medical Research Foundation of Oregon, AHRQ (1K12HS019456-01), the Physicians’ Services Incorporated Foundation in Canada, and Pfizer’s Medical Education Grant Program. IIPE is the Initiative for Innovation in Pediatric Education and is the entity that recognizes innovative educational proposals for pediatric
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residency training programs. More can be found at their Web site (http:// www.innovatepedsgme.org). Financial Disclosures: The Pediatric Research in Inpatient Setting Network Executive Council members (CPL, SSS, TDS, RS, JST, KMW) and staff (LEW) are supported in part for their work on behalf of PRIS by a grant from the CHA. TDS is supported by Award K23NS062900 from the National Institute of Neurological Disorders And Stroke and Seattle Children’s Center for Clinical and Translational Research and CTSA Grant Number ULI RR025014 from the National Center for Research Resources (NCRR), a component of the NIH. AJS is supported in part by an institutional K12 award from Oregon Health and Science University and the, grant 1K12HS019456-01. None of the sponsors participated in design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript. Its contents represent the views of the authors and are solely the responsibility of the authors; they do not necessarily represent the opinion, policies, or official view of their respective institutions or the NCRR or NIH.
REFERENCES 1. Yu H, Wier LM, Elixhauser A. Hospital Stays for Children, 2009. Rockville, Md: Healthcare Cost and Utilization Project; 2011. Statistical Brief 118. Available at: http://www.hcup-us.ahrq.gov/reports/ statbriefs/sb118.jsp. Accessed April 29, 2013. 2. Landrigan CP, Conway PH, Edwards S, Srivastava R. Pediatric hospitalists: a systematic review of the literature. Pediatrics. 2006;117: 1736–1744. 3. Frintner MP, Cull WL. Graduating Pediatric Residents With a Hospitalist Position, 2006–2010. Elk Grove Village, Ill: American Academy of Pediatrics; 2011. 4. Kohn LT, Corrigan J, Donaldson MS. To Err Is Human: Building a Safer Healthcare System. Washington, DC: Institute of Medicine Committee on Quality of Health Care in America; 1999. 5. Nabika S, Oki S, Sumida M, et al. Analysis of risk factors for infection in coplacement of percutaneous endoscopic gastrostomy and ventriculoperitoneal shunt. Neurol Med Chir (Tokyo). 2006;46:226–229. 6. Morse RB, Hall M, Fieldston ES, et al. Hospital-level compliance with asthma care quality measures at children’s hospitals and subsequent asthma-related outcomes. JAMA. 2011;306:1454–1460. 7. Paul R, Neuman MI, Monuteaux MC, Melendez E. Adherence to PALS sepsis guidelines and hospital length of stay. Pediatrics. 2012;130:e273–e280. 8. Tieder JS, Robertson A, Garrison MM. Pediatric hospital adherence to the standard of care for acute gastroenteritis. Pediatrics. 2009; 124:e1081–e1087. 9. Landrigan CP, Conway PH, Stucky ER, et al. Variation in pediatric hospitalists’ use of proven and unproven therapies: a study from the Pediatric Research in Inpatient Settings (PRIS) network. J Hosp Med. 2008;3:292–298. 10. Wang EE, Law BJ, Boucher FD, et al. Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) study of admission and management variation in patients hospitalized with respiratory syncytial viral lower respiratory tract infection. J Pediatr. 1996;129:390–395. 11. Fassl BA, Nkoy FL, Stone BL, et al. The Joint Commission Children’s Asthma Care quality measures and asthma readmissions. Pediatrics. 2012;130:482–491. 12. Hayes LW, Dobyns EL, DiGiovine B, et al. A multicenter collaborative approach to reducing pediatric codes outside the ICU. Pediatrics. 2012;129:e785–e791. 13. Kotagal UR, Robbins JM, Kini NM, et al. Impact of a bronchiolitis guideline: a multisite demonstration project. Chest. 2002;121: 1789–1797.
ACADEMIC PEDIATRICS 14. Sharek PJ, McClead RE Jr, Taketomo C, et al. An intervention to decrease narcotic-related adverse drug events in children’s hospitals. Pediatrics. 2008;122:e861–e866. 15. HCUPNet. Agency for Healthcare Research and Quality. Kids’ inpatient database, 2009 Available at: http://hcupnet.ahrq.gov/. Accessed January 29, 2013. 16. Ralston S, Garber M, Narang S, et al. Decreasing unnecessary utilization in acute bronchiolitis care: results from the value in inpatient pediatrics network. J Hosp Med. 2013;8:25–30. 17. Phillips SC, Saysana M, Worley S, Hain PD. Reduction in pediatric identification band errors: a quality collaborative. Pediatrics. 2012; 129:e1587–e1593. 18. Shen M, Shelburne J, Cooperberg D, et al. Pediatric Hospitalists Collaborate to Improve Discharge Communication. Kansas City, Mo; American Academy of Pediatrics; 2011. Available at: http:// www.aap.org/en-us/professional-resources/practice-support/qualityimprovement/Quality-Improvement-Innovation-Networks/Documents/ Discharge_COMMposter2012.pdf. Accessed April 29, 2013. 19. Baily MA, Bottrell M, Lynn J, et al. The ethics of using QI methods to improve health care quality and safety. Hastings Cent Rep. 2006;36: S1–S40. 20. Margolis P, Provost LP, Schoettker PJ, Britto MT. Quality improvement, clinical research, and quality improvement research—opportunities for integration. Pediatr Clin North Am. 2009;56:831–841. 21. Rauch DA, Lye PS, Carlson D, et al. Pediatric hospital medicine: a strategic planning roundtable to chart the future. J Hosp Med. 2012;7:329–334. 22. Srivastava R, Landrigan CP. Development of the Pediatric Research in Inpatient Settings (PRIS) network: lessons learned. J Hosp Med. 2012;7:661–664. 23. Keren R, Luan X, Localio R, et al. Prioritization of comparative effectiveness research topics in hospital pediatrics. Arch Pediatr Adolesc Med. 2012;166:1155–1164. 24. Narus SP, Srivastava R, Gouripeddi R, et al. Federating clinical data from six pediatric hospitals: process and initial results from the PHISþ Consortium. AMIA Annu Symp Proc. 2011;2011:994–1003. 25. Sectish TC, Starmer AJ, Landrigan CP, Spector ND. Establishing a multisite education and research project requires leadership, expertise, collaboration, and an important aim. Pediatrics. 2010;126: 619–622. 26. Starmer AJ, Spector ND, Srivastava R, et al. I-pass, a mnemonic to standardize verbal handoffs. Pediatrics. 2012;129:201–204. 27. Commission TJ. Improving hand-off communications: meeting national patient safety goal 2E. Joint Commission Perspect Patient Saf. 2006;6:9–15. 28. Riesenberg LA, Leitzsch J, Massucci JL, et al. Residents’ and attending physicians’ handoffs: a systematic review of the literature. Acad Med. 2009;84:1775–1787. 29. Agency for Healthcare Research and Quality. TeamSTEPPS: Strategies and Tools to Enhance Performance and Patient Safety: Guide to Action. Rockville, Md: Agency for Healthcare Research and Quality. Available at: http://www.ahrq.gov/professionals/education/ curriculum-tools/teamstepps/instructor/essentials/pocketguide.pdf; 2008. Accessed October 29, 2012. 30. Starmer AJ, Sectish T, Simon D, Landrigan CP. Impact of a resident handoff bundle on resident workflow patterns and verbal handoff practices. Presented at: Pediatric Academic Societies annual meeting, Denver, Colo, 2011. 31. Dougherty D, Conway PH. The “3T’s” road map to transform US health care: the “how” of high-quality care. JAMA. 2008;299: 2319–2321. 32. Bekmezian A, Teufel RJ II, Wilson KM. Research needs of pediatric hospitalists. Hosp Pediatr. 2011;1:38–45. 33. Ackerly DC, Parekh A, Stein D. Perspective: a framework for career paths in health systems improvement. Acad Med. 2013;88:56–60.
Quality Improvement Research in Pediatric Hospital Medicine and the Role of the Pediatric Research in Inpatient Settings (PRIS) Network Tamara D. Simon, MD, MSPH; Amy J. Starmer, MD, MPH; Patrick H. Conway, MD, MSc; Christopher P. Landrigan, MD, MPH; Samir S. Shah, MD, MSCE; Mark W. Shen, MD; Theodore C. Sectish, MD; Nancy D. Spector, MD; Joel S. Tieder, MD, MPH; Rajendu Srivastava, MD, FRCP(C), MPH; Leah E. Willis, MS; Karen M. Wilson, MD, MPH From the Department of Pediatrics, Division of Hospital Medicine, University of Washington School of Medicine, Seattle, Wash (Drs Simon and Tieder); Seattle Children’s Hospital, Seattle, Wash (Drs Simon and Tieder); Department of Pediatrics, Doernbecher Children’s Hospital (Dr Starmer), Oregon Health and Science University, Portland, Ore (Dr Starmer); Division of General Pediatrics, Department of Medicine, Boston Children’s Hospital, Boston, Mass (Drs Starmer, Landrigan, and Sectish); Centers for Medicare & Medicaid Services, Baltimore, Md (Dr Conway); Division of Sleep Medicine, Department of Medicine, Brigham and Women’s Hospital, Boston, Mass (Dr Landrigan); Harvard Medical School, Boston, Mass (Drs Landrigan and Sectish); Division of Hospital Medicine, Cincinnati Children’s Hospital Medical Center, Cincinnato, Ohio (Drs Conway and Shah); Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio (Drs Conway and Shah); Division of Hospital Medicine, Dell Children’s Medical Center of Central Texas, Austin, Tex (Dr Shen); Department of Pediatrics, University of Texas Southwestern, Austin, Tex (Dr Shen); Section of General Pediatrics, St Christopher’s Hospital for Children, Philadelphia, Pa (Dr Spector); Department of Pediatrics, Drexel University College of Medicine, Philadelphia, Pa (Dr Spector); Primary Children’s Medical Center, Intermountain Health Care (Dr Srivastava and Ms Willis), Department of Pediatrics, University of Utah Health Sciences Center, Salt Lake City, Utah (Dr Srivastava and Ms Willis); Pediatric Hospital Medicine, Children’s Hospital Colorado, Aurora, Colo (Dr Wilson); and University of Colorado School of Medicine, Aurora, Colo (Dr Wilson) The views expressed in this report are those of the authors and do not necessarily represent those of the US Department of Health and Human Services, the Agency for Healthcare Research and Quality or the American Board of Pediatrics Foundation. The authors declare that they have no conflict of interest. Publication of this article was supported by the Agency for Healthcare Research and Quality and the American Board of Pediatrics Foundation. Address correspondence to Tamara D. Simon, MD, MSPH, M/S C-9S-9, 1900 Ninth Ave, Seattle, WA 98101 (e-mail: Tamara.Simon@ seattlechildrens.org). Received for publication November 1, 2012; accepted April 12, 2013.
ABSTRACT Pediatric hospitalists care for many hospitalized children in community and academic settings, and they must partner with administrators, other inpatient care providers, and researchers to assure the reliable delivery of high-quality, safe, evidence-based, and cost-effective care within the complex inpatient setting. Paralleling the growth of the field of pediatric hospital medicine is the realization that innovations are needed to address some of the most common clinical questions. Some of the unique challenges facing pediatric hospitalists include the lack of evidence for treating common conditions, children with chronic complex conditions, compressed time frame for admissions, and the variety of settings in which hospitalists practice. Most pediatric hospitalists are engaged in some kind of quality improvement (QI) work as hospitals provide many opportunities for QI activity and innovation. There are multiple national efforts in the pediatric hospital medicine community to improve quality, including the Children’s Hospital Association (CHA) collaboratives and the Value in Pediatrics Network (VIP). Pediatric hospitalists are also challenged by the differences between QI and QI research; understanding that while improving local care is important, to provide consistent
quality care to children we must study single-center and multicenter QI efforts by designing, developing, and evaluating interventions in a rigorous manner, and examine how systems variations impact implementation. The Pediatric Research in Inpatient Setting (PRIS) network is a leader in QI research and has several ongoing projects. The Prioritization project and Pediatric Health Information System Plus (PHISþ) have used administrative data to study variations in care, and the IIPE-PRIS Accelerating Safe Sign-outs (I-PASS) study highlights the potential for innovative QI research methods to improve care and clinical training. We address the importance, current state, accomplishments, and challenges of QI and QI research in pediatric hospital medicine; define the role of the PRIS Network in QI research; describe an exemplary QI research project, the I-PASS Study; address challenges for funding, training and mentorship, and publication; and identify future directions for QI research in pediatric hospital medicine.
WHY IS QUALITY IMPROVEMENT (QI) IMPORTANT TO INPATIENT PEDIATRIC CARE?
approximately 16% of all hospitalizations and 9% of total costs for all patients, representing a total yearly cost of about $34 billion.1 The most common pediatric discharge diagnoses are respiratory illnesses—pneumonia, asthma, and acute bronchitis—followed by mood disorders.1 Pediatric
KEYWORDS: hospital medicine; hospitalists; implementation; pediatric; quality improvement; research networks
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inpatients are cared for in a variety of settings including freestanding children’s hospitals, community hospitals with or without dedicated pediatric beds, and children’s hospitals within a larger adult hospital. Although some pediatricians have practiced inpatient care for many years, the field of pediatric hospital medicine has emerged in the last 15 years2 and is now the fastest growing pediatric subspecialty.3 Pediatric hospitals have many functions. In addition to providing inpatient medical care to children, they serve as educational institutions, research laboratories, health care safety nets, and sources of employment. These missions sometimes compete, and as the Institutes of Medicine report, To Err Is Human, suggests, at times we do not meet our obligation to provide the best-quality care to patients.4 Pediatric hospital medicine physicians partner with administrators, other inpatient care providers, and researchers to assure the reliable delivery of safe, evidence-based, and cost-effective care. QI programs are our primary means to facilitate change.
ities with patients waiting for beds. On the other hand, in some cases, a shorter length of stay may represent an appropriate reluctance to offer unnecessary interventions. Pediatric hospitalists must understand the difference. Finally, the wide variety of settings in which pediatric hospitalists practice provides diversity but also complexity. Teaching services in academic hospitals present challenges to communication and balancing the needs of the learners with the needs of the patients. Community sites have fewer resources available for consultation and overnight coverage, and many staff members may not have extensive experience with pediatric care. The complex environment of the hospital is filled with an array of patients, families, physicians, other care providers, payers, and organizational factors. Such contextual factors cannot be dismissed as confounders or noise and simply ignored. Rather, they should be captured and considered as we seek to improve delivery of care in the pediatric inpatient setting. Pediatric hospitalists must deliver high-quality care for hospitalized children regardless of the setting. QI is the primary method with which pediatric hospitalists can understand systems and processes, and therefore effect change.
WHAT IS THE ROLE OF PEDIATRIC HOSPITALISTS IN QI? Pediatric hospitalists are a consistent presence on pediatric floors, and they often engage in QI activities as a part of their clinical responsibilities. Many pediatric hospitalists play important roles in their institutions’ QI efforts, including authoring clinical practice guidelines, serving on committees, and taking on leadership positions in departments of quality and safety. Pediatric hospitalists face unique challenges as they work to improve the quality of care. Even for some common and straightforward pediatric inpatient diagnoses, we lack the evidence to know what quality care actually represents. For instance, the understanding of the management of bronchiolitis, despite being one of the most common reasons for hospitalization, has advanced little over the last 3 decades.5 However, even an intervention proven by traditional research methods, such as the randomized clinical trial, may not be successful in real-world practice. Innovation development and adoption are interdependent and must be addressed simultaneously rather than in tandem; QI methodology can give us the tools necessary to translate interventions into effective programs at a broad range of centers. We also need more rapid adoption of existing knowledge. In many cases, adherence to higher-quality, evidence-based care is the exception rather than the rule.6–10 Pediatric hospitalists see a wide range of diseases affecting multiple organ systems, and they are often responsible for coordinating the opinions of multiple subspecialists. This can make providing quality care especially difficult when the diagnosis is unclear or when the subspecialists disagree. Many of our patients have complex chronic conditions, and we must balance the benefits and harms of interventions that may affect already damaged organ systems. Children have an average length of stay of 3.8 days.1 This creates a compressed time frame that may create a tension between providing children with high-quality care and facilitating discharges in busy facil-
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CURRENT STATE OF QI IN PEDIATRIC HOSPITAL MEDICINE Hospitals have many opportunities for QI activity and innovation. As embedded hospital workers, hospitalists have a unique understanding of the hospital setting. Many pediatric hospitalists are engaged in QI activities either informally or on guideline committees, and some have developed skills to lead QI initiatives through official roles as quality and safety officers. The American Board of Pediatrics (ABP) Maintenance of Certification (MOC) Part 4 requirement provides yet another avenue for increasing participation in hospital-based QI. Mandated reporting of quality and safety measures will further drive the dissemination of recommended practices.6,11 Although large-scale QI collaboratives such as those within the Children’s Hospital Association (CHA) have increasingly been used to disseminate recommended practices among a wide range of specialties,12–14 pediatric hospitalists have begun their own independent efforts. A grassroots effort has arisen within the pediatric hospital medicine community to bring QI collaboratives to nonfreestanding pediatric units and hospitals, where the majority of children are hospitalized.15 Founded in 2008, the Value in Inpatient Pediatrics (VIP) Network has become an inclusive improvement organization for pediatric hospitalists seeking to learn, share, and change across the continuum, from small community hospitals to tertiarycare academic centers. VIP initially targeted the slow pace of implementation of evidence-based care for bronchiolitis with a primary benchmarking initiative and recently published demonstrations of decreased bronchodilator utilization across the network.16 Additional initiatives have also demonstrated improvement with reductions in patient identification band errors and improved timeliness of discharge communication across participating sites.17,18 These
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efforts have been unique in that they occurred without any significant source of funding, yet each initiative involved several thousand children. For example, the collaborative audited 11,377 patients for identification band errors between September 2009 and September 2010, and decreased the error rate from 17% to 4.1% (a 77% relative reduction).17 In 2011, VIP joined the American Academy of Pediatrics (AAP) and is now part of the Quality Improvement Innovation Networks (QuIIN), which has facilitated continued development of projects and which has MOC credit available to participants.
IS IT QI? OR QI RESEARCH? As pediatric hospitalists work to change and improve local practices and systems to provide better care for our inpatients, and as they join collaboratives such as the VIP Network to disseminate successful QI initiatives from single to many institutions, we (and others) are struggling with defining the differences between quality improvement and quality improvement research. The Hastings Center defines quality improvement as “systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of healthcare.”19 This definition clearly conveys that QI is not a study design or analytic approach but rather the desired goal or end point. QI methods focus on standardizing the delivery of care, learning throughout the implementation process, and testing theories about processes and systems.20 These are often done for the benefit of one institution, and they may easily be adapted to the specific microsystem cultures in which they are implemented. However, QI initiatives can produce generalizable knowledge about systems of care and how best to change those systems when they are designed, developed, and evaluated with this as the end goal20; this represents quality improvement research. QI research applies a broad range of experimental and quasi-experimental methods, several of which are described in this special issue, in evaluating the effectiveness of a QI intervention. Such studies can provide insight into the institutional factors that may influence the adoption and maintenance of care delivery processes.20 QI research studies do not attempt to eliminate variability; rather, they seek to understand it. QI research often requires alternative study designs that do not fit into the traditional randomized controlled trial model; these are covered elsewhere in this supplement in more detail. Attention to methodological rigor in QI will allow pediatric hospitalists to conduct QI that leads to meaningful and sustained changes to the system of health care. Although the challenges to conduct of QI research are numerous, there have been some early accomplishments in the field of pediatric hospital medicine. One major accomplishment has been in the coordination and conduct of collaborative research efforts across multiple hospitals by the Pediatric Research in Inpatient Settings (PRIS) network. ROLE OF THE PRIS NETWORK IN QI RESEARCH The mission of PRIS is to improve the health of and health care delivery to hospitalized children and their fami-
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lies by providing valuable insight for the selection and design of research projects that both answer important questions and close the quality gap through rapid implementation and dissemination. Started in 2001 as an open hospitalist research network, PRIS received joint support from the Academic Pediatric Association (APA), the AAP, and the Society of Hospital Medicine (SHM). Early successes included a period of rapid membership growth and studies identifying opportunities to improve the quality of inpatient care. In response to the growth of hospital medicine, PRIS underwent a redesign in 2009. PRIS asked leaders in QI and implementation science— engaging such institutions as the Institute for Healthcare Improvement, National Initiative for Children’s Healthcare and Quality, and the Institute for Healthcare Delivery Research at Intermountain Healthcare—to join the PRIS advisory board.21 PRIS’s agenda now includes the conduct of QI research. Although member hospitals already invest institutional resources to tackle locally prioritized conditions, the PRIS Network is working with and across hospitals to understand how to improve health care delivery and advance QI research. PRIS has created a network of hospitalists with engagement of multiple stakeholders in a refocused organizational structure, including implementation experts to advise on QI research projects, with experience developing and conducting large-scale implementation research studies.22 In several proposed grants, PRIS will continue to address gaps in inpatient settings in the dissemination and implementation of recommended care for the most prevalent and costly diseases affecting hospitalized children by studying strategies to test the most common dissemination and implementation training strategies in diverse inpatient settings. PRIS hopes to establish capacity within more of the network hospitals to continually improve best practices in the real-world setting; by partnering with established front-line networks such as VIP QuIIN, we can improve the delivery of quality care to children across all health care settings. Today, however, PRIS is completing 3 large multicenter studies, all of which were applied for and funded during the redesign period and have implications for QI research in pediatric hospital medicine. The first PRIS study, the Prioritization Project, is funded by the CHA. Although it is not QI research per se, it has been used to inform QI in the CHA member institutions. The first stage of the Prioritization Project identified the inpatient medical and surgical pediatric conditions with high prevalence, high cost, and/or substantial variation in resource utilization.23 This work provided 43 CHA hospitals with scientifically rigorous data to prioritize their QI resources, and it engaged the clinical leadership to improve care within their hospital. In its second stage, PRIS is identifying the sources of variation in resource utilization across hospitals and developing condition-specific quality measures for 4 inpatient pediatric conditions (diabetic ketoacidosis, tonsillectomy, appendicitis, and pneumonia). The results will be used by CHA hospitals to identify opportunities to reduce unnecessary variation in care and implement best practices.
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The second PRIS study, Pediatric Health Information System Plus (PHISþ), is funded by the Agency for Healthcare Research and Quality (AHRQ).24 The PHISþ project links the clinical data (including laboratory, microbiology, and radiology data) from 6 children’s hospitals that already submit administrative data to CHA’s PHIS database. The primary purpose of PHISþ is to conduct pediatric comparative effectiveness research studies using clinical data. However, the potential for QI research is equally relevant, as interventions that rely on aspects of a patient’s course will be able to incorporate relevant data. The third PRIS study, IIPE-PRIS Accelerating Safe Signouts (I-PASS), is primarily funded through the US Department of Health and Human Services and the National Institutes of Health (NIH).25,26 The extraordinary efforts by the I-PASS study and implementation teams has helped the PRIS Network understand the effort required to systematically disseminate and implement a rigorous complex intervention in varied settings and still ensure fidelity to a rigorous study design targeting patient outcomes.
The 11 institutions were selected to participate on the basis of a known balance of complementary talent and skill sets of coinvestigators, including expertise in health services research, QI methodologies, faculty development, medical simulation, curriculum development, and data management and analysis. Both junior and senior faculty were invited to participate as coinvestigators at each site, recognizing the important role that engaging faculty at all levels of training would be in order for the intervention to have maximal uptake and impact. PRIS provided a structure and set of processes to help the I-PASS study investigators; in addition, the I-PASS study group partnered with the Initiative for Innovation in Pediatric Education (IIPE). Achieving IIPE project status required high-level institutional educational support, including letters of support from each hospital chief executive officer, department chair, designated institutional official, and residency program director. The coupling of a study team of investigators, educators, and clinicians with the institutional leadership ensured that all participating sites were thoroughly invested in the project months before project funding was secured. The I-PASS Coordinating Council meets regularly and developed a comprehensive manual of operations that includes standard operating procedures that ensure all study coinvestigators are awarded appropriate academic credit for their contributions. The Scientific Oversight Committee developed the numerous outcome measures. The Educational Executive Committee of the I-PASS Study Group used a rigorous approach to develop the educational curriculum and associated campaign materials. At each participating site, the I-PASS study design consisted of a 6-month baseline data collection period, followed by a 6-month wash-in period to implement the I-PASS handoff bundle intervention, followed by an additional 6 months of postintervention data collection. Data collection times were staggered across sites over the 3-year grant period, both to allow later sites the opportunity to benefit from the experience of earlier sites and to allow study leaders and staff the opportunity to focus their attention on a more manageable number of sites at any one time. A pre–post design at each site (with pre and post periods matched by time of year at each site to prevent confounding by time of year or resident experience effects) was intentionally chosen over the possibility of randomizing sites to intervention or control groups because of a lack of equipoise. Dissemination efforts have been accomplished by multiple presentations at national meetings utilizing both junior and senior faculty facilitators. Additionally, the IPASS Study Group launched a project Web site (http:// www.ipasshandoffstudy.com) where all curricular materials can be downloaded, free of charge, by any institution or individual interested in improving communication between health care providers using the I-PASS methods. By bundling evidence-based handoff interventions together and disseminating them through a multicenter research and education network, the I-PASS Study Group will continue to accelerate their adoption by institutions and translate the I-PASS handoff into common practice.
I-PASS: AN EXAMPLE OF ONGOING QI RESEARCH IN PEDIATRIC HOSPITAL MEDICINE I-PASS is an ongoing collaboration involving eleven academic institutions that aims to determine the effectiveness of a group of interventions, the I-PASS Handoff Bundle, in standardizing and improving handoffs of care between residents. The specific aims and outcome measures being tested in the I-PASS Study are: 1) to test the hypotheses that rates of serious medical errors, as well as verbal and written miscommunications, time spent by residents gathering and signing out data, and resident dissatisfaction with sign out, will decrease after implementation of the I-PASS Handoff Bundle; and 2) to determine the manner in which the I-PASS Handoff Bundle’s adoption and effects on primary and secondary outcomes are modified by hospital-level factors, including institutional safety culture and information technology support, and patient-level factors, especially the presence of a chronic disease or disability. The rationale for the I-PASS study is based on the premise that communication and handoff failures are the leading root cause of sentinel events.27 Prior research on handoff tools and processes identified team training, verbal mnemonics, and the use of written or computerized tools as strategies to improve handoffs and reduce medical errors.28,29 In a pilot study that preceded the ongoing multisite I-PASS study, an intervention combining all 3 of these interventions together as a handoff bundle was associated with a 40% reduction in overall medical error rates and significant decreases in both verbal and written miscommunication rates.30 The I-PASS study refined the bundle and is now testing it rigorously at additional institutions to demonstrate its effectiveness in other settings. Operationalizing the I-PASS study required input and partnership from numerous stakeholder groups and a complex organizational structure that delegated leadership, oversight, and tasks to key coinvestigators (Figure).
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Figure. Current organizational structure of I-PASS study group.
CHALLENGES TO PEDIATRIC HOSPITAL MEDICINE QI: FUNDING, TRAINING AND MENTORSHIP, AND PUBLICATIONS FUNDING The successful applications for funding for Prioritization, PHISþ, and I-PASS highlight a recent increase in funding for QI and QI research, but the question remains whether the United States is investing sufficiently to drive transformation as quickly as needed to achieve better health and better care at lower costs.31 Specifically, the federal government, primarily via the AHRQ and the NIH, is funding hundreds of millions of dollars’ worth of QI and implementation research annually. The Centers for Medicare and Medicaid Services (CMS) via the Innovation Center, Quality Improvement Organizations, Children’s Health Insurance Program, and other quality programs is now funding hundreds of millions of dollars annually to improve quality and transform the system to deliver better value. The Patient Centered Outcomes Research Institute (PCORI) is funding comparative effectiveness research; in addition, it is also significantly supporting dissemination and implementation research with at least 20% of their funding, likely to exceed $100 million. In recognition that funding comparative effectiveness research is necessary but not sufficient to drive system
improvement and uptake of evidence-based treatments, funding from PCORI and others focuses both on producing evidence and testing how best to implement evidence into practice and improve quality and outcomes. Despite these investments, challenges remain. Many of the programs above focus resources on Medicare patient populations, and uncertainty over the fiscal health of the United States may limit the funding available to AHRQ and the NIH. Thus we will continue to depend on nonfederal sources as well. Fortunately, nonfederal sources of QI and implementation research funding are growing. Foundations such as the Robert Wood Johnson Foundation have funded major efforts, including Aligning Forces for Quality. Increasingly, as payment is based on quality and value, providers such as hospitals will need to further invest in improving quality and value. Associations such as the CHA have played a role in investing in QI research, and this role will likely need to increase to meet the needs of their constituent hospitals to demonstrate their ability to meet quality and cost targets. Nonprofit provider institutions have a responsibility to the communities they serve to invest in better health for the population in their community. Collaboration, including public–private partnerships, is essential to test improvement methods, learn in rapid cycle, and spread successful interventions. The
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Prioritization Project collaboration between the PRIS network and CHA is a successful example of working together to understand underlying issues in variation in quality and cost performance and then to begin to test methods to improve quality and lower costs.
Attention to methodological rigor in QI will allow the hospitalists to conduct QI that leads to meaningful and sustained changes to the system of health care. However, the SQUIRE guidelines do not address the publication of QI research; specific guidance could help pediatric hospitalists improve their projects, as well as the resulting publications.
TRAINING AND MENTORING Currently only 25% of pediatric hospitalists have an advanced degree (master’s or PhD), and only 15% have completed a fellowship.32 Although there are well over 1000 pediatric hospitalists and 82% of these are at academic institutions,32 there were only 22 pediatric hospital medicine fellowships in 2013, and the majority train only a single fellow per year. In order to develop the scholarship skills of fellows in research and QI methodology, our field needs to continue both to support the development of new fellowship programs with scholarly content and to foster additional training opportunities in QI and QI research methodology. The Pediatric Hospital Medicine Annual Meeting, sponsored jointly by the APA, AAP, and SHM, has taken on a significant responsibility for disseminating this content. In addition to a precourse on leadership by the APA, the meeting has also developed core workshop curricula in both QI and research and has encouraged additional content submissions from hospitalists with this expertise. The APA QI Special Interest Group has also seen this challenge and sponsors an annual precourse to the Pediatric Academic Societies meeting in QI research. Although these opportunities are all excellent, they do not meet the needs of all interested pediatric hospitalists. Because many pediatric hospitalists are relatively junior, it can be difficult to find appropriate mentorship for young hospitalists, especially those with an interest in making a career of QI and QI research. Particularly for those who are doing QI and QI research, the standard promotions paradigms may not adequately reward their scholarly and academic work, and we need to continue to advocate for alternative promotions criteria to reflect this.33 PUBLICATIONS Publication of QI and QI research has also been a challenge for pediatric hospitalists, both because many hospitalists who are writing projects for publication do not have formal training in manuscript preparation, and because traditional manuscript publication guidelines have not provided sufficient guidance on the design, types of interventions, data collection, and analysis for QI or QI research. The Standards for Quality Improvement Reporting Excellence (SQUIRE) Guidelines for Quality Improvement Reporting were developed to provide a framework for reporting of QI projects. The SQUIRE statement consists of a checklist of 19 items (http://www.squire-statement. org) that authors need to consider when writing articles that describe formal studies of QI. Many checklist items are common to all scientific reporting, but they have been modified to reflect the unique nature of QI work.
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THE FUTURE OF QI RESEARCH IN PEDIATRIC HOSPITAL MEDICINE As the field of pediatric hospital medicine begins to mature, with the implementation of several large funded studies, the work of PRIS and VIP, and the continued growth of pediatric hospital medicine fellowships, we are looking toward the future. Our priority conditions for study now are broad because evidence is lacking in many areas, but such priorities include the Prioritization project conditions (diabetic ketoacidosis, tonsillectomy, appendicitis, and pneumonia) and bronchiolitis as the current major focus of VIP. Aside from specific conditions, studying the optimal delivery of interventions such as intravenous fluid use and pain management should be another priority. Pediatric hospitalist QI research will need to focus both on generic processes of care that span many organ systems and the more traditional disease-specific approach to investigation. Pediatric hospitals are complex systems, and successful conduct of implementation research will require organization on the part of hospitalists and the organizations we represent. To keep pace with changes to payment incentives, hospitals will need to further invest in improving quality and value. To keep up with demand for QI activities, both academic medical centers and community hospitals will need to create infrastructure to support faculty and staff interested in QI and implementation science. The improvement-focused line of scientific inquiry and service should be rewarded and nurtured through training, mentorship, and promotions. Pediatric hospitalists and the systems in which they work need to continue to invest in testing new methods to rapidly learn and improve in order to remain at the forefront of this wave of change for hospitalized children.
ACKNOWLEDGMENTS The authors would like to acknowledge the PRIS Network, a collaborative hospitalist research network sponsored by the Children’s Hospital Association (CHA), Academic Pediatric Association (APA), American Academy of Pediatrics (AAP), and the Society of Hospital Medicine (SHM). Details are available online (http://www.prisnetwork.org). The Prioritization Project is funded by a grant from the CHA and from the Health Research Formula Grant 4100050891 from the Pennsylvania Department of Public Health Commonwealth Universal Research Enhancement Program. PHISþ is funded by grant 1R01HSO986201 from the Agency for the Health Care Research and Quality (AHRQ). The I-PASS Study is primarily funded through a grant from the US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, grant 1R18AE000023-01. Additional funding for I-PASS has been provided by the Medical Research Foundation of Oregon, AHRQ (1K12HS019456-01), the Physicians’ Services Incorporated Foundation in Canada, and Pfizer’s Medical Education Grant Program. IIPE is the Initiative for Innovation in Pediatric Education and is the entity that recognizes innovative educational proposals for pediatric
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residency training programs. More can be found at their Web site (http:// www.innovatepedsgme.org). Financial Disclosures: The Pediatric Research in Inpatient Setting Network Executive Council members (CPL, SSS, TDS, RS, JST, KMW) and staff (LEW) are supported in part for their work on behalf of PRIS by a grant from the CHA. TDS is supported by Award K23NS062900 from the National Institute of Neurological Disorders And Stroke and Seattle Children’s Center for Clinical and Translational Research and CTSA Grant Number ULI RR025014 from the National Center for Research Resources (NCRR), a component of the NIH. AJS is supported in part by an institutional K12 award from Oregon Health and Science University and the, grant 1K12HS019456-01. None of the sponsors participated in design and conduct of the study; collection, management, analysis, and interpretation of the data; or preparation, review, or approval of the manuscript. Its contents represent the views of the authors and are solely the responsibility of the authors; they do not necessarily represent the opinion, policies, or official view of their respective institutions or the NCRR or NIH.
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