Perianal disease is an important complication of Crohn’s disease in children. In May at Digestive Diseases Week 2015, a meeting of nearly 15,000 gastroenterologists from around the world, Dr. Jeremy Adler (@jeremyadlermd) presented research investigating instances of perianal disease (perianal fistulas, fissures and other perianal lesions) in pediatric Crohn’s disease, using data from the ImproveCareNow pediatric IBD registry (known as “ICN2”).

Using data from ICN2, Adler’s research team identified racial and regional differences in the development of perianal disease across multiple centers in the ImproveCareNow Network. Their research has shed light on when perianal disease most commonly occurs (early in pediatric Crohn’s disease) and suggests that early therapy should be aimed at fistula prevention. They concluded that the ICN2 registry is a valuable tool for population-based studies (like this one, which included data from many patients with IBD, across many different geographic areas), and suggest that more studies like this one be conducted to identify and evaluate preventative therapies for complications of Inflammatory Bowel Disease (like perianal disease).

This novel pediatric IBD research highlights the power of data, carefully collected and curated over time, to answer questions about complex conditions such as Crohn’s disease and ulcerative colitis and to shine light on ways we can work to improve the care and the health of patients in the near term.

ICN2 is the largest and fastest growing pediatric IBD registry in the world, with data from over 19,000 patients with IBD and 115,000 visits as of May 2015. The ImproveCareNow Network currently includes 75 participating pediatric IBD centers in 34 states and the District of Columbia and two in England, with nearly 45% of Crohn’s disease and ulcerative colitis patients cared for by US pediatric gastroenterologists. The purpose of ImproveCareNow is to transform the health, care and costs for all children and adolescents with Crohn’s disease and ulcerative colitis by building a sustainable collaborative chronic care network, enabling patients, families, clinicians and researchers to work together in a learning health care system to accelerate innovation, discovery and the application of new knowledge. Data in the ImproveCareNow registry is used for improvement, research and innovation.

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Editor's note: The ImproveCareNow registry (ICN2) has grown dramatically over the past several years, and now, from the research standpoint, we are beginning to see the fruits of that labor. Jeremy Adler and colleagues have used the registry to carefully describe a specific phenotype of pediatric Crohn's disease across the network. We are only beginning to scratch the surface in utilizing not only the registry, but also the rich community network upon which ImproveCareNow is built. More and different types of research efforts are coming, and hopefully, the number of studies will continue to grow as quickly as the number of centers and patients have grown within the network.

Did you catch the article in HuffPost Health News about a large-scale comparison between the efficacy of Mindfulness Based Cognitive Therapy (MBCT) and anti-depressants?

This area, MBCT, is a growing interest of mine and I’m hoping to attend some trainings on it. I have informal training on mindfulness and use it myself, to great benefit! Here’s what I would say to someone else…

As a graduate student in a business school, I strive to apply what I’ve learned about management science to address problems of importance to society. So needless to say, working on research projects in partnership with the C3N Project and ImproveCareNow (ICN) has been educational and enlightening. Growth of the ImproveCareNow Network has brought both exciting opportunities and new practical challenges, as Sarah Myers discussed in her recent LOOP post. In the spirit of continuous improvement, ICN leaders wanted an enhanced, evidence-based understanding of Learning Labs and other models for collaboration at different levels of scale. And I was thrilled for the opportunity to support this effort.

Many of you will recall a survey distributed last summer by ImproveCareNow. The survey presented a series of questions with two scenarios for network-based group learning, asking respondents to choose the scenario which seemed most conducive to learning and improvement. Those paired scenarios appeared to be very similar; a few respondents even wrote to tell us that the survey was defective, presenting the same question over and over again! But, in fact we were using an advanced and efficient method, the discrete choice experiment (DCE), to collect feedback on strategies for continuous learning from within the network itself. Discrete choice methods – common in marketing research as well as health economics and policy studies – use experimental design to assess the relative importance that customers/end-users place on attributes of a given product, service, or scenario. For example, a DCE for the design of new laptop computers might examine factors such as weight, battery life, memory, and price. Comparison of patient treatment options with DCE might explore tradeoffs between efficacy, cost, and invasiveness.

Our DCE for ImproveCareNow evaluated three group learning techniques: micro-communities called “Learning Labs”, quality improvement curricula, and team-to-team mentoring. As a research team, we are extremely appreciative of the 149 survey respondents representing 63 ICN care centers. We had a response rate of 65%, increasing confidence that our results accurately represented network preferences.

Overall, we observed that ImproveCareNow participants preferred mixed Learning Labs (including both novice and experienced care teams) over cohorts of teams with similar levels of experience, sequential curriculum (introduction of topics in a structured succession) rather than a simultaneous overview of QI tools and interventions, and ad hoc mentoring based on focal topics rather than an assigned, permanent mentor team. We also observed interesting variation in preferences across subgroups based on individuals’ time in the network, professional roles, and characteristics of care centers such as patient population size. I am excited to share these results in greater detail – and most importantly, to discuss what we’ve learned with the ICN community – at the upcoming network-wide webinar on Tuesday May 12 (11 ET). Please join us to weigh in!

As improvement networks scale up, it is not enough to do more of the same in a bigger way… Understanding how to adapt structures for continuous learning as networks grow and change is necessary for development of learning health care systems. Engaging network participants to share their collective wisdom is essential for improving what ImproveCareNow does, and also for targeted improvements in costs, care, and outcomes.

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published by ImproveCareNow on behalf of Shannon Provost

Shannon M. Provost, MBA, is pursuing a PhD in Information, Risk, and Operations Management in the McCombs School of Business at the University of Texas at Austin and building a program of research around innovation ecosystems, social networks, and the science of improvement. She is also an Assistant Instructor of undergraduate business statistics. Shannon is grateful for learning opportunities which have emerged through her work as a visiting researcher at the James M. Anderson Center for Health Systems Excellence at Cincinnati Children’s Hospital Medical Center and as a member of the Institute for Healthcare Improvement faculty. Personal interests include travel, fashion, literature, beagles, and attempting to play golf.

Michael D. Kappelman, MD, MPH of the University of North Carolina at Chapel Hill (read the UNC press release here) and the ImproveCareNow Network has been awarded $7.9 million in funding from the Patient Centered Outcomes Research Institute (PCORI) to conduct a five year study comparing Anti-TNF Monotherapy versus Combination Therapy with Low Dose Methotrexate in Pediatric Crohn’s Disease.

The IBD Learning Priorities project was designed to give young adults, parents and clinicians in the IBD community a chance to ask the questions they felt were most important in the treatment of IBD. Using an online survey, families and clinicians submitted over 200 questions - or 'learning objectives'. Common themes included diet, diagnosis and individual care needs.

These questions will help us further understand what information those who are impacted by IBD really need. We expect to find some of these questions already have answers. And where there there is good research to answer these common questions, ImproveCareNow will work to develop and share this knowledge through family-centered tools and resources. Those questions that do not have complete answers will help prioritize future pediatric IBD research.

Below are a few examples of the learning objectives received from families and clinicians like you!

• Beyond enteral therapy, what is the role of diet in the maintenance of remission in IBD?

• Is 6mp safe? Will it hurt her liver anymore than it already is?

• We need more data on dual therapy with thiopurines and methotrexate. Specifically, will patients do better if these agents are started before starting biologics rather than starting them at the same time?

Stay connected with ImproveCareNow by joining our CIRCLE so we can send you updates on the continued progress of these important community-developed learning objectives and ensure you have access to the family-centered tools and information that are developed in response to some of these questions.

[Editor's note: One of the unique aspects of research in a large network such as ImproveCareNow (ICN) is the opportunity for collaboration.  Jennifer Dotson and Michele Cho both submitted protocols to the ICN Research Committee to study racial disparities in pediatric patients with IBD.  Both are young eager investigators.  The Research Committee helped make a connection, and the result has been the start of important collaborative research utilizing the ICN2 registry.  This work exemplifies the power of the ICN network: the power of people and the power of data.  I hope you enjoy reading about the outcomes of their work.  Steve Steiner, Co-Chair, ICN Research Committee]

Using ICN Data to Investigate Health Disparities in Children and Teens with Crohn's Disease

By Jennifer L. Dotson, MD, MPH and Michele Cho, MD

Health care differences due to race have been shown to contribute to suboptimal healthcare outcomes for minorities and low-income groups. Identifying differences among those at-risk is an essential step to improve healthcare delivery and ultimately outcomes, and to reduce costs for all patients. For our study, we wanted to look at racial differences during the initial presentation and medical management of children and teens with Crohn's disease. Specifically, we wanted to determine if there were differences in disease severity and treatment with medications between Black and White children at time of diagnosis. The ImproveCareNow (ICN) network gave us the opportunity to look at a large group of patients from across the country and was a valuable tool in facilitating this work. ICN contains data collected at the time of outpatient clinic visits and is able to track patients over time. Data was pulled from the ICN database for all patients under 21 years of age with clinic visit between September 2006 and October 2014. We then narrowed the list of patients by including only those that had a visit within 90 days of their initial Crohn’s diagnosis.

We are in the early stage of this study and would like to share some of our preliminary results.

There were 1728 patients (Black=222 (13%), White=1506 (87%)) from 46 sites included. The average age was 13 years and 62% were male. Black children had more Medicaid insurance (39% vs. 10%) than White children. There were no differences by nutritional status, body mass index, or growth status. There was no difference in disease activity based on the short Pediatric Crohn’s Disease Activity Index, however Black children had more severe disease based on Physician Global Assessment. 0.9% of Black children had perianal disease as compared to 0.5% of White children. Anti-TNFα therapy (medications such as Remicade or Humira) was more commonly prescribed for Black children (17% vs. 11%).

Racial and socioeconomic disparities have the potential to impact healthcare delivery and Crohn’s disease outcomes. This study identified several differences among newly diagnosed children and teens with Crohn’s within an outpatient quality improvement network. Specifically, Black children were more likely to receive treatment with anti-TNFα therapy than White children. This difference does not appear to be explained by differences in age, growth, nutrition, perianal disease or standardized disease severity scores, but rather by subjective assessment of disease severity and/or consideration of additional information such as endoscopic appearance that is not accounted for by the short Pediatric Crohn’s Disease Activity Index.

ICN helped make this research project a reality by providing a rich data set and facilitating a successful collaboration of two young physician scientists. Realizing we had similar research interests in health disparities, we decided to combine our efforts and focus on a single, large project together. We are delighted to be working together on this, along with our mentor team, and are thankful for the encouragement by the ICN network.

Jennifer Dotson, MD, MPH, is a pediatric gastroenterologist and principal investigator in the Center for Innovation in Pediatric Practice at The Research Institute at Nationwide Children's Hospital, Columbus, Ohio. She conducts clinical research focusing on improving healthcare delivery and reducing healthcare disparities, and outcomes-based research in children with inflammatory bowel disease (IBD). Her interests are studying hardships and barriers to care, and assessing potential health system solutions from the patient/caregiver perspective that impact clinical outcomes for children with IBD. When she is not taking care of patients and conducting research, she loves traveling with her family and spending time doing activities outdoors (hiking, kayaking, etc.).

Michele Cho, MD, is a pediatric gastroenterologist working in the greater Chicago area. She is part of the Center for Children’s Digestive Health and is the physician lead for ICN at her site at the Advocate Children’s Hospital in Park Ridge, IL. Outside of work, she enjoys running and participating in other outdoor activities. She is looking forward to summertime in Chicago.

The goal of medical research is to find answers that will improve the lives of patients. But how can we be sure the answers really matter if we don’t ask patients what they want and need to know?

ImproveCareNow is committed to supporting research that represents patient and family perspectives. As part of our funding from the Patient Centered Outcomes Research Institute and the US Agency for Healthcare Research and Quality, we are working with leading health care researchers from Children's Hospital of Philadelphia, Katherine Bevans, PhD and Chris Forrest, MD, PhD (selected publications by Dr. Forrest) to use new ways to engage everyone in the IBD community in setting our direction for learning. They have created a website called Patient Priorities to find out what YOU want and need to know about Crohn’s disease and ulcerative colitis (IBD). You don’t need any research experience to participate.

You will be asked to recall moments during your/your child’s diagnosis and/or treatment when you wanted more information, or had questions that were not answered. Maybe you had questions when comparing two treatment options, or making the decision to end a particular treatment. Any difficult moment when you needed more clarity and information is important for researchers to know about.

Responses to the 10-minute survey are anonymous and will be grouped with many other responses to develop a list of “Learning Objectives.”  Some Learning Objectives may be answered using existing research. Where there is good research to answer common questions, ImproveCareNow will be making more tools and resources for families available through care centers and in our online communities: Facebook, Twitter, here on LOOP, CIRCLE, the ICN Exchange and Smart Patients. Those Learning Objectives that are unanswered and require more research will be added to the ImproveCareNow research agenda.

We’ve heard from many patients with IBD and their parents. It would be great to hear from many more to be sure the Learning Objectives really represent a wide variety of experiences.

Here’s your survey: http://bit.ly/lrnobjs

This is an important opportunity for us to shape the future of IBD research. We will be sharing our results and what we’ve learned along the way, so you can see how we’re outsmarting IBD together.

Speak out. Tell ImproveCareNow what IBD questions need to be answered.

What do you wish you knew about Crohn's disease or ulcerative colitis? Do you have questions about diagnosis or treatment options? What about daily management of IBD? Maybe you've wondered if a certain drug or lifestyle change would help. These are important questions! The answers could have an incredible impact on your life, the life of your child, the lives of many patients living with IBD.

ImproveCareNow is ready to answer your important questions – but we need you to tell us what they are!

Teens and young adults with IBD, and their parents and clinicians are invited to participate in the IBD Learning Priorities Project - a study being conducted in partnership with Patient Priorities. Participants will be asked to share questions and concerns about IBD, and it's treatment, management, etc. in a confidential survey. The results will be used to create a list of the top learning objectives for ImproveCareNow to focus on.

Speak out! Tell us what you need to know. Go to patientpriorities.com to complete your brief survey, now.

What are the research assets of ImproveCareNow?

Certainly the large and rapidly growing database of patient information is beginning to be tapped as a research resource.

But the ICN community itself is a powerful resource as well!

The Research Committee has received several applications to conduct survey research. After asking the ICN community for feedback, the infrastructure is now in place to begin gathering a list of survey recipients, and we need you to sign up!

Why should you participate in survey research?

• Your views are important, and you can make a contribution to advancing knowledge and building a stronger network.

• Surveys are an important way to learn more about things such as research prioritization, trends in diagnosis and treatment, and how to build a better network.

• You support your colleagues with your participation!

"Survey - based research within ICN gives us the ability to gauge how pediatric GI practitioners approach specific aspects of IBD patient care in a quantifiable manner. This augments our "real world" understanding of the practices and attitudes of health care providers within ICN and therefore, can highlight areas of clinical practice we can target in our quality improvement efforts." - Sandra C. Kim, M.D.

Because we recognize the flood of emails you already receive, the Research Committee elected to create an opt-in mechanism that will allow investigators to target survey research only to those who want to participate. Your ICN key contact person has the ability to add or edit the contact information of all your team members (including all of your providers) in the ICN Contact Management System. Simply have your key contact select the Survey Study List button for all team members who want to participate!



Our success in survey research will depend on getting a large cohort of the ICN community involved - don't delay - it's time to opt-in!

Steve Steiner
Co-Chair, ICN Research Committee

When I was diagnosed with moderate to severe Crohn’s disease 7 years ago, I wanted a simple and straightforward “cure all” treatment. To my dismay, I learned that relying on one silver bullet drug, would not suffice. Controlling this disease was like trying to tame a wild animal and would require balancing many factors. I became attuned to how psychological stress and poor diet negatively affected my symptoms. With a careful combination of transient targeted steroids, immunomodulatory drugs, vigorous exercise, and lifestyle changes, I regained my ability to thrive. I returned to my former state of athleticism, regularly tackling the intense and unforgiving northern California waves with my surfboard.

I soon entered the University of California, Santa Cruz’s neuroscience and psychology programs. While I was intensely focused on my academics and extracurriculars, the foundational nature of the human brain became seemingly more important. Comprised of approximately eighty billion neurons or brain cells, the vast intricacy of this three pound organ is extraordinary: The relationships or “connections” between these neurons –– called synapses –– outnumber the stars in our home galaxy. These small spaces are in actuality busy microcosms of information transfer between neurons. Minute chemical messengers called neurotransmitters serve as the communicational media. It is widely believed that the way in which brain cells are connected and their chemistry determines our psychological state.

I took note: under times of intense pressure or stress my physical symptoms manifested. Was this just a mere coincidence? Or was there really something going on? With a neuroscientific lens, I investigated.

I found that the connection between the brain and body and its interactions in disease are well-recognized by the scientific community.¹ Modern day stress is seemingly connected to our most primal of reactions – activating a “fight or flight” response – that would be more useful to us in prehistoric times in our interactions with predation. A stress hormone called Cortisol serves to direct our body’s resources (in the form of glucose) away from non-vital functions like digestion and immune activity. For this reason, scientists believe that prolonged stress plays a pivotal part in a myriad of autoimmune conditions.

The extent to which psychological states influence the disease progression of IBD is still somewhat unclear. Numerous studies and review articles, however, suggest that these psychological states play a role in both direct disease progression and how patients deal and cope with their disease. ^{2, 3, 4, 5}

Reducing stress is just one of many changes that help me live with Crohn’s Disease. Further, just as important is staying informed and imaginative. This blog and the entire ImproveCareNow community represent a beautiful medium for these concepts to flourish. Thank you for your part in this community.

References:

1. Sternberg E, Gold P. The Mind-Body Interaction in Disease. Scientific American Special Edition. 2002:82-9.

1. Mawdsley JE, Rampton DS. Psychological stress in IBD: new insights into pathogenic and therapeutic implications. Gut. 2005;54(10):1481-91.

1. Mikocka-Walus AA, Gordon AL, Stewart BJ, Andrews JM. A magic pill? A qualitative analysis of patients' views on the role of antidepressant therapy in inflammatory bowel disease (IBD). BMC Gastroenterol. 2012;12:93.

1. Peters S, Grunwald N, Remmele P, et al. Chronic psychosocial stress increases the risk for inflammation-related colon carcinogenesis in male mice. Stress. 2012;15(4):403-15.

1. Sajadinejad MS, Asgari K, Molavi H, et al. Psychological issues in inflammatory bowel disease: an overview. Gastroenterol Res Pract. 2012;2012:106502.