Making the Team

Posted on 23 April 2013 by samisophia

In October 2012, I arrived wide-eyed and a little afraid at my first ImproveCareNow Learning Session. I remember walking into the big room with my luggage and taking in the scene – so many brilliant clinicians and researchers I admired and greatly respected all in one hotel for one weekend. And here I was, too. I am nineteen – and so to many, I’m just a kid still. I didn’t know what to expect, but I did expect to listen more than I spoke. After all, in a room full of some of my personal heroes, I was “just a patient.”

As the inaugural Patient Scholars, to say that Jennie and I have been given the opportunity to live a dream would be an understatement. For a girl who expected to listen far more than she spoke, my voice has been valued more than I could ever have hoped or imagined. Jennie and I are just two patients – but to think about how many patient voices can and will resonate at future Learning Sessions excites me more than I can express. It’s so clear to me now that “Just a patient” is not a concept that exists in ImproveCareNow.

On April 12th I returned to Chicago for the first Learning Session of 2013. Gutsy 2 (myself) may have been without her Gutsy 1 (Jennie) – but together through the art of virtual communication and the help of some friends, we didn’t let a sudden strike of illness take away our weekend of hard work and joyous celebration. We shared in a presentation on self-management support and treatment adherence. We opened up about our stories and the accomplishments of the PAC (Patient Advisory Council) over the past year. We were inspired by stories of progress and achievement coming from all around the network. I even learned a new dance – the PDSA – aptly named after a fundamental quality improvement measure – because QI is really at the heart of making care better and thus rightfully deserved a spot at the heart of the celebration! (I expect PDSA to go viral on YouTube any day now.)

For a moment, when I landed in Chicago, I felt that familiar sudden shock of fear. For just a moment, I felt little again, like I was “just a patient” with a lot of ideas on the fringes of a great big community. But, this time, when I entered the conference room, I knew I belonged in this community. In one year’s time, it’s my hope that more patients will have felt the joy of this kind of welcome.

Five years ago today, I was waking up early – colon all cleaned out – and driving to the hospital with my mom, neither of us knowing I wouldn’t be going home that day or that a whole new world was about to welcome us. Six months ago, when I arrived in Chicago for my very first Learning Session, I couldn’t have even imagined myself standing in front of such a brilliant crowd and sharing my story – a story that only just begins with a diagnosis and hardship – on the level I did last weekend. Today, I can’t imagine what comes next – but I know I’m humbled to have a voice that can share in the learning. I am eager to pass on the torch of leadership to the next Patient Scholars – because we all have stories, and many of the stories I heard last weekend touched me deeply and reminded me of why I do this.

I do this because, right now, another young girl and her mom are driving to the hospital – and they don’t know what comes next – but I do.

That young girl will get better. And maybe, if we all reach our hands out together to say that everyone can make a difference and is valued on our team, she’ll be able to help change care for the better for the next girl with IBD.

Like any good team, we are more than the names on the backs of our jerseys when we unite. In this Network we are more than the names we go by: patient, parent, researcher, clinician. I am so proud to have a jersey on the ImproveCareNow team.

Together, we have quite the winning streak. And one day, I really do believe that we will achieve that cure, together.

REACH Replication Study to be Presented at DDW2013

Posted on 20 February 2013 by ImproveCareNow

Dr. Richard Colletti – Network Director for ImproveCareNow – announced today that an ImproveCareNow study has been accepted for oral presentation at Digestive Diseases Week in May. This is a highly innovative study done in collaboration with the Department of Biostatistics and Epidemiology of the University of Pennsylvania. It is a replication of the REACH study, and the first pediatric comparative effectiveness study of anti-TNF drugs.

Congratulations to Mike Kappelman, Wallace Crandall and the research team. And congratulations and thank you to all of the centers whose data made this study possible. More comparative effectiveness studies are planned.

Here is the abstract:

Kappelman MD, Bailey LC, Crandall WV, Zhang P, King E, Joffe M, Colletti RB, Forrest CB and the ImproveCareNow Network

Real-World Clinical and Comparative Effectiveness of Infliximab in Pediatric Crohn’s Disease

Background and Aims: Clinical trials in pediatric Crohn’s disease (CD) are difficult to recruit for, enroll highly selected subjects, and utilize standardized protocols. Thus, efficacy data from trials may not be generalizable to clinical practice. Studies of real-world clinical effectiveness are needed to fully evaluate evolving therapeutic options. We sought to use data from a multicenter clinical registry (the ImproveCareNow Network, ICN) to evaluate the clinical and comparative effectiveness of anti-TNFα biological therapy in children with moderate to severe CD.

Methods: ICN maintains a registry of medication use and clinical and laboratory data collected during pediatric gastroenterology outpatient IBD encounters (33 centers in this analysis). We identified a cohort of new users of infliximab and adalimumab with characteristics (selection criteria) similar to subjects enrolled in the REACH clinical trial. To evaluate clinical effectiveness, Pediatric Crohn’s Disease Activity Index (PCDAI) scores and corticosteroid use were evaluated at the visit closest to 10 weeks following induction. Missing data were estimated by multiple imputation. Response (PCDAI <30 and decrease by ≥ 15 points), remission (PCDAI < 10), and steroid-free status were determined. To evaluate comparative effectiveness, we performed a trial simulation comparing 6 month outcomes of remission and steroid-free remission, adjusting for disease severity and medication use for the 6 months before the start of the trial, among biologic initiators and non-biologic users, using Cox proportional hazards models and generalized estimating equations.

Results: 192 biologic initiators (53% male, mean age 14.9 years, mean PCDAI 39.7) were included in the analysis. Overall, 80% experienced response, 39% remission, and 33% steroid free status at week 10. Among those on concomitant immunomodulators, 82% experienced response and 48% experienced remission (REACH clinical trial 88% and 59% respectively). In the trial simulation, 198 biologic trials were compared with 1157 non-biologic trials. Biologics were associated with increased remission (hazard ratio 1.5, 95% CI 1.1-2.0) and steroid free remission (hazard ratio 2.0, 95% CI 1.5-2.7), with corresponding number needed to treat (NNT) of 7.8 and 5.3.

Discussion: The real-world clinical effectiveness of anti-TNFα biological therapy observed in a multi-center pediatric IBD network is similar to the efficacy estimates from the REACH clinical trial. Concomitant immunomodulator use is associated with increased effectiveness. Compared with conventional care, biological therapy is more effective at achieving remission, particularly steroid-free remission. The NNT can be used to guide clinical decision making regarding risks and benefits. These findings support the use of the ICN registry for comparative effectiveness research.

C3N for CF

Posted on 14 February 2013 by ImproveCareNow

[Editor's Note: Erin Moore is "Doin' it for Drew"! Drew has Cystic Fibrosis (CF). CF is a life shortening genetic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States (70,000 worldwide). It is a chronic illness - meaning until a cure is found, CF is forever. Erin is collaborating with the C3N Project; exploring the creation of a Collaborative Chronic Care Network for CF. This post was originally featured on Erin's blog - 66 roses.]

I arrive for our clinic appointment around 7:45am. The last time we were here was 3 months ago. Usually, we are ushered back to a room within 15 minutes of arrival. A nurse greets us shortly thereafter to review our medicine list and address any issues that we’ve been having. Just the other day he was coughing up a storm but seems to have gotten over it. Should I talk to the dietician about his diet again? His weight is up and his stools seem “normal” but I’m always anxious about his lack of interest in food. I wonder if an RT is available to talk a little bit about his airway clearance. I don’t want to be a bother but I sure do think the airway clearance he had in the hospital this summer was more effective. I wish I knew what they were doing differently!

Next up is the doctor. She asks how things have been going. Today? Great! Last week? I was a little worried, but the cough he had seemed to go away. There was that one day that his stool was a little weird but that got better too, not sure what caused it. And frankly I can’t remember back farther than that. She checks him out and wants to review his labs since we are at his anniversary visit. His vitamin D is low, his breathing still sounds a little noisy, and a note that she has from his ENT seems to indicate that he may need another sinus surgery. She feels out whether I’d be open to a bronchoscopy at the same time. Maybe another CT is a better option. When I talked to the ENT last month it sounded like things were going well? I guess I don’t mind if they do a bronchoscopy while he’s under for something else, but I remember huge discussion with other CF parents on Facebook about CT scans and all the negative effects of radiation and I don’t know that I want to do that? I wish I could find that conversation! I ask questions about a game plan for if he needs IV antibiotics if we grow pseudomonas again, having read online about all different methods used for eradication but not knowing which is best and why. It’s hypothetical at the moment because they haven’t even swabbed him yet. I just have sort of a busy life and sometimes having a plan provides a sense of comfort for me. She suggests an action plan and I am mostly on board, except for the azithromycin because I saw a presentation somewhere that seemed to show compelling evidence against its use. I wish I could find that presentation to show her! I trust his doctor and want to follow her recommendations, but I have some reservations. I don’t think either of us has time to get into this as I’ve already taken up more than my fair share of appointment time. We agree to wait for the results of the culture to decide a course of action.

Next up is the dietician. Lucky for me, he has a “weird poop” while we are there so she can look at it and provide her thoughts. This isn’t what all of his stool looks like. I don’t really know how often his stool looks like this – sometimes once a day, sometimes 4 times a day, sometimes once a week. We talk for a bit about enzyme dosing and the calories he’s taking in, her offering suggestions for beefing up his intake and me adding them to the “notes” section in my iPhone, hoping I can get them down elsewhere before one of my kids deletes them by accident.

The social worker pops in to address some questions about starting preschool that I had mentioned to the nurse 2 hours ago. I had met with the Psychologist about a year ago to talk about his lack of interest in food, but never followed up, mostly because of both time constraints and cost. If only she could pop in and give me a couple of quick suggestions. But I have to go, we’ve already been here for almost 4 hours. While waiting for my discharge paperwork, a research assistant shows up to see if I’d be interested in participating in a study about I’m not sure what because my 3yr old is clambering to get out of that office. I agree anyway, get my discharge paperwork and fly out the door.

This summer, we were visiting family in Philadelphia and my son got sick. He was admitted to Children’s Hospital of Philadelphia for a pulmonary exacerbation. Not a single morsel of information about him and his history with Cystic Fibrosis was available to the doctors at CHOP. Many phone calls were made between fellows from my personal cell phone to understand his medical history and doctors asked me the same questions day after day before we trusted and understood each other and hashed out what was going on in the days leading to our admission. I know that it was in Drew’s best interest that we discuss everything about him ad nauseum, but it blew my mind that in this age of technology, there was no electronic medical health record that the doctors in Philadelphia could access to understand Drew to provide the best care for him quickly.

When Drew was a baby, we kept a diary of his formula intake and the corresponding output. We set up a nice little Excel chart and shared that with our dietician on a very regular basis. I credit that chart for his gained weight and reaching the 50th percentile by the time he was 6 months old and he has been able to maintain that to today when he is almost 3. I know that all patients aren’t equal, but wouldn’t it be great if that data, if our “patient reported outcomes” were cataloged somewhere so that we could share what we did and how it worked for us? Sure, I could take to the CF Mom’s Facebook page and ask about what high calorie snacks work for their 3 year olds and hope that some of those moms are online and eager to provide some feedback. But once that question is asked and answered, it just simply vanishes into cyberspace. I cannot tell you how many times I’ve said, “I know I’ve seen that somewhere”. Image the power of cataloging that data, those conversations, those findings. It can be used by patients, by doctors, by researchers and teachers. Just thinking about the power of that is what is driving me to stay involved and insist on nothing less.

I think you’re seeing my point, a point that was brought out in almost every session I sat through at the NACFC this year. The information that we currently have on patients in between visits is limited. Filling those gaps would give us a more complete picture of health. It would help doctors to intervene at appropriate times, times when patients might not call because in their mind “its just not that bad yet”, but doctors are able to identify a problem or a pattern that lets them know the direction something that’s “not that bad” is headed. They would be able to more easily determine if certain therapies were actually making a difference through the combine use of passive behavioral and active patient reported data, looking at a real-time view of what is going on with a patient, not what they remember to tell you when they are in clinic. The registry could be enhanced by identifying day to day trends and commonalities in patients sharing mutations. And all of this data can be used by researchers and scientists to figure out every last detail this disease and find therapies that work for every one of us. From a parent’s perspective, the C3N is what we need to make life easier and improve outcomes while we wait for our cure.

ICN Remission Rates: A Real Improvement

Posted on 29 January 2013 by ImproveCareNow

A control chart allows us to detect when there has been a significant change—a real improvement.

This graph shows that the remission rate has been increasing steadily since February 2012, and in August 2012 the remission rate crossed the dotted line (the upper control limit), indicating that a real improvement had occurred. It also shows that the average remission rate has increased from 60% in 2007, to 71% in 2008, to 75% in 2010, and to 77% in 2012. The ImproveCareNow Network will continue to apply the Model for Improvement and use QI tools to improve the remission rate to 80% or more.

The Search for New IBD Therapies & Cures

Posted on 8 January 2013 by sarahnocito

Last month Peter Margolis, MD, PhD – Scientific Director for the ImproveCareNow Network – was interviewed by Steve Usdin of BioCentury on the topic of Network Building. What jumped out at me was Peter’s response to the question: Can the Network that you’ve created also be used to help in the search for new therapies and cures?

Take a look at the video clip: BioCentury 12.30.12 | Network Building

I’ve worked with ImproveCareNow for over two years now and I am constantly impressed with the growing variety of positive outcomes that stem from the work being done across the Network. Although hugely important, it’s not simply about raising and sustaining remission rates for kids with Crohn’s and colitis.