Tuesday, April 4, 2017

Where do you stand?

Rather than using the Patient Registry data to recognize if your CF care center is above or below "average" on outcome measures like lung function, check out what's possible! Below is the data from 2015. These are the average lung function numbers at the Pediatric CF Care Centers across the US available on the CFF website. Why strive for "average" when you can see what's possible!

The range of average lung function from accredited CF Care Center to accredited CF care center spans from 105.8 to 76.8. Tri-Services Military Cystic Fibrosis Center has an average lung function of 105.8, while West Virginia University Charleston Division has an average lung function of 76.8. There are plenty of "guesses" as to why this variation exists, but it's time to learn and improve. We need to move past guessing and assumptions. I appreciate that socioeconomic differences exist. I appreciate that resources from center to center differ. The fact remains that until we focus effort on learning from one another and improving, outcomes in the CF community will not change. I'm not ok with with. Where do you stand?

This is what I'm talking about in my last post when I mention "variation". What if we could all learn from what the best centers are doing, the centers with the highest outcomes, to try to achieve things that aren't currently possible in other center with the current standard of care! It's time for us to become impatient, require this change, this learning, this opportunity to change the trajectory of our kids lives.

Click on the upper righthand corner of this image below to search for your center to see where you stand. Then tell me where you'd like to go from here!

I'm not okay with this (and you shouldn't be either!)

I wish I could dedicate all of my time to writing because it's the best way for me to relax. In my head I carry 1,000 thoughts that I regularly wish to share, but in the craziness of everyday life I can't seem to find the time to sit down and write it out. I want to get better about scheduling time to do this.

March was a crazy month for me. I've started to work with the FDA's Pediatric Advisory Committee in the Office of Pediatric Therapeutics. It's not a job job, just an advisory role that requires minimal time, but I did have to travel to DC for a meeting at the beginning of the month. It was a fascinating look into the decision making processes of the FDA to protect children and ensure safety of drugs and devices that go to market. I'm always eager to learn more about the complexities of this healthcare system.

Following the FDA meeting, I was off to our second CF Learning Network Community Conference that was nothing short of remarkable. The dedication of the teams in this network to improving outcomes faster fills me with hope. Finally, something that I can do, something that I can be involved in that has a direct impact on improving health and care. I can't place a PICC line, or develop the next big drug to cure this disease. I can fundraise but i'm not good at it. But this is something I can do that has the potential to transform CF care and outcomes.

Here's the thing that I don't think people understand: The efforts of the CF Foundation have been great, and I am grateful for advancements that we have made. But the truth remains:

  • The CF mortality rate across the country has not improved over the last ten years. 
  • The median survival in the US is 11 years less than median survival in Canada (at 50.9 years). 
  • The rate of pulmonary exacerbations in the CF community has not changed since 2004.
Additionally, and we all  know this, the variation in care and outcomes differs, not only between centers but between clinicians within the same center. I know dozens of people with CF who travel to X center because they can do whatever better than their primary center. Or patients who discuss online their preferences for one clinician over another to try to receive better care or achieve better health. And that's not okay by me. Let me repeat that: I AM NOT OKAY WITH THIS. We have to do better. We deserve better. Our care center data, the data used to make clinical decisions and set research priorities is two years old. We are operating with only a rearview mirror, and I'm trying to create a hypothetical dashboard so that we can look ahead and make decisions with confidence, understanding the value of our efforts. I need the rest of the CF community to recognize where we are and say with me that this is not okay, that we deserve better, and that we are committed to working together to achieve them. 

I'm working, with 13 care centers and 30 other parents & patients to create a system that allows us to learn from every interaction so that we can reduce this unintended variation in care, get the right thing to the right person at the right time, every time, and improve care and outcomes. We are working to understand how care is provided at the best CF Centers, learning from their processes and adapting them more quickly to the needs of our center so that we can reduce the unintended variation in care and outcomes. We want to be able to seamlessly share how we are achieving the outcomes at our center so that others can learn from what we know. For example, who knows that the infection control protocol at our care center is unique to our center and has dramatically decreased the rates of infection at our center, which can leads to improvement in mortality rates and survival? I would bet that not even all of the patients at our center know this, but if they did, and if they shared that, everyone would be banging down the doors to their centers saying, 'Hey! Look at them! We want what they have! Lower infection rates, longer lives! Let us help you learn from what they did and learn together about the impact that these changes might have at our center!" What if I had the data to show the secret sauce for Achromobacter eradication (I don't). But what if I was able to collect my data and show the impact on my health and then contribute that data to an enhanced registry so that the next person to acquire that bastard achromobacter didn't have to go through the guessing process for how to treat it? This is what I'm talking about. And it's possible! I know because i'm doing it. This is what the CF Learning Network is and aims to do. Everyone deserves access to this information, but there isn’t a process in place for sharing it. That's what we are changing. The current lack of organization within and across CF care centers results in variations in care and outcomes, and a lot of time wasted trying to recreate the wheel. Raise your hand if your center is working on infection control? Or transition? Or adherence (what does that even mean?!)  Now raise your hand if you're learning from or with another center who might be doing the same thing. Who knows what impact those efforts have? What exactly are you trying to change? What what are you using to determine whether those changes are an improvement? 

Quality care and good health outcome shouldn’t be dependent upon where you receive care. In the CF Learning Network, we believe that everyone has something to teach and something to learn, and that by working together in this new way we can change the pace of improvement in the CF community so that everyone has the best chance of living their healthiest life with CF. 

So we have this incredible Community Conference in March and are now gearing up to bring on 15 more CF centers because everyone is realizing the value of this learning model and that we cannot continue to sit by and watch things stay the same. Let me give you the example of the recent article about the life expectancy for people with CF in the US and Canada having a gap of 11 years. WHO IS OKAY WITH THIS?!?! Not me, in case that wasn't clear. Can we please get impatient? Every article written about that (like this one and this one and yes, even this one written by our very own CFF ) offer guesses for why this variation might exist. What I'm saying is that I'm tired of guessing, especially given that there is a way to stop the guessing and start the learning. We are in 2017. It has been 28 years since the CF gene was discovered. We collect a ton of data and our community includes a ton of smart, dedicated folks, clinicians and patients and parents, and we need to say that this is not acceptable anymore. We need to demand that we do better. We need to figure this out because our kids and our friends lives depend on it. We need to work together. 

In another couple of weeks I should have some data from our network that I can share to show the impact of this new collaboration, of our Learning Network model, on its ability 

This is getting lengthy so i'll wrap this up but want to try to keep writing, as "To survive you must tell stories", so says Umberto Eco. Here's the story I told following the community conference at the American Society of Clinical Pharmacology and Therapeutics about the role that patients and parents can and should play in drug development and healthcare improvement. It might sound familiar if you've been reading this blog for any amount of time, but here's what I had to say:

I was trying to think of a way to introduce myself and I thought that sharing a story would be the best way for you to get to know a little bit about me. It’s a story about my 7yo son who has cystic fibrosis. Cystic fibrosis, for those of you who dont know, is a genetic disease that primarily affects the lungs and digestive system, causing a thick sticky mucus to build up in the body which can lead to life threatening lung infections and impaired digestion. The Cystic Fibrosis Foundation recommends that people with CF be seen by their care team 4 times a year where they ask questions like ‘How’s everything going? What’s his cough been like? How is his appetite? Have you noticed any changes?” And my answers typically sound something like “Good!” and “Pretty normal” and “It was down a couple weeks ago but it seemed to improve.” It’s all subjective, and its mostly from memory. You see, i’m managing my son’s CF in the midst of parenting 3 other kids, working full time, and trying to maintain some semblance of a social life.

As I reflected on these clinic visits, I thought about the value that could come from having a way to quantify the answers to the questions that the doctors were asking us. I went to Facebook and then to Google to see what things other people were using to track stuff about their health. I found an online platform that I could use, and I started to track things about my sons health. And to my surprise, trends began to emerge. I could do personal experiments, looking at changes in my data with the addition or subtraction of a medication or therapy. My care team didn’t seem all that interested in my data, but I found it to be a fascinating learning resource. I was sharing what I found with other patients and parents online, getting their input and feedback on what I was learning.

Then around the beginning of March a few years ago, Drew developed a cough. It wasn’t like his normal cough, though I couldn’t put my finger on how it was different. The frequency wasn’t the same as it has been with other infections. The sound of the cough, something that I can’t quite yet quantify, was different – not totally wet and junky, not exactly tight. His appetite was down. I had talked to his doctor and we decided to try an oral antibiotic, a typical treatment for what they would call a Pulmonary Exacerbation. After a few days and little improvement, we decided that he needed to try IV antibiotics to see if we could kick this. It’s the standard next in line treatment option for an exacerbation. You’ll notice that throughout the course of Ivs his cough still didn’t return to baseline. I was working with my peer community online, and my care team, asking questions like “Did we choose the optimal combination of medications? Is there another treatment that might help better? Are we missing something?” We added a magnesium supplement about a week after we started the IVs, something that my online community of peers had suggested when his care team was left scratching their head, and then upon completion of the IVs tried a steroid to see if that would help. These were all guesses, some based on evidence and others based on anecdotes. All seemed to maybe help a little but weren’t bringing him back to his baseline. This mystery cough continues for over a month. Through all of this, both his doctor and I are monitoring his symptoms and brainstorming together, in agreement that we don’t know what’s going on. She suggests that we may need a hospitalization if these symptoms are going to continue so that he can be monitored more closely.
Desperate to not be admitted, I start digging into my data. What on earth had happened around the time that the cough had developed that may have caused this problem. The only change that I was able to note was that we had stopped Prevacid at the beginning of February, just a couple of weeks before this cough started. He had always been on Prevacid since birth, and we had decided with his care team to take him off of it to see if it was something that he needed or could do without. And when I asked the care team how we would know if it was working, they said that we would notice a change in his bowel movements if he needed it. He takes pancreatic enzymes to help his body digest food, and the Prevacid is a means to control the stomach acid, helping the enzymes pass through his stomach and make it to his pancreas to do their job. If we noticed a change in his bowel movements, then the enzymes weren’t doing their job in regulating fat absorption because they weren’t getting through the stomach intact. I wasn’t even considering how stomach acid might impact his cough. I shared my findings with his doctor and we agreed that restarting the Prevacid was not a bad idea to try.

We restarted prevacid and within a week his cough had returned to baseline.

This change in his care was the result of a suggestion that I had made, not the care team. And it was based on data that I had collected, data that to this day doesn’t exist in his electronic health record. And there was a cost to this! It was his health that suffered - days of school missed, infection control risks associated with PICC lines and hospital admissions, antibiotics that weren’t necessary for a kid whose threat of antibiotic resistance is a real issue. There were days of work missed for my husband and myself, and an impact on the rest of our family with the limited.

My name is Erin Moore. I am the mother of 4 kids and work with Cincinnati Children’s in Quality Improvement related to the patient and family experience of care, and with Eli Lilly as an Patient Advisor. I’m what you might call an ePatient - equipped, enabled, empowered and engaged in my health or the health of someone i care for, I also consider myself a Citizen Scientist. Citizen science (also known as crowd science, crowd-sourced science, or networked science) is scientific research conducted, in whole or in part, by an amateur (or nonprofessional scientist. I do this out of necessity. It’s not possible for any one of my sons doctors to understand all that there is to know about CF, let alone his personal experience with it. I consider it my job to learn all that I can to offer a personalized approach to treating him and giving him the best chance at a good health outcome. I collaborate with my peers, clinicians and patients, to share what we know and change what we can, together. There’s additional benefits to citizen science. The massive collaborations that can occur through citizen science allow investigations at continental and global scales and across decades—leading to discovery that a single scientist could never achieve on their own. Have you ever tracked something about your health - logged steps via a fitbit, or documented the days you’ve had a headache or the pounds lost on a particular diet? Contributing what you know to the improvement of your own outcomes and the outcomes of others is citizen science, and you may already be involved!

The question that I want to present today is though is what if the next person to have a problem similar to the one my son had could learn from our experience, seamlessly? What if there was a better way to learn together from every interaction, curating content from multiple sources, sharing the value that came from our individual interactions with it, building on it for the next person whose path it crosses?

We're creating this in the work I do with Cincinnati Children’s hospital on the development of learning networks, groups of patients, clinicians and researchers working collaboratively to design and test solutions and tools that have the potential to improve care and outcomes in rare diseases. We all have something to share and we all have something to learn. There is a desperate need for us to shift in healthcare from doing things for patients to doing things with them. The experiences of our everyday lives, in caring for these sick kids, or medically complex partners, or aging parents, our experiences are our expertise and both can and should be valued as complementary to the expertise that health care providers share.

My son has a multi-drug resistant bacteria growing in his lungs that has had us in and out of the hospital for years. The medical journals suggest that he will lose roughly 4% of his lung function every year. What I need is access to real-time, trusted, reliable information on everything from novel approaches to eradicate that bacteria, to reasons why having a certain pet could be detrimental to his health. I want to know what other parents know and have tried, and I want a doctor to weigh in on why those options may or may not be good for me. I want to hear about what tracking methods people use and how they connect with their doctor between visits, but even more, how its improving their care. I want other patients to feel empowered to ask about alternatives and suggest trying something new to their doctor, no matter how novel it may be. And then I want to work with the research team to develop the research agenda. I want the next person to ask these questions to intersect with the answers that I found, seamless. Access to information like this, to people, to life saving treatment options, should not be left to the chance of a desperate parent or patient stumbling upon it on Facebook. We really have an ethical and moral obligation to work together!

Here we are in 2017, with a tremendous opportunity to utilize existing technologies to expedite the delivery of the right treatment to the right patient at the right time, every time - stuff that can be useful in clinical care and in clinical research - and yet we're not. There are seamless intersections between people and information in almost every other aspect of our lives – my Amazon Dash button allows me to order new laundry detergent while I’m standing next to my washing machine when I realize that we are running low. Coffee for my Keurig automatically shows up every month in the quantity that the internet has figured out that we drink on a monthly basis. Netflix can give me recommendations of shows that I may like, a starting point if you will, based on my previous viewing preferences. Yet it takes 5 phone calls and a trip to the pharmacy to pick up a MAIL ORDER prescription that we have taken every month since my sons birth and will likely take until the day he dies. We use fax machines to get pre-authorizations and share medical records, MY data, that I often have to pay to get access to, and when I receive that paper version it is often full of errors.

You may recognize this screenshot from the movie Apollo 13 when the astronauts lives literally depended on fitting a square peg into a round hole . The NASA engineers dump everything to which the astronauts have access on the table, and are given the challenge of using what’s on the table to transform the round receptacle to fit the square filter. It’s an impossible task, but these people are solution-based thinkers and their friends’ lives are at stake. And they figured it out. They walked out victorious an hour later carrying a contraption that was once a non-existent solution. They used duct tape and cardboard and creativity and determination and never once said “we can’t do this.” They did it because they had to. And that’s exactly how the parents of children with rare disease are – innovating with cardboard and duct tape and creativity and determination and technology to save our kids lives, because if we don’t, no one will.*

Sharing my experiences on my personal blog and at the medical centers where we receive care has opened the door to many new opportunities for me as an ePatient, like the one I have that brought me here. I work with the clinical innovation team at Eli Lilly as an ePatient advisor, blogging and helping to guide them through feedback, providing insights on how increased focus on patient centeredness and real world evidence is changing the healthcare ecosystem and how these trends may affect drug development, and keeping the patient voice front and center in clinical trial innovation.

Patients and their families experience research and care in a way that you may never fully understand. Our expertise should be seen as complementary to the care teams and researchers, and I believe that the path to collaboration and ultimately improvement is a humble awareness of that shared humanity. There are days when I think about the fact that CF is a progressive and fatal disease that does not have a cure. Then I remember that life too is both progressive and fatal. I hope you’ll consider the value of including patients as partners, true patient integration, and the profound effect that it can have on improving health and changing outcomes.

*This paragraph was adapted from mom-blogger Kelle Hampton 

Sunday, January 1, 2017

The CF Learning Network

The Cystic Fibrosis Foundation has been a driving force behind research on therapeutics to increase longevity. It has a well-developed national Care Center Network, a transparent patient data registry, and long-standing quality improvement (QI) infrastructure. There are dozens of initiatives and thousands of people working tirelessly in the fight against this disease. Together, these assets have created a solid foundation on which to build a system to achieve transformative outcomes.

However, recent data suggest that progress has plateaued within the current CF care system:
  • The CF mortality rate declined from 2.1 per 100 in 1999 to 1.6 in 2004, but has not improved over the last ten years. 
  • The predicted median survival rose steadily from 28.9 years in 1999 to 39.3 years in 2014. But median survival in the US is 11 years less than median survival in Canada (at 50.9 years).
  • The rate of pulmonary exacerbations has not changed since 2004. The number of days of treatment required for these exacerbations has increased slightly, with home IV treatment days declining and days in hospital more than making up for that decrease.
  • Despite the accomplishments and transparency of the CFF Patient Registry, data are reported at more than a year lag, and the existing technology has not kept pace with advances in registry technology, much of which has the potential for real-time .
  • Cost pressures continue to rise both for clinical care and therapeutics.
If you've followed the work I've been doing in any capacity over the past several years, you're likely familiar with the terms "C3N" or "CF Care Model of the Future". We've made it! We're there! We are now, officially, the Cystic Fibrosis Learning Network (supported through a grant from the Cystic Fibrosis Foundation and the James M. Anderson Center for Health Systems Excellence at Cincinnati Children's Hospital). 

We're not the first disease community to do this. The Crohn's & Colitis community became a learning network (read thisImproveCareNow) in 2007. At the time, clinical research said something like the greatest potential for remission, an outcome measure in this disease community, was roughly 68% given the currently available medications. Once they organized themselves into a Learning Network, sharing across centers, creating a real-time data registry, involving patients and parents in the identification and creation of solutions and tools, they started to grow the number of patients in remission well beyond the amount suggested by clinical research. They now have more than 80% of their population in remission with no new medications, just simply by sharing seamlessly and stealing shamelessly what works best throughout their network; by thoughtfully testing out improvement initiatives using the Institute for Healthcare Improvements Plan - Do - Study - Act cycles; truly, by working together, learning from every interaction and spreading what works. 

There's also the Learning Network for the Heart Community, the National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC). For the past 7 years, a group of clinicians, researchers, and parents, from across 60 medical institutions have been collaborating to ensure that families of children, who receive a diagnosis of Hypoplastic Left Heart Syndrom (HLHS), and other univentricular hearts, have hope. Together, NPC-QIC and Sisters by Heart, a parent partner organization, have harnessed the power of quality improvement tools and methods to improve the health outcomes for these patients, promote transparency of outcomes data, and enhance communication between clinicians and parents. To date, patients have a 95% chance of surviving the interstage period, 77% of whom have satisfactory growth during the interstage period. Read their one pager, its fascinating - https://npcqic.org/sites/default/files/NPCQIC_1Pager_2016_11_15.pdf

There are more than just these two Learning Networks doing fascinating work. In fact, there are 5 well-established learning networks and 6 emerging learning networks, one of which is the CF Learning Network. 

Thirteen CF Programs were recruited for the first wave of the CF Learning Network in July of 2016 and each team includes at least one parent or person with CF on their team to collaborate on this work. Additionally, we have a team of Community Innovators, parents and people with CF who are organizing their improvement ideas and using QI methodology to grow the number of community members who are equipped and enabled with the skills they need to create and sustain strong care partnerships. We expect approximately 15 more teams will be joining the our network for the second phase of our pilot in the summer of 2017. In short, we are a group of patients, parents, clinicians and researchers working collaboratively to reduce the unintended variation in CF Care and ultimately improve outcomes by identifying and testing solutions and tools that have the potential to improve health and care in the CF Community, learning from every interaction and sharing what we've learned. Want to know if your center is participating? Ask them! Want to be a part of this? Join us! Email me (erin.moore@cchmc.org) and I'll send you the information for our monthly calls. Your center does not have to be participating for you to join us. This is about the community coming together, bringing everyone's good ideas and thinking about the impact that they have on the outcomes that are most important to the community, collectively. 

Our aim is to achieve outcomes that are not possible through the current system of CF Care. We're working to take the guess-work out of CF Care. We expect that, by December 2018, the pilot of our CF Learning Network will have demonstrated progress toward improving outcomes and established an infrastructure for ongoing collaborative learning so that your health outcomes aren't dependent on your zip code or what your doctor happens to know.

During the design phase we worked with all stakeholders in the CF Community to dream up the perfect system for CF care and then thought about what we would need to change in order to achieve that - What are we trying to change? How will we know that a change is an improvement? What changes do we need to make to see those improvements?

Check out this vision - what if we could create a system for CF care that achieved this, simply by working together smarter, in the Learning Health System Model. This gives me so much hope!

The CF Learning Network serves as an engine for innovation that designs, tests, pilots and implements innovative ideas that have the potential to change outcomes. Together this community is working to create an immensely different health system that improves health and quality of life for people living with cystic fibrosis.

This isn't a dream anymore! It's really happening, and I can't wait to show the world what we can do!