Clinical Research

Archive for Clinical Research

Are Women Better Surgeons? Patient-Generated Data Knows The Answer

As empowerers of patients and collectors of patient-generated data, we’re pretty bullish on the ability for this data to show insights. We fully admit to being biased, and view things through a lens of the patient experience and outcomes, which is why we had some ideas about a recent study that showed female surgeons had better outcomes than male surgeons.

The study, conducted on data from Ontario, Canada, was a retrospective population analysis of patients of male and female surgeons looking at rates of complications, readmissions, and death. The results of the study showed that patients of female surgeons had a small but statistically significant decrease in 30-day mortality and similar surgical outcomes.

Does this mean that women are technically better surgeons? Probably not. However, there is one sentence that stands out to a possible reason that patients of female surgeons had better outcomes.

A retrospective analysis showed no difference in outcomes by surgeon sex in patients who had emergency surgery, where patients do not usually choose their surgeon.

This would lead us to believe that there is something about the relationship between the patient and the provider that is resulting in better outcomes. We have seen this at Wellpepper, while we haven’t broken our aggregate data down by gender lines, we have seen that within the same clinic, intervention, and patient population, we see significant differences in patient engagement and outcomes between patients being seen by different providers.

Some healthcare professionals are better than others at motivating patients, and the relationship between provider and patient is key for adherence to care plans which improve outcomes. By tracking patient outcomes and adherence by provider, using patient-generated data, we are able to see insights that go beyond what a retroactive study from EMR data can show.

While our treatment plans, and continued analysis of patient outcomes against those treatment plans go much further than simply amplifying the patient-provider relationship, for example with adaptive reminders, manageable and actionable building blocks, and instant feedback, never underestimate the power of the human connection in healthcare.

Posted in: Adherence, Behavior Change, big data, Clinical Research, patient-generated data

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Boston University Center for Neurorehabilitation: A Novel Mobile Intervention For People With Parkinson’s Disease

In 2013, when we were a brand new m-health company, we had the good fortune to meet Terry Ellis, PhD, Director of the Center for Neurorehabilitation at Boston University. Dr. Ellis was an early investigator in the value of digital interventions, and saw an opportunity to partner with Wellpepper so that her team could focus on the new care models, and Wellpepper could focus on the technology. The first building blocks in the Wellpepper platform aligned closely with outpatient rehabilitation, and Dr Ellis and team wanted to prove that people who had Parkinson disease could improve strength and mobility without costly in-person visits. At Wellpepper, we also had an interest in proving that mobile health can improve outcomes, and also that those 50 plus could use mobile technology.

Persons with Parkinson Disease (PD) have been described as 29% less active than older adults without PD, and see a 12% decline in mobility for each year after their first diagnosis with the disease. In-person interventions with physical therapists can help, but in the usual care condition, a person has one in-person assessment at The Center for Neurorehabilitation, and may not be seen again for 6 months to a year, during which time there was a decline in mobility. Dr Ellis and team were looking for a way to prove out a novel intervention that could improve outcomes for these patients.

Patient Experience

This video does a great job of showing the patient experience, both with the clinician and while using the application at home.

User Journey from Wellpepper on Vimeo.

Outcomes

While Dr. Ellis and team are still analyzing additional data, and will be submitting to a peer-reviewed journal, and are exploring expanded studies on the topic, we can share some very promising results.

  • This study revealed that using mobile health technology to remotely monitor and adapt exercise programs between bouts of care in persons with Parkinson disease was feasible and acceptable.
  • On average, subjects engaged with the app every week for 85% (+/- 20%) of the weeks with an 87% satisfaction rating.
  • Significant improvements in physical activity, walking and balance measures were observed over 12 months.
  • People who showed lower exercise self-efficacy at the beginning of the study saw the greatest gains.

Technology

  • This technology used the Wellpepper platform, clinic application for iPad, and patient application for iOS. Requirements were for ease of use for both clinicans and patients. Features include the ability to record custom video of patients doing their exercises, for patients to record results, and for patients and providers to message securely with each other.
  • Fitbit was used for patients to track non-exercise activity, and this was the first integration of a consumer exercise tracker with the Wellpepper platform.
  • The entire Wellpepper platform is built on Amazon Web Services, in a HIPAA secure manner, which was a requirement for the study. No data was stored on mobile devices and all personal health information was encrypted in transit and at rest.
  • The Boston University team required a monthly data extract of all patient-generated data for their analysis purposes.
  • Post study, we were able to analyze anonymized patient-provider messages using a machine learned message classifier, and have presented this data at digital health conferences.

The positive preliminary results of this study, lead to a larger study with seniors at risk of falls, lead by principal investigator Jonathan Bean, MD from Harvard Medical School. Details of this intervention are available here. While Dr Bean is also in the process of submitting to a peer-reviewed journal, his assessment is that outcomes exceeded clinically significant measures.

We are looking forward to sharing more about the results of both of these studies when they are publicly available in peer-reviewed journals. If you are a researcher who would like to know more, contact us and we may be able to put you in touch with the study leads.

Posted in: Clinical Research, Exercise Physiology, Healthcare Technology, Healthcare transformation, M-health

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In Defense of Patient-Generated Data

There’s a lot of activity going on with large technology companies and others trying to get access to EMR data to mine it for insights. They’re using machine learning and artificial intelligence to crawl notes and diagnosis to try to find patterns that may predict disease. At the same time, equal amounts of energy are being spent figuring out how to get data from the myriad of medical and consumer devices into the EMR, considered the system of record.

There are a few flaws in this plan:

  • A significant amount of data in the EMR is copied and pasted. While it may be true that physicians and especially specialists see the same problems repeatedly, it’s also true that lack of specificity and even mistakes are introduced by this practice.
  • As well, the same ICD-10 codes are reused. Doctors admit to reusing codes that they know will be reimbursed. While they are not mis-diagnosing patients, this is another area where there is a lack of specificity. Search for “frequently used ICD-10 codes”, you’ll find a myriad of cheat sheets listing the most common codes for primary care and specialties.
  • Historically clinical research, on which recommendations and standard ranges are created, has been lacking in ethnic and sometimes gender diversity, which means that a patient whose tests are within standard range may have a different experience because that patient is different than the archetype on which the standard is based.
  • Data without context is meaningless, which is physicians initially balked about having device data in the EMR. Understanding how much a healthy person is active is interesting but you don’t need FitBit data for that, there are other indicators like BMI and resting heart rate. Understanding how much someone recovering from knee surgery is interesting, but only if you understand other things about that person’s situation and care.

There’s a pretty simple and often overlooked solution to this problem: get data and information directly from the patient. This data, of a patient’s own experience, will often answer the questions of why a patient is or isn’t getting better. It’s one thing to look at data points and see whether a patient is in or out of accepted ranges. It’s another to consider how the patient feels and what he or she is doing that may improve or exacerbate a condition. In ignoring the patient experience, decisions are being made with only some of the data. In Kleiner-Perkin’s State of the Internet Report, Mary Meeker estimates that the EMR collects a mere 26 data points per year on each patient. That’s not enough to make decisions about a single patient, let alone expect that AI will auto-magically find insights.

We’ve seen the value of patient engagement in our own research and data collected, for example in identifying side effects that are predictors of post-surgical readmission. If you’re interested, in these insights, we publish them through our newsletter.  In interviewing patients and providers, we’ve heard so many examples where physicians were puzzled between the patient’s experience in-clinic or in-patient versus at home. One pulmonary specialist we met told us he had a COPD patient who was not responding to medication. The obvious solution was to change the medication. The not-so-obvious solution was to ask the patient to demonstrate how he was using his inhaler. He was spraying it in the air and walking through the mist, which was how a discharge nurse had shown him how to use the inhaler.

By providing patients with useable and personalized instructions and then tracking the patient experience in following instructions and managing their health, you can close the loop. Combining this information with device data and physician observations and diagnosis, will provide the insight that we can use to scale and personalize care.

Posted in: Adherence, big data, Clinical Research, Healthcare Disruption, Healthcare Research, Healthcare Technology, Healthcare transformation, Interoperability, M-health, patient engagement, patient-generated data

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Falls Challenge

How might we enable older adults to live their best possible life by preventing falls? We have entered a challenge with AARP and IDEO to bring our proven falls solutions to the masses. Along side our partners at Harvard and Boston University, we believe that using mobile technology to enhance and scale a proven falls prevention program will lead to better life by increasing access to care and decreasing costs.

The challenge started with over 220 submissions and recently weeded down to the top 40. We’re thrilled to have made the first cut. Our method is proven and we invite you to participate in the next round to refine our idea and help achieve greater impact.

Click here to check out our entry!

 

 

Posted in: Aging, Clinical Research, Healthcare Technology, Outcomes, Physical Therapy, Research, Uncategorized

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HIMSS 2017 Recap: What’s Hot and What’s Hype

Wellpepper had a great HIMSS 2017 Conference with a very busy booth in the Innovation Zone, a panel on the current state of innovation, and a talk on Delivering Empathy Through Telehealth. Here are a few of our thoughts on the conference compiled from our team.Empathetic Care Through Telehealth

Cognitive and AI: Hype

Starting with Ginni Romety’s keynote, Cognitive and AI were definitely the buzzwords of the conference. Everyone is excited about the promise but it seems like the current status is not ready for takeoff. First, there’s a lot of work to get data out of the EMR, and second, no one seems quite sure what the killer use case is going to be. Immediately before HIMSS, MD Anderson announced that after a $62M investment they weren’t seeing value in IBM Watson and were pulling out of the program. That did not stop them from co-presenting with Mayo Clinic and Watson at the conference. The main use case seemed to be shortening the time to identify cancer patients for clinical trials from 30 minutes to 8 minutes. Another example, which just highlights the sorry state of clincial technology, was to use Watson on top of Epic to help staff figure out how to use features. During the session, Mayo CIO Christopher Ross referred to Watson as a toddler. While all of this was disappointing, it’s heartening that for once healthcare is on trend with the rest of the tech world, and possibly pointing to an accelerated evolution of health IT.

IMG_0611Patient Engagement: Hot

In 2016, patient engagement was also hot, but this year, we’d also say it was real. Buyers visited our booth with checklists of capabilities they wanted to see. Pilots were completed last year, and now they are making platform decisions for patient engagement. We’ve noticed this ourselves in the past 6 months, we’ve seen the patient engagement purchase decision elevated to the C-suite, and the decision being made based on capabilities that will address the needs of all patients and all service lines.

Interoperability: Hot

Compared to the previous year, we saw a lot more talk about interoperability, whether that was EMRs building out APIs and developer programs, the CommonWell Alliance, or talk about how block-chain could be used to both secure and transfer healthcare data. Understanding that data needs to flow with the patient, and also that a heck of a lot of data is being created outside the EMR (in patient engagement solutions for example), is driving a greater commitment to interoperability in the industry.

Healthcare Investment: Hot

The Sharks said so, so it must be hot. The HIMSS Venture+ Investment forum this year had a much more diverse set of pitches than previously, including a social venture. and was won by DiaCardio, a woman-led company from Israel automating evaluation of heart ultrasound.

The Affordable Care Act: Prognosis Unclear

Make no mistake, the potential repeal of the ACA is looming heavy even in health IT. Health systems Boehner, HIMSSare concerned about impact on Medicare and Medicaid revenue. While bundles and value-based care have been quite positively received, the current uncertainty is putting a hold on capital expenditures. (Did we mention that Saas can be accounted for as operating expense?) Possibly the most entertaining speculation on the ACA came from former house speaker John Boehner and former governor Ed Rendell. Rendell suggested that we repeal Obamacare and replace it with the Affordable Care Act. Boehner mused that repealing without a plan would place all the blame and problems with the current system firmly on the sitting government, and recommended that it not be repealed.

The Takeway?

We’re still optimistic. IT is increasingly having a seat at the table within healthcare. Although not all EMR implementations have been seen as a success for clinicians, we are seeing a shift to an expectation of better software for both patients and providers, for data to move smoothly, and the promise of insights and better care when that data can be analyzed and acted on. We’re already looking forward to HIMSS 2018 Las Vegas.

Posted in: big data, Clinical Research, Interoperability, patient engagement

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Better Living Through Big Data

This week I had the opportunity to participate on a lively panel at General Assembly Seattle organized by Seattle Health Innovators, and moderated by Corinne Stroum of Caradigm. Fellow panelists included Randy Wise formerly of Group Health and now at EveryMove, Ang Sun of Regence/Cambia, Lifesprite founder Swatee Surve, and Daniel Newton of Accolade.

Corrine sent us a series of great questions in advance, and we had a rich discussion and so many questions from the audience that we didn’t even get to half of them. It’s a big topic, and with payers, providers, and technologists on the panel there was a lot of opportunity for broad perspectives. There’s a discussion of having a follow-up to this panel to continue the conversation—stay tuned for more on that. The general themes of the discussion included the value of big data to influence individual health with examples like the quantified-self movement, but more generally how our ability to collect and analyze can lead to more personalized and better healthcare. img_3265

At Wellpepper, we have a lot of data to analyze. As Wellpepper CTO Mike Van Snellenberg pointed out in his Stanford MedX talk and I’ve also talked about in this paper in The Journal of MHealth, having data provides an opportunity to get answers faster than using the traditional scientific method. Rather than formulating a hypothesis, setting up an experiment, collecting data, analyzing the data, and then going back to the drawing board if your hypothesis is not born out, data enables you to ask a series of questions and get immediate and sometimes surprising answers.

The panel kicked off with the sharing of some surprising things that we’ve found from the data,  ranging from which mental health tools were favored by different populations to the ability to predict hospital readmissions. In addition to finding trends from explicit patient input, we also discussed the ability to draw insight from activities including social media and mobile usage patterns. Swatee mentioned the Instagram analysis that showed color scheme on photos was a predictor of depression.

The ability to combine both passive and active patient-generated data, and draw conclusions from broad date sets these data sources can help to deliver better care – resulting in what Daniel Newton referred to as “small data.” That is, I’m going to learn as much as I can about you, and then tailor care to you, which is the approach Accolade takes.

As with any talk on tracking and data, questions of privacy came up. While all the panelists thought that there have become standard terms for people to opt-in to sharing health data, describing the use of that data was deemed important. At this point, Ang Sun from Cambia (who admitted that, as a healthcare plan, they had a heck of a lot of data on people), mused that he wished his physician knew as much about him as Google did. Generally, there was consensus that, if the purpose of the data sharing was for connecting people with the appropriate healthcare services, people would opt in.

Our panel was pretty aligned on the idea that there is big value in big data for healthcare, but that the general applications and usage are still in early days. First, there are the privacy concerns and even laws. Second, current healthcare organizations using this first generation of EMRs have limited ability to look at aggregate data for trends. However, with new technology and personalized approaches to care, we see great promise in big data and predictive analytics for healthcare.

Posted in: Clinical Research, Healthcare Research, Research, Seattle

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MHealth and Big Data Are Catalysts for Personalized Patient Care

Although there are many complexities wrapped around our healthcare system, Stanford University’s 2016 Medicine X Conference starts finding solutions to improving patient care by focusing on increasing patient engagement and transforming how patients are treated in the system.

Wellpepper CTO Mike Van Snellenberg, who spoke at MedX in September with digital health entrepreneur and physician Dr. Ravi Komatireddy, addressed several important aspects of big data collection.

“Collecting big data is like planting trees. You need to plant the seed of the process or tooling,” says Van Snelleberg. “Over time, this matures and produces data.”

Mr. Van Snellenberg, who has collected and analyzed patient data at Wellpepper, discovered several key aspects of data collection that could improve care continuity for both patient and providers. He shared this to his MedX audience.

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“Wellpepper has already uncovered new understandings about which patients are most adherent as well as indicators of readmissions,” says Van Snellenberg. “That’s very valuable information.”

“We’ve discovered that, as you collect patient-generated data, these types of insights as well indications about the effectiveness of certain clinical protocols will be available to you. This will help allow for providers to encourage positive patient behavior,” he stated.

Mr. Van Snellenberg spoke further at an interview in October about collecting and using patient-generated data.

 

Question: What groups can benefit off the collecting of big data?

Snellenberg: Collecting patient-generated data can ultimately produce better outcomes and patient care for hospital and clinics as well as the patients themselves. The more in quantity and detail, the better it is to help produce good results. Data collection has tremendous value that can allow hospitals and clinics to learn more about their patients in between hospital visits, thereby filling in missing gaps in patient information. We also realized that collecting big data can potentially prevent complications or readmissions by identifying warning flags before the patient needs to return to the clinic.

And as mentioned, analyzing big data has provided us insights about which patients are most adherent. For example, we have found that patients with 5-7 tasks are adherent while patients with 8-10 tasks are not.

 

Q: What are some things you have discovered using patient-generated data?

MS: We were able to make observations on the patterns. We also discovered a strong linear correlation between the level of pain and difficulty of patients.

Traditionally, patient data remained in the hospital. This often left big gaps in knowledge about the patient in between hospital visits. By collecting and data in between visits to the hospital, you can discover important correlations that would not have been discoverable without data.

 

Q: What are some possible methods to collect patient data?

MS: Dr. Ravi Komatireddy, who worked in digital health, suggested several programs such as Storyvine and AugMedix.

Usually, data is collected by patients recording symptoms and experiences on a daily basis in a consistent manner and then managed afterwards. For example, patients themselves tend to keep track of their progress in diaries or using the FitBit to record the number of steps and heart rate.

 

Q: What are some of the most unique aspects about this year’s MedX?

MS: One unique aspect about the MedX Conference is that it provided more opportunities for diverse voices to be heard in addition to health professionals – including a mix of health patients, providers, and educators.

The mindset was also encouraged to change. Some of the convention’s most progressive talks on stage happened when phrases such as “How might we…” and “Everybody included” are brought up in the discussion.

The term “Everyone included” came up most often, pushing for more perspectives outside of JUST the physicians. MedX’s solution-oriented focus proves to be heading down a successful route to improving patient care in the healthcare system as well as acting as the initiative to open doors for new voices to be heard.

Posted in: Clinical Research, Healthcare motivation, Healthcare Research, Healthcare Technology, Outcomes, patient engagement, Research, Seattle

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A CJR Primer

Recently, I had the opportunity to attend a CJR Bootcamp put on by the Healthcare Education Associates in Miami, Florida. The boot camp setting was intimate, collegial, and well targeted. With the exception of a trio of cardio folks who wanted to get ahead of their bundles, all attendees were directly responsible for implementing bundles at their health systems . The two days were jam-packed with information ranging from understanding the legislation to influencing surgeon behavior to assembling a great team to implement CJR. I recommend that if you’re on the hook for bundles in your organization that you check out this or a similar training yourself.

There is too much to recap in a single blog post, so I’ll share some high-level takeaways:

Bundles Are Complex

Even advanced organizations had gaps in their knowledge and understanding when it comes to the complexity associated with bundles. CMS continues to evolve the requirements and guidelines, causing some implementation approaches to have to rely on predicting what’s going to stick.

For example, the original PRO guidelines were for HOOS and KOOS, which have now been changed to HOOSJR and KOOSJR. If you’re concerned about requirements changing, consider adopting requirements that will benefit you even if they change. Organizations that started tracking HOOS and KOOS have a leg (or knee or hip) up because they have historical outcome data and have hopefully streamlined their processes.

Bundles Require Multi-Disciplinary and Multi-Organizational Teams

Within an organization, you’ll need a multi-disciplinary team that includes clinical, administrative, operational and finance, technology, procurement and so on. You’ll also require an executive sponsor who will make sure senior leadership is aware of and supporting your initiative.

A recommended working group looks like this:

  1. Executive Sponsor(s)
  2. Physician Lead
  3. Project Manager(s)
  4. Care Navigator/Care Coordination Lead
  5. HER/IT Lead
  6. Data Analytics & Quality Leads
  7. Compliance Lead
  8. Legal Lead
  9. Communications Lead
  10. Gainsharing Program Support

You’ll need to be skilled in both project management as well as the ability to influence change. Consider all the stakeholders that need to be influenced – who are the best people to influence them and how?

Think about the rhythm of communication to different stakeholders. Too much and you overwhelm. Too little and people aren’t part of the process.

 Influencing Surgeons

One of the sessions focused on how to change behavior of surgeons. It was presented by Claudette Lajam, M.D. Assistant Professor of Orthopedic Surgery Chief Safety Officer at NYU Langone Orthopedics, who had the task of decreasing costs for implants and improving quality by getting Langone’s to use the right selection criteria. Dr. Lajam studied behavior change theory to implement the change, but it came down to understanding surgeon behavior. She presented them with data, and encouraged competition: each surgeon was able to see in a weekly report where they stood with respect to costs and quality against everyone else in the department.

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In the new model, hospitals are responsible for gain sharing with both upstream and downstream partners where they have less influence and insight. Understanding your top performing orthopedic and skilled nursing partners is key to a successful bundle. In some areas, this risk-and-gain sharing is causing consolidation where orthopedic groups are joining hospitals.

Note that with CJR, different from BPCI, conveners are not allowed. That is, hospitals can only share risk with orthopedic groups and skilled nursing facilities. Organizations that offer to manage your program and share the risk are not allowed to participate in any gain sharing.

Bundles Need Data: But People Don’t Have It

If you need to improve outcomes and lower costs, you need to know where you’re starting from.  To know where you’re starting from, you will need lots of data so that the impact of outliers is harmonized. Not many organizations have this level of detail across their entire pathway, either from organizational challenges or challenges of the system.

Sometimes, this is from a variation of care. For example, one surgeon has most of the complex cases, or another surgeon uses a different combination of implants and auxiliary materials.

Sometimes this is from the challenges of inter-organizational communication. For example, the handoffs between hospital and skilled nursing are notoriously bad – usually with hospitals not knowing where their patients ended up and skilled nursing not knowing why they are there.

Add to this that you can’tthis on top of not being able to find out if a patient is even in the CJR bundle for a period until the CMS data comes back.

So, you’ve got a complex challenge, with large and heterogeneous teams and organizations, and a lack of data. What do you do? Give up? Of course not.

First, attend a boot camp like this one.

Then, treat every patient like they are in a bundle and work on improving outcomes.

Finally, take a look at your position, risk, and low hanging fruit. Even if you only have a few patients in the bundle today, the private payers and self-insured employers are monitoring this closely.

There is Low Hanging Fruit

There are a few areas that have been identified as opportunities to lower costs without impacting quality:

  • Inpatient rehab has been targeted, and often cut. Patients need to get moving soon after surgery, but they may not need as many sessions with a PT directly. We have patients who are following their PT care plan through Wellpepper even in an inpatient setting.
  • Standardization and optimization of implants. Often the implant companies charge separately for each component for the implant and try to upsell on items like screws. Negotiating a standardized bundle can decrease costs here, as can evaluating patients for the best joint for their situation rather than using the surgeon’s favorite. (This was the project undertaken at NYU Langone.)
  • Decreasing the length of inpatient and skilled nursing stay. Equipping patients to be more self-sufficient with joint camps, educational materials, and mobile care plans can enable them to go home faster.

You are Here

Possibly because it’s early days and people are still figuring this out, there isn’t a consistent, phased approach to rolling out the CJR bundle. In fact, you can start anywhere. Or maybe you don’t have to.

First off, make sure you’re in one of the X areas where the bundle is being rolled out. If you are, find out who else is in your region. Your cost accountability is for the average for your region. If there are big spenders in your region, you may already be delivering total joints more effectively than others and may not need to change much besides starting to collect PROs.

Also, take a look at your Medicare population for joint replacement. If it’s low, you may only have a few patients that qualify for the bundle each year – which doesn’t mean that you shouldn’t strive to improve, but it may impact the amount of effort you put in initially.

Figure out where you are today and plan your efforts accordingly. Don’t try to do everything at once and understand that both your process and the information available will continue to improve.

Good luck!

Posted in: Behavior Change, Clinical Research, Healthcare Legislation, Healthcare motivation, Healthcare Research

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Finding Change and Honesty at Mayo Transform Conference 2016

mayo-clinic-logoAlthough the theme of this year’s Mayo Transform conference was “Change,” it might as well have been dubbed “Honesty.”

From keynotes to breakout sessions, there was a raw sense of honesty and acceptance of the fact that change is hard, and we’ve reached a point where the evolution in healthcare doesn’t seem to be happening fast enough.

When you’re as successful as Mayo, it might be easy to brush failure under the rug – which made this session, “We Made This Thing, But It Didn’t Go as Planned. Now What?” unique. Now that some of the initial hype for digital health has died down, we are in a phase of realistic optimism where sharing both wins and misses represents a realistic way forward.

This interactive session in three parts by Steve Ommen, MD, Kelli Walvatne, and Amy Wicks unfolded a bit like a mystery. Questions were posed to the audience at each phase for our input on what might have gone right and wrong. Not surprisingly, the attentive audience proved as capable as the presenters, and some of the most valuable insights came from the audience questions.

The case study in this session was a three-year process to develop a new interface and workflow for the cardiology clinic. Dr. Ommen and the other presenters did not tip their hands to whether the project was successful or not, and we had to tease out the wins and losses that occurred during each phase.

The presenters shared stories, but did not show any artifacts of the process such as flow diagrams, screenshots, or personas. This methodology was effective because, instead of getting bogged down in critique of particular elements, we were able to see the bigger picture of challenges that could apply to any innovation or clinical change.

At the end of the session, the presenters summarized their top takeaways as:

  • Not having enough credibility and evidence

Much of the Transformation team were experts in design, but not necessarily the clinical experience for this service line. There were some misunderstandings between what could work in theory and in practice, although the team did identify areas of workflow improvement that saved time regardless of whether the technology was implemented.

  • Change fatigue (or “Agile shouldn’t be rigid”)

The team tried to use a lean or agile methodology with two-week product sprints: iterating on the design and introducing new features as well as interface changes biweekly. This pace was more than what the clinical users – especially the physicians – could handle, but the design aimed to stay true to the agile process. In this situation, the process was not flexible to the needs of the end users and possibly exacerbated the first point of lack of credibility.

  • Cultural resistance

The team lost champions because of the process. It also seemed like they may have spent too much effort convincing skeptics rather than listening to their champions. One physician in the audience wondered aloud whether the way physicians were included in the process had an outsized impact on the feedback the team received about what was working and wasn’t working. From his own experience, he noticed that a physician’s authority is often a barrier to collaboration and brainstorming.

From audience observations, it seemed like there may have been some other challenges such as:

  • Scope/Success Definition

There wasn’t a clear definition of success for the project. While the problem was identified that the current process was clunky and the technology was not adaptive and usable, not all parties had a clear understanding of what constituted success for the project.

Looking back, Dr. Ommen suggested that rather than trying to build a solution that addressed all co-morbidities, they should have chosen one that worked for the most common or “happy path” scenario. The too-broad scope and lack of alignment on goals made it challenging to conclude success.

  • Getting EPIC’ed

When the project started, the team was largely solving for usability problems created by having two instances of Cerner and one of GE used in the clinical workflow. During the course of this three-year project, Mayo made the decision to ink a deal with Epic, rendering the current problem they were solving for obsolete.

Going for a smaller win early on might have delivered value to end users before this massive shift in the underlying medical records software.

So what happened?

You can probably tell from the recap that the project was shelved. However, the team did have some wins, certainly in their understanding of how to better run a project like this in the future as well as in helping the clinical team optimize their workflow.

What should you take away?

Know your users, iterate, and move quickly to deploy quick wins – but not so quickly as to alienate your stakeholders.

Finally, ask your peers: we’re facing similar problems and can learn together.

Posted in: Clinical Research, Healthcare motivation, Healthcare Research, Healthcare transformation, Outcomes, Research, Uncategorized

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Let’s Talk About Poop

The ups and downs of the first two keynotes at the 2016 Mayo Transform Conference were mirrored in the session The Challenges of Change which highlighted the story of Cologuard. Cologuard is a joint venture between Mayo Clinic and Exact Sciences whose sole goal for the venture was to create a less invasive way for early detection of colon cancer. They succeeded in this goal and were also the first product to receive FDA clearance and CMS reimbursement on the first day. Cologuard launched to much fanfare on national news.

Did they knock it out of the park? Yes. Are they wildly successful today? No. Why? Keep reading and I’ll tell you.

First let’s start with the problem. Colonoscopies, while effective, are not favored by most people. The preparation is extremely uncomfortable, they require general or partial anesthesia, and people need to take time off work. In addition, in some remote communities, it is difficult to get access to care from specialists. As a result, people put off or skip getting colonoscopies and by the time cancer is detected it is often too late. A clinical challenge with colonoscopies is that they are good at detecting left-side tumors but not right side tumors, the incidence of which has been increasing since the 1980s.

CologuardCologuard solves all of these problems. The test is designed to be used at home and is basically a nicely-packaged stool collection kit combined with specialized testing at Cologuard’s lab. No time, and no procedure required for an individual. As well, Cologuard is more effective than colonoscopy at detecting right side tumors, and comparably effective at left-side tumors. Since it’s a home collection, and all tests are processed at Cologuard, access to care is not an issue either and it’s widely used in the Alaska Native Tribal Health Consortium, which was presented as a success story.

Sounds great, yes? Everyone (aka people who at some point will need a colonoscopy or have already had one) I talked to about it thought so. So what’s the problem? As usual, what’s preventing this innovation is an issue of reimbursement. Colonoscopies are a profit center for healthcare organizations, and they are effective, so this isn’t necessarily a case of a better technology losing. It’s the case of a more patient-friendly technology losing, except in Alaska where there really isn’t a viable option for delivering colonoscopies. As well in violation of CMS, some payers are refusing to cover Cologuard.

Cologuard CEO Kevin Conroy was evasive when asked about pricing, which is more expensive than other screenings but pales in comparison to the coimg_0060sts of a procedure that requires booking an operating room and an anesthesiologist.

Let’s hope that a shift to value-based care changes this. From a patient’s perspective it can’t come soon enough.

PS Apparently a lot of single Cologuard kits are being ordered by cardiologists and other specialists. Conroy thinks they’ve recognized the value and are using the kits on themselves. Harrumph.

Posted in: Clinical Research, Health Regulations, Healthcare Disruption, Healthcare Legislation, Outcomes, Patient Advocacy, patient engagement, Patient Satisfaction

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LAM Conference – A patient’s perspective

Dr. George Pappas, LAM Regional Clinic Director

Last weekend, my husband and I attended the Regional TSC and LAM Conference at Swedish Medical Center in Seattle, WA. This conference covered current research developments, treatment options, and patient education. I attended because I wanted my husband to learn more about Lymphangioleiomyomatosis (LAM), because I am a patient. The LAM Foundation defines LAM as “a rare lung disease that usually strikes women during the prime of their lives… this disease is characterized by an abnormal growth of smooth muscle cells, especially in the lungs, lymphatic system, and kidneys.” LAM occurs almost exclusively in women, and it is usually misdiagnosed for years, often as asthma, emphysema, and/or bronchitis. LAM is considered a progressive disease, which can lead to lung transplantation 10 years post diagnosis or for some, like me, it progresses slower. Treatment with a mTOR inhibitor, Rapamune, may improve lung function, which was all the buzz at this conference, but unfortunately there is no cure.

This conference was coordinated by the patient advocacy networks, The LAM Foundation and TS Alliance, and was designed to provide patients with the opportunity to interact with the LAM scientific community, physicians, and patients. I have to be honest, I was surprised to see a packed room because there are only 3-5 LAM patients per million women in the world. I later learned that newly diagnosed patients traveled from as far as Alaska with their loved ones for the same reasons as I: to learn more about clinical drug trials, to ask questions, and meet other ‘Lammies’. This mutual interest was palpable during the presentation by Dr. Ray Yeung, a surgeon and renowned LAM expert. Hands were flying up with questions. Dr. Yeung spoke about the pros and cons of clinical trials, and the pathogenesis of Angiomyolipomas (AML) and LAM. Dr. Yueng had a great amount of positive energy for what he has learned about LAM through his research and it was awesome to hear from a scientist about the importance of patients getting involved in clinical trials.

After the session with Dr. Yeung, we had lunch and I got to talk to a very lovely woman that worked as a Patient Relations Advocate for Lundbeck, a pharmaceutical company that sponsored the conference. Her role was to bring the face of the company to the patient advocacy foundations and their patients, and in return be the voice of patients in order to always keep us in the forefront of the company’s mission. I was particularly impressed with this, especially coming from the pharmaceutical industry, which tends to get a bad rap as being money centric. I continue to be awestruck with her grace, attitude, and lovely disposition, and how she didn’t once talk about her company, but wanted to know more about ME, not my disease. I really hope that our talk (and the fact that I thanked her repetitively) and the other conversations she had with patients that gathered around us, made her journey worth it.

On the drive home, she really got me thinking about how important her role is, and how the information she gathered will be priceless to both Lundbeck and to the LAM community; what she learned cannot be found in any search engine or book. I believe there is a huge disconnect between patients and some of the key players in making us… well, not patients anymore. The folks that advocate for us are so important because not only do they form an overarching understanding of disease, research treatments, help us keep symptoms under control, argue with the insurance companies, help us manage setbacks, etc., they also help us realize there is meaning to getting up in the morning and living life knowing we are not alone. It’s like having a big mama bear always looking out for you, so you can focus on you and not your disease.

Upcoming events…
The International Rare Diseases Research Conference & LAMposium, Cincinnati, OH, Sept 22-25, 2016
LAM Regional Conference, Cleveland Clinic, November 5, 2016.

Posted in: chronic disease, Clinical Research, Managing Chronic Disease, Patient Advocacy, patient engagement, Rare disease, Research, Seattle

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