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Center for Personalized Healthcare March 2014

From Concept to Reality: The Most Important Things You need to Build Your Personalized Healthcare Program

The field of personalized healthcare is still in its infancy. Without a precedent, it is often difficult to pioneer a clear path. We use the latest technology combined with earlier findings in patient care to make the best decisions moving forward. It’s rigorous but generally we remain on course to integrate the cornerstones of personalized healthcare into our standard of care here at Cleveland Clinic.

As leaders, members of our department often get asked, “What must be in place before we can expect to implement a personalized healthcare approach into our clinic?” Although we feel people anticipate answers like high tech electronic health record, ability to effectively handle big data or availabity of monster budgets, our answer often shocks people—especially when they learn the answer is not even tangible.

Based on our experience thus far, we have found the following three things to be paramount in the launch of a successful personalized healthcare initiative.

Open-mindedness of clinicians, leadership, and patients. This may sound too elementary but it is a truth we stand firm with. Your efforts will increase exponentially if you are not fighting an uphill battle. We have discovered that one way we could prepare our landscape for the inclusion of personalized healthcare was to maintain continuous campaigns to educate and create awareness. By approaching our population of clinicians and patients with an informative and open learning environment, we have hopefully curtailed the common question, “what is personalized healthcare?” The backbone of most of our educational efforts has been the importance of family health history and patient activation.

Second on the list of requirements is willingness to learn. One highly effective and telling way to gauge how our audience learns was to simply ask them. We built a survey that went to our clinicians so that we could learn about them before we educated them. If you present new materials in a way consistent with preferred learning modes, you have a better chance of building meaningful foundations for your program.

Finally on this list is the commitment to building systems that help make integration of this information more efficient. Electronic systems will make it easier but are not essential. This may be the most encouraging news of all and it gets back to organizational buy-in; if you have it, you have a green light. In fact, if you don't have a commitment from your executive team, you should rethink the viability of your efforts. Many projects in personalized healthcare have run aground when management failed to take ownership or at least sponsorship.

These intangible traits are very difficult to measure and are almost always a result of culture within an organization. For example, an innovative health center is more likely to espouse new approaches for standard of care. This is not to say change is impossible in all organizations, it simply means that education efforts should be scalable accordingly.

An Interview with Dr. Michael Rothberg About Shared Decision-making

As healthcare reform is taking shape here in the U.S., we are hearing more about shared decision-making as a way to improve value and patient satisfaction. Dr. Michael Rothberg, Chair of Cleveland Clinic’s Medicine Institute Center for Value-Base Care Research, shares his experience with shared decision-making in the setting of primary care.

JD: How would you define shared decision-making?

MR: Shared decision making is a process of decision making in which patients and physicians make a decision together, incorporating the patient’s unique values, beliefs and medical condition.

JD: In what circumstances would you encourage shared decision-making?

MR: Shared decision making is appropriate for most medical decisions. It is particularly useful for those decisions in which there is no obvious right answer, or when decisions involve tradeoffs that mean different things to different people. For example, imagine a patient has heart disease and experiences chest pain when she walks up 2 flights of stairs. She has a stress test that shows she may have a blockage in one of her coronary arteries. Although that sounds serious, studies have shown that placing a stent in that artery will improve her symptoms for a time, but will not reduce her risk of having a heart attack, so the decision to have the procedure should hinge on how bothered she is by the symptoms, and how much risk she is willing to undergo to have relief for a year or two. No physician can answer that question for her, so shared decision making is important. Shared decision making is also appropriate for patients who are trying to decide whether to have a prophylactic mastectomy to reduce their risk of breast cancer, to take cholesterol lowering medication to reduce the risk of developing heart disease, whether to choose peritoneal dialysis over hemodialysis, whether and how to be screened for colon cancer, and when to start insulin for type 2 diabetes.

JD: Are there any circumstances in which you would advise against shared decision-making?

MR: There is not much role for shared decision making in emergency situations. So physicians should not ask a patient who is vomiting blood whether they would like to undergo endoscopy or if a patient is having uncontrolled seizures whether they would like to receive antiseizure medication. There is also no room for shared decision making when the decision is requires a lot of technical expertise. There is no need to ask the patient what voltage we should start with for cardioversion or what type of sutures to use in sewing up a laceration. However, once you start examining medical decisions, you realize that most of them could be shared, if physicians were willing to explain the issues to patients. Something that seems technical—whether we should use a drug eluting stent or a bare metal one—actually has implications that a patient could understand. The drug-eluting stent is more expensive and requires that the patient take an antiplatelet medication for an extended period of time, while the bare metal stent is more likely to get blocked and require another procedure. These are issues about which the patient may have a preference, but they don’t even realize there is a choice to be made.

JD: In your experience, do patients prefer this approach? How about physicians?

MR: In my experience, patients do prefer to be part of the process, once they realize that they can be, and that they have important information to contribute. Although some patients want to rely on the physician to make the ultimate decision, they do want their opinion and preferences to be heard. Although this process can take more time, which can definitely slow down a physician’s day, in the end, if the patient is involved in the decision, we may end up using fewer resources because we give patients what they want. In a value-based world, this will make it worth the physician’s time to provide this sort of information. At the same time, physicians are probably less likely to be sued if they present the patient with all the information and the patient makes an informed decision, so informed decision making offers physicians peace of mind, too. In the end, the greatest satisfaction comes from giving patients the healthcare that they want.

Lori Weinstein, Personalized Healthcare Hero Award Recipient

This quarter’s recipient, Lori Weinstein, is the Senior Director, Service Line Marketing. Lori has been an integral advisor and team-member in our efforts to bring awareness and educate about personalized healthcare. Lori has played an active and engaged role with the CPH team, providing critical feedback and offering creative suggestions for marketing, awareness, and education. She has facilitated opportunities which have allowed CPH to better build awareness of its initiative, and she has helped to plan and market key events, such as the 2012 Personal Healthcare Month Health Talk featuring chef Rocco Whalen.

In addition to Lori’s efforts at Cleveland Clinic, she also plays an active role in the Personalized Medicine Coalition (PMC), a national organization that promotes and advocates for personalized healthcare. Her alignment with PMC helps to strengthen Cleveland Clinic’s role as a leader in the field of personalized healthcare.

Our team has enjoyed working with Lori. We have particularly appreciated her time and willingness to brainstorm ideas and create solutions. We appreciate her expertise and professionalism and her ability to connect us to many opportunities. We thank Lori for her commitment and her dedication to helping us bring awareness to the personalized healthcare initiative. Her presence on our team will undoubtedly advance our success in the local and international scientific community.

Personalized Medication Program Gene-drug Pair Implementation Goals for 2014

In the previous issue of our e-newsletter, we introduced you to our newest team member: Pharmacogenomics Clinical Specialist Dr. J. Kevin Hicks. In this issue, Dr. Hicks shares his vision for the goals for gene-drug pair implementation in the Personalized Medication Program for 2014.

1. Implement pharmacogenetic testing for HLA-B*15:02 – anticonvulsant drugs (carbamazepine, phenytoin, fosphenytoin, oxcarbazepine, eslicarbazepine acetate, and lamotrigine). The Personalized Medication Program has integrated the gene-drug pairs HLA-B*57:01-abacavir and TPMT-thiopurines into the clinical workflow. The next gene-drug pair targeted for clinical implementation is HLA-B*15:02 – anticonvulsant drugs, with Best Practice Alerts guiding test ordering and pharmacotherapy recommendations. Individuals who are carriers of the HLA-B*15:02 allele have an increased risk of carbamazepine-induced Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Individuals who carry the HLA-B*15:02 allele are approximately 100-fold more susceptible to carbamazepine-induced SJS/TEN than those who are non-carriers of the allele. The HLA-B*15:02 allele is more prevalent in some ethnicities (Asian populations) than others (African and European), therefore the Personalized Medication Program will target those of Asian descent for HLA-B*15:02 genotyping.

2. Implement pharmacogenetic testing for CYP2D6 – pain medications (codeine, tramadol, hydrocodone, and oxycodone). Serious and fatal adverse events have been observed in pediatric patients who were prescribed codeine after a tonsillectomy and/or adenoidectomy and had evidence of rapidly metabolizing codeine. In response, the FDA issued a boxed warning stating that codeine is contraindicated for pediatric patients following tonsillectomy or adenoidectomy. Codeine is a pro-drug that is metabolized by CYP2D6 to the more active form morphine. CYP2D6 genotyping may help identify individuals who are ultra-rapid metabolizers, in which they process codeine into morphine faster than normal. CYP2D6 ultra-rapid metabolizers may be exposed to a larger amount of morphine than expected, which can lead to respiratory distress and potentially death. The opposite can also occur. CYP2D6 poor metabolizers process codeine into morphine slower than normal, so those individuals may not receive appropriate pain relief. A CYP2D6 pharmacogenetic test can help predict how a patient may respond to codeine-containing medications. It is important to note that adverse reactions to codeine can occur in adults, as well as in the absence of tonsillectomy or adenoidectomy.

Personalized Healthcare Highlighted in Dr. Cosgrove’s New Book, The Cleveland Clinic Way

How important is personalized healthcare in the future of medicine? Important enough to be considered one of eight trends that will define the future of medicine according to Dr. Toby Cosgrove in his new book, The Cleveland Clinic Way.

In his book, Dr. Cosgrove describes personalized healthcare as the approach by a physician or health system that uses information about the individual patient (not the population) to help develop treatment strategies. While these approaches can result in better outcomes for patients, Dr. Cosgrove points out that personalized healthcare can also go a long way to increase the value patients receive for their health care dollars. In an age where the market will demand better outcomes and leaner operations, it’s most appropriate to consider tailor made approaches as a real solution.

Dr. Cosgrove divides the field of personalized healthcare into three distinct clinical applications: risk assessment based on family health history, customizing therapies and patient activation. The Center for Personalized Healthcare is making effective strides in all of these areas. From our tool for clinical risk assessment based on family health history (MyFamily) to our Personalized Medication Program (PMP), we are well anchored but nimble enough to adapt to changing technology platforms.

So what does all this mean for you and your patients? Admittedly, personalized healthcare is robust in concept, but according to Dr. Cosgrove, there are things you can have your patients do today. First and foremost, encourage them to become true partners in their healthcare. This is the activation part and often the most difficult, but we know that it is a cornerstone to improving outcomes and increasing value. Also, encourage patients to collect and share their family health history if they haven’t already.

While it is only one piece of the puzzle, personalized healthcare has the potential to dramatically change the way healthcare is delivered, and in doing so, aligns with Cleveland Clinic’s mission of putting Patients First.

Deploying Personalized Medicine for Smarter Therapeutic Targeting of Brain Tumors

Cleveland Clinic’s Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center offers genomic profiling primarily for patients with new or recurrent glioblastoma, or atypical or malignant meningioma. It can provide a more rational basis on which to choose drug therapies, be they conventional or investigational, by offering data about particular characteristics that a patient’s tumor may have.

“The genomic profiling is looking for specific pathways within the tumor that we might target,” Dr. Gene Barnett, Director of the Burkhardt Brain Tumor Center, explains. “The results can help us avoid treatments that are not predicted to be helpful while suggesting other treatments that are more likely to be in the patient’s best interest.” Historically, he says, patients have been treated with a standard drug paradigm or an investigational therapy without knowledge of whether their specific tumor would or would not benefit from that approach.

The tissue analysis uses next-generation sequencing to assess for hundreds of known cancer genes, and results are available in two to three weeks. The process requires an adequate amount of tumor tissue, so testing cannot be performed for all eligible patients, particularly if they have had a needle biopsy. However, in some cases more invasive or larger biopsies can be performed so that tissue can be submitted for comprehensive testing.

The testing is very sensitive in finding many types of gene abnormalities, Dr. Barnett says. Nearly two-thirds of all tissue samples assessed are found to have at least one actionable gene alteration. Because the profile is of the tumor, not the patient’s own genome, it does not necessarily provide any information about heritability of the patient’s condition.

Dr. Barnett adds that more experience and information are needed before genomic testing is incorporated into clinical guidelines. “This type of testing may very well become part of the standard of care for management of certain tumors, but we’re not there yet.”

Meanwhile Dr. Barnett and his Burkhardt Brain Tumor Center colleagues are focused on refining this personalized medicine service to their patients and assessing its benefits, as there is of course no guarantee that it will generate results useful for guiding therapy for any given patient. “In some patients, the results have suggested new routes of treatment we would not have considered on our own,” Dr. Barnett says. “But it’s too early to say how effective it is or not.”

What’s New in the News?

In this segment of the Center for Personalized Healthcare E-newsletter, we highlight a recent journal article or news story that focuses on personalized healthcare topics. This quarter’s article is from researchers at Genomic Health, Inc. and Cleveland Clinic. The study describes the Oncotype DX® Prostate Cancer Assay, which predicts aggressive prostate cancer in patients with early-stage prostate cancer. This RT-PCR assay was developed and validated using fixed paraffin-embedded needle biopsies, which allows the test to be run with a minimal amount of tissue. The Oncotype DX® Prostate Cancer Assay can assist physicians in personalizing treatment decisions for patients with early-stage prostate cancer.