Tuesday, May 19, 2015

CTMS Site Visits

On Friday and then again on Monday, approximately 10 MHRI leaders went on a 'road trip' to evaluate Clinical Trial Management Systems (CTMS). 


A CTMS is a workflow and repository of clinical trials administration, operations and management activities. It adds value by streamlining and standardizing the planning, execution and tracking of clinical research.  By acquiring a CTMS system with our academic partners at Georgetown, we will have a common platform that will allow for efficient, effective and compliant conduct of clinical trials across the system.

After sending out a formal 'Request for Proposals' and conducting demonstrations with vendors here at MedStar-Georgetown, we narrowed it down to two final CTMS vendors.  For these, we wanted to see it in action and talk to the team that implemented them within a busy academic hospital -  we were fortunate that UT (Univ of Texas) Southwestern in Dallas and Yale-New Haven Hospital in Connecticut were nice enough to host us, each for a day. 

As you can see from the pictures below, we had expertise from several areas of our MHRI research operation attend and were joined by our colllagues from Georgetown University Medical Center.  We learned a lot and will be in a much better position to get a CTMS system that works best for us.  The plan is to select the system over the next few months and start installation in the upcoming academic year.






Monday, May 18, 2015

Personalized Medicine: Better, Together

 Guest Blogger: Subha Madhavan, Ph.D., Director, Innovation Center for Biomedical Informatics, Georgetown University Medical Center. Follow her on twitter: @subhamadhavan
“Nirvana or Gattaca?” was the title of the panel on the future of Personalized Medicine at the 1776 challenge festival health day last week. 1776 is a global incubator and seed fund that helps startups revolutionize education, energy, health, transportation and cities. The health day was co-sponsored by MedStar Innovation Institute (MI2) and I had the great opportunity to discuss new developments and challenges in Personalized Medicine, on a panel moderated by Politico’s Arthur Allen, with Kavita Patel of the Brookings Institution, Jasvir Zonobi of Kuveda and Grant Elliott of Ostendio.

Personalized Medicine (or the newer term Precision Medicine) promises to revolutionize healthcare. The rush of innovation enabled by big data has made possible precision medicine, or the tailoring of medical treatment to the individual characteristics of each patient. Near daily discoveries of biomarkers, molecular profiling techniques, and the other tools of precision medicine have stimulated innovative research and inform regulatory decision-making about genetic diagnostic tests or specific treatments for patients with cancer, cardiovascular diseases, neurological disorders and other conditions.
There are more than 15,000 tests for over 2,800 genes. These tests can identify inherited susceptibility to conditions ranging from hearing loss to sudden cardiac arrest. Some genomic tests have the ability to predict disease before symptoms occur. A patient who learns that he/she has inherited cardiomyopathy, for example, can benefit from lifestyle changes and disease-monitoring options to avoid the risk of sudden death. Patients with melanoma, leukemia, or metastatic lung, breast, or brain cancers are now routinely offered a “molecular profiling” in some clinical centers including at MedStar Health; this allows their physicians to select tailored treatments that can greatly improve the chances of survival. Targeted therapies paired with genomic tests are giving fresh hope to late-stage cancer patients and their families. Research is showing that genetic testing to titrate dosing of blood thinner drug Warfarin resulted in 31% fewer hospitalizations overall thus reducing total cost of care.

However, before precision medicine is universally applied in healthcare practice, lingering practical and policy issues need to be examined and resolved. This was the primary topic of discussion for the 1776 panel. We discussed technology challenges associated with converting Patient’s $1000 genome to just few bytes of data in the Electronic Health Record to support the decision support process for the clinician; should genomic data be considered the 19th HIPAA identifier; the complexity of laws and regulations that govern personalized medicine products and services; and finally coverage and payment policies that govern which genomic tests are paid for and evidence required to prove their clinical and economic value. Smart teams of innovators, regulators, payors, policy makers, clinicians and researchers are activated and are working hard to make personalized medicine a routine aspect of health and healthcare.

For our part within the MedStar Health system, we have initiated comprehensive molecular testing for refractory, metastatic cancers. Efforts are underway to collect and curate patient outcomes in standardized databases to demonstrate value of molecular diagnostic testing. Recently, a new collaboration between Georgetown Lombardi Cancer Center, MedStar Washington Hospital Center’s Cardiology department and the Georgetown Innovation Center for Biomedical Informatics (ICBI), funded by MHRI pilot clinical research grant program, is building a predictive model to assess cardio-toxic risk in women with breast cancer who are treated with Trastuzumab, a personalized, targeted therapy. AACR and PanCAN recently awarded a collaborative grant to develop a molecular algorithm for treatment of Pancreatic adenocarcinoma. Many more such efforts are needed to make personalized medicine mainstream in our healthcare systems. As Medicine v2.0 moves in the direction of predictive, preventive, personalized and participatory, patient involvement and shared decision-making will be key.


Thursday, May 14, 2015

HIV H.O.P.E

MHRI associates are doing some great work that is helping many across the region.  Some of these projects are 'implementation science' which puts new ideas into action in the community to advance the health of those we serve. HIV H.O.P.E. is one of those great programs that I want to share with you today.

HIV H.O.P.E. (Homecare Outreach Patient Engagement) is a Washington D.C. Department of Health – HIV/AIDS, Hepatitis, STD and TB Administration (HASTA) funded program developed by Dr. Glenn Wortmann, which started in 2013, and has a staff of three people (Cleo Johnson, RN,  Marques Davis, Community Health Worker (CHW) and Antonio Pineda  - HIV tester).  

HIV H.O.P.E. consists of three parts: Homecare, HIV testing, and Community Outreach.  Cleo Johnson, RN, provides homecare services to patients that have uncontrolled HIV viral loads. The services that are provided to the patients and family members are disease education, medications and side effects and resistance. 

Lab work and virtual visits with an infectious disease physician are also provided in the home for patients that are having trouble making it to the hospital for follow up visits.  Marques Davis, Community Health Worker also provides home visits and assists patients with obtaining social needs such as support groups, transportation to appointments, matching patients with case managers and providing resources for household living assistance.  Since December 2013, a total of 41 patients have been provided homecare services and 22 of those patients are undetectable or have at one time become undetectable. 

HIV H.O.P.E. also performs free HIV testing in the emergency department to patient waiting to be seen by the physician, which is performed by Antonio Pineda and Cleo Johnson, RN. Antonio Pineda also oversees a support group for HIV positive patients at MWHC. Since November 2013, 1,560 people have been tested for HIV.  The last part of HIV H.O.P.E. is Community Outreach.  During community outreach events Cleo Johnson, RN gives a presentation and has an open discussion on HIV; Marques Davis provides HIV testing along with a condom demonstration. Recently, Cleo was recognized from MWHC community relations for her participation in their Speakers Bureau. The community enjoyed her participation on HIV and commended her efforts so much that she was presented with a recognition award. 

Since 2014 HIV H.O.P.E. has hosted 6 HIV testing events, all located inside of MWHC, and has also been invited to participate in 4 different community events. 

Tuesday, May 12, 2015

Good Catch Monday's

Every Monday, the MedStar Quality and Safety Department recognizes someone who has made a "good catch" to help raise awareness and to continue our journey as a High Reliability Organization. This past Monday, MHRI was recognized for a catch during one of our research studies. Read below for this particular story and how we all work together to keep our patients safe.



Medical research is not always easy-to say the least! Participants in clinical research are a critical part of advancing knowledge and clinical care. One of the most important aspects of successful research is in engaging and retaining study patients that fit the requirements of each very specific study. MedStar Health Research Institute (MHRI) is the research arm that conducts research throughout our organization, and one that you will undoubtedly hear more about in the coming weeks and months. In the Good Catch story that follows, you will see how a successful research program is contingent upon safe, high quality care delivered by care providers and research teams alike across our system. Not only does the Allergist at MGUH go above and beyond to keep this particular study on track, but the entire MedStar team is recognized by the patient as having delivered good care. 

Today's Good Catch is from MedStar Health Research Institute
A study participant came in to take part in a research study. It had been determined that he was qualified to participate, however, one exclusion of this particular study was allergy to any of the medications that could possibly be used in the study. This participant had reported a reaction to Bactrim (a sulfa drug) about 20 years ago, which could indicate risk of allergy to one of the medications of the study. The participant was unclear if the reaction he had had was a true allergy to sulfa drugs. He was very interested in participating in the study, but the research team and patient needed a better understanding of his allergy risk before proceeding. The research team offered to connect him to an allergist to learn more about his allergy status.

Once the study sponsor and IRB approved allergy testing, with specific testing using the possible study medicine, the team was able to get the participant in to see MGUH Allergist, Dr. Stefano Luccioli, on short notice. On behalf of the research team at the MedStar Community Clinical Research Center, Amy Loveland, GRADE Program Manager shared: "We were beyond impressed that Dr. Luccioli was able and willing to work this participant into his schedule with one day's notice, having had no previous interactions with us. His documentation of his impressions and recommendations in the medical record were crystal clear, reflecting exactly what we all needed to know on behalf of the patient. Dr. Luccioli worked our participant in at the very last minute in order to accommodate our research timelines.  The participant remarked to us how friendly and helpful everyone at Dr. Luccioli's office was, and how smoothly the whole process went. With a system as large as MedStar, it is heartening to know that we can call upon colleagues across the system and they will do whatever they can on behalf of our research participants.  The final bonus is that the participant communicated to us his satisfaction with every MedStar team member with whom he has had contact."

The research team is  happy to report that the participant successfully completed his medication allergy testing. He was cleared to participate in the study and his diagnosis of "sulfa allergy" was clarified in his medical record to "Bactrim allergy". He was recently randomized into the study and now has a better understanding of his own medical condition.

Thank you Dr. Luccioli, Amy and the entire team at MHRI, for constantly working so hard to keep our patients safe.



 
Be proactive. Be reliable. Be a hero.

Friday, May 8, 2015

19th Annual MWHC Research Day


Earlier this week, I was privileged to speak at the 19th annual Research Day at MedStar Washington Hospital Center, an event I’ve been attending for almost 15 years!  

For those of you who aren’t familiar, Research Day is residents’ opportunity to submit their research they’ve conducted to a panel of experienced clinician researchers and compete to recognize 'best in class' by being selected for an oral presentation and ultimately win a cash prize (and, of course, bragging rights). Participants’ submissions are broken into one of four categories: either manuscript or poster from first to third year residents (Post Grad Year (PGY) 1-3) or, manuscript or poster from fourth to eighth year residents (PGY 4-8).  

There was a double winner this year – Shawn Tejiram, MD, a PGY-2 general surgery fellow working in the Firefighters' Burn and Surgical Research Laboratory.
Tejiram said, "I've long had a desire to perform basic science research and really understand academic medicine. I'm fortunate that Dr. Jeffrey Shupp's lab has provided me with those opportunities. It was an exhilarating experience presenting our ongoing work to the MedStar faculty. Winning both awards was unexpected, but it represents the collaboration of everyone in our lab and I'm proud to have worked with them."

A week before the event all the poster finalists were hung in True Auditorium at MWHC and then finally, on May 2nd, both oral and poster finalists presented the findings of their research.

From the burn lab to improved radiation treatment for breast cancer to bedside nanotechnology, there was a lot of promising research presented at this year’s event. As the Keynote speaker I encouraged the residents to find ways to research healthcare delivery and remember their role they play in advancing health as part of the MedStar system.

As we look to the next 20 years of resident research day, I will be working with the education leaders across MedStar and hope to make Research Day for residents and fellows bigger and more visible, perhaps tying it to the success of our annual system wide Symposium.

Congratulations to all the winners, listed below.

An online version of the complete 2015 Research Day book, containing full manuscripts and all abstracts, can be found at

Manuscripts:
PGY 1-3
Shawn Tejiram, MD
General Surgery/Burn Research
“Pressure Therapy Augments Collagen Composition in Hypertrophic Scar”
PGY 4-8
Athansios Bikas, MD
MedStar Health Research Institute Fellow
“Induction of Oncosis in Glucose-Deprived Thyroid Cancer Cells”

Posters:
PGY 1-3
Shawn Tejiram, MD
General Surgery/Burn Research
“Vascularity and Perfusion Are Influenced by Compression Therapy in A Porcine Model of Hypertrophic Scar”
PGY 4-8
Zarah Lucas, MD
Hematology/Oncology
“Pilot project to determine the predictive value of microRNAs in breast cancer brain metastases”



Wednesday, May 6, 2015

Wearing the MedStar Colors

So when I was sent this picture (of Christine Alhambra, Communications and Marketing Coordinator at MHRI, and Michele Lee Clements, Research Planning Manager at MHRI), I asked what was the occasion? 

"We are wearing MedStar colors by coincidence and had to capture it! :)"

It is also very spring like. Thanks for the MedStar spirit ladies - can't wait to see what you come up with tomorrow!