More News & Breakthroughs
Dr. Lee Gemma leads post-market approval study testing long-term safety and efficacy of Cardiac Contractility Modulation device.
Cardiac Contractility Modulation (CCM) is a device-based treatment for heart failure that applies high voltage, long-duration biphasic signals to the right ventricular septal wall during the absolute myocardial refractory period. In contrast to a pacemaker, CCM signals do not elicit new cardiac muscle contractions; rather, they enhance the heart’s natural ability to contract over a long period of time. MCRI investigator Dr. Lee Gemma, MD, FHRS is leading the OPTIMIZER Trial (NCT03970343, sponsored by Impulse Dynamics) at Mount Carmel to evaluate the long-term safety and efficacy of the Optimizer Smart System, the only FDA-approved device for the delivery of CCM therapy. Outcomes from prior, smaller CCM studies have demonstrated CCM is safe and effective in improving exercise tolerance and quality of life in heart failure patients.
The MCRI welcomes Ann Salvator to the newly created role of Trauma Research Specialist at Mount Carmel Health System.
The MCRI, in collaboration with Trauma Services, recently created a new position of Trauma Research Specialist to serve investigators and service research initiatives that will support the verification requirements for Mount Carmel East to become a Level I Trauma Center. Ann joins Mount Carmel with over 16 years of experience as a Trauma Research Coordinator at Akron General Hospital, a Level I Trauma Center. In that role, she collected and analyzed data from state and national trauma registries and worked closely with trauma surgeons to publish manuscripts and prepare presentations for trauma-related meetings. A biostatistician and epidemiologist by training, Ann has authored over 40 peer-reviewed articles during her career. She is also the Founder and Director of a non-profit charitable organization called YOCAMA that provides health, dental, and developmental screenings to Navajo preschool children. We welcome you to the team Ann!
Is Minimal Residual Disease (MRD) useful in directing therapy in patients with multiple myeloma?
Technological advancements in genetic sequencing now enable the detection of very small numbers of myeloma cells (as few as 1 in 1,000,000!) that remain in the bone marrow of patients following treatment. Referred to as Minimal Residual Disease (MRD), the detection and monitoring of these remnant oncogenic cells has proven to be critical for monitoring remission status and detecting risk of relapse. The DRAMMATIC Study (NCT141729) developed by the Southwest Oncology Group (SWOG) and championed locally by Oncology Research Nurse Rosemary Zacks, seeks to test whether MRD status is useful for either directing continued maintenance or stopping maintenance with FDA approved (lenalidomide) or experimental (lenalidomide + daratumumab/rHuPH20) maintenance therapies. Multiple myeloma patients enrolled in this study will be followed for up to 15 years to (1) contribute to our understanding of the clinical utility of MRD for directing therapy, and (2) identify the best maintenance therapy regimen and application for multiple myeloma patients.
Resident Research Spotlight – Tyler Gilliland, MD (General Surgery
The opioid epidemic has not diminished during the COVID-19 pandemic. In fact, the Centers for Disease Control reported that opioid overdose deaths increased during 2020. Previous studies have shown that about 12.5% of adults who use prescription opioids “misuse” them, defined as "(1) use without a prescription of the respondent's own; (2) use in greater amounts, more often, or longer than the respondent was told to take them; or (3) use in any other way a doctor did not direct the respondent to use them." Prescriptions for pain control after surgery represent a significant percentage of prescribed opioids, and many patients do not take the full amount prescribed. This leaves a reservoir available for potential misuse. Tyler Gilliland, MD, PGY-5 General Surgery resident, is conducting a study designed to determine an appropriate amount of opioids to prescribe for post-surgery pain control with the aim to provide adequate pain relief while minimizing leftover medications. The study includes patients undergoing a planned general surgery procedure and who complete a questionnaire at their 2-week post-op visit which asks about their use of pain medications (opioid and non-opioid), their satisfaction with their pain control and whether they went to the emergency department or their physician due to inadequate pain control. Once these data are captured, analysis will identify a prescribed opioid quantity that is adequate for the vast majority of patients. Education will be done to inform surgeons of this amount and then patients will undergo the survey again, to see if the quantity of opioids prescribed has changed while maintaining adequate pain control for post-operative patients. The goal of this study is high quality of care and safety for patients and their family and friends.
2022 MCHS Interprofessional Research & Evidence-Based Practice Day
Mark your calendars to attend the May 4th, 2022 Interprofessional Research & Evidence-Based Practice Day. This annual event will feature research, quality improvement and evidence-based practice projects conducted by Graduate Medical Education resident physicians, faculty and students of the Mount Carmel College of Nursing, MCHS pharmacy residents and others in the MCHS community. This event typically receives praise for the variety of interesting and relevant topics and engaging keynote speakers. In 2021 the event was held virtually, and offered to colleagues across Trinity, with attendees from New England to California. We are planning to host the conference virtually again in 2022.
MCRI Balanced Scorecard Highlights – FY21, Q4
Mount Carmel Research Institute (MCRI) recently compiled the balanced scorecard results for the last quarter of fiscal year 2021, ending 6/30/2021. Key highlights include:
- Resident Investigator Survey. Every six months key MCRI customer groups, including Graduate Medical Education (GME) physicians, are surveyed to determine how well MCRI is meeting their needs. The brief survey asks resident respondents if MCRI is helpful in navigating the research process, improving the quality of residents’ projects and in identifying resources for conducting research. The mean (SD) response was 4.8 (0.3) out of 5, with 5 meaning “strongly agree”.
- MCRI Investigator Growth. The number of active investigators at Mount Carmel Health System grew by 12.9% in FY21 (171 193).
- 5-year i-10 Index Factor. Between FY17 and FY21, there were 58 peer-reviewed publications (indexed in PubMed) authored by MCHS investigators with at least 10 citations. Importantly, this metric, which is referred to as the 5-year i-10 Index Factor, grew over each of the past 3 quarters at MCHS.
MCRI Investigator Robin Driver, RN leads perinatal research testing peppermint oil to reduce urinary catheterization in postpartum women.
Covert and overt postpartum urinary retention following vaginal or cesarean delivery increases the prevalence of urinary catheter use which negatively impacts both length of stay and patient satisfaction. Against that background, MCRI perinatal researcher Robin Driver, RN seeks to test peppermint oil vapor as a safe and low-cost strategy to promote voiding and reduce urinary catheterization in postpartum women. The Postpartum Urinary Retention with Essential Oils trial (PURE, NCT03319498) is directly related to the MCHS hospital performance strategy focused on length of stay reduction and has garnered status queries and collaborative requests from across the country. Staff of the Mother Infant Unit at Mount Carmel East have enrolled 51 patients to date and the team is seeking to expand and expedite enrollment to meet the target of 390 participants.
Dr. Noah Jones enrolls first MCHS patient in trial testing Transcatheter Mitral Valve Repair to treat mitral regurgitation.
Mitral regurgitation (MR) is the most frequent valve disease in the U.S., with significant MR affecting >4M Americans. Unfortunately, ~50% of patients with severe MR do not undergo surgery due to high surgical risk from advanced age, multiple co-morbidities, or lack of familiarity with guidelines. For these patients, Transcatheter Mitral Valve Repair (TMVR) offers promise as a minimally invasive approach for the treatment of severe MR in patients with prohibitive or high surgical risk. MCRI Investigator Dr. Noah Jones is leading the ENCIRCLE Trial (Sponsored by Edwards Lifesciences) at Mount Carmel to test the safety and effectiveness of a TMVR system in patients with severe symptomatic MR for whom commercially available surgical treatment options are unsuitable due to clinical, anatomic, or technical considerations. The first patient at MCHS was enrolled in July and will be followed for up to 5 years to track their improvement in heart function.
Resident Research Spotlight – Sam Faught, MD (Internal Medicine) and Alex Savage, MD (Orthopedic Surgery)
Osteoporosis is a serious disease that often doesn’t manifest itself until a patient experiences a fracture which can lead to pain, limited mobility and a lower quality of life. Fortunately, screening for osteoporosis and its precursor, osteopenia, can identify who should be treated to prevent fractures. However, some studies suggest that osteoporosis and osteopenia are undertreated despite screening with dual X-ray absorptiometry (DEXA) scans. Sam Faught, MD,(left) Internal Medicine PGY-3 and Alex Savage, MD,(right) Orthopedic Surgery PGY-4, are investigating the prevalence of treatment for osteopenia and osteoporosis after a DEXA scan indicates low bone mineral density. GME faculty William DiFilippo, MD, Program Director for Internal Medicine and Richard Fankhauser, MD, Program Director for Orthopedic Surgery are the project mentors. This IRB-approved study will look at 983 patients who underwent a DEXA scan with respect to the follow-up they received. If the results indicate a higher proportion of Mount Carmel patients should receive treatment, the project will move into a second phase examining an intervention to improve these numbers. This study highlights the collaboration between the Internal Medicine and Orthopedic Surgery programs to promote best care for patients.