2016
Global Health Innovations
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The Team
Student Team: Demetri Monovoukas, Matthew Nojoomi, Shravya Srigiri, Scott Stanley
Clinical Advisors: Krishnamohan Lalukota, MBBS, MRCP, Arpan Chaudhuri, MBBS, MD, Abhijeet Shelke, MBBS, MD, DNB, Ronald Berger, MD, PhD, Harikrishna Tandri, MBBS, MD, Youseph Yazdi, PhD, MBA, Soumyadipta Acharya, MBBS, PhD, Aditya Polsani, MS, Naresh Pagidimarry, MS
Sponsor: Medtronic Team — Wade Demmer, Yong Cho, Erin Reisfeld, Pankti Shah, Thomas LulicAbstract
The 2015-2016 CBID-Medtronic team represents the third year of a global health collaboration initiative between Johns Hopkins and Medtronic. The overall goal of the project is to identify and address the most significant barriers preventing pacemaker adoption in India, particularly in the more underdeveloped regions. After multiple visits to the field, the team identified that secondary-care facilities in India lack adequate treatment capabilities for emergent bradycardic patients. The standard of care for these emergency patients involves the implantation of a temporary pacemaker until they are effectively stabilized or receive a permanent pacemaker. However, because secondary-care facilities in India typically do not have catheterization labs, implanting cardiologists, or other necessary resources, they are unable to perform temporary pacemaker procedures. Due to the relevance of temporary pacing in the overall patient care pathway, the team has chosen to focus on increasing access to temporary pacing at the secondary-care level in order to increase the overall number of patients who go on to receive permanent pacemakers.
The team’s proposed solution is a pacemaker lead navigation simulator, to help increase the confidence and competency of blind lead navigation at secondary care facilities. The simulator consists of an anatomically accurate model of the heart vasculature that provides electrical signal feedback as an indication of lead position in order to educate and familiarize physicians with the lead navigation procedure. As the user advances a lead through the simulator, the electrogram (EGM) signal corresponding to the location of the lead tip is displayed on a monitor that represents the ECG machine used during the actual procedure. The lead navigation simulator not only allows for less experienced physicians, such as emergency and critical care doctors, to gain experience performing lead navigation, but it also encourages the practice of ECG-guided navigation, a reliable and proven technique used in the US. The simulator directly addresses the lead navigation barrier by increasing physician confidence and helping achieve proper lead placement, which ultimately minimizes associated complications.
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The Team
Student Team: Chanya Elakkad, Joseph Pia, Victor Yu and Sam Zschack
Clinical Advisors: Soumyadipta Acharya, Youseph Yazdi, Alain Labrique, Azadeh FarzinAbstract
Over 66% of newborn deaths happen during the first week of life due to the fragile immune system of the neonates that results in the rapid development of fatal conditions. In lower income countries, the majority of the population receives their primary health care by trained community health care workers (CHWs). The majority of births in the developing world occur at home, so the CHWs are critical to providing clinical assessments and referrals to healthcare facilities. Despite proven success of this intervention, the limited number of trained CHWs and frequency of visits creates a bottleneck for care. Because of this, the timing of proper assessment aligning with the onset of symptoms is happenstance. One caregiver that is not limited in their ability to monitor the neonate is the mother. We identified theunmet need to design interventions to improve maternal recognition of neonatal illness at home and prompt care seeking behavior.
A task shifting of neonatal assessment and recognition of danger signs to mothers is a promising strategy to improve early identification of neonatal illness. To accomplish this our team has developed INFORM (INfant monitoring FOR Mothers), a system that provides reliable and consistent monitoring of infants for identification of danger signs of severe illness during the critical first week of life to facilitate early referral of sick neonates. INFORM consists of two parts – an Interactive Voice Response (IVR) based mHealth platform and a low cost reusable wearable device. CHWs can enroll mothers into this system and provide them with the wearable device close. Once the mother or a family member notifies the system that she has given birth through a simple SMS or call, INFORM’s mHealth platform places a voice call to the mother or family of a newborn infant every day during the critical first seven days of life, starting a “virtual CHW visit”. The system will walk a mother through a clinical assessment of her baby and the wearable device will provide accurate measurements of the critical vital signs, temperature and breathing rate. Using this system, mothers will finally be empowered to identify severe neonatal illness effectively and in a timely manner.
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The Team
Student Team: Amal Afroz Alam, Emily Eggert, Neha Goel, Elizabeth Lebling, Sean Mattson
Clinical Advisors: Soumyadipta Acharya, MD, MSE, PhD, Nick Durr, PhD, Paul Nagy, PhD, FSIIM, Junaid Razzak, MBBS, PhD, James Bon Tempo, MS, Khanjan Mehta, MSAbstract
Many developing countries face challenges providing primary healthcare to their populations, resulting in increased disease burden, mortality, and healthcare-related poverty. Rural populations feel this lack of access most, as they are far from the major cities where health resources are concentrated. In India, for example, over 70% of the population lives in rural areas, but 60% of healthcare infrastructure is located in urban centers. There are as few as one doctor per thousand patients, and low-skill, unlicensed practitioners often serve the needs of the rest of the population.
Telemedicine, or medical care that is delivered or supported by telecommunication, has developed as a common technique for addressing the care access and quality gap. Because it allows for a doctor to provide consultation remotely, telemedicine is a natural solution for bringing care to a last mile setting. However, gaps still exist between the healthcare needs of remote communities and the type of care that telemedicine platforms can support. These gaps include lack of low-bandwidth capabilities, reliance on highly-trained healthcare providers, and platforms that are highly-tailored for specific tasks or use cases.
InteleCare (Figure 1) aims to address these shortcomings by using a knowledge-engineered expert system to task shift healthcare activities from skilled physicians to minimally-trained healthcare workers. Using the Knowledge Enabled Clinical Information (KECI) software platform, InteleCare can support Community Health Workers (CHW) to take a comprehensive patient history and conduct a quality physical exam. It is built on top of OpenMRS, a robust patient data management system, so physicians can view patient data, make clinical recommendations.
The InteleCare system can support private sector health systems, global development organizations, NGOs, and governments to improve their telemedicine capabilities, bringing higher quality care to more people.
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The Team
Student Team: Kendall Covington, Sakina Girnary, Teja Maruvada, Ramji Rengarajan, Kavya Singampalli
Clinical Advisors: Soumyadipta Acharya, MD, PhD; Rashmi Asif, MBBS; Cherrie Evans, CNM; Tor Inge Garvik, MS; Jennifer Gilbertson, MSE; Lindsay Litwin, MPH; Pushkar Ingale, MDes; Swati Mahajan, MBBS, MPH; Harshad Sanghvi, MD; Pallavi Sinha, MBBS; Rachel Willardson, MSAbstract
Each year, 350,000 women and 2 million babies die from birth-related complications. In India specifically, the UN Millennium Development Goals 4 and 5 aim to reduce high infant mortality rates, decrease the maternal mortality ratio, and increase birth attendance by skilled health professionals. To achieve this, nursing schools that are currently training students using a standardized curriculum have recently added Skills Labs to expose students to skill-based and simulation-based training practice, apart from a clinical internship during the final year of nursing education. However, many of the labour monitoring skills taught in the curriculum are not translated to the clinical site due to the lack of interactive, immersive and integrated training. This leads to a lack of nurse empowerment to make important decisions in emergent situations that can save both the mother and child.
We have developed a training system to improve the current labour monitoring training system by integrating the measurement, recording, interpreting and acting aspects, habituating nursing students to make more timely measurements and decisions, and encouraging a low-dose high-frequency training approach without the need for direct faculty involvement. Our device, Physim, allows students to practice and learn measurements, plot data onto a partograph, and make decisions throughout the progress of labour. It incorporates a physical model containing modules for fetal heart rate, contractions, and cervical dilatation, which connects to a flipbook user interface where the user plots data on a partograph. After each measurement is complete, the student assesses the parameters to ensure that labour is progressing normally and appropriate actions are taken.
PhySim offers significant advantages over the traditional case study approaches by encouraging dialogue and discussion among the students and enhancing the learning for both the user and the operator. PhySim also incorporates group-based simulation, that has been shown extensively to improve learning comprehension and retention.This system habituates the student to take measurements in a timely manner, make decisions at each time point after measurements are taken, and contextualize those measurements in the progression of labour. By providing exposure to both the normal and abnormal progression of labour in the training setting using a low dose high frequency training routine, students will be able to build their confidence before reaching the clinical site, and will be better-equipped to make evidence-based decisions in practice.
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The Team
Student Team: Kelly Lacob, Maddie Wilson, Alison Wong, MD, and Stacie Zwolski
Clinical Advisors: Tigistu Adamu, MD, Lindsay Litwin, MSPH, Rachel Willardson, MS, Robert Malkin, MS, PhD, Ed Hutton, James Cobey, MD, Barclay Stewart, MD, Youseph Yazdi, PhD, MBA, Soumyadipta Acharya, PhD, MDAbstract
For the first time in history more people are dying from a lack of access to safe, essential surgical care than from communicable diseases. The Lancet Commission’s Global Surgery 2030 report and the World Bank report on the importance of surgery in developing countries recently placed this issue at the forefront of the global health agenda. One of the greatest but most underserved barriers to safe surgery is the availability of functional biomedical equipment; it is estimated that 50-70% of all biomedical equipment in developing countries is partially or completely nonfunctional, resulting in approximately a 10% referral or cancellation rate for surgeries.
Tech Connect is a mobile application that provides technicians with the resources they need to ensure that functional surgical equipment is available where and when it is needed most, effectively increasing patient access to safe surgery. There are five main features to Tech Connect: 1) digitized troubleshooting flowcharts that break down the most common problems and associated repairs into manageable steps; 2) skill tutorials for commonly needed mechanical, electrical, and plumbing skills; 3) resource libraries that include generic guides from respected institutions such as the World Health Organization and Engineering World Health as well as references to equipment-specific manuals from manufacturers; 4) a Call an Expert function that connects techs in real-time to product or thematic area experts who can assist them through repairs; and 5) convenient capability to notify hospitals and central medical stores of the need to order spare parts, directly through Tech Connect. Tech Connect also collects data and generates a report every time it is used, providing highly useful information to hospitals, Ministries of Health, and medical device companies that can be used for policy, procurement, and training decisions, among other uses. Our design is backed by ethnographic research as well as data that proves giving technicians access to generalizable skills and informational and human resources can allow them to repair up to 70% of equipment malfunctions.
We have demonstrated proof-of-concept by trialing our MVP with 40 potential end-users in Ethiopia.The response was extremely enthusiastic, suggesting we are moving in the right direction. We also received valuable feedback that will be implemented in future development. Once Tech Connect is finalized, we plan to generate revenue through annual subscriptions to the application, which provides end-users with access to the support services and Ministries of Health, hospitals, and medical device companies with access to the analyzed data. The primary distribution channels will be through university and vocational training institutions, but we can also reach techs already in the field through in-service training workshops.
U.S. Healthcare Innovations
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The Team
Student Team: Sakina Girnary, Ramji Rengarajan, Kavya Singampalli, Victor Yu, Stacie Zwolski
Clinical Advisors: Umang Anand, PhD, Jon Resar, MD, Kenton Zehr, MD, Kaushik Mandal, MBBS, MD, Rani Hasan, MD, Peter Johnston, MD, Sammy Zakaria, MD, MPH, Steven Brooks, MD, MBA, Aditya Polsani, MS, Youseph Yazdi, MBA, PhD, Soumyadipta Acharya, MD, MSE, PhDAbstract
An estimated 1.6 million people in the United States have moderate to severe tricuspid regurgitation (TR), a condition in which the tricuspid valve leaflets do not coapt, creating an orifice that allows blood to flow backwards from the right ventricle into the right atrium. If left untreated, this condition can cause edema, liver congestion, shortness of breath, and right heart failure, among other complications that significantly reduce patient quality of life. The one-year survival rate for severe TR patients is a mere 64%. Despite the severe implications of TR, the disease is largely under-treated in the medical community since the current treatment carries too high of a risk. The standard of care is an open-heart surgery in which an annuloplasty ring is secured around the valve annulus to reduce dilation, allowing the leaflets to coapt. Operational mortality rates for this procedure range from 8-12% for a patient’s first open heart procedure and 10-25% for a reoperation. The alternative to surgery is medical management with diuretics, which does little to improve patient quality of life. Of the 340,000 patients diagnosed with moderate-severe TR annually, only 10,000 receive the surgical treatment that they need. Our team is developing a low-risk percutaneous (catheter-based) treatment system in order to address the large underserved patient population with severe functional TR. There has been substantial development in such percutaneous intervention technologies in the structural heart space over the past 15 years. In the tricuspid space, companies have recently begun developing percutaneous solutions that either replicate sub-optimal surgical techniques or have yet to prove long-term efficacy. The surgical technique that our solution is replicating percutaneously, ring annuloplasty, has been proven surgically to significantly reduce the degree of tricuspid regurgitation, provide the highest freedom from recurrence of TR, and has the highest durability compared to other approaches. We are currently working through the iterative loop of designing, manufacturing, and testing in ex vivo pig hearts with the goal of soon being ready for in vivo implantation of our device in animals. We will continue to iterate based on the results. All aspects of our design will be continually validated by our team of physicians in order to ensure that we are developing a solution that will be safe, efficacious, and has the potential to become widely adopted.
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The Team
Student Team: Kelly Lacob, Sean Mattson, Matthew Nojoomi, Maddie Wilson, Alison Wong, MD, and Sam Zschack
Clinical Advisors: Justin Sacks, MD, MBA, Clifford Weiss, MD, Bill Padula, PhD, Andrew Malinow, MD, Amanda Owens, CWOCN, Bill Lansinger, Youseph Yazdi, PhD, MBA, Soumyadipta Acharya, MD, PhDAbstract
Pressure ulcers are injuries to the skin and underlying tissue, usually over a bony prominence such as the sacrum, ischial tuberosities, heels, or back of the head. They occur as a result of prolonged pressure compounded by secondary factors such as shear and moisture, and can begin to form in as little as two hours—a window smaller than the length of many common surgeries or the frequency with which healthcare providers are able to regularly check on their bedbound patients. The extent of damage from prolonged pressure does not become apparent until days later, making it difficult to know where or when was the precipitating event and how to act to prevent it. Existing risk scores miss 60% of patients who go on to develop pressure ulcers and current preventative methods have a high financial and time cost, limiting widespread implementation for all patients.
Despite being classified as Never Events by the Agency for Healthcare Research and Quality in 2008, meaning they are avoidable and therefore unacceptable, 3-6% of all patients still develop pressure ulcers while in hospital, leading to more than 1.8 million new cases in the U.S. every year. Not only are hospitals not reimbursed for the cost of treating these wounds, with an average cost of $37,000, but hospitals in the lowest performing quartile also receive cuts in overall federal reimbursements. Altogether, pressure ulcers cost the U.S. health system over 11 billion dollars annually, equivalent to 44% of total wound care spending.
Our solution, the Mercury Patch, is comprised of two main components: a wireless pressure-sensing adhesive patch, and a software user interface. The adhesive patch is approximately 4 inches in diameter and provides force-offloading, shear protection, and moisture control while collecting pressure data via a smart-sensing layer. The patch can communicate wirelessly to any device, displaying current pressure, pressure over time, how much the patient has been moving and when he or she was last repositioned. The system can also integrate with the patient’s electronic medical record, streamlining documentation.
From the data provided, doctors and nurses will have objective data on a patient’s pressure ulcer risk and be able to provide targeted interventions and care plans. By checking the pressure readings via the device, they can also be assured that patient repositioning has been effective. Since the Mercury Patch is low-cost and integrates into existing workflow, it can be used preventatively for all patients. Not only will this improve the quality of patient care and save hospitals money, but by providing a record of movement it will help ensure that patients are getting the necessary activity toavoid other serious complications. The Mercury Patch is the only option on the market that empowers healthcare providers to provide their patients with proactive, informed, and personalized pressure ulcer prevention and care.
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The Team
Student Team: Amal Afroz Alam, Emily Eggert, Elizabeth Lebling, Demetri Monovoukas, Scott Stanley
Clinical Advisors: Youseph Yazdi, PhD, MBA, Andrew Lane, MD, Chris Jeffers, PhD, JD, Bob Storey, Cathy Becker, Ary ChernomorskyAbstract
Chronic rhinosinusitis (CRS), recurrent and persistent inflammation of the nasal sinuses, is a chronic condition that affects almost one in eight Americans, yet few options exist for reliable treatment of the disease’s debilitating symptoms. Patients with CRS find it difficult to lead a normal life while faced with headaches, insomnia, painful facial pressure, and persistent infections. While almost every CRS sufferer uses sinus rinses daily, this regimen is ineffective for patients with the most advanced forms of the disease. As a result, sufferers must try increasingly expensive and invasive treatments, ultimately sending over half a million people to undergo functional endoscopic sinus surgery (FESS) every year. However, the procedure only marginally increases the efficacy of saline rinses and will have to be revised in a third of patients within three to six years. Overall, this process is costly for both the individual and the healthcare system, as patients spend thousands of dollars on over the counter treatments, incur $8.6 billion in direct surgical costs, and cause $24 billion in lost economic output annually. In an effort to help patients who have received FESS better rinse their sinuses, competitors have developed treatments such as balloon sinuplasty and nasal stents that attempt to open sinus ostia and maintain sinus patency. However, none of these options ensure reliable sinus access or facilitate direct sinus irrigation. Salient ENT addresses these shortcomings with the Hana Catheter (Figure 1), a product designed to bring saline and other therapeutic fluids directly to inflamed sinus tissues. The Hana Catheter system includes a novel, low profile nasal device and an external rinse bottle that interfaces with the internal catheter. By providing a conduit through constricted sinus openings, the Hana Catheter can increase fluid delivery up to eight-fold over the standard of care. This solution provides a more targeted treatment delivery option for CRS patients, which can minimize recurrent symptoms and reduce the need for surgical revision procedures.
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THE TEAM
Student Team: Kendall Covington, Chanya Godzich Elakkad, Teja Maruvada, Joseph Pia, Shravya Srigiri
Clinical Advisors: Edward James (Jamie) Wright, MD; Nikolai Sopko, MD, PhD; Caroline Garrett, DA Soumyadipta Acharya, MD, PhD; Youseph Yazdi, MBA, PhD; Aditya Polsani, MSABSTRACT
A urethral stricture is a fibrotic narrowing of the urethra, which acts like a tough scar tissue and leads to voiding complications. With symptoms including frequent and painful urination, penile inflammation, increased risk of urinary tract infection, and even renal failure if not treated early enough, its ramifications have serious impacts on the quality of life for affected men across the globe.
Existing options for patients fall into two buckets: effective invasive open surgery (urethroplasty), and minimally invasive procedures (dilation, urethrotomy, or self -catheterization) with subpar outcomes. Patients typically begin with a minimally invasive treatment such as dilation or urethrotomy, (~160,000 performed annually in the U.S. alone). These often end up with a recurrence, as rates of recurrence average at 70%, and are as high as 91% for a repeat procedure. Although the gold standard treatment, urethroplasty, is suggested if they experience a recurrence, many undergo repeat ineffective treatments to avoid open surgery. This cycle not only aggravates the patient’s condition but is also economically inefficient to the health care system.
uCure is developing TAURUS, a minimally invasive tool for the treatment of urethral strictures. It allows transurethral delivery and fixation of an autologous graft which widens the urethra and promotes healthy epithelialization and healing, resulting in improved urine flow. TAURUS bridges the best of both worlds, by empowering urologists to treat strictures with greater efficacy and durability than current minimally invasive options (urethral dilation – mechanically widening the stricture, and urethrotomy – cutting the stricture), without the need for more invasive, open surgery and the associated risks. The use of a graft provides the benefits of urethral reconstruction, which is recognized to have significantly reduced stricture recurrence relative to the existing minimally invasive approaches. Minimal invasiveness makes our system less morbid than surgery and preferable to patients, and enables frontline urologists to deliver a durable, effective treatment option.
Our team has conducted preliminary tests in situ, and are performing preliminary tests in live animals to refine our device specifications. We expect to begin our formal ACUC approved rabbit study in the next month. The results of our rabbit study will inform our design and development of a dog study for transition to human scale. Through these activities, our team will be better positioned to develop an effective and durable clinical solution for urethral stricture disease, which can impact patients and empower urologists across the world.
