More Access to Health Records, New Tools May Help Patients, Researchers

May 19th, 2015

APPLE

A frequently heard expression in some digital circles says that data “wants to be free.” Whether or not that’s true (your cable provider might disagree), clearly health records are more accessible now than they were not all that long ago.

A few decades back, the only way most people could get access to their medical records kept by a healthcare provider would be to take the provider to court. That had begun to change, even before the landmark enactment of HIPAA in 1996, which wrote into the nation’s law privacy protections for a patient’s personally identifiable health records, and made explicit a patient’s right to access his or her own medical information.

Of course, just having that right did not automatically make gaining access easy or convenient. But as technology evolves and some healthcare providers become more attuned to health consumers’ needs and interests for access to data, they are increasingly finding ways to leverage new electronic health records systems to make the process easier.

One prominent example is a recent 12-month trial carried out by three U.S. health care systems — Boston’s primary care and teaching hospital Beth Israel Deaconess Medical Center, with its suburban clinics; Pennsylvania’s Geisinger Health System, an integrated network of rural clinics; and the University of Washington-affiliated safety-net hospital, Harborview Medical Center. They tested the OpenNotes system, which offers healthcare providers a way to share their clinical notes with their patients.

The demonstration project involved 105 volunteer primary-care physicians and about 19,000 patients, who were registered into a secure internet portal and told their physician would use it to let them see online their test results, notes on their medications, and other portions of their medical records.

As reported in the British Medical Journal this February, by the end of the year-long study, two-thirds of the patients viewed the OpenNotes system positively, saying it helped them better understand the state of their health, how to care for themselves, and the need to keep taking their prescriptions. Although doctor-patient communications improved, physicians reported it did not cause a significant increase in demands on their time.

Greater openness of healthcare records is also aided by the profusion of technology easing access. Providers are moving away from keeping records on proprietary servers, and towards making use of cloud storage. Wider adoption of consumer-accessible devices like tablets and mobile and wearable devices is being seen in delivery of care and clinical research.

Even before the recent, much-ballyhooed appearance of the Apple Watch, wearable devices that monitor the user’s health and fitness had become big business. Fitbit, for example, says it has sold about 21 million devices since launching in 2007, and over half that total were sold in 2014 alone. Some devices can capture data on your sleep cycle or report in extensive detail on how well your heart is functioning, or monitor reproductive cycles.

Many clinical researchers view both these trends as potentially helpful. Greater information sharing can assist trial recruitment efforts, and advances in areas such as wearable devices can simplify data collection, often providing it in real time, and aid in monitoring clinical trial participants.

Health Providers Face Complex Transition to ICD-10 Records System

May 12th, 2015

Medical providers in the U.S. are currently facing an October 1 deadline for moving their electronic health records systems from the current ICD 9 standard to ICD-10, the tenth version of the periodically revised International Statistical Classification of Disease and Related Health Problems devised by the World Health Organization.

Some medical groups and members of Congress remain opposed to the change, calling it needlessly complex and burdensome, especially for smaller operations. Though the switchover deadline has been extended three times, it seems increasingly likely the October 1 deadline will hold, forcing providers to adopt the new system to be reimbursed by federal health programs such as Medicare and Medicaid.

The ICD-10 code is used to designate diseases, symptoms, findings, social factors and external causes of diseases or injuries. The U.S. version has two parts: over 68,000 diagnostic code items in ICD-10-CM; and about 76,000 codes for inpatient procedures in ICD-10-PCS.

Proponents of the new system say the ICD-9 code doesn’t capture enough data for a thorough analysis or the most accurate billing; the American Medical Association warns the conversion will be costly – its estimates range from mid-five to low-six figures – and burdensome, especially for individual and small group practitioners, and wants repeal of the federal mandate for ICD-10.

The delays thus far to the originally scheduled January 2012 start date were intended to give providers more time to learn and implement the new system, update or replace software and train staff. The most recent delay came last year, after a law moving through Congress to revise physician reimbursement rates in Medicare mysteriously picked up a provision pushing back the ICD-10 conversion deadline a year.

In the new 114th Congress, Rep. Ted Poe (R-TX) and a handful of co-sponsors on April 30 introduced a bill (HR 2126), which would block the Department of Health and Human Services (HHS) from mandating use of ICD-10. A determined opponent, Poe once went to the House floor to ridicule ICD-10 as overly bureaucratic, pointing out it contains a code entry for walking into a lamppost, and separate codes for a first attack by a turkey and for a second attack by a turkey.

In 2013, Poe had offered a similar bill, then known as the “Cutting Costly Codes Act,” which never saw action in either of the House committees (Ways and Means and Energy and Commerce) to which it was assigned; the lead sponsor has never served on either of those panels, which have also received his latest bill.

The Senate lacks a companion bill for the Poe measure, but at a recent hearing on 2016 funding for HHS, freshman Senator and physician Bill Cassidy (R-LA) suggested to HHS Secretary Sylvia Burwell the agency hold off two more years before penalizing practitioners who have not adopted ICD-10. HHS has already stated payment claims should continue to use ICD-9 up until ICD’s scheduled start date (many larger practices say they’re already prepared to use either systems), so Dr. Cassidy apparently wants HHS to keep processing and paying claims using ICD-9 for several more years. In arguing for a further delay, Cassidy notes the Centers for Medicare and Medicaid itself has predicted claim denials and accounts receivable waiting times may double after ICD-10 takes effect.

At this point, however, it appears likely ICD-10 will go live on October 1. An April survey by a software testing firm asked hospital executives if they believed the most recent deadline would hold firm; 87% of respondents predicted it would.

New Full-Body Scanner Helps Skin Cancer Early Detection

May 5th, 2015

Researchers in Germany report they have developed a prototype of a new full-body scanning device which should aid dermatologists in making earlier, more reliable detection of skin cancer. Early detection is crucially important for fighting melanoma. Yet even though it generally develops on a visible site, about one-fifth of melanoma cases are not diagnosed until the cancer has advanced into its late stages, when it is most difficult to treat.

The new full-body scanner grows out of the DermaScan project at the Magdeburg University Clinic for Dermatology and Venereology. Clinic director Professor Dr. Harald Gollnick came up with the idea for a full-body scanner as a substitute for the time-consuming and hard to monitor dermatoscopic full-body examinations patients typically undergo.

Changes in a mole is a classic cancer warning signal, but documenting the size, color, texture and other features of each individual mole takes large amounts of time and is frequently hard both to document at examination and to track over time – especially with patients who may have more than a hundred moles to record and monitor.

Starting in 2001, Gollnick’s team of researchers, along with the Fraunhofer Institute for Factory Operation and Automation and two medical technology and imaging firms began work on coming up with hardware and software that can scan almost all of a patient’s body rapidly and reliably, and store and present the data in later comparisons in ways making monitoring quicker and more useful.

The prototype already in use at the Magdeburg University Clinic places an unclothed patient standing on a rotary table inside a glass-enclosed scanner about the size of a shower stall. As the table slowly revolves, a special diffused lighting system resembling daylight shines on the patient, as digital cameras document every mole from several angles. Using this data, the scanner then creates and stores true-scale, high-resolution images of the patient’s skin – one researcher likens it to computerized tomography for the skin — and makes later comparison much easier, faster and more reliable than current systems. The Magdeburg full-body scanner captures 90% of the patient’s skin surface, leaving only the patient’s soles, scalp and genital areas to be scanned by traditional dermatoscopic methods.

Dermatologists can use all the help they can get battling melanoma and other forms of skin cancer. While most forms of cancer have shown declining mortality rates in recent years, largely due to improved methods of detection and treatment, the same unfortunately has not been true for melanoma, the most readily metastasizing and thus most dangerous form of skin cancer. Although melanoma is only the third most common type of skin cancer (after the easier to treat and less likely to spread basal cell carcinoma and squamous cell carcinoma), its mortality rate has been on the rise and its incidence has been increasing for at least three decades.

The American Cancer Society (ACS) estimates that over 80,000 Americans will be newly diagnosed with skin cancer this year (excluding basal cell and squamous cell carcinomas), and of those, nearly 74,000 cases will be melanoma, with other forms of skin cancer affecting nonepithelial skin accounting for the remainder. Melanoma will also claim almost 10,000 lives in the U.S. this year, the ACS also predicts, about to-thirds men to one-third women (even though it is the second most-diagnosed cancer in women, and only the fourth most-common form in men).

In Policy Change, FDA Clears Direct-to-Consumer Genetic Screening Test

April 28th, 2015

For the first time, the U.S. Food and Drug Administration (FDA) has approved direct sales to consumers of a test to screen healthy persons for genetic variations that might mean their offspring could inherit a serious health condition. The agency has approved sale of a test to identify carriers of Bloom Syndrome, a very rare genetic disorder which increases cancer risk, shortens height and causes other health problems.

In giving its first-ever approval of a direct-to-consumer genetic screening test to 23andMe, a genetic diagnostics company based in Mountain View, California, the FDA also made a broader change in policy, reclassifying the carrier screening test as a class II medical device. In addition, the agency plans to issue for public comment new proposed regulations that would exempt tests of this sort from having to go through premarket clearance.

Such a regulatory change, if ultimately adopted, would affect far more than the relative handful of people at risk for Bloom Syndrome, which is most prevalent among persons descended from Ashkenazi Jews; even there, the disease only affects about 1 in 50,000.

Bloom Syndrome is an autosomal recessive inherited condition, in which the DNA of a parent not visibly affected by the disease carries one copy of a normal gene along with a mutated gene. That parent would consequently have a 50-50 chance of transmitting the mutation to his or her child.

If the other parent also carries the same combination of a normal gene and a mutated one, the child will have a 50 percent chance of becoming a carrier (by receiving a mutated gene from one parent and a normal one from the other), a 25 percent chance of being free of the mutation (by inheriting a normal gene from each parent), and a 25 percent chance of having the genetic-linked disease (by inheriting mutated genes from both parents).

The FDA based its less rigorous classification for the test on its view that making it easier to access could help parents obtain useful information about autosomal recessive conditions they might pass to their offspring, and that such consumers need not always go through a health professional in order to get a screening test.

At the same time, however, the FDA will require the test maker to include product labeling that would enable users to readily use the test and understand test results. If sold over the counter, the test will also be required to provide purchasers with information on how they can gain access to a qualified clinical molecular geneticist, or the equivalent, to help them with counseling before and after the test.

To persuade the FDA to approve its new genetic screening test, 23andMe performed studies demonstrating it accurately detected lab samples collected from known carriers of Bloom Syndrome. The maker also did another study showing persons unfamiliar with the test’s device for collecting saliva were able to use it, and tested randomly recruited trial participants reflecting the nation’s general population to show the test instructions were easy to follow and test results could be readily understood.

In 2013, an FDA warning letter stopped 23andMe from marketing a full genomic screening service, for which it had not obtained premarketing clearance and which the agency said, had not offered adequate proof its tests were reliably accurate and clinically meaningful.

Clinical Trial Seeks First New Alzheimer’s Treatment in a Decade

April 8th, 2015

Alzheimer’s disease is a debilitating, progressive neurodegenerative disease affecting close to five million Americans. The Alzheimer’s Association estimates the disease is responsible for at least 60%, and perhaps as much as 80%, of all dementia cases, and afflicts more than 10% of Americans over age 65, and one-third of those over age 85. Worldwide, some estimates put the number of people with Alzheimer’s as high as 40 million.

While not observable in the living, autopsies show microscopic growth of abnormal clumps of beta-amyloid protein plaque and neurofibrillary tangles within and between brain cells of Alzheimer’s patients. While these are associated with the disease, it is still not known whether they cause it, or result from some other cause.

Since family history is the second greatest risk factor, trailing only age, Alzheimer’s also appears to have a genetic factor. Alzheimer’s is usually first identified in patients age 65and up – most commonly by difficulties in assimilating or remembering new information, impaired reasoning, personality changes or other mental or physical irregularities. In less than 5% of cases, onset comes much earlier, and a specific genetic link has been identified for this form of the disease.

Some current treatments can bring temporary easing of symptoms, but thus far no treatment has been discovered that reverses or stops the progression of Alzheimer’s. The disease’s prevalence, virulence and costs – the annual costs of treating an American with Alzheimer’s is somewhere around $50,000 — has drawn $565 million in government research this year seeking its causes and better treatments, and numerous private companies are seeking to develop effective remedies.

In hopes of discovering the first new treatment in a decade, a Phase II clinical study, bearing the label NOBLE, is now underway at about 50 U.S. hospitals hopes to enroll 450 people between the ages of 55 and 85 with mild to moderate Alzheimer’s. It aims to assess whether a new experimental drug, T-817MA, helps prevent or slow the loss of brain nerve cells.

The NOBLE trial is funded entirely by the drug’s developer, Toyama Chemical Ltd., part of Japan’s Fujifilm Group. Running the clinical trial is the Alzheimer’s Disease Cooperative Study, a National Institutes of Health-supported clinical trials consortium based at the University of California San Diego. The lead researcher is Dr. Paul Aiser, a leading Alzheimer’s authority.

All participants in the trial are already taking the leading current treatment drug (donepezil, also known by the trade name Aricept), and some are also taking memantine (trade name Namenda), another treatment of a different type. The trial will randomly divide participants into three groups. One group will receive a placebo; the other two groups will receive the experimental drug, in one of two dosage levels. All participants will be tested for memory, other mental functions and overall ability to function, and will receive regular physical exams, blood tests and brain scans.

Toyama has been working on the drug since 2005. In 2008-2011, a more limited trial in the U.S. and Canada using only one dosage level suggested T-817MA has the potential to slow down cognitive and functional decline in Alzheimer’s patients.

Begun in March 2014, the NOBLE trial is scheduled to last until March 2016. New participants are still being sought.

Clinical Trials Bring New Immunotherapy Treatment for Lung Cancer, Melanoma

March 16th, 2015

Successful clinical trials have led to Food and Drug Administration approval on March 4 of an immunotherapy drug seen as a breakthrough for hard-to-treat cases of the most common form of lung cancer.

The new remedy, nivolumab (tradenamed Opdivo by developer Bristol-Myers Squibb), is the first approved treatment using the body’s immune system, rather than chemotherapy, to fight squamous cell non-small cell cancer (NSCLC), found in seven out of every eight lung cancer patients. Lung cancer causes the most cancer deaths in the U.S. (nearly 160,000 last year), and about 225,000 new lung cancer diagnoses are made each year.

A randomized clinical trial included 272 people with advanced NSCLC who had previously been treated with platinum-based chemotherapy drugs. After starting treatment, the 135 patients who received Opdivo had an average survival time 3.2 months longer than the 137 patients who received docetaxel, a leading taxane-type chemotherapy drug also marketed under the names Taxotere and Docecad.

Tumors shrank or disappeared in about 15% of patients given the new drug, and among them, 59% saw the improvement continue for more than six months. In contrast, chemotherapy typically brings such results in 10% or less of NSCLC patients, and the trial participants had already taken chemotherapy treatments without success.

The trial, planned to continue through June this year, was stopped more than three months ahead of schedule, since its results showed a clear survival advantage for patients given the new immunotherapy treatment.

The new drug works by attacking the PD-1 protein, which some cancer cells make as a shield against the immune system. By lowering that shield, the drug enables the patient’s immune system to fight the spread of cancer cells.

Dr. Rachel Sanborn, an oncologist with the Providence Cancer Center in Portland, Oregon, which participated in the SNCLC trial, hailed the FDA’s approval of the first-ever immunotherapy treatment for lung cancer an exciting development, calling it “the beginning point, not the end point.” While all participants in the clinical trial had previously received chemotherapy, future trials are planned to examine whether the drug could be a first-line treatment.

Opdivo had qualified for priority review by the FDA, a program that speeds review of drugs designed to treat serious conditions with the potential of bringing significant improvement in either or both safety or effectiveness.

The drug had won FDA approval last December for treating melanoma, responsible for almost 10,000 deaths in this country annually, making it the nation’s fifth most prevalent form of cancer. That trial involved patients who could not be treated by surgery or whose cancer had metastasized and did not respond to chemotherapy.

Like the case with the lung cancer trial, the melanoma trial finished three months early, and qualified for priority review at the FDA. The agency also designated it as a potential breakthrough therapy and accorded it special orphan-drug procedures.

That clinical trial found almost a third of 120 participants with inoperable or metastatic melanoma experienced tumor shrinkage; the shrinkage persisted for over six months in about a third of those patients.

Encouraged by the drug’s performance with two forms of cancer, researchers plan to test whether it can show similar results against other forms of the disease.

FDA Eyes Easier Access to Experimental Drugs for Seriously Ill Patients

March 3rd, 2015

The U.S. Food and Drug Administration (FDA) has proposed simplifying the procedures by which seriously ill patients can be allowed “compassionate use” of experimental drugs. The agency on February 4 issued a draft guidance document entitled Individual Patient Expanded Access Applications: Form FDA 3926, and will take public comments for 60 days.

Saying it wants to create a “streamlined alternative” to its current process of applying for what the agency calls “expanded access” to investigational drugs (which are being reviewed but have not yet been approved by the FDA). The agency’s Expanded Access Program aims to provide patients with serious or immediately life-threatening conditions for which there are no other comparable or satisfactory treatments an alternative avenue for getting access to drugs that may help.

The FDA says it already approves nearly all the expanded access applications it receives – last year, for instance, it rejected only nine of the 1,873 applications it received, and agency records show the FDA turned down just 33 (or about one-half of one percent) of the 5,995 expanded access applications it got over the last five years.

But the agency has been criticized for how complex its expanded access applications process is. The current system requires all expanded access submissions to file a summary form used for investigational new drug applications (IND 1571), which pharmaceutical firms submit when seeking FDA approval to run clinical trials for a drug under development. Since the IND 1571 is designed for drug developers and summarizes extensive information – one senior agency official says it calls for 26 distinct categories of information and seven attachments — the FDA estimates it takes 100 hours to complete.

But the overwhelming share of expanded access applications come not from drug makers trying to expand clinical trials, but from physicians filing on behalf of a single patient. In fact, 97% of expanded access applications the agency received in 2014 covered either an emergency or regular single-patient use. The FDA says it’s concerned the daunting form and its administrative burdens may be too much in such cases. In fact, unwieldy FDA expanded access procedures may have helped fuel the “right to try” movement, which has already led several states to enact laws allowing patients to take non-FDA approved drugs.

The agency’s proposed solution is to create the new Form 3926, for use by doctors seeking to gain access to an experimental drug for a single patient. The FDA says this simplified form could be completed in less than an hour, not the 100 hours for an IND 1571.

The new form would ask for eight fairly straightforward data categories. These include: the patient (for privacy reasons, only the patient’s initials are used), plus: the patient’s clinical data; treatment data on the drug and planned usage; a letter from the drug maker authorizing product use; information on the supervising physician and his or her qualifications; and an agreement that, absent an emergency triggering different procedures, the expended access treatment won’t start for 30 days – the period FDA has to review INDs).

As at present, under the new guidance a physician seeking emergency approval for expanded access could call FDA for authorization to start treatments; in such cases, a written form must be filed within 15 days of getting authorization.
Besides the new guidance, the FDA has recently created a new webpage to summarize for patients their expanded access options.

Expanded Access to Clinical Trial Data Gains Ground

February 3rd, 2015

One of the greatest frustrations for medical researchers is knowing they have access to only a fraction of data from completed clinical trials. With limited exceptions, such as some government-funded research, clinical trial sponsors determine whether data from those trials ever see the light of day. Limited data-sharing has drawn criticism from many academics and researchers, and helped spur the open-data movement, which calls for wider availability of clinical trial data.

Several recent developments, however, suggest researchers are making significant headway in gaining greater access to data from a much wider range of clinical tests.

In a new report released January 14, the National Academy of Arts and Sciences-affiliated Institute of Medicine (IOM) calls for requiring clinical researchers to set a timetable for sharing trial data as part of registering a clinical trial. Calling for a research culture where data sharing is the “expected norm,” the non-profit, non-governmental advisory group’s preliminary report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, recommends specific timelines for making clinical trial data available.

Clinical trial researchers should have a maximum of 18 months after a trial has been completed to release data, the IOM report says. The trial sponsors and researchers should disclose full analyzable data sets, along with metadata (describing this as “data about the data,” including such items as trial protocols, statistical analysis plans, and analytic coding). Even earlier, the preliminary IOM report calls for summaries of trial results (including adverse events) within a year after a trial’s end, and access to analytic data sets supporting published results within six months of publication. The IOM report recommends making exceptions, however, for studies done in support of regulatory applications, however.

New England Journal of Medicine editor-in-chief Dr. Jeffrey Danzen, one of the 12 members on IOM’s Committee on Strategies for Responsible Sharing of Clinical Trial Data, the authors of the new report on ways to make clinical trial data more widely available for other researchers, recently asserted in his publication clinical researchers “need to change how we think about data.” He advocates it be seen as a community resource, rather than as personal property.

While greater sharing of clinical test data would benefit research and public health, at the same time the IOM report notes the need to minimize foreseeable risks by protecting a variety of interests. These include: trial participants’ privacy; sponsors’ stakes in intellectual property rights and commercial confidentiality; proper recognition for researchers for their discoveries; discouraging invalid secondary analyses of released data (which could invite litigation and make clinical trials less trusted by the public;, and reassuring research institutions data-sharing rules do not amount to new unfunded mandates.

The report contains an extensive slate of recommendations, including trial sponsors insisting on data release plans for all studies they fund, and a multi-stakeholder group creating data-sharing principles and an infrastructure to enforce wider access to trial data.

The IOM report was sponsored by a group of 23 industry, federal agencies (the FDA and NIH), charitable and medical organizations. One of those sponsors, Johnson & Johnson, recently gave another boost to the open-data movement, by expanding its data-sharing under the Yale University Open Data Access Project. The firm, which earlier said it would share its pharmaceutical data with the Yale project (which as an intermediary responds to requests for the data), became the first company to agree to provide data on trials of its medical devices and diagnostics.

If You Suffer From Chronic Lung Infection This Clinical Research Study May Be For You

January 17th, 2015

clinical trials for chronic lung infectionsPulmonologists from major medical centers across the world are recruiting patients with non-cystic fibrosis bronchiectasis (BE) to participate in two clinical trials with Pulmaquin.

Patients with BE who have chronic respiratory infections with the microorganism Pseudomonas aeruginosa have a severe form of the disease that can lead to poor quality of life and untimely death.  BE is a condition characterized by abnormal dilatation of the airways, often associated with chronic infection.  The patient’s lung function is often irreversibly reduced compared to that found in healthy individuals.  BE is frequently observed in patients with cystic fibrosis  (CF). However, it is a condition that affects over 100,000 people without CF in the United States.  Many of these patients are non-smokers and the origin of their BE is unknown.

Two international clinical research studies are underway to evaluate the safety and effectivness of Pulmaquin®, an investigational drug that is inhaled once daily.  The trials compare Pulmaquin to placebo in the management of chronic lung infections with P. aeruginosa in patients with non-cystic fibrosis BE.  Investigators will evaluate this by determining how long it takes for participants to experience their first pulmonary exacerbation.  A pulmonary exacerbation is the new appearance or worsening of respiratory signs and symptoms such as cough, wheezing, chest congestion or shortness of breath, fever, or fatigue. Other important clinical endpoints, including the patients’ quality of life will also be evaluated.

If you or someone you know is interested in learning more please visit The Clinical Trial For Chronic Lung Infections.

Study Seeks Model Care for Chronic Kidney Disease Combined with Other Conditions

January 7th, 2015

clinical trialsA recently announced NIH-supported national multicenter project plans a five-year study of individuals diagnosed with three common chronic diseases: chronic kidney disease, hypertension and diabetes.

Each of those conditions affects millions of Americans. About a third of the nation’s adults experience hypertension, while about one in seven adults in the U.S. has chronic kidney disease, and one in ten is diabetic. The three conditions are frequently found in combination; about half of adults with chronic kidney disease also suffer from diabetes, and many also have high blood pressure.

The national study’s principal investigator, University of Texas Southwestern Medical Center nephrologist Dr. Miguel Vasquez, says these common correlations make studying each chronic condition by itself “not the real world for clinicians.” Instead, the new research project, the first of its size and type, aims to study evidence for which treatments are most effective for patients with this frequent combination of conditions.

First, the study plans first to identify patients with these multiple conditions in a wide variety of treatment settings. In addition to Dr. Vasquez’s institution, other participating research centers include Dallas-based Parkland Health and Hospital System, the Arlington-based non-profit Texas Health Resources, the Veterans Administration’s North Texas Health Care System, and Connecticut integrated primary-care group ProHealth Physicians, Inc.

Representing veterans’ hospitals, private hospital systems, safety-net hospitals and accountable care organizations, these providers will provide data from diverse healthcare settings and patient populations. For example, of the VA healthcare system’s 8.4 million enrollees nationwide, over two-thirds have hypertension, 34% have diabetes and 20% chronic kidney disease. Similarly, the roughly 350,000 patients cared for by ProHealth Physicians includes about 90,000 with high blood pressure, 26,000 with diabetes and 25,000 with chronic kidney disease.

After identifying a broad group of patients with all three conditions, the project will then examine data on which treatments most reduce such negative outcomes as hospitalization, readmission, cardiovascular events, and death for such patients. Although effective treatments are available separately for each of the three conditions, the study will look for which clinical practices most reduce unfavorable outcomes among patients with all three conditions.

Ultimately, the project hopes to develop an integrated care model for such patients, to be shared widely with primary-care providers, showing which early interventions may slow the progression of chronic kidney disease to end-stage renal disease, and thus not only improve patient health but also hold down healthcare costs.

Two parts of the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute, will oversee the study, known as “Improving Chronic Disease Management with PIECES” or “ICD Pieces.”

PIECES is an information technology platform developed by co-investigator Dr. Ruben Amarasingham, the president and CEO of the Parkland Center for Clinical Innovation. The platform will pull data from electronic health records to identify high-risk patients, then evaluate early detection strategies, and identify real-time methods for bringing the most useful care and resources to high-risk patients.

The large-scale project is one of three recent NIH-funded research projects studying multiple chronic conditions, all supported by the NIH Health Care Research Collaboratory, with research awards totaling over $19 million over a five-year period.