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Pragmatic Clinical Trials Leverage Valuable Informatics Tools

September 13, 2017
by David Raths
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PCORI-funded centers developing approaches to identify and recruit potential patients and gather data

As the Patient-Centered Outcomes Research Institute (PCORI) funds more comparative clinical effectiveness research studies, informatics researchers are developing new tools to identify and recruit potential patients and gather data.

On Sept. 12, the Patient-Centered Outcomes Research Institute (PCORI) board approved spending $97.9 million to fund 11 studies comparing different approaches to improving care for a range of health conditions.

These comparative clinical effectiveness research studies rely heavily on informatics infrastructure to recruit patients and gather data.

In a recent presentation at Duke University, Russell Rothman, M.D., the vice president for population health research at Vanderbilt University Medical Center, described some of the informatics infrastructure of one PCORI-funded study, ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness).

ADAPTABLE is a $14 million, three-year pragmatic clinical trial that is comparing the effectiveness of two different daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. Its goal is to enroll 20,000 patients. Pragmatic trials are designed to reflect “real-world” medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care.

The Duke Clinical Research Institute is the coordinating center for ADAPTABLE.

Dr. Rothman, who serves as the co-chair of the steering committee of the study, is also the principal investigator of the PCORI-funded Mid-South Clinical Data Research Network (CDRN), centered at Vanderbilt University Medical Center (VUMC). The CDRN includes academic health centers, community hospitals and a range of outpatient practices including primary care, specialty practices and safety net facilities that serve diverse populations across the Southern United States.

The Mid-South CDRN has data on 9 million patients, Rothman said. “We have data going back to as early as 2004 in the network,” he added.

It encompasses three large health systems:

 • The Vanderbilt Health System, which currently includes electronic medical records for over 2 million patients;

• The growing Vanderbilt Healthcare Affiliated Network (VHAN), which currently includes 45 hospitals, 300 ambulatory practices, and will cover over 3 million patients in the mid-South;

•  A partnership with Greenway Health and other national organizations to provide access to over 1,600 practices and 16 million patients across the country; and

•  The Carolinas Collaborative, which includes University of North Carolina at Chapel Hill, Duke University and Health Sciences South Carolina and reaches over 9 million patients.

The CDRN also has been working on linking EHR data to claims data such as an all-payer claims database in Tennessee to get more complete pictures about patients, which Rothman said is key to studying outcomes.

The Mid-South CDRN has developed tools and capacities to support comparative effectiveness research and pragmatic research. It has methods to develop and validate computable phenotypes for identification of particular patient groups.  It can extract clinical data from electronic health records, claims, and other data sources.  It also has developed tools for electronic identification, contact, consent and recruitment of patients. 

Based on his presentation and details from the CDRN website, here are some tools developed to support pragmatic clinical trials:


The Mid-South CDRN uses the PCORnet Common Data Model Version 3 as the main syntactic and semantic standard. It leverages standard terminologies and coding systems for healthcare to enable interoperability with and responsiveness to evolving data standards.

They have taken EHR data from health systems and transformed it into the common data model to run queries against. There are 80 such data marts nationwide. 

The CDRN also used REDCap, a secure, web-based application that allows users to build and manage online databases and surveys.

REDCap uses a study-specific data dictionary to eliminate all programming requirements for the creation of electronic case report forms and participant survey instruments for individual studies.


The Synthetic Derivative Record Counter (RecordCounter) is a web-based tool that provides exploratory data figures for research planning purposes and feasibility assessment. The RecordCounter allows the user to input basic medical data such as demographic information, ICD 9 and CPT codes, medications, labs, keyword document searches, as well as searching for available genetic data on subjects.

The Phenotype Knowledgebase website, PheKB, is a collaborative environment for building and validating electronic phenotype algorithms. PheKB has tools to enable cross-site collaboration for algorithm development and validation. These include electronic discussion and phenotype update notifications for a given phenotype; the ability to post algorithm validation details and tools for validation of algorithms including chart review forms and automated calculation of validation statistics such as specificity and sensitivity; and an integrated data dictionary and dataset validation tool used to ensure consistent formatting and coding of data sets to be shared.


ResearchMatch, launched in 2009, is a disease-neutral, online volunteer-researcher matching service. Currently, over 100,000 volunteers, over 4,000 researchers, and 128 institutions are using ResearchMatch to streamline the connection between researchers and volunteers.

The studies are taking advantage of Electronic Recruitment via email.  Vanderbilt has a variety of patient portals including MyHealth and MyResearch at Vanderbilt that can be used for patient recruitment.  (Rothman said 30,000 patients have signed on to MyResearch at Vanderbilt, agreeing that they would be willing to be contacted directly about any study that fits their conditions.)

Additionally, patients with an encounter in Epic can be recruited electronically.

Electronic-Consent (e-Consent) is a newly evolving platform for consenting patients either on site or at home using a computer-based consent form rather than traditional paper documentation.  Consent forms can be implemented in REDCap, and patients can access consent forms via computer, mobile phone or tablet. Vanderbilt can recruit patients in REDCap via voice calls and SMS text messages. With this module enabled, participants can take automated surveys by phone or text message.

“We were able to survey over 10,000 patients in less than six months by leveraging these informatics approaches,” Rothman said.

ADAPTABLE is the first large pragmatic clinical trial in PCORnet. Researchers identified patients with coronary artery disease through phenotype and consented them electronically. Patients are being randomized into low-dose or regular aspirin groups and followed electronically for two years by pulling their electronic health record data and surveying patients as well. The goal is to see what the optimal dose of aspirin is. “We have been recommending aspirin for decades and still don’t know what the optimal dose is. We are excited to be answering that question in a pragmatic way.”

“PCORnet is a powerful network for pragmatic research,” Rothman said. “Informatics alone is insufficient to conduct pragmatic trials, but informatics approaches can help to identify, retain and follow patients.”

Among the projects the PCORI board approved on Sept. 12 was an $8.8 million study on opioid use among patients with chronic pain, assessing whether cognitive behavioral therapy or pain self-management therapy is more effective at alleviating pain and reducing opioid use.

The board also approved nearly $38 million to fund five studies to improve treatment of multiple sclerosis and an additional $18 million to fund two projects related to treatment for young patients with sickle cell disease who are transitioning to adult care.

Finally, the board approved $32.8 million for three studies that aim to generate real-world evidence through pragmatic study designs:

• An $8.5 million project comparing two types of therapy to lessen problems with swallowing in patients undergoing radiation therapy for head and neck cancer. One group of patients will proactively receive therapy while undergoing radiation, and the other group will receive therapy only if difficulty with swallowing occurs after radiation. 

• An $10.8 million study involving patients undergoing surgery to fix a broken bone in a limb that will determine which of two commonly available preoperative antiseptic skin solutions is better for reducing hospital-acquired surgical-site infections.

• A $13.4 million study to compare the effectiveness of two cavity-prevention techniques—a simpler treatment involving fluoride varnish and silver diamine fluoride, and a more-complex treatment involving sealants and fluoride varnish. The study is comparing the two techniques when delivered in school-based programs to Latino and Hispanic children in areas with a scarcity of dental care providers and clinics.


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Successful OpenNotes Implementations Require Portal Changes, More Communication

December 14, 2018
by David Raths, Contributing Editor
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Some health systems report low note-opening rates; others haven’t measured
The OpenNotes movement, in which healthcare organizations offer patients access to their clinical notes in the portal, has spread like wildfire. In just a few years it has grown to 184 confirmed health systems, with another 31 that have implemented but not documented their use, and more expressing interest every day. Yet at many healthcare organizations, the percentage of portal users reading clinical notes is still quite low, according to a new white paper and recent webinar by the nonprofit OpenNotes team.
When OpenNotes asked clinical groups for data on note-opening rates, most said it was something they did not measure, and indeed most EHR portal designs do not make it easy for them to gather that data. The OpenNotes team did collect data from 26 organizations and found that four organizations, two with homegrown EHR systems and two on Epic, had the best open rates — ranging from 21 to 34 percent, followed by eight organizations with 6 to 10 percent, with the bottom 14 reporting only 0.27 to 5 percent open rates. 
“We were stunned by the results,” said John Santa, M.D., M.P.H., OpenNotes’ director of dissemination. In many organizations, turning on OpenNotes was described as a non-event. “Sad to say that is because in some cases not much is happening,” added Santa, who played a leadership role in starting the Northwest OpenNotes Consortium and he now leads the development of future consortia. One problem is that in some cases patients are not aware of their notes or can’t find them. “Now we do know of many robust implementations where tens of thousands of patients are seeing their notes and are feeling the benefits,” Santa stressed. “But for OpenNotes to lead to best outcomes, we need to take steps to maximize the benefits.”
Their white paper notes that from the data they have gathered, “it is likely multiple factors, including portal navigation, lack of or ineffective reminders to read notes, and insufficient communication strategies contribute to low note-opening rates.”
“What we have learned is that turning it on is not sufficient,” said Cait DesRoches, DrPh, OpenNotes’ executive director and associate professor of medicine at Harvard Medical School. “Evidence suggests patients are not aware that they can read notes or they can’t find them.” Additionally, clinician anxiety around transparency is still an obstacle, she said. 
Santa noted discrepancies among customers of different EHR vendors. He said that while there are many Cerner, Allscripts and Meditech customers deploying OpenNotes, they have not developed ways to generate note-opening rates for customers. Epic, he said, has launched multiple near- and long-term changes to improve note-opening rates and included note-opening metrics in recent versions of its dashboard.
During the webinar Marcia Sparling, M.D., a rheumatologist and medical director for informatics and specialties at the Vancouver Clinic in Vancouver, Wash., made some observations about her organization’s experience. The Vancouver Clinic started piloting OpenNotes in 2014. It has a high patient portal usage rate of 82 percent, and early note-opening rates were close to 20 percent. But when the clinic did an Epic upgrade with a redesign of MyChart, the rate fell to 11 percent. “We looked at how we could help patients find the notes and why they might be missing the prompts,” Sparling said. They made a few changes. First, after-visit summaries generate an e-mail urging patients to log in, a hyperlink directs them to their past appointments page, and once there, they see wording that says “Click on your clinical notes.”
“We re-labeled that tab to ‘clinical notes’ to be more obvious,” she said. The current rate or note opening sits between 22 and 24 percent, she added, noting that there are some wide variations between specialties, although there is no obvious explanation for the disparities.
The OpenNotes white paper spells out the steps the Vancouver Clinic took to improve their note-opening rates: 
• Quick Link within MyChart patient portal (labeled ‘View clinical notes shared by your provider’); 
• Text at top of Visit Summary section directs patients to click on Clinical Notes tab; 
• MyChart home page ‘News for You’ contains paragraph on notes and a hyperlink; 
• Notes are viewable on both the Visit Summary report and the Clinical Notes tab (with some exceptions); 
• Clinicians’ notes are shared by default (with a few exceptions); 
• Auto MyChart message sent to portal user when visit is closed: Message subject reads ‘New MyChart@TVC Visit Note’; the body of message contains navigation steps and hyperlink directing patients to Appointment and Visits page.
OpenNotes is in the early stages of working with clinicians, patient groups and EHR vendors to develop metrics around use of the portal and note-opening rates. It says the definition used by Epic is reasonable as a starting point (this definition applies to notes shared over any defined time frame): Numerator = Notes listed in denominator that are viewed by a patient portal user. Denominator = Signed notes from completed encounters written on a portal active patient (or patients activated within a month of the visit) that are shared to patient portal.

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Who Isn’t Using Patient Portals? New Study Sheds Light on Portal Use

December 12, 2018
by Heather Landi, Associate Editor
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About two-thirds of adult patients did not use an online patient portal in 2017, and research indicates vulnerable and disadvantaged patients are less likely to use these technology tools, according to a study published in the November issue of Health Affairs.

Technologies such as online patient portals, which provide secure internet access to medical records and test results in addition to email communication with providers, can improve health care quality. And, evidence thus far shows that access to online portals increases patients’ engagement and adherence and may reduce unnecessary utilization and spending.

However, while the majority of adults in the United States believe that online access to personal health information is important, disparities in portal access exist.

“Findings from multiple studies that analyzed different population groups, including nationally representative samples, consistently show that members of racial and ethnic minority groups, older patients, and people of lower socioeconomic status are less likely than others to access an online portal,” the study authors wrote. The study was led by Denise Anthony, professor of health management and policy and sociology in the Department of Health Management and Policy, University of Michigan School of Public Health. Anthony and her co-authors also note that “inequities in access to new and beneficial technologies can exacerbate existing disparities in health.”

One national study, a March 2017 by the U.S. Government Accountability Office (GAO), found that only about 15 to 30 percent of patients who were offered access to a portal used it, with lower use among people living in rural and high-poverty areas.

“To identify appropriate levers that can be used to address inequities in online portal access, policy makers and providers must have a clear understanding of who is and is not accessing portals, as well as the reasons for not accessing them,” the study authors said.

For the study, titled “Who Isn’t Using Patient Portals and Why? Evidence and Implications from a National Sample of U.S. Adults,” researchers analyzed information about 2,325 insured respondents to the nationally representative 2017 Health Information National Trends survey to examine characteristics of patients who do not use portals and the reasons why they don’t them. By identifying who is not using portals and why, the researchers sought to uncover barriers and reduce disparities.

The study indicates that about two-thirds (63 percent) of insured adults with a health care visit in the previous 12 months reported not using an online patient portal. The research indicates that nonusers are more likely to be male and age 65 or older, have less than a college degree, not be employed, live in a rural location, be on Medicaid, and not have a regular provider.

These factors, along with race, were also related to whether a patient reported receiving an offer to use a portal.

Relative to females, males had significantly higher odds of not being offered access to and not using a portal, the study indicates. Members of racial minority groups (specifically, non-Hispanic blacks and non-Hispanics of other races—including Asian Americans, Native Americans, Native Hawaiians, and Pacific Islanders) had significantly greater odds of not being offered a portal. Among only those who were offered a portal, these groups reported rates of using a portal comparable to the rate of non-Hispanic whites.

The study also found that people with only a high school diploma or less were significantly less likely than those with college degrees to have been offered access to a portal. Patients with Medicaid insurance were significantly more likely to report not having been offered access to a portal and not using one, compared to people with other insurance.

Patients who lacked a regular provider were significantly more likely to report not having been offered access and not using a portal.

When evaluating reasons why people did not use a portal, the researchers did not find evidence of disparities in technological barriers. The reasons patients gave for not using portals included the desire to speak directly to providers and privacy concerns, both of which require recognition of the important role of provider communication and patient-provider relationships, the study authors note.

The study authors conclude that healthcare providers will need to address patients’ privacy and security concerns to enhance provider-patient communication.

“Reducing disparities in portal use will require that providers, particularly those serving vulnerable populations, communicate with all patients about portal use and have the capacity to discuss these technologies with patients,” the study authors wrote.

“Health care providers and plans can increase patients’ use of portals and narrow disparities in that use through direct communication about the benefits of portals, while also addressing patient-specific needs and concerns. Such interventions will require recognition that providers’ communication with patients takes time—an extremely scarce resource in clinical practice today,” the study authors concluded, while also noting that careful monitoring of who is and who is not using new technologies, and why, and designing technologies to address patients’ needs, will help ensure that such innovations do not exacerbate disparities but rather lead to improvements for all.

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AMIA, AHIMA Call for HIPAA Modernization to Support Patient Access

December 7, 2018
by Heather Landi, Associate Editor
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Modernization of the 22-year-old Health Insurance Portability and Accountability Act (HIPAA) would improve patients’ access to their health information and protect their health data in a burgeoning app ecosystem, according to two leading health IT industry groups.

During a briefing on Capitol Hill Wednesday, leaders with the American Medical Informatics Association (AMIA) and the American Health Information Management Association (AHIMA), health informatics and health information management experts discussing how federal policies are impacting patients’ ability to access and leverage their health data.

While other industries have advanced forward with digital technology and have improved individual’s access to information, and the ability to integrate and use information, such as booking travel and finding information about prices and products, healthcare has lagged. Healthcare has not been able to create a comparable patient-centric system, AMIA and AHIMA leaders attested.

“Congress has long prioritized patients’ right to access their data as a key lever to improve care, enable research, and empower patients to live healthy lifestyles,” AMIA president and CEO Douglas B. Fridsma, M.D., Ph.D., said in a statement. “But enacting these policies into regulations and translating these regulations to practice has proven more difficult than Congress imagined.”

“AHIMA’s members are most aware of patient challenges in accessing their data as they operationalize the process for access across the healthcare landscape,” AHIMA CEO Wylecia Wiggs Harris, Ph.D. said. “The language in HIPAA complicates these efforts in an electronic world.”

AMIA and AHIMA recommend that policymakers modernize HIPAA by either establishing a new term, “Health Data Set,” which includes all clinical, biomedical, and claims data maintained by a Covered Entity or Business Associate, or by revising the existing HIPAA “Designated Record Set” definition and require Certified Health IT to provide the amended DRS to patients electronically in a way that enables them to use and reuse their data.

According to AMIA and AHIMA, a new definition for “Health Data Set” would support individual HIPAA right of access and guide the future development of ONC’s Certification Program so individuals could view, download, or transmit to a third party this information electronically and access this information via application programming interface. Alternatively, a revision of the current DRS definition would provide greater clarity and predictability for providers and patients.

The groups also noted that a growing number of mHealth and health social media applications that generate, store, and use health data require attention as part of a broader conversation regarding consumer data privacy.

Congress should “extend the HIPAA individual right of access and amendment to non-HIPAA Covered Entities that manage individual health data, such as mHealth and health social media applications, the two groups said. The goal is uniformity of data access policy, regardless of covered entity, business associate, or other commercial status, the group leaders said.

Beyond HIPAA, during the briefing Wednesday, panelists discussed the success of efforts to share clinical notes with patients during visits, including the successful OpenNotes initiative, and recommended that federal officials look for ways to encourage more providers to share notes with patients through federal policies, such as Medicare and Medicaid payment programs.

“More than two decades after Congress declared access a right guaranteed by law, patients continue to face barriers,” Thomas Payne, M.D., Medical Director, IT Services, UW Medicine, said in a statement. “We need a focused look at both the technical as well as social barriers.”

What’s more, AMIA and AHIMA recommended federal regulators clarify existing regulatory guidance related to third-party legal requests, such as those by attorneys that seek information without appropriate patient-direction.

“HIM professionals continue to struggle with the existing Office for Civil Rights guidance that enables third-party attorneys to request a patient’s PHI,” Harris stated. “We recognize there are necessary circumstances in which a patient has the right and need to direct their health information to an attorney. However, AHIMA members increasingly face instances in which an attorney forwards a request for PHI on behalf of the patient but lacks the information required to validate the identity of the patient. As a result, the HIM professional is challenged as to whether to treat it as an authorization or patient access request, which has HIPAA enforcement implications

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