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April 19, 2022 05:00 AM

How hospitals are navigating doctor, patient interoperability challenges

Jessica Kim Cohen
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    One year ago, a tranche of new healthcare regulations designed to get data moving freely from providers to patients took hold.

    The long-awaited regulations, requirements of 2016’s landmark 21st Century Cures Act, have been expected to force a “culture change” in healthcare, according to Micky Tripathi, who leads the Health and Human Services Department agency tasked with implementing many of the Cures Act’s data-sharing requirements.

    “That is starting to slowly happen,” said Tripathi, chief of HHS’ Office of the National Coordinator for Health Information Technology. “Just like with anything, culture change takes a lot. It doesn’t happen overnight.”

    ONC received 274 complaints about healthcare entities allegedly blocking access to patient data from April 5, 2021—when the agency’s data-sharing rule went into effect—through January 2022, averaging roughly one complaint per day. Most complaints came from patients, which Tripathi said suggests that consumers are becoming aware of the requirements.

    “We’re starting to get some real traction,” he said.

    While patients could already request access to their data under the Health Insurance Portability and Accountability Act, the Cures Act sets the expectation that data must be shared unless it meets one of eight specific exceptions, such as if a physician believes releasing data will result in patient harm. The ONC rule—which applies to healthcare providers, health information exchanges and some developers of health IT software—goes hand-in-hand with a companion rule from the Centers for Medicare and Medicaid Services that governs payers.

    The Cures Act requirements shift the mindset in healthcare from sharing data only when it’s permitted under HIPAA to assuming that data should almost always be shared. It has required hospitals and health systems to revamp how they think about providing patients with health data, a process that hasn’t been without growing pains.

    “There’s a lot we had to do besides just the technical changes,” said Dr. Trent Rosenbloom, director of the patient portal at Vanderbilt University Medical Center in Nashville.

    The testing dilemma

    One of the most common data-sharing rule concerns ONC has heard is how to manage automatically releasing lab results to patients as soon as they’re available, according to Tripathi.

    While the rule doesn’t require providers to proactively share data with patients, it mandates that providers share that information without delay once a patient requests it. Creating the process to release records immediately upon patient requests can be complicated, leading many hospitals to release all results automatically and find other means to stave off patient concerns.

    At Vanderbilt, like many organizations, that means providers don’t have a chance to review and interpret results before a patient receives them, since patients and providers are getting results from the lab at the same time. Patients receive that data through a patient-facing system connected to the electronic health record, known as a patient portal.

    Some providers felt patients would prefer to receive their results during a conversation with a physician, rather than through a message on a screen—particularly for serious and life-changing diagnoses, like cancer, Rosenbloom said.

    There were also concerns that patients wouldn’t be able to understand their results and would be confused without an explanation from their care team.

    Tripathi said that while providers should be giving patients access to their data, physicians can use their discretion. A physician can discuss lab tests with patients during a medical appointment, and ask whether they would prefer to see their results immediately or wait until a clinician reviews them.

    “Patients are all over the map on that,” Tripathi said.

    Vanderbilt has opted to alert patients in their after-visit summaries and the patient portal that they should give their physicians time to review the results. The health system also tells patients that they can choose not to open results until they hear from their physician.

    Vanderbilt encourages physicians to let patients know about the new process during appointments and discuss potential next steps depending on certain test results.

    It’s unclear whether the move to immediately release lab results has created more work for physicians, Rosenbloom said.

    Vanderbilt has experienced a rise in messages sent to clinicians through the patient portal since the change, according to a study published last year in JAMA Network Open. The number of daily messages patients sent to clinicians within six hours of viewing a test result nearly doubled after the move.

    But that’s not necessarily a bad thing, according to Rosenbloom, a co-author on the study. He said it’s evidence that the health system has successfully engaged patients.

    The health system will continue to study how this change has affected physicians’ work, he said. The study didn’t investigate the content of the messages, so it’s possible that the new messages are adding work—but it’s also possible they’re replacing conversations that previously would have happened in person or over the phone.

    Early research results show patients often send messages confirming they’ve seen the results or asking about next steps.

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    Embracing ‘open notes’

    The next phase of ONC’s rule starts Oct. 6, when providers will have to share a broader set of electronically held health data, including medical images, billing records and even the clinical notes that summarize medical appointments.

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    Under the first phase of the rule in April, organizations were only required to share data included in ONC’s U.S. Core Data for Interoperability—a standardized, but limited, set of data elements.

    Salem Health Hospitals & Clinics, a two-hospital system in Oregon, started sharing clinical notes with patients in its ambulatory group more than five years ago, but expanded that capability to its inpatient providers more recently as it prepares to comply with the next set of data-sharing requirements, said Shea Corum, the system’s chief information officer.

    “This was a big change,” Corum said. “It took some time for us to educate our organization and have conversations about the fears and the risks.”

    Typically, an after-visit summary provided to patients is designed to be read and understood by patients, while the rest of the record is meant for trained healthcare professionals.

    Providers had expressed concerns that patients could misinterpret a message written candidly for another clinician, becoming confused or even offended by their descriptions.

    That’s been a particular point of concern for specialists.

    A study published in Nature last year found that many ophthalmologists were concerned that patients would have trouble understanding their clinical notes and could lead patients to worry more. The study’s authors wrote that ophthalmology notes are “often indecipherable even to highly educated clinicians outside of ophthalmology,” with complex abbreviations and images.

    Doctors in a JAMA Oncology viewpoint also raised concerns that open access to clinical notes could lead to anxiety for patients, who may reach out to clinicians more frequently.

    With a shift to openly sharing clinical notes with patients, it can be difficult to hit a balance between wanting notes to be appropriate for patients to read while still ensuring a comprehensive medical record for the rest of a patient’s care team.

    That’s a topic Cait DesRoches, an associate professor of medicine at Harvard Medical School, has been studying for years. She’s executive director of OpenNotes, a research group that advocates for sharing clinical notes with patients. The group dates back to 2010, with a pilot in which 105 primary-care doctors at three health systems released clinical notes to their patients.

    “Patients were uniformly very positive about it,” she said. “Clinicians reported few changes to their workflow.”

    Hospitals are acutely concerned about adding to providers’ workload as clinicians are reporting rising rates of burnout, especially amid the COVID-19 pandemic.

    The pilot’s results, published in Annals of Internal Medicine in 2012, found that at most 8% of physicians across the three sites reported spending more time addressing patients’ questions outside of visits, at most 21% reported they were taking more time to write their notes and 3-36% reported changing the content of their clinical notes.

    But all the participating physicians continued to share clinical notes with their patients after the pilot ended, and patients reported myriad benefits.

    Since then, researchers and clinicians involved in OpenNotes have continued to study how to best share data across medical specialties.

    Most providers don’t change the way they document care, DesRoches said, and patients still see benefits. Patients tend to recognize that clinical notes serve various purposes and may include technical terms.

    There are exceptions. A 2019 study in Practical Radiation Oncology found that while all radiation oncology patients who accessed clinical notes found them useful, a small group of patients did report negative effects. Roughly 11%, 6% and 4% of patients, respectively, indicated reading clinical notes led to increased worry, confusion and finding information they regret reading.

    But generally, research has found that most patients who have access to clinical notes feel more in control of their care, according to DesRoches, along with better understanding of their diagnosis and adherence to treatment plans and medications. It can also help to avoid errors as patients are able to identify inaccuracies in their records.

    It can even help patients gain trust in their care team.

    “Even among patients who don’t read their notes … just the offer of the notes seems to have a relational benefit for that trust,” DesRoches said.

    Beyond transparency

    To help guide patients through their medical records, some hospitals have turned to care team members. Technology could also play a supporting role, health IT experts say.

    Baptist Health in Jacksonville, Florida, had already been sharing clinical notes with patients before the data-sharing rule went into effect, said Aaron Miri, the system’s chief digital and information officer. He’s also a co-chair of the Health Information Technology Advisory Committee that works with ONC.

    The health system set up training for medical staff that encourages clinicians to re-read notes with the patient perspective in mind. That ideally results in clinicians not using as many abbreviations or complex medical terminology, and in cases where they must, contextualizing what it means for patients.

    For example, physicians wouldn’t just note they performed a biopsy, Miri said. They would explain why the test was run and the results of the test. Physicians should also consider including a patient’s body mass index rather than writing that they’re obese, and not abbreviating in ways that can be easily misinterpreted—such as not writing “shortness of breath” as “SOB.”

    At organizations that haven’t already been sharing clinical notes with patients, Miri suggested they start preparing for it well before the October deadline.

    “We’re literally asking clinicians to change what some of them have been doing for 20, 30, 40 years … in terminology and abbreviation,” he said. “That’s not going to happen overnight.”

    There’s also the potential to bring in other members of the care team to help patients understand their notes, without all of it falling on physicians’ shoulders.

    Grace Cordovano, a board-certified patient advocate and co-founder of Unblock Health, which is developing a digital platform for patients to request access to health data, said she’s noticed an improvement in providers sharing test results more quickly, as well as sharing clinical notes, since ONC’s rule went into effect.

    Cordovano said she’d like to see healthcare organizations set up a patient access or health information management role designed to support and guide patients who have questions about their health records, similar to a concierge desk. That could prove particularly useful for patients who have low health literacy or who aren’t comfortable with digital technology.

    “It’s going to be an incremental process,” she said of the Cures Act data-sharing requirements. “It hasn’t been a light switch, where all of this information that patients need available is available yet. But we’re moving in the right direction.”

    Providing patients with access to their data isn’t just about giving patients what they say they want or improving the patient experience in the abstract. It can have concrete implications for patient safety, said Dr. John Lee, chief medical information officer at Pittsburgh-based Allegheny Health Network.

    If a patient’s demographic data is captured inaccurately or their record accidentally is merged with another, a physician could be confused about their medical history. That could lead to a physician mistaking a patient’s allergies or denying someone an immunization, if their records erroneously show they’ve already received one.

    But if a patient is able to review their information, they can set the record straight and provide corrections.

    The next challenge, according to Lee, is applying technology to tailor clinical notes depending on the reader, hopefully one day making medical data more “consumable” for patients.

    He said he hopes to see the health technology industry create tools—such as those that use artificial intelligence—that present needed information to patients, as well as tools that highlight the most relevant data for clinicians reviewing a patient record.

    “Just because you have data doesn’t mean that it’s actually useful,” he said. “We have to take that next step.”

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