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AMIA Urges More Work on FDA’s Decision Support Guidance

February 6, 2018
by Heather Landi
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In comments submitted to the Food & Drug Administration (FDA) this week, the Bethesda, Md.-based American Medical Informatics Association (AMIA) said new draft guidance is well-timed to initiate a broad discussion over the future of clinical decision support (CDS) and patient decision support (PDS) software.

AMIA officials noted that several trends are converging to transform the delivery of knowledge resources through decision support software for patient care and wellness, including cloud-based computing, machine learning, and improved patient access to their clinical data. However, according to AMIA, the FDA’s draft guidance was incomplete, given a lack of discussion regarding how FDA would regulate CDS and PDS still considered medical devices.

AMIA’s comments are in regard to the FDA’s regulatory oversight of CDS software intended for healthcare professionals and PDS software intended for patients and caregivers who are not healthcare professionals.

Section 3060 of the 21st Century Cures Act of 2016 (Cures) compels the FDA to exclude certain software functionalities from the definition of device. This legislative language effectively prohibits the FDA from regulating that software as a device, which then may require pre-market review, clinical trials, and other clearance activities. According to AMIA, some of these excluded functionalities describe what is commonly understood as CDS, and the patient-facing equivalent, PDS.

“However, not all CDS/PDS was excluded from the definition of the device by Cures. This draft guidance tries to articulate where the line between regulated device and unregulated functionality lies per the FDA’s interpretation of Cures,” AMIA officials state.

AMIA supported development of the FDA’s guidance, but the group warned of “lingering confusion among developers and clinicians trying to determine whether specific decision support software is, or is not, considered a device.” According to AMIA, some of the criteria used to determine if a functionality should be excluded is ambiguous. For instance, one criterion requires independent review of the basis for recommendations presented by the CDS/PDS, and FDA describes such review to be independent if the clinician/patient does not “rely primarily on such recommendations, but rather on their own judgement,” AMIA says. Unfortunately, this caveat is founded in the Cures statute, so while ambiguous, it remains part of the equation to determine if the functionality is a device.

To be useful and practical for its intended audiences, AMIA recommended that the FDA articulate why examples of software are categorized as exempt or not, using the criteria established by Cures. AMIA also recommends that the FDA include discussion regarding it’s intended regulatory controls for CDS software considered a device, even if the intended regulatory controls are still in development.

What’s more, AMIA also urges the FDA to include discussion regarding the anticipated literacy levels, and their variance, across intended users of patient decision support software functions.

In 1997, AMIA led a consortium of diverse stakeholders to develop a framework for monitoring and regulating clinical software systems. This consortium recommended that “the FDA focus its regulatory efforts on those systems posing highest clinical risk that give limited opportunities for competent human intervention,” and it established a decision algorithm for FDA to use in its regulation of standalone clinical software systems as medical devices.

Since that time, AMIA notes, cloud computing and machine learning have changed the way decision support software can impact patient care. “CDS and PDS functionalities can be based on a trained neural network, multivariate regressions, or fuzzy logic with perhaps millions of data points, enabling a data-driven approach to decision-making at the bedside. This new paradigm also creates new risks to patient safety, and requires new thinking around regulation,” the group noted.

“Twenty years ago, AMIA led a national dialogue over how to regulate software,” AMIA president and CEO Douglas B. Fridsma, M.D., Ph.D., said in a statement. “Now is the time to revisit old assumptions, and the informatics community is eager to help.”

 

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How BI Tools Are Helping Jefferson Health Battle the Opioid Crisis

September 21, 2018
by David Raths, Contributing Editor
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Helping clinical leaders identify prescribing patterns across the health system

Making health system changes to address the opioid crisis is challenging if you don’t have actionable data about prescribing patterns. With guidance from their chief medical officer, the business intelligence team at Jefferson Health in Philadelphia took advantage of the recent enterprise EHR implementation to create dashboards highlighting potential prescribing issues. Internal EHR development teams have already made changes to address the issues they found.

In a recent interview, Cara Martino, enterprise business intelligence manager at 14-hospital Jefferson Health, said that Jefferson was one of the first health systems to implement its Epic EHR and Qlik Sense at the same time. Many organizations that go live on Epic use Crystal Reporting, she said. “It was the combination of the two that allowed us to do this project,” she added. Before going live on Epic and using this new BI tool, Jefferson clinicians used a bunch of disparate systems for ambulatory, inpatient and emergency department physicians. “We weren’t able to aggregate the data,” she recalled.

Jefferson departments had tried to look at opioid prescribing previously, but “they were trying to manually abstract opioid data from the system, compile it in Excel, and try to see trending across the continuum of care, but they really weren’t able to do that very well,” Martino said. “Once we went live with Epic, we were able to standardize the work flow of entering the opioid order and prescription, and Qlik Sense allowed us to look at it from that enterprise view and to slice and dice the data a bunch of different ways.”

In response to the opioid epidemic in the Philadelphia area, Jefferson has created an opioid task force. In January 2018, Edmund Pribitkin, M.D., Jefferson’s chief medical officer, came to the BI team because he saw they didn’t really have good data to share. “We were bringing physicians and pharmacists together in a room to think through what we can change to address the opioid crisis,” Martino said, “but they didn't’ have baseline data to understand where we are going wrong.”

Pribitkin asked the BI team to develop a high-level dashboard with five key metrics to share at the clinical chair department level: 

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• Prescriptions by provider and service;

• Number of orders with over 100 pills;

• Prescriptions written for more than 7 days, 5 days and 3 days;

• Patients with two or more opioid prescriptions within 30 days; and

• Morphine-equivalent daily doses over 50.

The metric around patients with two or more prescriptions within 30 days had been difficult to see when data was being entered in a lot of different ordering systems, but is much easier now because everyone is ordering through Epic.

Within a month, the BI team had a prototype created. In the dashboard, you can pick a patient with the most scripts, and below it populates the different providers who are prescribing for them. “Sometimes you pick someone on the higher end and only one person is prescribing to them. Usually it is a chronic pain clinician, and it is probably appropriate,” Martino said. “But then you pick someone who has six different providers providing them opiates. They may have no idea about each other. Now we get to have that conversation about what we can do in the EHR to notify them at the time of ordering that the patient already has something prescribed. Also, our quality department can notify these six providers via e-mail. They might ask whether we should refer this patient to a chronic pain physician. If they really need this much pain medication, are we treating them the right way?”

Showing clinical leaders a trending graph such as prescription orders of 7 days or more can have an impact on ordering trends and EHR recommendations. Martino, who is a nurse herself, described an example of how her team worked with clinician informaticists who build EHR workflow tools to make some key changes.

They saw in the data that there were examples of doctors were prescribing six opioids to the same patient within two minutes. On further examination, they found that clinicians were entering orders incorrectly and quickly canceling them. But the e-prescription interface with the pharmacy system wasn’t necessarily canceling the incorrect orders, and the patients could have six prescriptions waiting for them at the pharmacy.

“Our first step was to get a message out to providers to let them know if you are prescribing and sending to an outside pharmacy, you need to pick up the phone and talk to the pharmacy about a change in an order and make sure they know which is the correct one,” Martino said. They also worked on the pharmacy interface to generate those canceled order messages, so that if something is ordered and then canceled within 30 seconds, it alerts the pharmacy not to prepare it.

The BI team saw another EHR change that they thought might make a big difference in prescribing patterns. In the EHR quick buttons, duration of the prescription defaulted to 10 days. The quick button on order days had choices of 7, 10, 15 or 30. “We knew those were too high,” she said. “We wanted 3, 5 or 7.”

They worked with an emergency department doctor who was also an informaticist to pilot that change in the ED. “In the first month, we saw a drop from 32 scripts over 7 days to just two,” Martino said. The following month they saw a reduction of more than 65 percent in prescriptions of more than 7 days. “The best part is no one complained or said they were looking for the 10 button and it wasn’t there,” she added. Now that change is being rolled out enterprise-wide.

Although there are some other requests from clinicians for data about opioid prescribing, Martino said the BI team’s current goal is to help more clinicians gain insights into the data that already exists. “It is really hard to go from an institution that was not data-rich and had disparate systems and manually collected data to one that has one EHR and a robust BI tool that allows us to slice data in a million different ways,” Martino said. “We are trying to get the clinicians comfortable with the tools. There is so much we can do, but we have to get the data to the right people and educate them about how we are pulling it out of the EHR. It is easy for this not be a priority for clinicians because they are so invested in taking care of their patients. It is our job as informaticists to go to their meetings and talk about changes we can make. It is also important for us to have clinicians on our team and to be able to offer that informaticist viewpoint.”

 

 


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Survey: Physicians Sour on Value-Based Care Metrics, EHRs

September 19, 2018
by Rajiv Leventhal, Managing Editor
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They new research has several key findings related to value-based care, health IT and burnout

More than 50 percent of U.S. physicians who receive value-based care compensation said they do not believe that the metrics the reimbursement is tied to improve the quality of care or reduce costs, according to a new survey.

The research comes from The Physicians Foundation, an organization seeking to advance the work of practicing physicians and helps them facilitate the delivery of healthcare to patients. The Foundation’s 2018 survey of U.S. physicians, administered by Merritt Hawkins and inclusive of responses from almost 9,000 physicians across the country, reveals the impact of several factors driving physicians to reassess their careers.

Specifically, the new survey underscores the overall impact of excessive regulatory/insurer requirements, loss of clinical autonomy and challenges with electronic health record (EHR) design/interoperability on physician attitudes toward their medical practice environment and overall dissatisfaction—all of which have led to professional burnout.

The research revealed several key findings, including that value-based compensation is directly connected to the overall dissatisfaction problem, which is tied to metrics such as EHR use, cost controls and readmission rates, etc. Forty-seven percent (compared to 43 percent in the 2016 survey) of physicians have their compensation tied to quality/value, but when physicians were asked if they believe that value-based payments are likely to improve quality of care and reduce costs, 57 percent either disagreed or strongly disagreed that this is the case, while only 18 percent either agreed or strongly agreed that it is.

As one responding physician put it: “We are no longer in the business of healthcare delivery, we are in the business of ‘measures’ delivery.” More than 13 percent of physicians are not sure if they are paid on value.

What’s more, the research found that 88 percent of physicians have reported that some, many or all of their patients are affected by social determinants. Conditions such as poverty, unemployment, lack of education, and addictions all pose a serious impediment to their health, well-being and eventual health outcomes. Only one percent of physicians reported that none of their patients had such conditions.

Additional notable findings from the research included:

  • 18.5 percent of physicians now practice some form of telemedicine
  • 80 percent of physicians report being at full capacity or being overextended
  • 40 percent of physicians plan to either retire in the next one to three years or cut back on hours—up from 36 percent in 2016
  • 32 percent of physicians do not see Medicaid patients or limit the number they see, while 22 percent of physicians do not see Medicare patients or limit the number they see
  • 46 percent of physicians indicate relations between physicians and hospitals are somewhat or mostly negative

Coupled altogether, 78 percent of physicians said they have experienced burnout in their medical practices, according to the survey’s findings. And the results show that one of the chief culprits contributing to physician burnout is indeed the frustration physicians feel with the inefficiency of EHRs.

“The perceptions of thousands of physicians in The Physicians Foundation’s latest survey reflect front-line observations of our healthcare system and its impact on all of us, and it’s sobering,” Gary Price, M.D., president of the Foundation, said in a statement. “Their responses provide important insights into many critical issues. The career plans and practice pattern trends revealed in this survey—some of which are a result of burnoutwill likely have a significant effect on our physician workforce, and ultimately, everyone’s access to care.”

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Brigham Health’s 3-Pronged Approach to Reducing EHR’s Contribution to Burnout

September 18, 2018
by David Raths, Contributing Editor
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Focus is on individualized training, reducing unnecessary clicks, voice recognition tools

Research studies have found that “burnout” is nearly twice as prevalent among physicians as among people in other professions.  Physician surveys have found that 30 to 60 percent report symptoms of burnout, which can threaten patient safety and physician health. With EHR documentation ranked high among aspects of their work physicians are dissatisfied with, Brigham Health in Boston has taken a three-pronged approach to reducing the pain.

Brigham Health, which is the parent organization that includes Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital and the Brigham and Women’s Physicians Organization, rolled out its implementation of Epic in 2015. In a Sept. 18 presentation that was part of the Harvard Clinical Informatics Lecture Series, Brigham Chief Information Officer Adam Landman, M.D., said the organization’s initial EHR physician training was eight hours of classroom training on where to find things in the EHR instead of focusing on workflows and how to use the EHR to support it.  “Our experience was not the best,” Landman admitted.  They followed up with tip sheets, a help desk and a swat team to do service calls, but providers only rated those interventions as somewhat helpful, so Brigham informaticists re-doubled their efforts to:

• Improve the EHR;

• Provide one-on-one training in the clinical setting; and

• Offer voice recognition software and training.

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Landman said IT teams at Brigham feel a sense of urgency about reducing the burden of EHR documentation. “Burnout is an epidemic, and the EHR is a component of this,” he said, adding that the changes are not just a one-year cycle but must involve continual iterative improvements. “We need to be more aggressive about making changes,” he said.

He described some efforts to reduce notifications and remove clicks from the medication refill process. They also removed a hard stop when discontinuing a medication. Those three changes alone reduced the number of clicks per month by 950,000 across the health system.

They also worked to reduce clinical decision support alerts with very low acceptance rates by turning them off. Three alerts with very low acceptance rates were turned off. “If we thought they were important, we would fine tune them to increase the acceptance rate,” Landman stressed. “That is part of clinical decision support lifecycle management. But we will continue to iterate to reduce the number of unnecessary clicks.”

A year and a half ago, Brigham also created a one-to-one support program, in which an expert trainer would meet the physicians in their practice and help them with their work flow. A pilot project involved four specialties, including general surgery. Each session was 90 minutes to two hours long, and providers were offered one or more follow-up sessions, as well as optional training on speech recognition. After seeing some negative feedback on their initial classroom training, the one-to-one sessions were met with a very positive response. Almost 95 percent said it was valuable, and 95 percent said they thought their efficiency with the EHR would improve following the training. Based on that early success, the training effort is now being rolled out to much larger groups of physicians at Brigham and across the Partners HealthCare network.

In another attempt to improve documentation turnaround time, Brigham has made voice recognition tools and training available to physicians. They made two-hour training sessions mandatory for those interested in adoption, with additional personalization sessions also available. Informaticists partnered with departments to build department-specific order sets. (Brigham also started offering 15-minute e-learning sessions for residents.) More than 90 percent of surveyed physicians said the training met expectations, and 70 percent said they would be willing to have additional training, Landman said. Currently 5,000 physicians across Partners are trained to use voice recognition tools with the EHR.

Landman also cited a study that compared U.S. and international use of Epic that saw a huge disparity in length of documentation notes. The U.S.-based users’ notes were nearly four times longer on average than those of their international counterparts. Epic users overseas tend not to complain about the burden of documentation, he noted. This has to do with how the provider notes are used in billing, he said, adding that CMS is working on proposals to change billing requirements that may alleviate some of the documentation burden for physicians.

In closing, Landman urged informatics colleagues to think about working on EHR optimization research and studying the impact of policy and technology changes. “New technology tools can seem fun and exciting, but for physicians who see up to 100 patients per day, they can be quite overwhelming,” he said. “We don’t want physicians spending half their time doing administrative work.”

 

 

 

 

 


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