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2018 RESEARCH SUMMIT: WORK BEGINS TO ANALYZE DATA IN RAPIDLY EXPANDING ACP PRO VENOUS REGISTRY

By Vanessa Salvia

Contributing Editor

Anticipation was high for many members of the phlebology community going into an April 21 closed-door research summit held alongside the International Vein Congress in Miami, convened to discuss how to make the most of the American College of Phlebology’s Patient Recorded Outcome Venous Registry, or PRO Venous Registry.

This is the second annual research summit. The first one on April 21, 2017, brought

together American College of Phlebology (ACP) leadership and other industry and registry thought leaders for an open discussion about the data captured by the ACP PRO Venous Registry and the immediate needs of the medical community and items that can be addressed using the database.

The registry, which was first envisioned in 2009 by Marlin Schul, MD, a specialist in venous and lymphatic medicine in Lafayette, Ind., currently has 109 physicians participating. Most submit their data through an electronic medical records process, but a few participate using manual entry.

There are more than 36,000 individual patients and more than 150,000 patient records to date. With more than 640 data fields covering aspects of deep and superficial venous disease and lymphatic disease, the ACP PRO Venous Registry comprehensively represents the practice of vein and lymphatic care. Soon, the 67 vein centers owned by Vein Clinics of America and the 70 centers owned by the Centers for Vein Restoration will also begin importing their data on a weekly basis into the PRO Venous Registry.

As the ACP advances on its “New Horizon” campaign to embrace advocacy, education and research, the summit brought together a committee led by seven physicians and directed by Joseph Jenkins, MD, a vein surgeon from Dubuque, Iowa, with the intention of determining how to develop quality measures for vein care along with research questions that can be asked of the data in the registry.

“I walked out of the summit thinking that myself and my committee have a lot to do,” Dr. Jenkins said with a laugh. “We have all this information and we need to start delving in and analyzing the data.”

Naomi Sinclair, the ACP research and registry director, spoke highly of the summit outcome. “It went well,” she described. “We broke people out into small groups that matched what they do for a living with each group headed by an appointed table leader. Each group worked together to develop research/registry questions and presented their results. We obtained some very useful information.”

Participants were experts from seven areas: endovenous ablation headed by Kathleen Gibson, MD; sclerotherapy headed by Domenic Zambuto, MD; ambulatory phlebectomy headed by James Heinz; deep veins/pelvic veins headed by Peter Pappas, MD; lymphedema headed by Chris Pittman, MD; compression headed by Yung-Wei “Willy” Chi, DO; and venous ulcerations headed by Caroline Fife, MD.

“I thought it was a very successful meeting,” said ACP Board of Directors President Neil Khilnani, MD. “The idea is try to craft new research questions that we could answer using our registry in seven different subject areas, and then also to craft what might be considered quality measures that track the performance of physicians.”

Each of the presenters used a variety of techniques, from paper to PowerPoints, to illustrate the challenges and opportunities they had in their area of expertise. Dr. Khilnani said each table did a fantastic job in the time that was allotted to identify where the gaps in the data are, identify the types of questions that would be appropriate, and the types of data that would have to be collected to answer those questions.

“Ultimately at each table we determined the more impactful, important issues and we can now drive towards them being answered,” Dr. Khilnani explained. “Our plan is to take those research questions, put them into individual documents that each table captain will present to the ACP’s research committee and eventually work toward both answering the questions and potentially even changing what we’re collecting in our registry so we have the data we need in order to accomplish what we want to accomplish.”

 

NEW RESEARCH FRONTIERS

About 5 percent of the patients in the registry are lymphedema patients and about 2 percent are thrombotic patients, Dr. Schul said. The rest are a mix.

That’s a lot of data on interventions and complications, and plans are now in place to take great strides to use that data effectively through research, partnering with industry on products and market research, and improved patient care for those disorders where less is understood about procedures and interventions.

Dr. Jenkins said that with the amount of data that is in the ACP PRO Venous Registry, it will be possible to answer some large-scale research questions.

“Instead of having 75 people in a study done by a tertiary care center or university medical center to answer some of these questions, the hope is we can answer them with several thousand people,” he said. “That’s the beauty of the registry.”

It’s soon to be achievable, he explained, given the questions that the tables asked at the research summit. Once the data is analyzed, ACP can take the data to the research committee and ask them to find someone to research the questions. Then the researcher will already have the data and the questions, and ACP can provide a grant from the ACP Foundation to fund the research.

“We are on the cutting edge,” Dr. Jenkins said.

 

REGISTRY BACKGROUND

Back in 2009, Dr. Schul hired an assistant to put all his patients into an existing registry. It was costly, duplicate work. The data also revealed a lack of quality of life measures.

“The question became, ‘What should we capture and how were we going to show a benefit from this? because the data available at that time just wasn’t powerful.”

Drs. Schul and Chi had a vision of capturing patient’s voices as they collected data, avoiding duplicate entry and automating the data entry. That was not possible until they started working on their platform of templatized data.

“It’s the aggregate of data that matters,” Dr. Schul explained. “It’s how you establish best practices when you’ve got many different technologies that are being used and many different providers with different approaches.”

With a large amount of data and some quality measures in place, it is much easier to show that one approach works better than another at reducing pain, or that risk of recurrence is less with one approach than with another.

“All of these things are reportable,” he explained. “Patients do their part by filling out these questionnaires — and these questionnaires are simple, using six questions and 18 more that are about the severity of a given symptom — so it’s easy and with that then you get more users, you get more compliance, you get something that can actually measure vein care in our country. We’re on the cusp of that.”

 

QUALITY MEASURES DEFINED

Each table was given the information (mapping document) within ACP PRO Venous Registry, and was tasked with coming up with a minimum of two questions in their area of expertise that needs to be answered from a research standpoint.

The other goal was to discuss what was needed to achieve Centers for Medicare and Medicaid Services (CMS) certification of the registry. In 2016, ACP PRO Venous Registry was designated a Meaningful Use specialized registry by CMS as part of its EHR Incentive Program. However, as of now it is not CMS-certified as a sub-specialty registry. To achieve that, the team is tasked with developing quality measures that satisfy CMS.

MIPS, Medicare’s Merit-Based Incentive Payment System, and MACRA, the Medicare Access and CHIP Reauthorization Act, are the programs that determine Medicare payment adjustments whereby eligible professionals may receive a payment bonus, a payment penalty or no payment adjustment.

In 2017, Dr. Jenkins said the quality portion of MIPS reporting accounted for 60 percent of a physician’s score. MIPS and MACRA don’t provide payment adjustments unless their quality measures are reached, but for many venous patients, and particularly lymphedema patients, there are no accepted quality measures.

Dr. Jenkins said he is meeting quality measures by asking some of his patients things that don’t reflect his vein care, such as whether one of his vein patients has received a colonoscopy screening for cancer. Not only is that extra data he has to put into his records that doesn’t affect his vein care, it’s not asking the questions that truly matter regarding this patient’s venous disease experience.

“The point of getting the registry certified by CMS is that you’re providing them with quality measures that are useful in the vein world.”

Only one quality measure is currently recognized and that’s one provided by the Society of Interventional Radiologists regarding endovenous ablation of the great saphenous vein. In order to provide that quality measure, the physician must be a member of that society, so Dr. Jenkins’ and others’ vein practices don’t qualify.

“I have to use six other measures from primary care,” he said. “I’m measuring colonoscopy, BMI, smoking, fall risk, medications in the elderly and pneumococcal vaccines. I don’t even give pneumococcal vaccines but I use that and we collect that.”

Dr. Jenkins and his committee are now focused on having at least six quality measures that are vein-specific.

 

PRO VENOUS REGISTRY

The ACP’s PRO Venous Registry is one of three registries in the vascular and venous space for research. The Vascular Quality Initiative or VQI, is now governed by the Society for Vascular Surgery Patient Safety Organization. The other one, Venous Patient Outcome Registry (VPOR), is a registry database that is now the property of the ACP.

While the others are built on manual data entry, the PRO Venous Registry uses EMR exports of information. When the doctor fills out EMR forms to be transmitted to CMS so they can be paid, the PRO Venous Registry taps into those EMR forms and automates the data submission process to map the physician’s EMR exports into the registry.

This means that the participating physician fills out the forms one time for CMS, but the PRO Venous Registry allows them weekly or monthly exports of all their patient outcome information automatically into the registry.

 

PLANNING FOR THE FUTURE

Dean Bender, ACP and ACP Foundation executive director, said the biggest benefit to the summit lies in the fact that it can successfully bring together influencers from industry as well as patient care to discuss where resources need to be invested to understand venous and lymphatic disease and help patients.

“Our corporate partners, as well as our physician partners, come together and share different ideas of what the future will be and we’re able to do that in a way that’s not commercially driven or rife with ulterior motives,” Bender said.

Dr. Schul agreed. “This type of meeting is great because there’s no ego,” he said. “It’s really about what’s best for the collective body of physicians and the patients. We’ve got a lot of bright minds that are focused on patients that want to come out of this summit with a new set of initiatives. We’ve got a machine that’s collecting data and that data is growing exponentially, and it’s soon to be the largest registry in the world. That’s not a bad position to be in.” VTN

 

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Larry Storer

Larry Storer

Larry Storer has been editor of Vein Therapy News for 10 years. He has edited computer, shelter and medical publications at Publications & Communications LP for 30 years. He was also a corporate vice president and editorial director before retiring. Larry graduated from Baylor University with a BA in journalism and an MA in communications; and from Lamar University with a MED in school administration. He taught beginning and advanced reporting, beginning and advanced editing and editorial writing at Baylor University. Larry was a reporter, and city and news editor of the Beaumont Journal, and opinion editor at the Beaumont Enterprise and Beaumont Enterprise-Journal. He was also the founding managing editor of the Yuba City (California) Daily Independent-Herald.