Clinical Registries: Getting Necessary & Costly

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Many tout the benefits of clinical registries because they allow for benchmarking of one provider to another, linking measurement to performance improvement and leading to the betterment of overall quality of care. However, some point to the costs as potential drawbacks to individual providers that are getting increasing pressures to participate.

Here to stay

There are at least three types of clinical registries: procedure/therapy/encounter-based, disease-based and population-based registries, according to the American Heart Association's (AHA) policy statement on registries (Circulation 2011;123:2167-2179). "Registries also can be classified from a functional perspective, such as whether the registry is used to conduct clinical research, to perform quality measurement or to provide feedback to clinicians for quality improvement," the recommendations read.

In the past, when the quality of healthcare in the U.S. has been measured, significant gaps in care, unexplained variation in care delivery and outcomes and medical errors have been revealed. As a result, registries have been on the rise. They seek to provide benchmarks from which physicians can compare themselves to peers. Importantly, they also allow the cardiovascular community to monitor itself, without the interference of government regulations.

The specialty of cardiology, which relies heavily on clinical data, offers a plethora of registries, such as the Society of Thoracic Surgeons (STS) Database, the AHA-Get With the Guidelines (GTWG) initiatives and the American College of Cardiology's (ACC) National Cardiovascular Data Registry (NCDR) programs. Some suggest that regardless of the practice type and the cardiac patients served, registries provide something for everyone.

Vincent J. Bufalino, MD, president and CEO of Midwest Heart Specialists, says the 50-cardiologist outpatient facility in Elmhurst, Ill., measures outcomes through registries and provides quarterly feedback to physicians on measures, such as blood pressure control, cholesterol control or medication management.

Initially, Bufalino's cardiologists resisted. "All practitioners assume their outcomes are near perfection, but when we started measuring within my group in the early 2000s, there were a lot of 70s," he explains. "This refocused everyone's efforts internally, because they all wanted to be as good as they could be." Midwest Heart recently reported 28 consecutive quarters with 520,000 patient visits, and they were in the 90-plus percentile on every measure, he says.

However, Bufalino attributes his outpatient practice's capability to measure outcomes to its EHR system, an asset many outpatient practices lack. But, he adds, "Like it or not, we are being measured, and we are going to be measured more and more."

Also, registries can be used to inform healthcare policy. For instance, in a study funded by the FDA, a subset of hospitals participating in the CathPCI registry took part in an investigation of bleeding complications associated with various groin closure devices (J Invasive Cardiol 2005;17[12]:644-650). This study linked VasoSeal (Datascope) to a significantly higher rate of vascular complications, which led to the removal of that device from the U.S. market.

Transparency on full throttle

"Clinical registries must be designed with sufficient safeguards, rigor and transparency to ensure that the primary functions of the registry are well served," according to the AHA policy statement, on which Bufalino was the lead author. In fact, transparency for physicians and patients seems to be the driving force behind these registries.

The public's need for information may soon find satiation in healthcare. "Provider data are more frequently going to be available for public scrutiny," says Frederick A. Masoudi, MD, senior medical officer for the NCDR and a cardiologist at the University of Colorado Denver, who sees a broad movement toward public accountability for quality of care. "It is a pretty common theme across medicine, particularly in cardiology."

As an example, the STS database is the largest such registry in the world, including more than four million surgical records and representing more than 90 percent of adult  cardiac surgery groups in the U.S. In 2011, the STS agreed to share the data on heart bypass surgery with Consumer Reports to help patients make informed decisions.

"This decision by the STS is part of the new era of transparency in making sure that patients can make informed decisions," says David R. Holmes, MD, ACC president and a cardiologist at the Mayo Clinic in Rochester, Minn. "Part of that decision-making relates to the expertise of the physician, as well the expectation of the patient, so we will continue to see progressive transparency with outcomes."

However, Holmes adds that such transparency is accompanied by several caveats: Data entered and released have to be absolutely correct and risk adjusted. For risk adjustment, if the outcomes of a specific physician are worse because he or she treats sicker patients than another physician who treats less sick patients, then an appropriate method should be applied to adjust for that, Holmes says.  

Having the appropriate, qualified personnel, or FTEs, inputting and checking the information is "highly valuable," Masoudi says, to ensure the accuracy of the data and maintain data standards.  

Holmes references a third caveat of transparency through an analogy to car rental agencies, namely when Avis was ranked No. 2 car rental agency behind Hertz. "In healthcare, would you ever use Avis?" he questions. "Probably not, even though a lot of people like Avis and have good success with it. If you are talking about healthcare as a service and ensuring it has a reasonable, safe and effective profile, is there room for an Avis in healthcare?"   

Cost burden

"[F]unding and sustainable business models are among the most significant challenges facing the expanded use of clinical registries," according to the AHA policy statement.  

Holmes, who acknowledges registry costs as "substantial" to providers, identifies three components of expenses: participation in the registry itself; FTE costs for data input; and FTE costs to ensure that the data are correct and audited. "While these costs may be chalked up for cost of performing quality care, those costs are never reimbursed," Holmes says.

While a few of the registries are supported by industry, most require participation dues and implantation fees. In 2011, the participation fees for the NCDR's IMPACT registry were $5,685, and the implementation fees were $1,000.

"The cost to participate annually is relatively small, but it's the FTE costs that are most expensive, in addition to the IT infrastructure," Bufalino says. "We spend several hundred thousand dollars a year to maintain our EHR's ability to analyze data."

Most hospitals and inpatient settings have to maintain at least one full-time FTE whose sole job is to collect information, verify accuracy, connect to the registries and input the data. It is a cost that no one covers, explains Bufalino, adding that a more sustainable business model needs to be developed, with subsidies from the government or the medical device and pharmaceutical industries.  

Masoudi points out that the amount of personnel required is highly variable, depending on the the practice or hospital's EHR and the degree of interaction with the registry.

The goal is that these costs could lead to an improvement in the quality of healthcare, and a health system that recognizes those achievements. "This cost of doing business [with registries] now may hopefully get to the point where quality institutions have all the latest information to provide the latest feedback," says Holmes, "and there will hopefully be a time when providers are reimbursed for quality—which doesn't presently occur in the U.S."
The National Cardiovascular Data Registry Programs
Registry Program Clinical Area Partnering Organizations Participants/ Records
CathPCI Diagnostic cardiac catheterization and percutaneous coronary intervention ACC, SCAI 1,144 hospitals, >10,000,000 patient records
ACTION Registry®— GWTG™ Acute myocardial infarction ACC, AHA, SCPC 456 hospitals, >125,000 patient records
ICD Implantable cardioverter–defibrillator ACC, HRS 1,482 hospitals, >400,000 patient records
CARE Implantable cardioverter–defibrillator ACC, SCAI, SCVIR, AAN, AANS/CNS, SVM 185 hospitals, >10,000 patient records
IC3 (Improving Continuous Cardiovascular Care) Coronary artery disease, heart failure, cardiac rehabilitation, hypertension, diabetes and atrial fibrillation ACC, MedAxiom, and Spirit of Women 175 practices (>600 offices), >150,000 patient records
IMPACT Pediatric and adult congenital cardiac catheterization ACC, SCAI, AAP 11 pilot hospitals
AANS/CNS = American Association of Neurological Surgeons/Congress of Neurological Surgeons; AAP = American Academy of Pediatrics; ACC = American College of Cardiology; AHA = American Heart Association; HRS = Heart Rhythm Society; SCAI = Society for Cardiovascular Angiography and Interventions; SCVIR = Society of Interventional Radiology; SVM = Society for Vascular Medicine; and GWTG = Get With The Guidelines. Source: Touch Briefings, US Cardiology. 2009. Rumsfeld et al.