The Promise of Patient Registries

Clinical quality improvement beyond benchmarks.

By Chris E. Stout, PsyD; Grace Wang, BA; Julie Roper, PT, DPT; and David Nelson, MBA

As health care in the United States becomes increasingly patient-centric, hospitals, clinics, and other health care practices must strategically adjust their business models to focus on patient experience, and more specifically, patient outcomes. More than ever, health care professionals must know what works for which patients and why. Evidence-based medicine and evidence-based practice are more important to clinicians than ever before. While an evidence-base is predicated on having a robust literature from which to base reviews and consensus guidelines, generally only studies with positive findings pass peer review muster.¹ Thus, studies that should be helpful and guiding are often of little practical value. An approach that may address this concern is the increasing use of patient outcomes registries, which, when designed and applied suitably, can provide clinicians and other stakeholders with a real-world picture of treatments and their efficacy.²

What is a Registry?

A registry is an organized system for data collection that allows for improved patient function evaluation and the storage, accessibility, and comparability of clinically relevant information and patient measures. From a clinician’s perspective, this means he or she now has access to data based on large numbers of patients on any given diagnosis. This data can help him or her understand the diagnosis and treat patients more effectively. According to Gliklich and Dreyer from the Agency for Healthcare Research Quality (AHRQ) in 2007:

Patient registries are organized systems that collect data for scientific, clinical, or policy purposes. Registries are a valuable complement to randomized controlled trials in determining real-world outcomes in the practice of medicine. They do not generally have restrictive inclusion or exclusion criteria, nor do they specify what therapy the health care provider must adhere to. They can be used to evaluate outcomes for diverse purposes ranging from the natural history of a disease, to the safety of drugs or devices, to the real-world effectiveness of therapies.³

Ideally, patient data collection is synthetic to the clinical process, meaning it should be gathered in real time by health care providers during treatment. Once entered into an electronic medical record system, the data immediately becomes available in the registry for treatment, reference, and archiving purposes. Contrast the immediacy of available information in a patient registry with the slow, oftentimes multiyear delay-to-industry and associated expense of randomized controlled trials and the benefits of a patient registry become exceedingly obvious. Consequently, registry datasets are constantly growing and therefore provide constantly improved information, which is available for a wide variety of custom analyses by physician, payer, or referral source—or any combination thereof.

In other words, physicians, physician organizations, or referral sources can now make determinations based on large amounts of data in regard to the extent to which clinicians are treating a patient in accordance with evidence-based guidelines. Similarly, payers can access information on how treatment, procedures, or medical devices are actually used and their efficacy in varying patient populations, which could be valuable for defining coverage policies.²

The use of registries enhances patient care and clinical knowledge, not only by improving patient outcomes and allowing for creation of actionable insights, but also by providing a platform for intelligence-sharing and collaboration with other scientists, research institutions, and physicians.

Outcome Registry Leaders

Numerous health care and medical associations have taken leading roles in developing outcomes registries, including the Society of Thoracic Surgeons, the American Association of Orthopaedic Surgeons (AAOS), the American Physical Therapy Association (APTA), and ATI Physical Therapy (ATI). Collaborations between registries allows for more vigorous benchmarking opportunities and for collaborative sharing of non-Protected Health Information (PHI) among research institutions and governmental agencies, along with universities and medical schools.

The APTA announced its plan to develop a patient outcomes registry in mid-2014, envisioning a full launch of the project in 2015. Using a “hub-and-spoke” data collection method, their Physical Therapy Outcomes Registry gathers information from many different sources (the spokes) and archives it in a centralized location (the hub). In an effort to have a comprehensive dataset, the APTA is partnering with other organizations.⁴

Along with other organizations, the AAOS collaboratively supports the American Joint Replacement Registry (AJRR), which focuses specifically on hip and knee implants. These are timely diagnoses to concentrate on due to the increase in surgeries from the baby boomer generation. In 2011, the pilot program gathered data on over 3,600 total joint arthroplasty procedures. Just one year later, that number had grown to 30,000.⁵ By the end of 2013, it had jumped once again to 70,000. The AJRR reported that after registry initiation and best practice identification, joint registries like their own have shown up to a 50 percent decrease in revision rates. They also reported that with a nationwide 2 percent decrease in revision rates, Medicare could save over $65 million.⁶

One of the most notable orthopedic registries was conceived by David Ayers, MD, chair and professor of Orthopedics and Physical Rehabilitation and the director of the Musculoskeletal Center of Excellence at UMass Medical School; it is called Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR). This registry is comprised of knee and hip replacement patient outcomes data collected from 30,000 surgeries by 150 surgeons at 70 hospitals in 24 states. Now that the FORCE-TJR has seen participation rate success, its founders are starting to address more nuanced issues like how to use the reporting to improve health care, and what type of information is palatable for the general public.⁷

Recently presented and published findings from FORCE-TJR describe obesity as the cause of younger aged patients requiring joint replacement procedures,⁸ as well as using clinical outcomes as warning signs for device failures.⁹ It is thus reasonable to suspect the broader findings of such quasi-epidemiological work will be scalable and useful in policy development, patient safety, treatment efficacy, and in informing clinical practice.

Building an In-House Registry

It is the shared belief that a great deal of a company’s past, present, and future growth is dependent on the accessibility of patient rehabilitation data. As patient outcomes have become a focal point in the industry, practices should get involved in registries (and possibly the creation of its own), and it should be a logical and beneficial next step. Using a registry allows practices to identify where the highest quality care is being delivered in the most cost-effective manner so it can investigate and replicate best practices elsewhere.

In addition to all the benefits of registries noted, building an in-house registry naturally lends itself to other areas of quality improvement. For example, registry development presupposes the availability of tools that will allow for near-immediate reporting and tracking at a higher level of sophistication and complexity. Resultant reports can then be used to gauge clinician performance based on risk adjusted patient aspects like body mass index, age, and comorbidity. Thus, utilization (the amount of functional status change per visit) can be risk-adjusted, resulting in optimal numbers of visits for any given patient type. For example, data from a registry could help to determine how many visits and what exercise difficulty level a patient with a comorbidity of chronic obstructive pulmonary disease should undergo. Using statistical data to make these kinds of decisions could be beneficial to the patient’s health, instead of deciding based on merely gut or tradition.

Additional benefits include improved clinical operations and management, empirical quality improvement studies, and human resource factors, to name just a few. While this is obviously a helpful tool in current payer-models and situations, such analytic ability becomes even more important when considering and competing for bundled payment contracts as well as capitated or shared risk ventures and payment arrangements.

There are also vetting processes to gain feedback as well as exposure if one is to build one’s own registry. The Effective Health Care Program of the Agency for Healthcare Research and Quality (AHRQ) conducts and supports research focused on the outcomes, effectiveness, comparative clinical effectiveness, and health care services. In fact, AHRQ has developed what they refer to as the Registry of Patient Registries (RoPR). Quoting from their website, RoPR “allows for registry owners to provide information about Classification and Purpose (the type of registry and its purpose), Contact and Conditions of Access (circumstances under which the registry can be contacted, and contact information for those interested in collaboration, participation, and/or data access), Progress Reports (includes information about the growth of the registry and any relevant references to available progress reports), and Common Data Elements (descriptions of registry-specific standards, scales, instruments, and measures).”¹⁰

The most direct way to be cataloged in RoPR is to first submit one’s nascent registry to ClinicalTrials.gov. This site, run by the federal government, is a registry and findings database made up of both publicly funded “private” clinical studies. Albeit US based, studies can come from anywhere in the world, as long as protocols are approved.11

The Future of Registries

It is clear that the days of providing care autonomously or self-reliantly are coming to a close. In order to succeed, it is important to know what practices others are using to determine whether or not they work, and to adjust accordingly.

Furthermore, as industry registry leaders, governmental entities, and professional guilds and associations advance their datasets and capabilities, registry capabilities will become more sophisticated. For example, such analytics should/will be able to trigger actions—in the form of processes, alerts, notifications, or recommendations—that can positively impact (or protect) a practice’s, a pharmaceutical or device manufacturer’s, or a hospital’s clinical and financial outcomes. This would not only improve operational performance, patient outcomes, and competitive standing, but also further support innovation in one’s respective field of specialty. 

Dr. Chris Stout, PsyD, is the vice president of research and data analytics at ATI Physical Therapy and a clinical professor at the University of Illinois at Chicago, College of Medicine. He can be reached at chris.stout@atipt.com.

Grace Wang, BA, is an editorial assistant/writer at ATI Physical Therapy. She can be reached at grace.wang@atipt.com.

Dr. Julie Roper, PT, DPT, is the director of clinical performance management at ATI Physical Therapy. She can be reached at julie.roper@atipt.com.

Mr. David Nelson, MBA, is the chief strategy officer at ATI Physical Therapy. He can be reached at david.nelson@atipt.com.

References

1. Stout CE, Hayes RA. The Evidence-Based Practice: Methods, Models, and Tools for Mental Health Professionals. Hoboken, NJ: John Wiley & Sons, Inc.; 2005.

2. Gliklich RE, Dreyer NA, Leavy MB, eds. Registries for Evaluating Patient Outcomes: A User’s Guide: 3rd Edition. Rockville, MD: Agency for Healthcare Research and Quality; 2014.

3. Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. dba Outcome] under Contract No. HHSA29020050035I TO1.) AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality. April 2007.

4. Quintiles and APTA announce plans to develop new outcomes registry. The American Physical Therapy Association Web site. www.apta.org/Media/Releases/APTA/2014/6/10/. Published June 10, 2014. Accessed April 2, 2015.

5. Etkin CD, Hobson SE. American Joint Replacement Registry continues to grow. The American Association of Orthopaedic Surgeons Web site. www.aaos.org/news/aaosnow/oct12/research2.asp. Published October 2012. Accessed April 2, 2015.

6. The American Joint Replacement Registry. What is the AJRR? The American Joint Replacement Registry. Published February 27, 2014.

7. Clark C. Functional outcomes data for joint replacement ups the quality ante. HealthLeaders Media Web site. www.healthleadersmedia.com/page-1/QUA-314942/Functional-Outcomes-Data-for-Joint-Replacement-Ups-the-Quality-Ante. Published April 2, 2015. Accessed April 2, 2015.

8. Tarkan L. Adding pounds, then new knees. The New York Times. November 11, 2013. http://well.blogs.nytimes.com/2013/11/11/adding-pounds-then-new-knees/?_r=2. Accessed April 2, 2015.

9. Ayers D, Franklin P. Improving care through outcomes reporting. www.modernhealthcare.com/article/20131130/MAGAZINE/311309981/improve-care-through-outcomes-reporting#.Published November 30, 2013. Accessed April 2, 2015.

10. About the Registry of Patient Registries. Agency for Healthcare Research and Quality Web site. https://patientregistry.ahrq.gov/about. Accessed April 14, 2015.

11. ClinicalTrials.gov Web site. https://clinicaltrials.gov/. Accessed April 14, 2015.