Outcomes Research and Evidence-Based Practice in O&P: Forging Ahead

During the past several decades, the face of health care has changed dramatically in the United States. As the traditional health care model has been replaced with a managed care model, most health care disciplines have moved toward evidence-based practice fueled by outcomes research. For the O&P profession, this shift to evidence-based practice has proceeded at a much slower pace, and the path has been fraught with myriad difficulties and barriers.

Early efforts at conducting O&P outcomes research in the 1990s stalled and fizzled out. Despite this, the drive toward fostering outcomes research in O&P has slowly forged ahead, and the profession now seems poised to make significant strides toward helping evidence-based practice become a reality.

Overcoming barriers

One large barrier that has hampered the O&P profession’s transition to outcomes and evidence-based practice is that for many practitioners, the terms represent a nebulous, vague concept that they may need to face sometime in the future. Further compounding this confusion is the fact that outcomes and evidence-based practice are to a large extent intertwined and interconnected.

“I think many practitioners still do not understand,” said Scott Cummings, PT, CPO, FAAOP, treasurer of the American Academy of Orthotists and Prosthetists and the chair for the Academy’s Research Council. “They probably just cannot get their arms around it because they are so busy with the day-to-day stuff.”

Cummings characterized evidence-based practice as having three components – objective data, practitioner expertise and individual patient circumstances – that then are used to determine the best treatment options, or evidence-based practice. Outcomes research and studies are related to the first component, objective data.

“Outcomes research happens to be perfectly suited for our profession because unlike basic science research, you do not need a laboratory. It does not necessarily have to be expensive or long and drawn out, which basic science research usually is,” Cummings said. “There are all sorts of different types of research, and outcomes research tends to be more toward the simple end in terms of sophistication.”

Another reason Cummings believes outcomes research is well-suited to the O&P profession is its ability to collect data from multiple companies and practitioners across the country. However, this hinges on developing the right tools and measures to address the scientific question being examined.

“If we can develop the right tool or the right measure and have many different sites accessible to collect this information, we can spread this all over the country with multiple practitioners and multiple patients involved, and in that way we get a larger import of data in a quicker turnaround time with a more diverse cross section,” Cummings said. “That is important to what we need to do now.”

Practitioner expertise

Historically, the O&P profession has relied heavily on the second component to evidence-based practice, practitioner expertise. Although O&P practitioners have done “a nice job with that,” Cummings noted, using objective data to help guide clinical decisions is important for several reasons.

“Right now, there are so many sophisticated options for treatments, I think it becomes more difficult for any one practitioner to know about all of those options,” Cummings said. “Furthermore, the third party payers are now demanding justification for what it is we do.”

The demand from third party payers has been a large force fueling the drive for outcomes research and evidence-based practice in orthotics and prosthetics. As the number of orthotic and prosthetic devices that incorporate technological advancements has increased exponentially in recent years, so too has the cost of such devices, and third party payers now expect to see objective data justifying these increased costs.

“We are being denied, and our patients are being denied, utilization or access to new technology,” said Dennis Clark, CPO, president of Point Health Centers of America and president of Clark and Associates Prosthetics and Orthotics. “The big example might be microprocessor-controlled knees, and one of the reasons is we do not have the evidence-based data to show the value.”

Clark noted third party payers frequently deny payment for expensive high tech O&P devices as being experimental or not medically necessary. Evidence-based care and outcomes research gives third party payers a reason to approve such devices.

“Our profession’s best resource will be clinicians utilizing the data and appropriate measurement tools to qualify patients for these higher cost prostheses and orthoses, and then showing the value of that after they have received them through evidence-based care and outcomes data,” Clark said.

Academy’s efforts

In the past several years, the Academy has worked to further the O&P profession’s transition toward evidence-based practice by spearheading or supporting several initiatives such as the following:

  • State-of-the-Science Conferences
  • Research Council
  • Outcomes Initiative
  • O&P Education and Research Foundation
  • Research Terminology Glossary.

In 2002, the Academy began holding State-of-the-Science Conferences (SSCs). The SSCs convene a group of experts who examine a topic in depth by reviewing the literature, determining current practice and identifying future research areas on specific topics. Funding for the SCCs has been provided primarily by grants from the U.S. Department of Education, and Cummings noted the Academy is “moderately optimistic” that funding will be continued for another year.

To date, a wide range of O&P topics have been covered by the SSCs. One SSC, convened in 2005 and entitled “Outcome Measures in Lower-Limb Prosthetics,” explored existing O&P lower extremity outcomes tools. SSC findings are published in the Journal of Prosthetics and Orthotics and also are posted on the Academy’s Web site. In addition, practitioners can earn continuing education credits for several of the SSC offerings through the Academy’s Paul E. Leimkuehler Online Learning Center.

Another Academy initiative is the Research Council, which was formed in August 2005. The Research Council’s primary mandate is to foster self-sustaining research efforts that produce peer-reviewed O&P research and move the profession toward evidence-based practice. The Research Council also is charged with providing research education for practitioners and enhancing the profession’s research capacity.

A recent joint collaboration of the Academy and the American Orthotic and Prosthetic Association (AOPA) led to the development of the Outcomes Initiative. The Outcomes Initiative was started approximately a year ago after AOPA approached the Academy to explore ways the two organizations could jointly promote outcomes research in the O&P profession. Funding for the initial meetings of the Outcomes Initiative Steering Committee was provided by AOPA, and AOPA also dedicated funds to hire a project director to manage the Initiative’s activities, Cummings said.

“Essentially, the Outcomes Initiative is designed to develop the parameters and priorities of what it is we need to study, how to study, and which tools we recommend to be used,” Cummings said. “The thought has been considered that if we were to generate or accumulate enough funding, we would be able to hire a principal investigator who would actually interpret the data for us and produce a report.”

Cummings noted, however, that the actual data collection would be left to individual practitioners and private practices. To date, the Outcomes Initiative Steering Committee has met several times to discuss ways to bring the message about the importance of outcomes research to the average O&P practitioner.

Another recent Academy initiative is the O&P Education and Research Foundation, which recently received 501(c)(3) status as a separate, nonprofit organization. Cummings noted the foundation has set its initial goals at attainable levels with the expectation of providing funding for pilot studies.

“The foundation will essentially be employed to promote evidence-based practice within the O&P profession by supporting research and the necessary education to go along with that research,” Cummings said.

One of the most recent projects undertaken by the Academy was the creation of a research terminology glossary that Cummings refers to as “research 101 terms.” The glossary, which is posted on the Academy’s Web site, is intended to help O&P practitioners become better consumers of research by helping them understand the terms that are included in research studies.

“This whole thing is not going to work if we have two dozen PhDs producing work that goes largely unnoticed by the profession,” Cummings said. “I feel like we just need to keep getting the message out there so that practitioners will embrace this concept and be willing to utilize the information to the patient’s advantage.”

Assessment tools

Patient assessment tools also play an important part in conducting outcomes research and developing evidence-based practice. A pilot data collection program is currently under way for one long-awaited O&P assessment tool, the Orthotics and Prosthetics Users’ Survey or OPUS.

The OPUS assessment tool, which focuses on upper and lower extremities, consists of four modules. One module covers functional status, another addresses quality of life, a third module examines patient satisfaction with the device, and the fourth module assesses patient satisfaction with the clinic services, said Allen Heinemann, PhD, director of the Center for Rehabilitation Outcomes Research at the Rehabilitation Institute of Chicago and a professor in the department of physical medicine and rehabilitation at Northwestern University’s Feinberg School of Medicine.

The pilot data collection program will be conducted at two Scheck and Siress practice locations and will be coordinated by Jason Wening, MS, CP, the clinical research director at Scheck and Siress. The survey will be completed by lower extremity patients receiving a new prosthetic or custom orthotic device.

Data will be collected for 4 months and will track patients from the beginning of their care up to 3 months after completion of service delivery. Wening noted the data collected at the two office sites will be processed by Heinemann’s staff and then returned to the pilot locations, where it will be looked at from a clinical perspective.

“Our take is really how can we use this as a clinical tool and how can we use it to best assist our practitioners from a perspective of making sure they know what is working and what is not working, as well as starting to use it for third party payers,” Wening said. “Hopefully, we can get something out of it in return from a clinical perspective that will help us determine if we are doing what we think we are doing clinically and also looking at how we can start to implement other outcome measures across all 10 of our offices.”

In addition to the pilot data collection program, OPUS also will become available commercially within the next 3 to 6 months through a partnership with Focus on Therapeutic Outcomes (FOTO). FOTO is adding OPUS to its Patient Inquiry (PI) software, as well as a care type for Orthotics and Prosthetics, to enable outcomes data collection with OPUS and to make the survey available initially to current subscribers.

“What we provide is the software platform, and so what we will have is a finished software product that enables the O&P providers to easily gather the OPUS survey and have reporting for each individual patient and be contributing to the national database,” said Judy Holder, manager of provider relations at FOTO.

A two-pronged marketing approach will be used to make OPUS available to current FOTO subscribers as well as to O&P clinics that are not FOTO subscribers. In addition, Holder noted FOTO is hopeful that a relationship can be developed that would allow a data exchange between FOTO’s PI software and the Orthotic Prosthetic Information Expert (OPIE) practice management software. This would eliminate any duplicate data entry for those who use OPIE and wish to use the PI software to gather outcomes data with OPUS.

Ability Pro

Another newly released patient assessment tool is Ability Pro, which is a Web-based patient survey system that Clark characterizes as being a customer satisfaction or quality assurance program and patient communication follow-up program. The tool allows practitioners to follow-up with their patients via telephone, mail or online. Beginning on the day of delivery of a device, practitioners can use the survey to glean data by asking patients questions.

“From that information, we can improve the quality of care that we are providing,” Clark said. “On the day of delivery of an orthosis, for instance, we might ask more administrative things, ‘Was your clinician courteous and knowledgeable? Was your appointment made at a convenient time for you? Did you get care and use instructions? Was a follow-up appointment made for you?’”

Clark said that negative answers would immediately trigger a follow-up event with patients and result in a series of communications. After 2 weeks, patients would be sent a second survey to complete, and the second survey then would include some outcomes questions.

“On day one, certainly, it is hard to assess the outcomes data, so in the beginning, it is patient satisfaction, and then when the practitioner gets more involved in filling out these surveys, it becomes more objective outcomes information gathering,” said Clark, who noted the evidence-based outcomes portion of the survey should be available to practitioners by the AOPA meeting in September.

With Ability Pro, data are collected and stored in a centralized Web-based location. Each individual location would collect their own data and also have access to their own data as well as regional and national information. In addition, Clark noted the data can be used as a tool to create a best practices scenario.

“The care that we provide is not just the prosthesis or the orthosis. The care that we provide is also measured by the administrative activities we do, at least by the people who are receiving the care, and so we will be able to measure all of those things to try and improve,” Clark said. “Until we can show empirically the value of what we bring and the effects that we have on the lives of the patients we serve, we are going to continue to be pushed down in the percentage of health care dollars that we receive. This is the way for us as a profession to take positive action to show the value of what we do and consequently stem the tide of continued reduced reimbursement.”

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Mary L. Jerrell, ELS is a correspondent for O&P Business News.

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