19 minute read
Meaningful MEASURES
by AOPA
O&P FACILITIES STEP UP THEIR DATA COLLECTION EFFORTS TO IMPROVE PATIENT CARE AND DEMONSTRATE VALUE
By CHRISTINE UMBRELL
NEED TO KNOW
• In a movement toward evidence-based practice, several O&P facilities have formalized their policies and procedures regarding the collection and use of outcomes measurements. • Facilities are capturing both performance-based and patient-reported measurements and storing data in patients’ charts, involving both clinicians and patients in the process. • Some patient-care facilities are leveraging data to inform clinical decision making, share progress with patients, and provide evidence of the value of O&P intervention to payors. • Lower-limb prosthetic patients remain the current focus of outcome measures at most facilities, but some clinicians have developed upper-limb measures, and others are planning to capture lower-limb orthotic outcomes in the near future.
O&P FACILITIES HAVE taken disparate approaches to collecting outcome measures during the past few years, with varying degrees of commitment and a broad array of approaches to leveraging the data. As the O&P profession prioritizes this important activity and moves toward evidence-based care, those same facilities are expanding their effort, and several are formalizing their policies and procedures. Leaders in the O&P field believe that formalized data collection and aggregation efforts will enhance patient care, demonstrate the value of O&P intervention, and aid in O&P research and development initiatives.
At Hanger Clinic, for example, capturing outcome measures has become a strategic process and “part of our culture,” explains Maggie Baumer, JD, clinic manager at Hanger Clinic in Springfield, Massachusetts. Hanger Clinic clinicians regularly conduct outcome assessments on their patients. “Collecting this data helps the entire field recognize and promote best practices,” she says. “This awareness can inform access to optimal care and coverage for those with limb amputation.”
At Ability P&O, August marks the official debut of a new tool: an outcome measures database and digital solution, according to Brian Kaluf, BSE, CP, FAAOP, clinical outcome and research director. The tool will assist in real-time clinical decision making while aggregating data for future clinical assessments.
Maggie Baumer, JD
Hannah Christie, CPO, oversees a patient taking the TUG test at Scott Sabolich Prosthetics & Research.
Christie assists the patient in a 10-Meter Walk Test. Christie watches the patient maneuver the Four-Square Step Test.
Standardizing Data Collection
The solution was developed by Ability P&O and Scott Sabolich Prosthetics & Research, with support from the Ottobock North America clinical research and services team, led by Andreas Kannenberg, MD (GER), PhD, executive medical director for Otto Bock Healthcare LP. For now, the solution focuses on lower-limb prosthetic measures but will expand later to include other measures, such as lower-limb orthotic and upper-limb prosthetic outcomes, says Kaluf.
In determining which measures to include for lower-limb prosthetics, “we relied on our experiences and how
we have utilized outcome measures in the past,” explains Kaluf. “We selected measures in consideration of the unique needs of patients in the United States.” The team also referred to guidance from the American Academy of Orthotists and Prosthetists, as well as recommendations from Ottobock and Scott Sabolich Prosthetics & Research, according to Kaluf.
Both performance-based and patient-reported measurements related to lower-limb loss are included. The Timed Up-and-Go (TUG), the Four-Square Step Test (FSST), the Activity-Specific Balance Confidence (ABC) Scale, the AMPPRO mobility predictor, the 10-Meter Walk Test, the Six-Minute Walk Test, the Prosthetic Limb Users Survey of Mobility (PLUS-M), Socket Comfort Score, and the EuroQol Five-Dimension FiveLevel test all factor into the solution, says Scott Sabolich, CP, an owner of Scott Sabolich Prosthetics & Research. The patient-reported measurements require less time of clinicians because patients can complete those forms on their own; however, the performance-based tools must be conducted in the clinic, by certified prosthetists or properly trained assistants or technicians, Kannenberg says. The Ottobock team developed software and a database in Europe to collect and analyze the measures as part of the company´s outcomes initiative, according to Kannenberg.
Scott Sabolich, CP Christie evaluates the patient via the AMPRO.
For the new tool to function properly, a clinician or employee inputs demographic data, amputation details, and comorbidities information. Once the relevant outcome measurements are collected and stored in the database in a HIPAA-compliant fashion, the software creates reports for clinicians to consider in their clinical decision making, says Kannenberg. It also provides reports that can be shared with physicians or insurance companies. For now, each facility that uses the solution can access only its own patient data. Informing Clinical Care
Formalized outcome measurement protocols enable O&P professionals to embrace “outcomes- or data-informed clinical care,” says Kannenberg.
The primary purpose of the tool is “to assist clinicians in gathering and interpreting results for individual patients, and to provide actionable data immediately,” says Kaluf. The solution generates real-time reports that aid clinicians—and patients with whom they share information—in understanding how a patient’s status compares to that of other people in similar situations.
The solution, notes Kaluf, is designed to evaluate the important lower-limb domains, including mobility, fall risk, socket comfort, and health-related quality of life. He explains how the solution can aid in clinical decision making, for example, by assessing fall risk. “For fall risk, the solution is designed to capture four measures [TUG time, FSST time, ABC score, and walking speed] and automatically note if a patient may be at greater risk of falling,” he says. Then the clinician can take action— for example, by recommending that a more stable prosthesis be fit, and/ or by referring the patient to an allied healthcare professional, such as a physical therapist. “This saves clinicians time and increases the utility of outcome measures.”
Similarly, for socket domain, the measures help determine “if the patient’s socket comfort has decreased over time, and the tool helps tell you when the socket might need to be replaced,” says Kaluf.
Clinicians use information from the tool to help them determine what type of device would be most useful for a particular patient. Component selection becomes less arbitrary and is more dialed into patient-specific needs. As Sabolich points out, the tool is not product-specific.
Brian Kaluf, BSE, CP, FAAOP
Digitizing Patient-Reported Outcomes
Capturing meaningful data directly from patients is an important part of a sustainable outcome measurements protocol. At Hanger Clinic, practitioners have implemented updated protocols to ensure the process is both easy for patients and informative for clinicians. “Over recent years, our process has evolved to digital direct input, moving away from paper processes,” explains Erin O’Brien, CPO, FAAOP, clinical education specialist for Clinical and Scientific Affairs at Hanger Clinic. Patients provide results to standardized assessments via their smartphone Erin O’Brien, prior to their appointments. “This has improved the CPO, FAAOP consistency and efficiency of collecting outcomes, with clinicians able to see the results of the patient’s self-report questionnaires in real-time and within our electronic health records system,” she explains. During the ongoing COVID-19 pandemic, this digital transition has reduced the amount of time spent in the clinic and “reduces the risk of exposure to our patients and staff,” she adds. “Our outcomes program allows the assessments to be collected remotely, and our clinicians can act proactively on the results of those assessments.”
The facility’s scheduling system generates reminders to ensure patients complete their assessments at appropriate points during their care, adds O’Brien, which helps both office administrators and clinical staff remember which patients need to have an outcome measure completed at various appointments. Andreas Kannenberg, MD (GER), PhD
O&P Outcome Measures Become More Advanced, Fine-Tuned
The more formalized efforts to collect outcome measures are the culmination of many years of effort by forward-thinking O&P professionals working to advance and elevate the O&P profession. “The science behind outcome measures has advanced greatly over the past 10 or 15 years,” says Brian Hafner, PhD, a professor at the University of Washington (UW) and a principal investigator at UW’s Center on Outcomes Research in Rehabilitation. Hafner was involved in developing the Prosthetic Limb Users Survey of Mobility (PLUS-M), used to measure mobility of Brian Hafner, PhD adults with lower-limb amputation. By working with measurement experts at UW during development of the PLUS-M, Hafner says his team learned contemporary techniques to develop better outcome measures. Now the team is creating a similar measure for lowerlimb orthosis users, with funding from DoD and AOPA. In addition, Hafner is collaborating with other O&P professionals around the country to develop new performance-based and self-report measures for lower-limb prosthesis users.
“The recommended approach to developing outcome measures has really evolved” and become more rigorous since some of the early O&P-specific measures were introduced, says Hafner. “For example, we now engage target respondents and other stakeholders early in the development process so that we know we’re measuring the right concepts and using the right language to design questions.” Hafner explains that involvement of target respondents in this manner has allowed them to ensure questions are well understood by respondents, thereby providing clinicians and researchers with better information.
Newer instruments are more often being designed with the input of hundreds or thousands of patients, instead of dozens of individuals, as was sometimes the precedent for early O&P outcome measures, according to Hafner. “So now, when you create the instrument, you have reference or normative data, which can help clinicians or researchers apply this outcome measure with the knowledge of where their patient is, and benchmark themselves along the continuum of people in the United States,” Hafner says. “Being able to provide that context has been very helpful to our field.”
Sharing patient-specific data with patients so they are involved in their care decisions is another key use of data collected via outcome measurements. At Hanger Clinic, Baumer says they explain “how the data is used to assess their mobility and quality of life. We also place this in context of others who are similar based on certain demographics. This helps patients understand how their recovery process is going in a comprehensive way and can also help them set goals for themselves and their healthcare team.”
Each patient type has different measures that are pertinent to those specific patients, “which is why our outcomes measures vary depending on why the patient is being seen,” says Erin O’Brien, CPO, FAAOP, clinical education specialist for Clinical and Scientific Affairs at Hanger Clinic. For lower-extremity prosthetics patients, Hanger uses the PLUS-M and the Well-Being subsection of the Prosthesis Evaluation Questionnaire Taavy Miller, PhD, CPO
(PEQ-WB) to assess patients’ mobility, quality of life, and satisfaction. “On the other hand, for scoliosis we are using radiographic information and adherence monitoring to track the patient’s progress over time,” she explains. Each patient’s outcome measure information is stored in their chart to be used to inform clinical decisions.
“A big hurdle to the utilization of outcomes measures to inform patient care has been the translation of scores and results into a consumable product for patients and clinicians,” O’Brien explains. “This was the springboard for Hanger Clinic’s trademarked Mobility Empowerment Scorecard, or ME Scorecard. This individualized patient report provides information in a way that is easily consumed by clinicians, patients, and caregivers.” In addition, the information is always available, so clinicians can reference it during future appointments to track progress and set goals.
“We hear of numerous cases where patients see their scores and … are motivated to improve their condition,” explains Taavy Miller, PhD, CPO, research scientist for Clinical and Scientific Affairs at Hanger Clinic. She cites the example of an individual with an above-knee amputation who reported falling every day. “Unfortunately, while a microprocessor knee would have benefited her, she did not qualify as a K2 ambulator,” Miller recalls. However, utilizing her outcomes measures, Hanger Clinic clinicians put a plan in place that included increased activity and physical therapy, which subsequently elevated her to K3 status—and qualified her for the microprocessor knee. She no longer experiences falls, according to Miller.
Composite Triple Action® AFO
BeckerOrthopedic.com
Advances in Upper-Limb Outcome Measures
MOST O&P FACILITIES are prioritizing lowerlimb prosthetic outcome measures for now— but at Arm Dynamics, where upper-limb prosthetic patients are the key demographic, prosthetists and therapists have developed their own novel outcome measures. “Upper-limb is a very unique population,” comprising less than 10 percent of Americans with limb loss, says John Miguelez, CP, FAAOP(D), president and senior clinical director. “But in the industry in general, there’s a very high abandonment rate,” so his company developed outcome measures to boost prosthesis acceptance rates and improve patient care. “We want to optimize the rehabilitation potential of each patient; to motivate them throughout the rehabilitation process via data-driven specifics, so they can understand where they’re improving, even if it’s subtle, and where they need additional attention; and to look at aggregate • The Wellness Inventory is a patient screening tool that outcome measures to create benchmarks,” he explains. helps identify psychosocial changes that could have a
Those goals led the company to convene its clini- negative impact on rehabilitation or success with the cians several years ago to identify what was missing prosthesis, and screens for issues such as pain, PTSD, in the current measures. They also recruited a psycho- depression, and other quality-of-life issues. metrician to help refine questions before validating measures. “Then, we partnered with the U.S. Food and Miguelez and Baun believe using Drug Administration and tested these measures with our these tools has improved clinical decipatient population,” Miguelez says. sion-making over the past several years.
“The beauty of these measures is we can use them “The moment-to-moment ability to impact with any level of [upper-limb] amputation,” says Kerstin patient care” has been the most significant Baun, MPH, OTR/L, national director of therapeutic benefit, says Miguelez. In addition, the services. And the measures are “manufacturer-agnostic.” Arm Dynamics team has uncovered some
Clinicians at Arm Dynamics now regularly imple- interesting statistics. Through the Wellness ment the three outcome measures developed in-house, Inventory, the team learned that individaccording to Baun: uals with partial hand loss have a higher • The Capacity Assessment of Prosthetic Performance feeling of disability than those with higher levels of amputafor Upper Limb (CAPPFUL), an assessment tool tion—at least according to their patient base. “That helps us designed to measure upper-limb prosthetic perfor- approach each case and be mindful of the unique populamance during common activities, enables therapists tion,” Miguelez says. to identify a patient’s functional challenges and then Arm Dynamics is sharing de-identified data from its modify treatment plans to improve outcomes. outcome measures with referral sources and payors. • The Comprehensive Arm Prosthesis and Rehabilitation “My aspirational hope is that others will have access to
Outcomes Questionnaire (CARPROQ) is a [these types of] measures to create a standard of care, then patient-reported outcome measure presented in enhance that care,” says Miguelez. “It really involves buy-in question-and-answer format. by all the clinicians and the patients.”
John Miguelez, CP, FAAOP(D) Staff at Arm Dynamics, including Kerstin Baun, MPH, OTR/L, rely on extensive outcome measures to optimize each patient’s function. Kerstin Baun, MPH, OTR/L
Providing Evidence for Payors
In addition to elevating patient care, standardized outcome measurement processes and the information they provide to show improvement in patient outcomes have become critical to claims submissions. O&P facilities are increasingly receiving pushback about documentation, Kannenberg says, “so we need to collect data to demonstrate that the prostheses and orthoses we fit on patients really work.”
Sabolich agrees that O&P must prepare for payors to begin requiring test results to ensure reimbursement. “We need to set an industry standard, then we can justify product selection to payors with satisfaction rates, test scores, and fall risk calculations,” says Sabolich. “The O&P field should do this on their own and bring it to the payors.”
By being proactive with outcome measurements and sharing positive outcomes, O&P facilities can help lead the transition to evidence-based care. “We need to try to ‘shape the change,’ so others who aren’t qualified don’t make decisions for us,” says Kannenberg. “We need to set the stage and say, ‘We have a set of outcome measures that can be assessed in everyday practice and deliver usable results.’”
—SCOTT SABOLICH, CP
Aggregating Data for R&D
Hanger Clinic has already begun leveraging its outcome measurement protocols to aggregate data to conduct research and improve standards of care. The company “has demonstrated a continued commitment to the O&P field through clinical research and education efforts that span beyond our organization through partnerships with leading researchers, professionals, and manufacturers,” Miller explains. “Dissemination of results from our outcomes program is a key component of research to ensure data is translated into evidence that supports clinical care and health policy.” She points to published research articles written by Hanger Clinic clinicians, including studies in the Mobility Analysis of Amputees (MAAT) series as well as the recent Outcomes Assessment and Dissemination (OASIS) publication.
Visit us at AOPA
Booth #319
AOPA Workshops September 9th
10:00 a.m. - noon 1:00 p.m. - 3:00 p.m.
Workshops to discuss: • Contracture
Management • Indy 2 Stage • Open heel design • Toe walking solutions
You are in control!
Surestep’s Indy 2 Stage
Combine any variation of the Surestep SMO with any AFO to create unique solutions that best serve your patients. This exceptional ”orthosis within an orthosis” allows for the SMO to be locked into the AFO, or it can be easily removed to be used independently. Children can work through a variety of transitional skills without impeding normal muscle function.
To learn more visit surestep.net or call 877.462.0711
Those studies have helped clinicians make more informed decisions. “For example, there were previously numerous times where clinicians were assessing and noting various comorbidities,” explains Miller. “As some of these comorbidities were not pertinent to prosthetic rehabilitation, it created confusion in developing a plan of care.” In the second analysis from Hanger’s MAAT 2 series, it was “clearly determined” which comorbidities should be accounted for when developing an effective plan of care, according to Miller. “Now our evaluations are subsequently more targeted and promote more effective care planning.”
At Kaluf’s facility, “we can look at all of the patients at Ability, or at just one location, over the course of a year, and conduct a data analysis” that can lead to improved care, he explains. In addition, the Ottobock research team leverages the de-identified data collected at its patient-care facilities to both conduct research and inform device development. Kannenberg explains that researchers “can analyze the data and see if there are any weak spots or need for improvement, or to identify unmet patient needs.”
—BRIAN HAFNER, PhD Expanding the Data Pool
O&P stakeholders that are formalizing outcome measures protocols call on others in the industry—large and small—to implement their own approaches, to ensure all O&P facilities are preparing for evidence-based care and looming reimbursement requirements.
Brian Hafner, PhD, a professor at the University of Washington (UW) and a principal investigator at the UW’s Center on Outcomes Research in Rehabilitation, has been involved in several efforts to educate the clinical field about the importance of using outcome measures. Hafner, who helped develop PLUS-M, one of the most widely accepted O&P patient self-report instruments, says his team is working on identifying barriers to measurement so that the O&P profession can find ways to address them. “For example, we are learning about situations where prosthetists-orthotists may want or need help from other rehab professionals to administer outcome measures.”
Hafner’s team also is undertaking outreach efforts to communicate that this process doesn’t have to be difficult. “It [measurement] does take a little time, but there’s also value to it.” His team focuses on developing tools that integrate well into normal clinical practice.
For smaller facilities, “it can be more of a challenge to use these measures,” concedes Hafner. But the UW team and many others are working to ease the transition. “All the tools we develop [at UW, including the PLUS-M] are free, they’re available on our website; I make myself available to answer questions; and I help with translations into other languages in my spare time,” Hafner says. “My hope is that even small clinics will find ways to integrate them into clinical practice.” He also is pushing for electronic health record companies to integrate outcome measures into their systems to increase access for smaller facilities.
“If your clinic doesn’t use outcome measures, then I believe you are going to start to fall behind,” says Hafner. He encourages small facilities to start “using at least one self-report measure and one performance-based test related to the construct that you think is most relevant to that individual patient.” He recommends resources from groups like the Academy; its website features lists of recommended outcome measures and a “how-to” video series designed “to properly administer outcome measures and correctly report results.”
“Collecting outcome measures in O&P clinical work allows clinicians to utilize quantifiable data to monitor the individual patient-specific effect of a treatment plan, improves the clinician-patient shared decision-making communication, and provides objective justification to payors for a certain treatment plan,” says Miller. “It is important for each clinic to consider their workflow and how they can incorporate outcomes collection into their practice because it takes a team approach to support the integration of an outcomes program.”
Christine Umbrell is a contributing writer and editorial/production associate for O&P Almanac. Reach her at cumbrell@contentcommunicators.com.
