Outcomes: Creating Medical Services with P&O Devices

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By Phil Stevens, MEd, CPO, FAAOP

The P&O profession is somewhat unique among the allied healthcare disciplines in that our efforts can be reduced by some to the provision of devices rather than the provision of medical services. As eager as we are to distance ourselves from the labels of vendor and durable medical equipment, the fact that we ultimately provide a tangible product in the form of an orthosis or a prosthesis can create the misconception that our services are limited to devices. In many ways, the differences between our devices and our healthcare services are found in our commitment to an outcome. When an outcome is identified at the initiation of treatment and obtained through the course of treatment, then the devices we provide are rightly seen as the means to a larger, more important end.

Within our discipline, we have several different audiences that have a vested interest in these outcomes. At times our patients need to be shown what the devices are doing for them. Alternately, case managers may want to see the impact of our interventions in the functional abilities of their clients. In other instances, payers are keenly interested in assuring that the provided medical services assist the patient in reaching some predefined minimal standard of performance. In each case, P&O clinicians may be called upon to report the outcomes associated with the intervention. Several resources can be used to verify, document, or quantify these outcomes. The purpose of this article is to review a series of case studies in which steps were taken to capture the outcome of a P&O intervention, each time taking the emphasis off of the device itself and placing it upon the service rendered.

Audience One: The Patient

Patients who come to our offices present with challenges and deficits. Whether it is verbalized or not, each patient has one or more objectives in coming into the clinic. The success of the encounter ultimately rests on the extent to which the service we provide meets patient expectations. In many instances, it may be necessary for clinicians to help patients identify the outcome associated with a given device.

Take the case of JV, who presented with a rare congenital abnormality in which she had a complete lack of plantarflexor function on her left lower limb. She had lived with this physiologic anomaly throughout her life and was now a young mother of very active children. For several years, her treatment had been limited to a custom foot orthotic that supported the unusual contours of her foot and accommodated a modest leg-length discrepancy. However, she had reached a point where her gait deficits had begun to cause hip and low-back pain, and she was willing to consider a larger device if it would help address her discomfort and improve her gait symmetry.

Figure 1

Figure 1: Right loading response, no AFO.

Figure 2

Figure 2: Left loading response, no AFO.

Figure 3

Figure 3: Right loading response, AFO delivery.

Figure 4

Figure 4: Left loading response, AFO delivery.

Figure 5

Figure 5: Right loading response, AFO follow-up.

Figure 6

Figure 6: Left loading response, AFO follow-up.

JV's deficits were such that an appropriate AFO for her would limit her dorsiflexion (replicating the function of the absent plantarflexors) while permitting plantarflexion during loading response. This can be mechanically obtained through the provision of double adjustable ankle joints with anterior rods and posterior springs, further optimized through the use of the anterior panel of a ground-reaction AFO. However, as a young woman, JV was fashion-conscious and aware of her appearance. Upon seeing a sample AFO similar in design to the one that was being considered for her, she expressed reluctance to wear the bulky device but did give somewhat begrudging consent. With that, we initiated the course of treatment.

Despite efforts to prepare the patient for the size of the AFO, on the day of fitting, the appearance of the device on her leg and its relative bulk in her shoe upset her. When she stood up to walk with the device, its benefits were clinically apparent immediately. It addressed much of her leg-length discrepancy, restored a third rocker to her left lower limb, and created much more symmetrical step lengths. However, because the patient had walked with certain compensations her whole life, the new gait felt awkward to her. The device in question was biomechanically appropriate and met our predetermined goals, but it was both bulky and awkward to the patient at the time of delivery.

Resource One: Slow-Motion Video Capture

Fortunately, a colleague in the office had recently contrived a simple, inexpensive means of video capture. A GoPro camera was attached to a distance-measuring wheel that could be pushed parallel to the patient as she walked down the hallway. The camera fed the digitally captured video to a smart phone in real time, allowing the clinician to verify camera position as the patient walked down the hallway and quickly download the video onto a laptop computer.

Once transferred to the laptop, Kinovea, a free, downloadable computer software (www.kinovea.org), was used to review the gait video in slow motion, down to frame-by-frame analysis when desired. In a matter of minutes, gait video in the AFO and no-AFO conditions was obtained and could be reviewed with the patient. Reviewing the patient's no-AFO gait allowed her to perceive the extent of her deficits with respect to such considerations as step symmetry, contralateral heel rise, and body posture during loading response in the absence of our intervention (Figures 1-4). While the device was initially perceived as both awkward and bulky, JV was able to see its immediate effects upon her gait. The differences that she saw were enough to convince her to take the device home and begin acclimating to full-time use. The video analysis was repeated at the patient's two-week follow-up appointment (Figures 5-6).

In this case, the capture and analysis of slow-motion video allowed the patient to overcome her initial aversion to a bulky AFO and unfamiliar gait by shifting her awareness from the device to the outcome, namely the improved symmetry of her gait. By the follow-up appointment, the patient had fully acclimated to the new orthosis and was very grateful for the services she had received.

Audience Two: Case Managers

As a rule, case managers tend to be strong advocates for the patients they represent. However, they are more likely to advocate for a desired outcome than for an individual device or component. Connections that may be intuitive to clinical practitioners in O&P are less evident to case managers who are required to look out for the needs of their patients across a broad spectrum of concerns and healthcare disciplines. As a result, case managers may be more responsive when a given component is requested in the context of how it will address a specific deficit in the patient's current functional abilities.

Consider the case of HG, who presented eight years post mid-length right transfemoral amputation. The patient was in his mid-70s and covered by a workers compensation fund. A previous provider had requested a microprocessor-controlled knee joint for HG, but the request had been denied, and HG was then using a conventional hydraulic knee joint.

In speaking with the patient at our initial consultation, he described his practice of walking about a mile a day for exercise, suggesting a fair level of physical conditioning. When asked why he did not go farther, or what held him back from higher activity levels, the patient cited his fear that the knee might inadvertently buckle underneath him. He continued by citing a recent fall that, while it had not caused any significant injury, was always in the back of his mind and influenced his daily activity level.

Clinically, a knee with stance-phase microprocessor control was indicated to address his insecurities, but this component had been previously denied. Our task was to request the intervention a second time, with the intent of focusing on the expected outcome with the intervention rather than the component itself.

Resource Two: The Activity-specific Balance Confidence Scale

Rather than qualitatively describe the insecurities of HG as a patient with a transfemoral amputation, we chose to administer the Activities-specific Balance Confidence (ABC) Scale as a means of objectively quantifying HG's balance confidence. The ABC is a 16-item questionnaire that asks patients to "indicate your level of self-confidence in doing the activity without losing your balance or becoming unsteady by choosing a corresponding number from 0 percent to 100 percent where 0 percent indicates no confidence and 100 percent indicates complete confidence." Each of the 16 questions begins with the phrase, "How confident are you that you will not lose your balance or become unsteady when you...."

The initial ABC score for HG was quite low and suggested severe compromise to his balance confidence. However, by using a standardized outcome measure, we were able to reference his score of 25.3 percent against the scores of other populations, allowing the case manager to place the extent of the deficit in some context. Quoting from the original letter of medical necessity we submitted for HG:

"While originally developed to predict fall risk in the elderly, this instrument has received extensive validation within the amputee community. In a clinical trial of 435 amputees-all of whom were seen on an outpatient basis-had been using a prosthesis for at least six months, and [had] reported daily prosthetic usage, the average confidence score on the ABC was 62 percent (Miller 2001). By comparison, a similar survey of 475 'older adults' in the geriatric community yielded an average confidence score of 91 percent (Myers 1998). When (HG) filled out the questionnaire, his confidence score was 25.3 percent, reflecting a very concerning lack of confidence in his current prosthetic system. For example, (HG) reported on 25 percent confidence that he will not lose his balance or become unsteady when walking around the house and only 10 percent confidence in his balance when walking in a crowded mall environment.

"This lack of confidence in his prosthesis appears to be holding the patient back from full daily activity. He reports that he currently walks about a mile a day, reflecting the physical ability for higher activity, but is restrained by his fear of incidental knee buckling."

The letter went on to cite several studies in which the use of microprocessor-regulated knees had decreased the number of reported stumbles and falls, improved the negotiation of stairs and slopes, improved balance, and led to spontaneous increases in activity levels. These were the very goals that could be seen as the next step in HG's rehabilitation. By connecting our component recommendation to an objectively quantified deficit and demonstrating the ability of that component to address that deficit, we were able to take the focus off of the device and place it onto the expected outcome.

Our relationship with the case manager was further improved after the component change was authorized and the patient had received an Ottobock C-Leg compact and retook the ABC. Within a few weeks of the component change, HG's ABC score had increased from 25 percent to 45 percent. This change reflected an improved outcome and maintained the emphasis of our care on the patient's functional outcome rather than on a specific device. The ABC allowed us to report several improvements in balance confidence during fundamental activities of daily living (Table 1). A cautious patient, HG's confidence continued to improve with maintained use and experience with the new knee.

Audience Three: Medicare

Given the recent proliferation of Medicare audits on prosthetic claims, prosthetists are all too familiar with Medicare's requirement that patients demonstrate certain minimal abilities, either prior to the provision of services or within a reasonable amount of time after the provision of services to substantiate the necessity of certain component types. This places clinicians and referring physicians in the unenviable position of trying to predict future function for patients with recent amputations, balancing the desires to facilitate a maximal recovery with caution toward overestimating the patient's potential.

The challenge is further augmented by a fee system that fails to incentivize routine aggressive follow-up. While we see new prosthetic patients multiple times throughout the fitting process, once the prosthesis has been fit, our involvement begins to taper off, with continued visits largely limited to maintenance adjustments to the prosthesis. However, even though Medicare does not reimburse the prosthetic community for these followup appointments, the audit process holds them accountable in producing evidence that the patient ultimately met minimal functional standards or for documenting an unforeseeable reason why the patient did not attain the standard.

Consider the case of GS, a patient who had recently undergone a unilateral long transfemoral amputation secondary to vascular compromise when he came to our clinic. He had faced an extended hospitalization following his amputation secondary to an infection that led to severe disuse atrophy and made it very difficult to predict his functional potential.

Based on his general fitness level prior to his infection and his hospitalization, the patient was assigned a K2 functional level, with careful documentation of a current ability to ambulate on level surfaces at fixed cadences but with a potential to be able to traverse low-level barriers. The patient received his prosthesis and demonstrated K1 function on the delivery date. He was lost to follow-up for several months following another infection, returning to the clinic only once more about three months later for minor adjustments to the prosthesis before transferring to a different care facility and once again being lost to follow-up. Following the patient's death about a year later, we received the audit from Medicare, taking back payment on the claim and asking us to demonstrate the patient's K2-level function.

Resource Three: Outpatient Physical Therapy Treatment Notes

In addressing requests for the documentation of functional abilities well after the provision of prosthetic services, the physical therapy (PT) community is a tremendous resource. While our hours with the patient are largely spent prior to and during the fitting process, the PTs' time with our patients is largely after the receipt of the prosthesis. Further, because they are not reimbursed for prosthetic services, there is no perceived conflict of interest in their documentation of a patient's progress.

In the case of GS, the prosthetic clinic notes following the delivery of the prosthesis were very sparse, with only a single follow-up visit having occurred. However, detailed PT notes were able to fill that gap. From them we learned about the unforeseeable infection that occurred immediately following his receipt of his prosthesis, which prevented him from using the prosthesis for another three months. The PT notes go on to document a gradual increase in walking stamina and endurance and the negotiation of environmental obstacles in the form of a short flight of stairs on three successive appointments about four months after the receipt of his prosthesis.

Notes from this time period state "...(GS) is now able to transfer from wheelchair to walker and begin walking with supervision only. He is stand[ing] by assist up and down two steps with two handrails and can turn and sit on his four-wheel walker. He is also able to transfer from his walker to standing and ambulate with standby assist. His endurance is improving each day...."

Further progress on stair negotiation was documented at subsequent appointments. At an appointment about six months after the receipt of his prosthesis, GH's PT documented that he "...went outside on the incline and rough parking surface and back into the building. He tolerated this well." This note indicates a clear demonstration of the patient's ability to negotiate environmental obstacles, consistent with K2-level function.

Using the PT notes as a resource, we were able to demonstrate to Medicare auditors that the patient in question ultimately obtained the outcome that its statutes require, and we received full payment on the claim. A similar strategy has been used to defend K3-level function justifying such components as microprocessor knees and dynamic response feet. In both scenarios, the Medicare audit process suggests that its interests lie in outcomes more than components. If the anticipated outcome can be demonstrated through a combination of physician, prosthetist, and PT progress notes, eventual payment on the claims can be reasonably expected.

Conclusion

Whether to meet the expectations of individual patients, persuade case managers, or substantiate payment on Medicare claims, the O&P profession will be called upon increasingly to delineate the outcomes of its services beyond providing a piece of equipment. In doing so, several resources can be used including digital video, standardized outcome measures, and the progress notes of other allied healthcare professionals.

Phil Stevens, MEd, CPO, FAAOP, is in clinical practice with Hanger Clinic, Salt Lake City, Utah. He can be reached at