February 2016

Active Stance: Patients with at-risk feet need collaborative care

active-stance

By Terrence P. Sheehan, MD

In a recent editorial in The Lancet Diabetes-Endocrinology,1 Lipsky and colleagues wrote that diabetic foot disease “…is not a one doctor disease—it demands multidisciplinary care. Furthermore, as a notoriously unglamorous problem, the disease depends on dedicated clinicians working together in a team of healthcare providers to care for a complex patient—a scenario some disparage, but we relish.” I share this perspective.

Although a number of studies demonstrate the benefits of caring for patients with feet at risk using a multidisciplinary team approach, to my knowledge, with the exception of Veterans Administration (VA) hospitals, such teams are rare in the US. When Adventist Rehabilitation Hospital of Maryland opened in 2001, I established a collaborative care team for patients with limb loss, which we call an “amputee clinic.” The team concentrates on supporting the person with limb loss and enabling him or her to achieve the best possible outcome, including preservation of the remaining limb after the amputation.

The success of the approach, coupled with evidence from the literature in support of multidisciplinary management of limb loss, prompted the Amputee Coalition to form a Limb Loss Task Force. In 2011, the task force drafted the Roadmap for Limb Loss Prevention and Amputee Care Improvement,2 which included a call for the creation of prevention partnerships. This was followed in 2012 by the Roadmap for Preventing Limb Loss in America,3 which advocated the use of multidisciplinary diabetic foot care teams to reduce the incidence of amputation. Currently, the Amputee Coalition is putting together a third report, based on the March 2015 meeting of the National Limb Loss Task Force.  This report’s focus is the formations of centers that serve as “model systems of care” for those with at-risk feet or limb loss. This is similar to what has been done for other vulnerable groups, such as those with spinal cord injury (1972), traumatic brain injury (1987) and burns (1994).4 While our team is primarily focused on preventing a second amputation, another goal is to help patients with diabetes and other vascular conditions avoid a first amputation, in collaboration with the Adventist Acute Hospital System in Montgomery County, MD.

Studies demonstrate the benefits of caring for patients with feet at risk using a multidisciplinary team approach. So why are such teams so rare in the US?

A time-honored approach

Sanders et al described the antecedents of the collaborative team approach to amputation prevention in a 2010 article in the Journal of Vascular Surgery.5 The authors noted the first hospital-based foot clinic was established by Elliott P. Joslin, MD, and members of the Massachusetts Chiropody Association at New England Deaconess Hospital in 1928. Shortly thereafter, in the mid-1930s, Joslin established a team approach to diabetes care that included foot care, nutritional therapy, exercise, treatment of infection, and surgical treatment as needed. Several decades of team evolution (which included the addition of vascular surgical specialists and general surgeons) grew the clinic and the practice into a respected center for revascularization and limb preservation.

In the 1960s, Paul W. Brand, MD, pioneered hand and foot care for patients with Hansen disease in Carville, LA, and a number of his techniques and practices were adapted for the management of diabetic ulcers. Brand was joined by other medical practitioners in the 1980s, creating a model of interdisciplinary care that included orthopedics, podiatry, physical therapy, physical and rehabilitative medicine, and an on-site facility for the customization of footwear (new shoes, shoe modifications, and insoles). The team provided care throughout the process of ulcer healing, and offered lifetime rehabilitation after treatment based on the assumption that patients would always be at risk of a new ulceration.5

Sanders and colleagues acknowledged the contributions of the American Diabetes Association in promoting multidisciplinary diabetes care, and the successes in amputation prevention achieved by the VA (which built on the successes of Brand and his colleagues with Hansen disease patients).5

Reductions in amputations

Figure 1. Adventist HealthCare Physical Health & Rehabilitation’s physical therapist works with a patient during one of his outpatient therapy sessions, which are per- formed to improve physical strength, coordination and endurance after the loss of a limb. (All photos courtesy of Adventist HealthCare Physical Health & Rehabilitation.)

Figure 1. Adventist HealthCare Physical Health & Rehabilitation’s physical therapist works with a patient during one of his outpatient therapy sessions, which are performed to improve physical strength, coordination and endurance after the loss of a limb. (All photos courtesy of Adventist HealthCare Physical Health & Rehabilitation.)

A number of large-scale studies, mainly conducted in Asia and Europe, demonstrate the efficacy of a collaborative team approach in reducing lower extremity amputations (LEAs).

Chang Gung Memorial Hospital (Taiwan, China): In a 10-year retrospective study, Hsu et al reported significant declines in LEA rates using a multidisciplinary team approach.6 The researchers investigated the nontraumatic LEA rate in diabetic foot patients from 2004 to 2013. Patients were enrolled from inpatient populations, emergency department visits, and outpatient departments. Following the establishment of a wound-care protocol and an integrated multidisciplinary team, the LEA rates for hospitalized patients from 2010 to 2013 declined 60% compared with the period from 2004 to 2009, and rates for emergency and outpatient departments declined 62%. The authors attributed declines to the introduction of an efficient treatment pathway with on-time debridement and early intervention through the efforts of the multidisciplinary team.

Ipswich Hospital (Suffolk, UK): Krishnan et al showed significant reductions in the incidence of total, major, and minor LEAs after the introduction of multidisciplinary teams.7 The reductions continued over 11 years, despite a significant increase in the number of people with diabetes treated at the hospital during the same period. In this prospective study, the incidence of total amputations fell 70% (81.6% for major amputations, 21% for minor amputations) while the diabetic population grew by 76%. The authors attribute the significant LEA reductions to improved foot care services delivered via multidisciplinary teams.

Madigan Army Medical Center (Lakewood, WA): Driver et al8 observed a significant decrease in LEAs after the establishment of a limb preservation team and foot care management plans for patients. According to the authors, “concern over the rate of lower extremity amputation in diabetic patients prompted the establishment of a specialized foot clinic (Limb Preservation Service or LPS)” in 1995. Since then, the medical center has been caring for people at high risk for diabetic foot problems. Patients undergo screenings to categorize their risk for ulceration and amputation (low, moderate, or high), and receive management plans appropriate to their risk levels. These plans include regular examinations (the higher the risk, the more frequent the examination), educational counseling, diagnostic tests, footwear modifications, and specialist referrals as needed.

From 1999 to 2003, the number of diagnosed diabetic patients increased by 48%, while the number of LEAs decreased by 82%. The authors cited “the benefits of a focused limb preservation team,” and noted the temporal association between the establishment of the team approach and the decrease in LEA incidence. They further observed that “unlike private practice, MAMC presents few traditional barriers to specialist referral or to communications among specialists.”

3rd Health Care Area of Madrid (Spain): Rubio et al documented a significant reduction in incidence of LEAs in people with diabetes after the introduction of a multidisciplinary team for managing diabetic foot conditions.9 The researchers analyzed the incidence of LEAs before and after the 2008 introduction of the team, which was coordinated by an endocrinologist and a podiatrist. No change in the incidence of minor or total amputations was observed in either the diabetic or nondiabetic populations, but the incidence of major diabetes-related amputations was reduced by 34%. The success was attributed primarily to the multidisciplinary team.

Health Care Districts, Area 6 Murcia (Spain): Alcala et al10 demonstrated a significant decrease in elective amputations and in major amputations following the establishment of two multidisciplinary teams. The first team, called the “Critical Pathway Committee,” was established in 2000 to focus on patients admitted to hospitals with diabetic foot infections, ischemic gangrene, or both. The committee consisted of a diabetologist, emergency medicine specialist, anesthesiologist, surgeon, infectious disease specialist, radiologist, pharmacist, physical medicine and rehabilitation specialist, psychiatrist, family physician, and social worker.

In 2006, a diabetic foot clinic was established in the primary hospital, also incorporating a team approach. The team consisted of a general surgeon, physical medicine and rehabilitation specialist, diabetes nurse, physical therapist, orthotist, and orthopedic shoemaker, all of whom worked closely with the departments of endo­crinology, orthopedic surgery, vascular surgery, and interventional radiology, and liaised with primary health care units in the area.

The retrospective study compared the number of amputations between 1998 and 2001 with the number of amputations between 2001 and 2012, and found a 47% decrease in all major amputations and a 66% decrease in elective amputations. The combined effects of the Critical Pathway Committee and the diabetic foot clinic were credited with the improvements.

Helsinki Area Hospitals (Finland): Eskilinen et al11 observed significant reductions in overall amputations in both diabetic and nondiabetic patients after a multidisciplinary team approach was adopted in 1993. A retrospective analysis of major LEAs in Helsinki from 1990 to 2002 showed a 23% reduction in mean annual incidence of major amputations in patients with diabetes toward the end of the study period compared with the early years of the study. The mean annual incidence of major amputations in nondiabetic patients declined 40% during the same period. The authors concluded the increased use of vascular surgery and the establishment of the multidisciplinary team both played important roles in the reduction of major amputations.

Bispebjerg Hospital (Copenhagen, Denmark): Holstein et al observed a significant reduction in major amputations in people with diabetes associated with an increase in revascularization procedures and the establishment of a multidisciplinary diabetic foot clinic.12 The retrospective study, which covered the years 1981 to 1995, showed a 75% decrease in major diabetic leg amputations (59% decrease in type 1 patients, 84% decrease in type 2 patients). Specifically, the authors noted the decreases correlated with the increased use of infra­popliteal bypass reconstructions (starting in 1987) and the establishment, in 1993, of a multidisciplinary team consisting of a vascular surgeon, diabetologist, specially trained nurses, an ortho­pedic surgeon, and an orthopedic shoemaker.

University Hospital (Lund, Sweden): Larsson et al13 observed a “substantial long-term decrease in the incidence of major amputations…as well as a decrease in the total incidence of amputations in diabetic patients” after the implementation of a medical and orthopedic program for prevention and treatment of diabetic foot ulcers via a team consisting of a diabetologist, orthopedic surgeon, diabetes nurse, podiatrist, and orthotist, all working closely with the departments of vascular surgery and infectious disease. According to the authors, the program led to a 78% decrease in the incidence of major amputations from January 1982 to December 1993 and a 49% reduction in the total annual number of amputations. In addition, the reamputation rate decreased by 17%.

The Dulwich Study (UK): Also worth noting is this study, which focused not on amputation prevention but rehabilitation and quality-of-life outcomes for amputees.14 The collaborative team consisted of a physical therapy coordinator, a visiting prosthetist and medical officer from a local prosthetic supplier, and a surgeon. By the end of the study period (1985-1986), the team approach had reduced inpatient stays by 20 days compared with the baseline period (1981-1982) and the need for physical therapy by 94%, and increased the proportion of patients discharged with a prosthesis by a factor of five.

Examples from the clinic

Figure 2. Terrence Sheehan, MD, chief medical officer for Adventist HealthCare Physical Health & Rehabilitation, checks in to observe and report on the progress of a recent amputee patient.

Figure 2. Terrence Sheehan, MD, chief medical officer for Adventist HealthCare Physical Health & Rehabilitation, checks in to observe and report on the progress of a recent amputee patient.

I started working with an interdisciplinary team during my training in the VA hospitals, and my commitment to the approach was reinforced by the literature demonstrating its benefits; both of these led me to institute a collaborative approach at Adventist. As a physiatrist specializing in physical medicine and rehabilitation, I coordinate a team consisting of a physical therapist, nurse, peer visitor (an amputee volunteering to help
patients), prosthetist/orthotist, and, if needed, a mental health professional.

We hold care clinics every other week, during which patients are evaluated, managed, and educated by the team members sequentially—all with a view toward preventing further amputations and enabling patients to continue participating fully in their lives. While ensuring that a patient is appropriately fitted with a prosthesis and learns to use it properly, for example, I also educate him or her on how to protect the other foot. We reinforce the need to follow up with other team members, including vascular specialists and podiatrists, and make sure patients know there is a place to go if they have even the smallest skin breakdown or trauma—in which case, they know they have to see me quickly.

My colleagues and I recently applied for a Patient-Centered Outcomes Research Institute (PCORI) grant15 to help document our success by comparing our collaborative approach with usual care in patients who have undergone an amputation. Meanwhile, we have plenty of examples from our practice that demonstrate the effectiveness of the approach in enhancing quality of life and potentially saving lives.

In my experience, when patients wake up after an amputation, the whole course of their lives depends on who counsels them at that point— a surgeon, a social worker, a family member, or a collaborative team. Take “John,” for example. A 56-year-old patient with diabetes, he chose to participate in Adventist’s CARF (Commission on Accreditation of Rehabilitation Facilities)-accredited Amputee Specialty Program. The team guided him through the healing process, helping him adjust to the fact that he had lost a limb, and also giving him an idea of what to expect next, and a vision for the future.

When he came to us, John was convinced he would have to stay in a nursing facility for the rest of his life. The team flipped that expectation around by ensuring he remained as healthy as possible and was educated on what to expect day by day—meeting his therapist, meeting the peer visitor who would support him during this part of the rehabilitation process, and understanding that our expectation was that he would be up and around, learning to use a prosthesis, and back home within four to six weeks, if not sooner. And that’s exactly what happened: He spent a week in a nursing facility while his prosthesis was being made, then we brought him back in, taught him to use the prosthesis and sent him home.

John has returned to the clinic several times since his discharge. He needed his prosthetic socket remade, which is common if a person’s limb matures after limb loss, but otherwise he has done just as we planned—getting “back to his life” and helping take care of his mother.

Another example is a woman we nicknamed “Auntie Mame,” after the 1955 novel about an eccentric woman who travels the world and has madcap adventures. She came to us from an acute-care hospital about 10 years ago, at age 83 years, after a below-knee amputation due to vascular disease. When I met her, she was lying in bed, convinced her life was over. We took her through the program, and she ended up volunteering weekly as a peer visitor at the hospital and ultimately fulfilled her goal of traveling to Israel, Italy, and Ireland.

We also had an 80-year-old woman with an above knee amputation due to diabetes who went to a nursing facility for a short period and then insisted she wanted to go home. Going home, however, involved negotiating a 44-step staircase. We taught her how to use a prosthesis with the latest technology, including a computerized knee, and she was eventually able to meet her goal of getting herself up those stairs independently so she could go home. She lived in the comfort of her home with her son for the next four years before succumbing to other medical issues.

Figure 3. The clinic director of the outpatient clinic at Rio Sport&Health in Gaithersburg, MD, assists a patient on the antigravity treadmill, which helps reduce recovery time from a sports-related injury or orthopedic condition.

Figure 3. The clinic director of the outpatient clinic at Rio Sport&Health in Gaithersburg, MD, assists a patient on the antigravity treadmill, which helps reduce recovery time from a sports-related injury or orthopedic condition.

Amputation rates are significantly higher for those 65 years and older than for younger age groups—and, shockingly, the rates for ethnic minorities are close to double the rate for whites, a major health disparity. Without a collaborative team that has a vision of a positive outcome and the wherewithal to make it happen, these patients, in particular, end up languishing at home or in a nursing facility, often unnecessarily.

In our experience, even younger people will benefit more from a collaborative team than from usual care. Several years ago, we worked with a young man (aged 18 years) who fell while skiing, breaking the tibia and disrupting the blood supply to his leg. He had an amputation at the knee and was despondent. We took him and his family through an educational process and made sure he got the right prosthesis. He went back to school and recently married and started working as an engineer. We remain in close contact with him and his family, dealing with any issues that may arise, because an amputation affects a person for the rest of his or her life.

Beyond adjusting a prosthesis, we monitor the person’s overall health—physical, mental, and quality of life. All of this is much easier when all the providers and caregivers are on the same page, working collaboratively.

Moving the US forward

Why isn’t collaborative care—not just postamputation, but also for anyone with feet at risk due to systemic issues—the norm in the US?  Currently, hospital wound centers, with the exception of those in the VA system, are reimbursed for treating wounds, not for preventing them. If no one pays for a collaborative team effort to save a limb, it doesn’t happen.

Yet, if we think about it, any person who experiences nontraumatic limb loss at one point was at risk. Within that risk period, their care most likely was fragmented, which can contribute to the risk of amputation. It is rare that a patient I’m treating says, “I knew I was at risk of losing my limb.”  The vast majority say, “I had no idea this could happen to me. It happened so quickly, and now my life is turned upside down.” That’s often because they didn’t receive appropriate education—that is, they weren’t told all people with diabetes have at-risk feet, or that a first callus can start the ulceration process, or about regular foot exams and other preventive measures that might have facilitated prompt treatment and made amputation unnecessary.

As a patient goes down the “at-risk” road, not seeking foot care or doing daily foot inspections, something as seemingly benign as a callus persists. Bacteria can grow under the dead tissue, which leads to infection. Once an infection starts, untreated, it can spread quickly, often to the bone.16 The person ends up in the emergency department, often because diabetes or peripheral vascular disease (PVD) kept the body’s sensory alarm from switching on in the presence of severe injury. Asked why he or she waited to be treated, the patient says, “Oh, my foot didn’t really hurt, it just got red and smelly and stuff like that.” By that time, it’s too late.

We clinicians know this; the literature is clear. The answer: We need to come together and collaborate to prevent the needless loss of a limb.

As my colleagues and I wrote in the June 2015 issue of the Journal of Ethics, losing a leg or foot is associated with increased risk of multiple health issues, including osteoarthritis, back pain, joint pain, and osteoporosis/osteopenia.17 Amputation also negatively impacts body image, self-esteem and quality of life. Simply put, it’s something we want to avoid. And if it happens, we want to ensure patients have access to all the medical and psychosocial resources needed to help them live a full life, despite an amputation. As noted earlier in this article, there is great disparity in the US with regard to the care of those who are at risk for limb loss as well as those who have already lost a limb to amputation.

As we consider how to move the US forward in the use of preventive and collaborative care approaches, Barshes et al provide some suggestions for research and practice efforts.18 First, the role of primary prevention needs to be clarified. In addition, the recognition of PVD needs to improve, and treatments aimed at limb preservation begun as early as possible. Finally, more research aimed at diabetic foot complications and their prevention needs to be funded. The authors point to a “yawning gap” between the impact of these complications and the funding for research to improve their prevention and management.

I would add that we need more emphasis on prevention of originating events such as ulceration. This can be addressed through a focus on early use of skin and soft tissue protection and management protocols for the feet of patients at risk. It is not rocket science, and it is not expensive. For the most part, it means education; a footwear system that includes a padded sock, possibly a custom insert, and a well-fitting shoe; and regular monitoring.

We know that once a person is diagnosed with diabetes, PVD, or both, he or she is at risk of ulceration and amputation from that moment on and for the remainder of his or her life. The medical literature, as well as our clinical experience, indicates that collaborative care helps to significantly reduce that risk. Therefore, it is in the best interests of patients, practitioners, and the healthcare system to move quickly and collaboratively forward, providing treatment, education, and ongoing monitoring.

Terrence P. Sheehan, MD, is chief medical officer at Adventist Rehabilitation Hospital of Maryland, medical director for the Amputee Coalition, and a Scientific Advisory Board member for the Institute for Preventive Foot Health.

REFERENCES
  1. Lipsky BA, Apelqvist J, Bakker K, et al. Diabetic foot disease: moving from roadmap to journey. Lancet Diabetes Endocrinol 2015;3(9):674-675.
  2. Roadmap for Limb Loss Prevention and Amputee Care Improvement, A Report of the Limb Loss Task Force Amputee Coalition and National Limb Loss Information Center. Amputee Coalition website. http://www.amputee-coalition.org/wp-content/uploads/2015/03/Roadmap-for-Limb-Loss-Prevention-and-Amputee-Care-Improvement-2011.pdf. Published January 27, 2011. Accessed January 26, 2016.
  3. Roadmap for preventing limb loss in America, recommendations from the 2012 Limb Loss Task Force. Amputee Coalition website. http://www.amputee-coalition.org/wp-content/uploads/2014/09/lsp_Roadmap-for-Limb-Loss-Prevention-and-Amputee-Care-Improvement_241014-092312.pdf. Published February 2012. Accessed January 26, 2016.
  4. Model Systems Knowledge Translation Center. msktc.org/sci. Accessed January 26, 2016.
  5. Sanders LJ, Robbins JM, Edmonds ME. History of the team approach to amputation prevention: Pioneers and milestones. J Vasc Surg 2010;52(3 Suppl):3S-16S.
  6. Hsu CR, Chang CC, Chen YT, et al. Organization of wound healing services: the impact on lowering the diabetes foot amputation rate in a ten-year review and the importance of early debridement. Diabetes Res Clin Pract 2015;10(1):77-84.
  7. Krishnan S, Nash F, Baker N, et al. Reduction in diabetic amputations over 11 years in a defined UK population. Diabetes Care 2008;31(1):99-101.
  8. Driver VR, Madsen J, Goodman RA. Reducing amputation rates in patients with diabetes at a military medical center. Diabetes Care 2005;28(2):248-253.
  9. Rubio JA, Aragon-Sanchez J, Jimenez S, et al. Reducing major lower extremity amputations after the introduction of a multidisciplinary team for the diabetic foot. Int J Low Extrem Wounds 2014;13(1):22-26.
  10. Martinez-Gomez DA, Moreno-Carrillo MA, Campillo-Soto A, et al. Reduction in diabetic amputations over 15 years in a defined Spain population: benefits of a critical pathway approach and multidisciplinary team work. Rev Esp Quimioter 2014;27(3):170-179.
  11. Eskelinen E, Eskelinen A, Alback M, Lepantalo M. Major amputation incidence decreases both in non-diabetic and in diabetic patients in Helsinki. Scand J Surg 2006;95(3):185-189.
  12. Holstein P, Ellitsgaard N, Olsen BB, Ellitsgaard V. Decreasing incidence of major amputations in people with diabetes. Diabetologia 2000;43(7):844-847.
  13. Larsson J, Apelqvist J, Agardh CD, Stenstrom A. Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach? Diabet Med 1995;12(9):770-776.
  14. Ham R, Regan JM, Roberts VC. Evaluation of introducing the team approach to the care of the amputee: the Dulwich study. Prosthet Orthot Int 1987;11(1):25-30.
  15. Improving methods for conducting patient-centered outcomes research. Patient-Centered Outcomes Research Institute website. http://www.pcori.org/funding-opportunities/announcement/improving-methods-conducting-patient-centered-outcomes-research-1. Accessed January 26, 2016.
  16. Lipsky B. Medical treatment of diabetic foot infections. Clin Infectious Dis 2004;39(Suppl 2):S104-S114.
  17. Gailey R, Castles J, Kucharick J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev 2008;45(1):15-29.
  18. Barshes NR, Sigireddi M, Wrobel JS, et al. The system of care for the diabetic foot: objectives, outcomes and opportunities. Diabet Foot Ankle 2013;10;4.
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