PAVE ing the way to improved limb preservation Jeffrey M. Robbins, DPM Director, Podiatry Service VACO November 17, 2012

Learning Objectives At the conclusion of this activity, the participant will be able to: A. Describe the importance of the Prevention of Amputation in Veterans EverywhereProgram B. List the components of calculating foot risk score C. Discuss the morbidity and mortality associated with first onset diabetic ulceration

Disclosures Jeffrey M. Robbins, DPM has no financial interest or relationships to disclose.

“Every system is perfectly designed to get the results it gets “Every system is perfectly designed to get the results it gets.” Paul Bataldan

Veterans Medical Programs Amendments of 1992 (PL102-405) Emphasized importance of highest quality amputee care Identified veterans with amputation as a special disability group Chartered the Advisory Committee on Prosthetics and Special Disabilities Programs

PAVE 1. PURPOSE: This Veterans Health Administration (VHA) Directive defines the scope of the care and treatment provided to veteran patients at risk of primary or secondary limb loss. This is accomplish through the Prevention of Amputation in Veterans Everywhere (PAVE) Program

1993 PACT Program Launched Developed to meet the changing needs of veterans more neuropathy, PVD and diabetes fewer traumatic amputations New issues in 2006 with returning OEF/OIF Vets Established a model of care to prevent or delay amputations Proactive early identification of “at risk” populations Especially veterans with diabetes Track from date of entry to discharge back to the community

Policy 3. POLICY: It is VHA policy that the PAVE program be established at all VA medical centers. The program will at a minimum provide for

Policy: Screen/Risk Assess/Refer 1. Screening of at-risk populations 2. Identification of high risk patients 3. Timely and appropriately referral

Policy: Mental Health Consult 4. Each patient who has suffered an amputation should be offered a visit by their mental health consultation team, to assess coping and provide support as needed either in an individual or group format. (This approach avoids stigmatizing anyone as being singled out as having mental or emotional issues and also minimizes the potential for missing someone who is 'suffering in silence")

Policy: Identify and Track 5. Development of a system to identify and track patients with amputation or those at risk for amputation. NOTE: (The VACO Patient Care Services PAVE ProClarity Cubes are an acceptable resource from which to develop such a system)

Policy: Champion 6. A PAVE coordinator to provide for (a) organizational support for the PAVE team, (b) communication conduit between administration and PAVE/Amputee clinic team providers, (c) a smooth transition of the DOD patient into the VA system

Policy: Interdisciplinary Committee 7. A PAVE Committee should be established to coordinate efforts to address the primary amputation prevention needs of “at risk” patients, and the secondary amputation prevention needs for those patients who have already suffered an amputation. This includes patients who had their amputations outside the VA system of care (e.g. OEF/OIF, private hospital, etc). This may be accomplished by the PAVE coordinators incorporating their efforts in existing primary amputation prevention committees within the medical centers.

VA Central Office PAVE Oversight Committee The field based PAVE Oversight Committee made up of clinical leaders from endocrinology/diabetes, podiatry, PM&R, Prosthetics, nursing the VISN’s, OQP responsible for recommendations for data collection and analyses to permit program evaluation of the screening, surveillance, salvage, and rehabilitative components of the PAVE program, including the following

Policy 1. Identification of veterans at risk for or who have sustained an amputation Age adjusted and stratified rates of major (AKA and BKA) and minor amputations, and lower extremity non-venous ulcers Patient knowledge and performance of recommended self foot care practices, and satisfaction with foot care. VISN and Facility adherence to the PAVE Directive with respect to formal policies and coordination strategies

Proposed: Program Improvement The PAVE committee will use these analyses to identify best practices from the field, and to make recommendations to achieve excellence in patient centered care to the PAVE Oversight Committee for program improvements Recommendations RE: self foot care behaviors

Opportunity: SFCB Let patients know that these self care behaviors are important to their provider Allows the provider to reinforce the behavior in a quick and efficient manner.

CPRS Follow-up on Self Foot Care Behaviors Are you or your caregiver having an problems inspecting your feet every day? Can’t see or can’t reach Can we offer you a mirror, etc. Are you or a caregiver having an problems washing your feet? Can we offer you a sponge on a stick, etc. Do you walk barefoot?

Policy: Defines Responsibility A. The Network Director is responsible for: B. Medical Center Director C. Chief of Staff D. PAVE Coordinator

Program Components Directive provides recommendations for; Foot Checks Foot Examinations Risk Score assignments Referral strategy Provides guidelines not mandates!

Foot Screening 1. FOOT Screening This would involve: a. Visual inspection of the skin surface for any lesions, deformities, color or temperature changes or ulcers; b. Screening for circulation, i.e., the palpation of pedal pulses in the foot; and c. Sensory testing using a Semmes-Weinstein 5.07 monofilament to check for loss of protective sensation.

Foot Examination 2. FOOT Examination This involves a more in-depth evaluation of the foot’s circulation and sensation as well as foot deformities. During this examination, patients are evaluated by a "foot care specialist," e.g., Prevention of Amputation in Veterans Everywhere (PAVE) program member, vascular surgeon, podiatrist, or other health care professional demonstrating appropriate education, training, competencies and licensure necessary to provide such care

Foot Risk Score RISK ASSESSMENT LEVEL "At-risk" is defined as patients with diabetes, peripheral vascular disease and/or end stage renal disease, who are considered highly susceptible to develop foot ulcers. “High Risk” is defined as any patient who has had an amputation for any reason, and patients with a foot risk score of 2 or 3.

Foot Risk Score a. Level 0, Normal Risk. These patients have no evidence of sensory loss, diminished circulation, , ulceration, or history of ulceration or amputation. Patients with diabetes should receive foot care education and annual foot screening. These patients do not require therapeutic footwear. b. Level 1, Low Risk . These individuals demonstrate one or both of the following Foot deformity or minor foot infection (and a diagnosis of diabetes). Patient education, preventative care and annual foot screening are required. The patients in this category and the following two categories (Level 2 and Level 3) should not walk barefoot. Special attention is to be directed to shoe style and fit. These individuals do not need therapeutic footwear.

Foot Risk Score c. Level 2, Moderate Risk. These individuals demonstrate sensory loss (inability to perceive the Semmes-Weinstein 5.07 monofilament) and may have one additional finding below. Diminished circulation as evidenced by absent or weakly palpable pulses, (this would require follow-up examination to determine level of vascular disease before a final risk score can be determined) Foot deformity or minor foot infection (and a diagnosis of diabetes).

Foot Risk Score These individuals require: therapeutic footwear and orthoses to accommodate foot deformities, to compensate for soft tissue atrophy, and to evenly distribute plantar foot pressures. Patient education, regular preventive foot examination and care in podiatry or other foot care specialty clinic. Patient health education (PHE) must include the implications of sensory loss and the importance of daily foot inspections. NOTE: May require Diabetic Socks and Depth Inlay Shoes based on clinical judgment.  

Foot Risk Score Level 3, High Risk. These individuals demonstrate peripheral neuropathy with sensory loss (inability to perceive the Semmes- Weinstein 5.07 monofilament) and diminished circulation and foot deformity or minor foot infection (and a diagnosis of diabetes). or any of the following by itself Prior ulcer, Osteomyelitis or history of prior amputation Severe PVD (intermittent claudication, dependent rubor with pallor on elevation, or critical limb ischemia manifested by rest pain, ulceration or gangrene., Charcot’s joint disease with foot deformity. End Stage Renal Disease These individuals are at highest risk of lower extremity events. Individuals in this category require extra depth footwear with soft molded inserts. They may require custom molded shoes and braces (e.g., double upright brace, patella tendon bearing orthoses, etc.). More frequent clinic visits are required with careful observation, regular preventive foot care, and footwear modifications. NOTE: May require Diabetic Socks, Depth Inlay Shoes or Custom-Molded Orthopedic Shoes based on clinical judgment.

Who are our patients? Patients 1,514,197 Age Avg 69.3 Amputation Last 18 Mos 7,176 Hx Amputation Last 10 Years 45,134 Hx Charcot Foot 4,794 Hx Diabetes 1,260,752 Hx ESRD 18,385 Hx Foot Deformity or Surgery 377,053 Hx Gangrene 7,648 Hx Neuropathy 322,610 Hx Non-Healing Ulcer 58,440 Hx Osteomyelitis 13,105 Hx PVD 300,765 Hx PVD Surgery 9,007 Hx Smoking % 20.12%

Outcomes: Risk Levels

Outcomes: Ulcers

Outcomes: Amputations

Outcomes Mortality

Summary Best system anywhere but we need to do even better We have been following patient centered medical home principals Must do better to convince patients to engage in self foot care practices. PAVE and ASoC coordination, co-operation should help us improve the system of care.