Comorbidity Screening and Referral by Prosthetists
Condition: Limb Ischemia; Low Back Pain; Depression; Neuropathy;Peripheral; Amputation
MeSH terms: Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Ischemia
Study type: Interventional

Summary: 
      Lower-limb amputation is associated with life-altering and life-limiting comorbidities.
      Currently, onus is on primary care providers to diagnose, educate, and refer patients for
      appropriate management. Recently our laboratory has found, however, that of adults
      post-amputation seen in an outpatient Limb Loss Clinic presenting with comorbidities, >50%
      are unaware they have signs of peripheral arterial disease and/or neuropathy. Lack of patient
      awareness and thus, inadequate comorbidity management, may contribute to suboptimal patient
      outcomes post-amputation. As a first step in this research line, the proposed project will
      help determine if comorbidity screening by prosthetists during routine care visits for
      patients post-amputation may enhance comorbidity awareness, increase patient satisfaction in
      prosthetic services, and reduce gratuitous prosthetic service utilization. During a follow-up
      visit, seventy patients following a unilateral lower-limb amputation will be randomized into
      either a standard-of-care group or a standard of-care plus group. The standard-of-care plus
      group will receive clinical screenings by a certified prosthetist for peripheral arterial
      disease, peripheral neuropathy, depression, and high-risk for persistent back pain; patient
      education on findings; and each participant's primary care provider will receive screening
      results. The long-term goal of this research is to determine if prosthetists can maximize
      their utility in an interdisciplinary care team, while enhancing patient outcomes
      post-amputation.
    


Intervention name(s): Standard-of-Care; Clinical Screening
Intervention type(s): Other; Other
Intervention description(s): Participants with a major unilateral transfemoral or transtibial amputation will undergo a standardized medical history and medication review, complete questionnaires evaluating prosthesis use, comfort, and mobility, receive a clinical examination of height, weight and limb circumference, and complete three performance-based mobility outcome measures.; Participants will complete the following self-report questionnaires: (a) the Patient Health Questionnaire-9 item, which may suggest major depression and/or suicidal ideation; and (b) the STarT Back Screening Tool, a 6-item tool used to screen for greater than low-risk for persistent, bothersome and disabling low back pain. Prosthetists will perform palpation of the contralateral dorsalis pedis and posterior tibial pulses and note presence or absence, as an indicator of peripheral arterial disease. Prosthetists will evaluate protective sensation of the contralateral foot through Semmes-Weinstein monofilament assessment of the great toe, the 1st and 3rd metatarsal heads. The prosthetist will record the results in a letter that is sent to the patient's primary care provider, and provide a copy of the letter to the patient after discussing the results for each of the screens.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: comorbidity; peripheral arterial disease; sensation; back pain; mental health; amputation