Comorbidity Screening and Referral by Prosthetists

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.

Conditions

• Limb Ischemia
• Low Back Pain
• Depression
• Neuropathy;Peripheral
• Amputation

Interventions

OTHER

Standard-of-Care

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.

OTHER

Clinical Screening

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.

Sponsors & Collaborators

• Independence Prosthetics-Orthotics, Inc.

  collaborator UNKNOWN

• Orthotic and Prosthetic Education and Research Foundation (OPERF)

  collaborator OTHER

• University of Delaware

  lead OTHER

Principal Investigators

• Jaclyn M Sions, PhD, DPT · University of Delaware

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-09

Primary Completion

2023-01-30

Completion

2023-01-30

Countries

• United States

Study Locations