Comorbidity Screening and Referral by Prosthetists

University of Delaware

Status: Completed

Conditions: Neuropathy;Peripheral; Limb Ischemia; Amputation; Depression; Low Back Pain

Treatments: Other: Standard-of-Care; Other: Clinical Screening

Study type: Interventional

Funder types: Other

Identifiers

NCT05410548

1865677

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English-speaking and -reading
• Unilateral transtibial (i.e., below-knee) or transfemoral (i.e., above-knee) amputation
• Utilization of a prosthesis for at least 1 year
• Willingness to have screening results communicated to their primary care provider
• Receiving prosthetic care at Independence Prosthetics-Orthotics, Inc.

Exclusion criteria

• Cognitive impairment precluding ability to consent to study participation
• Contralateral limb amputation greater than toe-level
• Severe vision or hearing loss
• Receipt of a replacement prosthetic component within the 3 months prior to study enrollment
• Hospitalization within the 3 months prior to study enrollment

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Standard-of-Care

Other group

Description:

Patient participants will receive routine standardized prosthetic follow-up care by a certified prosthetist, including evaluation of prosthesis use, prosthesis-enabled mobility, socket comfort and sock ply usage, falls, body anthropometrics, and functional mobility.

Treatment:

Other: Standard-of-Care

Standard-of-Care + Clinical Screening

Experimental group

Description:

In addition to routine, standardized prosthetic follow-up care, patient participants will receive comorbidity screening for contralateral limb peripheral arterial disease, peripheral neuropathy, major depression, and greater than low risk for persistent low back pain. Participants will be educated on clinical screening findings, provided a copy of their screening results to share with their medical providers, and their results will be securely sent to their primary care provider.

Treatment:

Other: Clinical Screening

Other: Standard-of-Care