Comorbidity Screening and Referral by Prosthetists

Not Applicable

Completed

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

• Registration Number: NCT05410548
• Lead Sponsor: University of Delaware

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Study Start: 2022-06-09
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Inventory-short form	3-month follow-up	This 9-item survey assesses how the individual feels about the services they have received. Items are rated from 1 (none of the time) to 7 (all of the time) and summed for a total possible score of 7-63. Higher scores indicate greater satisfaction.
Prosthetic service utilization	through study completion, an average of 3 months	Number of patient care minutes extracted from each participant's electronic medical record
Orthotic and Prosthetic Limb User Survey of Mobility (OPUS): Satisfaction with Device and Services	3-month follow-up	This questionnaire evaluates device function, fit, and cosmesis, as well as education, timeliness, and courtesy of the practitioner through 21 items. Items are scored on a 5-point Likert scale and higher scores indicate greater satisfaction. Items 1-11 are summed for the Satisfaction with Device subscale score (range: 11-55) and items 12-21 are summed for the Satisfaction with Services subscale score (range: 10-50).

Trial Locations

Locations (1)

University of Delaware STAR Campus; 🇺🇸 Newark, Delaware, United States