Comorbidity Screening and Referral by Prosthetists

Not Applicable

Completed

• Conditions: Amputation; Low Back Pain; Depression; Neuropathy;Peripheral; Limb Ischemia
• Interventions: Other: Standard-of-Care; Other: Clinical Screening

• 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

Arm && Interventions

Group	Intervention	Description
Standard-of-Care + Clinical Screening	Standard-of-Care	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.
Standard-of-Care	Standard-of-Care	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.
Standard-of-Care + Clinical Screening	Clinical Screening	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.

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