Clinical trial NCT05410548: Comorbidity Screening and Referral by Prosthetists
Official title: Can Comorbidity Screening and Referral by Prosthetists Enhance Post-Amputation Care?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Limb Ischemia
Low Back Pain
Depression
Neuropathy;Peripheral
Amputation
Keywords: comorbidity
peripheral arterial disease
sensation
back pain
mental health
amputation
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Independence Prosthetics-Orthotics, Inc.
name: Orthotic and Prosthetic Education and Research Foundation (OPERF)
First posted: 2022-06-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Orthotic and Prosthetic Limb User Survey of Mobility (OPUS): Satisfaction with Device and Services
timeFrame: 3-month follow-up
measure: Client Satisfaction Inventory-short form
timeFrame: 3-month follow-up
measure: Prosthetic service utilization
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware STAR Campus
state: Delaware
Study officials:
affiliation: University of Delaware
name: Jaclyn M Sions, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
References: