Comorbidity Screening and Referral by Prosthetists

Can Comorbidity Screening and Referral by Prosthetists Enhance Post-Amputation Care?

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.

Study Overview

• Status: Completed
• Conditions: Depression; Low Back Pain; Amputation; Neuropathy;Peripheral; Limb Ischemia
• Intervention / Treatment: Other: Standard-of-Care; Other: Clinical Screening

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • University of Delaware STAR Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Experimental: Standard-of-Care + 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthotic and Prosthetic Limb User Survey of Mobility (OPUS): Satisfaction with Device and Services	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).	3-month follow-up
Client Satisfaction Inventory-short form	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.	3-month follow-up
Prosthetic service utilization	Number of patient care minutes extracted from each participant's electronic medical record	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: Independence Prosthetics-Orthotics, Inc.; Orthotic and Prosthetic Education and Research Foundation (OPERF)
• Investigators: Principal Investigator: Jaclyn M Sions, PhD, DPT, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: back pain; mental health; sensation; peripheral arterial disease; amputation; comorbidity
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Behavioral Symptoms; Peripheral Nervous System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Back Pain; Depression; Peripheral Arterial Disease; Low Back Pain; Neuritis; Psychological Well-Being; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 1865677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified patient participant data are available from the corresponding author upon reasonable request and with completion of a data use agreement to protect participant confidentiality.
• IPD Sharing Time Frame: Individual patient participant data that underlie results will be available beginning 3 months following publication of the primary results and ending 5 years following publication of the primary results to researchers who provide a methodologically sound proposal and complete a data sharing agreement.
• IPD Sharing Access Criteria: Proposals should be directed to J. Megan Sions, PT, DPT, PhD, the study's principal investigator, in writing at megsions@udel.edu. To gain access to individual patient participant data, requestors will need to sign a data access agreement with the principal investigator's home institution, i.e., the University of Delaware.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No