Comorbidity Screening and Referral by Prosthetists

Sponsor

University of Delaware (Other)

Overall Status

Recruiting

CT.gov ID

NCT05410548

Collaborator

Independence Prosthetics-Orthotics, Inc. (Other), Orthotic and Prosthetic Education and Research Foundation (Other)

Enrollment

Location

Arms

11.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Limb Ischemia Low Back Pain Depression Neuropathy;Peripheral Amputation	Other: Standard-of-Care Other: Clinical Screening	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Patient participant satisfaction surveys, which are a primary outcome, will be collected in sealed envelopes and data will be entered by a research team member who is not a practitioner conducting the intervention. Satisfaction data will be stored in a separate database that is concealed from practitioners until the last participant completes their 3-month follow-up. Three-month follow-ups will occur remotely and without practitioner input. Patient care minutes will be extracted from the electronic medical record generated during actual patient visits.

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Jun 6, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

May 26, 2023

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

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).
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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