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Clinical Trials/NCT05410548
NCT05410548CompletedNot Applicable

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

University of Delaware1 site in 1 country70 target enrollmentStarted: June 9, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Client Satisfaction Inventory-short form

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
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.

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Standard-of-Care

Other

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.

Intervention: Standard-of-Care (Other)

Standard-of-Care + Clinical Screening

Experimental

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.

Intervention: Standard-of-Care (Other)

Standard-of-Care + Clinical Screening

Experimental

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.

Intervention: Clinical Screening (Other)

Outcomes

Primary Outcomes

Client Satisfaction Inventory-short form

Time Frame: 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

Time Frame: 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

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jaclyn Sions

Assistant Professor

University of Delaware

Study Sites (1)

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