Comorbidity Screening and Referral by Prosthetists

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410548
• Other study ID #: 1865677
• Status: Completed
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: May 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Back Pain
• Depression
• Ischemia
• Limb Ischemia
• Low Back Pain
• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Delaware STAR Campus	Newark	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
University of Delaware	Independence Prosthetics-Orthotics, Inc., Orthotic and Prosthetic Education and Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Prosthetic service utilization	Number of patient care minutes extracted from each participant's electronic medical record	through study completion, an average of 3 months