跳至主要内容
临床试验/NCT05410548
NCT05410548已完成不适用

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

University of Delaware1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年6月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Client Satisfaction Inventory-short form

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: 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.

干预措施: 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.

干预措施: Clinical Screening (Other)

结局指标

主要结局

Client Satisfaction Inventory-short form

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaclyn Sions

Assistant Professor

University of Delaware

研究点 (1)

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