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 Delaware2 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

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
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

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

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 (2)

Loading locations...

相似试验