Can Comorbidity Screening and Referral by Prosthetists Enhance Post-Amputation Care?
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
- 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
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
Jaclyn Sions
Assistant Professor
University of Delaware
