跳至主要内容
临床试验/NCT04427124
NCT04427124Unknown不适用

Impact of Multidisciplinary Critical Limb Ischemia Team on the Utilization of Vascular Studies, Patient Management, AMPutation and Long-term Outcomes: The CLI-AMP Registry

Hendrick Medical Center0 个研究点目标入组 200 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Change in in-hospital and long-term mortality rates

研究概览

简要总结

Single-center, observational registry study with a prospective and retrospective arm to evaluate the impact of multidisciplinary CLI teams and protocol on amputation rates, vascular studies, revascularization, in-hospital and long-term outcomes.

详细描述

It is well known from large Medicare and National Inpatient Sample databases that vascular evaluations in patients with critical limb ischemia (CLI) and at risk for amputations remains extremely low. However, this data is largely pulled from the early 2000s with a scarcity in studies from this recent decade. A recent study showed that Medicare patients from 2011 showed that 23% of patients received primary major amputation. In a recent retrospective analysis preformed at this institution, all amputation patients from 2011-2017 were evaluated for vascular work up and long-term mortality. This cohort included 698 patients with 1009 amputated specimens (major and minor). This means that this institution is preforming around 140 amputations per year, which can be considered unacceptably high. Only 50% received any form of vascular study (ankle-brachial index, doppler ultrasound, and computed tomography angiography) within the year prior to amputation. Furthermore, only 30% of patients received an angiogram within the year prior to amputation. In addition, all major amputations received histopathological analysis, which confirmed that 62% the specimens were graded with severe atherosclerosis. Even in this present decade, with the knowledge that CLI patients are not receiving proper evaluation and treatment leading to amputation which is associated with extreme mortality rates and a large economic burden, health care facilities are not improving their care.

Multidisciplinary teams are a recommendation from the American Heart Association/American College of Cardiology guidelines for managing peripheral vascular disease. Multidisciplinary team approaches in other cardiovascular diseases, such as structural heart disease, has long been validated. Literature regarding the implementation of "CLI Teams" remains scarce and not widely adopted. However, institutions that have implemented a CLI Team that engages with specialists from multiple disciplines have shown successful decrease in amputation rates and increases in vascular evaluations and revascularization in these patients. The goal for this study is to establish a hospital-based, physician and nurse led, multidisciplinary team to deliver comprehensive care to CLI patients. We believe it is important to document the experience of building a CLI Team and care protocols to provide insight and validated data for other programs to implement. The multidisciplinary team will include vascular interventionalists, hospitalists, podiatry, wound care, infectious disease, nephrology, orthopedics, pharmacists, emergency department physicians, mid-level providers, nursing staff, and vascular technologists. The ultimate goal is amputation prevention and wound healing through comprehensive vascular care and data driven patient outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • >18 years of age
  • CLI of the lower extremity
  • Willingness and ability to participate in the study and meet follow-up requirements

排除标准

  • Pregnancy
  • <18 years of age
  • Incarcerated patients
  • Patients who receive amputations due to trauma or cancer
  • Wound, gangrene, or amputation of the upper extremities
  • Unwillingness or inability to participate in the study and meet follow-up requirements

结局指标

主要结局

Change in in-hospital and long-term mortality rates

时间窗: 2 years

Change in the number of major amputations within the hospital

时间窗: 2 years

Decreased percentage

次要结局

  • Change in wound healing(2 years)
  • Change in the percentage of non-invasive vascular evaluations in patients with CLI and at risk for amputation (ABI, DUS, CTA)(2 years)
  • Change in hospital length of stay(2 years)
  • Change in percentage of patients receiving invasive angiogram and revascularization (Endovascular or Surgical).(2 years)

研究者

发起方
Hendrick Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joji Varghese

Principal Investigator

Hendrick Medical Center

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