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临床试验/NCT02767011
NCT02767011已完成不适用

Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections Following Arterial Revascularization With Groin Incision

CAMC Health System0 个研究点目标入组 30 人开始时间: 2016年7月1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
发起方
入组人数
30
主要终点
30-Day Readmission (Any)

研究概览

简要总结

Abstract:

It is intuitive that post discharge surgical complications are associated with increased patient dissatisfaction, and directly associated with an increase in medical expenditures. It is also easy to make the connection that many post hospital discharge surgical complications including surgical site infections could be influenced or exacerbated by patient co-morbidities. The authors of a recent study reported that female gender, obesity, diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive pulmonary disease, dyspnea, and neurologic disease were all of among significant predictors of surgical site infections after vascular reconstruction was performed. The main concern for optimal patient care especially in geographically isolated areas of West Virginia is to have early, expeditious, and prompt diagnosis of early surgical site infection with subsequent indicated interventions. This theme will lead to patient satisfaction, minimizing third party interventions and decrease the total cost associated with these complications. Nevertheless, it seems reasonable to believe that monitoring using telehealth technology and managing the general health care patients receive after a hospital vascular intervention will improve overall health and reduce post-operative complications.

Aims/Objectives:

1. The primary objective of the current project is to compare early and late outcomes for patients who receive post discharge health care monitoring (which includes using Telehealth electronic monitoring; THEM) to patients who receive standard of care (SOC) and routine discharge instructions and no monitoring.

Methods:

  1. Randomize patients who are scheduled to have revascularization interventions with groin incisions to receive either telehealth electronic health care monitoring or normal standard of follow-up care.
  2. Follow patients for 4 weeks, record any 30-day hospital readmissions or complications. In addition, have participants complete the follow-up survey questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Patients with any planned vascular procedures with cut-down access to the groin and treated by one of the Charleston Area Medical Center -Vascular Surgeons in the Vascular Center (VCOE) will be consented and enrolled.

排除标准

  • do not plan to do follow-up visit at the VCOE;
  • history of dementia;
  • do not have home internet service with WIFI or live outside of the provided cell coverage area (cell coverage will be provided for patients without internet WIFI).

研究组 & 干预措施

THEM

Experimental

Patients receive telehealth electronic health care monitoring.

干预措施: Tele-Health Electronic Monitoring (THEM) (Other)

Standard of Care (SOC)

No Intervention

Patients receive normal standard of follow-up care

结局指标

主要结局

30-Day Readmission (Any)

时间窗: 30-day

Yes/No was patient readmitted? Patients were monitored for 30 days to see if they were re-admitted to the hospital for any reason. Percentage of patients with 30-day readmission.

Access Site/Wound Infections.

时间窗: 30-day

Yes/No did patient any access site or would infections? Access site wounds for the patients were monitored for 30 days for any wound infections.

30-day Wound Readmission

时间窗: 30-day

Yes/No was patient readmitted for wound infection? Patients were monitored for 30 days to see if they were re-admitted to the hospital for wound infection. Percentage of patients with 30-day readmission for wound infection.

次要结局

  • The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score(30-day)
  • Myocardial Infarction(30-day)
  • Stroke(30-day)
  • Death(30-day)
  • Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18)(30-day)
  • Number of Participants With Home Nursing Visits(30-day)

研究者

发起方
CAMC Health System
申办方类型
Other
责任方
Sponsor
主要研究者

Albeir Mousa

Albeir Mousa MD

CAMC Health System

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