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Clinical Trials/NCT02767011
NCT02767011
Completed
Not Applicable

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

CAMC Health System0 sites30 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Vascular Disease
Sponsor
CAMC Health System
Enrollment
30
Primary Endpoint
30-Day Readmission (Any)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
July 2016
End Date
July 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CAMC Health System
Responsible Party
Principal Investigator
Principal Investigator

Albeir Mousa

Albeir Mousa MD

CAMC Health System

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

30-Day Readmission (Any)

Time Frame: 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.

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

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