Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections (THEM)

C

CAMC Health System

Status

Completed

Conditions

Peripheral Vascular Disease

Treatments

Other: Tele-Health Electronic Monitoring (THEM)

Study type

Interventional

Funder types

Other

Identifiers

NCT02767011
15-169

Details and patient eligibility

About

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: 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. Follow patients for 4 weeks, record any 30-day hospital readmissions or complications. In addition, have participants complete the follow-up survey questionnaires.

Enrollment

30 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

THEM
Experimental group
Description:
Patients receive telehealth electronic health care monitoring.
Treatment:
Other: Tele-Health Electronic Monitoring (THEM)
Standard of Care (SOC)
No Intervention group
Description:
Patients receive normal standard of follow-up care

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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