Clinical trial NCT02767011: Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections
Official title: Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections Following Arterial Revascularization With Groin Incision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: surgical site infection
Lead sponsor: CAMC Health System
Sponsor class: OTHER
Collaborators: name: WVCTSI
First posted: 2016-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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:

1. do not plan to do follow-up visit at the VCOE;
2. history of dementia;
3. 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).

Primary outcomes:
measure: 30-Day Readmission (Any)
timeFrame: 30-day
measure: 30-day Wound Readmission
timeFrame: 30-day
measure: Access Site/Wound Infections.
timeFrame: 30-day
Secondary outcomes:
measure: The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score
timeFrame: 30-day
measure: Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18)
timeFrame: 30-day
measure: Number of Participants With Home Nursing Visits
timeFrame: 30-day
measure: Stroke
timeFrame: 30-day
measure: Myocardial Infarction
timeFrame: 30-day
measure: Death
timeFrame: 30-day
Other outcomes:
Locations:
Study officials:
References:
citation: Mousa AY, Broce M, Davis E, McKee B, Yacoub M. Telehealth electronic monitoring to reduce postdischarge complications and surgical site infections after arterial revascularization with groin incision. J Vasc Surg. 2017 Dec;66(6):1902-1908. doi: 10.1016/j.jvs.2017.07.063.