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

NCT02767011 | Completed Results

• 1 other identifier: 15-169
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Peripheral Vascular Disease

Keywords

surgical site infection

Outcome Measures

Primary Outcomes (3)

• 30-Day Readmission (Any)

  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.

  30-day

• 30-day Wound Readmission

  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.

  30-day

• Access Site/Wound Infections.

  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

Secondary Outcomes (6)

• The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score

  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

• Stroke

  30-day

• Myocardial Infarction

  30-day

Study Arms (2)

THEM

EXPERIMENTAL

Patients receive telehealth electronic health care monitoring.

Other: Tele-Health Electronic Monitoring (THEM)

Standard of Care (SOC)

NO INTERVENTION

Patients receive normal standard of follow-up care

Interventions

Tele-Health Electronic Monitoring (THEM) OTHER

Patients in the intervention group (THEM) will receive a tablet computer and home monitoring medical devices with sensors to transmit the information to a central website that will be monitored by care managers. Medical devices will include weight scales, blood pressure cuffs and blood glucometers. Clinical care mangers will remotely monitor the patients and all electronic readings. Clinical care managers will call or send text messages to the patients based on alerts generated by the tele-health monitoring system.

THEM

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CAMC Health System: lead
• WVCTSI: collaborator

Related Publications (1)

• 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.

  PMID: 29169546 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mike Broce
• Organization: Charleston Area Medical Center Research Institute

mike.broce@camc.org

304-388-9923

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Albeir Mousa MD

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 10, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 18, 2019
• Results First Posted: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share