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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02767011
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Information provided by (Responsible Party):
Albeir Mousa, CAMC Health System

Brief Summary:


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.


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.


  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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Other: Tele-Health Electronic Monitoring (THEM) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections Following Arterial Revascularization With Groin Incision
Study Start Date : July 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: THEM
Patients receive telehealth electronic health care monitoring.
Other: Tele-Health Electronic Monitoring (THEM)
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.

No Intervention: Standard of Care (SOC)
Patients receive normal standard of follow-up care

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score [ Time Frame: 30-day ]
    The Difference between baseline and 30-day quality of life (Short-Form 8) Physical summary T-scores. The short-form (SF-8) Health Survey is an 8-item survey designed to measure quality of life. The SF-8 has 8 questions that first measures eight ordinal items (i.e., 1-5 Likert scale): general health, physical health functioning, role physical, bodily pain, vitality, social functioning, mental health and emotional roles. Summing the responses of the 8 items can be used to report an overall measure of physical and mental functioning. The raw Likert scale scores are converted to normalized standard T scores with a mean of 50 and standard deviation of 10. Measuring physical and mental health both before and after an intervention, as continuous summary scores can indicate better self-reported quality of life with higher scores. A difference score of 0 would indicate no change, while a larger positive difference score would indicate an increase in self-reported quality of life.

  2. Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18) [ Time Frame: 30-day ]
    Patients' satisfaction was compared using the General Satisfaction sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18). The PSQ-18 contains 18 items (questions) that can measure seven dimensions of satisfaction: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Responses to the PSQ-18 require a selection on a Likert scale from 1 Strongly Agree to 5 Strongly Disagree with some of the questions worded in such a manner that agreement reflects greater satisfaction (1, 2, 3, 5, 6, 8, 11, 15 & 18). These responses were "re-coded" in order for a larger number to reflect greater satisfaction. Next, two individual items (3 and 17) are summed and averaged to produce the general satisfaction sub-scale. A larger number reflects greater satisfaction, with a range of 1 to 5.

  3. Number of Participants With Home Nursing Visits [ Time Frame: 30-day ]
    Yes/No did the patient have (any) home nursing visits during the 30-day follow-up period.

  4. Stroke [ Time Frame: 30-day ]
    Yes/No did patient have a stroke. Patients were monitored for 30 days for stroke.

  5. Myocardial Infarction [ Time Frame: 30-day ]
    Yes/No did patient have myocardial infarction. Patients were monitored for 30 days for myocardial infarction.

  6. Death [ Time Frame: 30-day ]
    Yes/No Did patient die? Patients for monitored for 30 days for death.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Study Documents (Full-Text)

Documents provided by Albeir Mousa, CAMC Health System:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Albeir Mousa, Albeir Mousa MD, CAMC Health System Identifier: NCT02767011     History of Changes
Other Study ID Numbers: 15-169
First Posted: May 10, 2016    Key Record Dates
Results First Posted: April 18, 2019
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Albeir Mousa, CAMC Health System:
surgical site infection

Additional relevant MeSH terms:
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Vascular Diseases
Surgical Wound Infection
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Arterial Occlusive Diseases