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

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tele-Health Electronic Monitoring (THEM)
Sponsored by
CAMC Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Vascular Disease focused on measuring surgical site infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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:

  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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    THEM

    Standard of Care (SOC)

    Arm Description

    Patients receive telehealth electronic health care monitoring.

    Patients receive normal standard of follow-up care

    Outcomes

    Primary Outcome Measures

    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 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.
    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.

    Secondary Outcome Measures

    The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score
    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.
    Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18)
    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.
    Number of Participants With Home Nursing Visits
    Yes/No did the patient have (any) home nursing visits during the 30-day follow-up period.
    Stroke
    Yes/No did patient have a stroke. Patients were monitored for 30 days for stroke.
    Myocardial Infarction
    Yes/No did patient have myocardial infarction. Patients were monitored for 30 days for myocardial infarction.
    Death
    Yes/No Did patient die? Patients for monitored for 30 days for death.

    Full Information

    First Posted
    May 5, 2016
    Last Updated
    April 15, 2019
    Sponsor
    CAMC Health System
    Collaborators
    WVCTSI
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02767011
    Brief Title
    Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections
    Acronym
    THEM
    Official Title
    Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections Following Arterial Revascularization With Groin Incision
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CAMC Health System
    Collaborators
    WVCTSI

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Vascular Disease
    Keywords
    surgical site infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    THEM
    Arm Type
    Experimental
    Arm Description
    Patients receive telehealth electronic health care monitoring.
    Arm Title
    Standard of Care (SOC)
    Arm Type
    No Intervention
    Arm Description
    Patients receive normal standard of follow-up care
    Intervention Type
    Other
    Intervention Name(s)
    Tele-Health Electronic Monitoring (THEM)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    30-Day Readmission (Any)
    Description
    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.
    Time Frame
    30-day
    Title
    30-day Wound Readmission
    Description
    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.
    Time Frame
    30-day
    Title
    Access Site/Wound Infections.
    Description
    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.
    Time Frame
    30-day
    Secondary Outcome Measure Information:
    Title
    The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score
    Description
    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.
    Time Frame
    30-day
    Title
    Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18)
    Description
    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.
    Time Frame
    30-day
    Title
    Number of Participants With Home Nursing Visits
    Description
    Yes/No did the patient have (any) home nursing visits during the 30-day follow-up period.
    Time Frame
    30-day
    Title
    Stroke
    Description
    Yes/No did patient have a stroke. Patients were monitored for 30 days for stroke.
    Time Frame
    30-day
    Title
    Myocardial Infarction
    Description
    Yes/No did patient have myocardial infarction. Patients were monitored for 30 days for myocardial infarction.
    Time Frame
    30-day
    Title
    Death
    Description
    Yes/No Did patient die? Patients for monitored for 30 days for death.
    Time Frame
    30-day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    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: 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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29169546
    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.
    Results Reference
    derived

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