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
About this trial
This is an interventional prevention trial for Peripheral Vascular Disease focused on measuring surgical site infection
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).
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
NCT ID
NCT02767011
First Posted
May 5, 2016
Last Updated
April 15, 2019
Sponsor
CAMC Health System
Collaborators
WVCTSI
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
Learn more about this trial
Tele-Health Electronic Monitoring to Reduce Post Discharge Complications and Surgical Site Infections
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