Peripheral Vascular Disease
Conditions
Keywords
surgical site infection
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.
Interventions
OTHERTele-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.
Sponsors
CAMC Health System
WVCTSI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access Site/Wound Infections. | 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. |
| 30-Day Readmission (Any) | 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. |
| 30-day Wound Readmission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score | 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. |
| Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18) | 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. |
| Number of Participants With Home Nursing Visits | 30-day | Yes/No did the patient have (any) home nursing visits during the 30-day follow-up period. |
| Stroke | 30-day | Yes/No did patient have a stroke. Patients were monitored for 30 days for stroke. |
| Myocardial Infarction | 30-day | Yes/No did patient have myocardial infarction. Patients were monitored for 30 days for myocardial infarction. |
| Death | 30-day | Yes/No Did patient die? Patients for monitored for 30 days for death. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THEM Intervention Group. Received Tele-health monitoring | 16 |
| Control Control Group (received standard of care) | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | THEM | Control | Total |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 7.2 | 65.7 years STANDARD_DEVIATION 7.3 | 64.0 years STANDARD_DEVIATION 7.3 |
| BMI | 27.7 kg/m^2 STANDARD_DEVIATION 4.3 | 29.1 kg/m^2 STANDARD_DEVIATION 7.1 | 28.3 kg/m^2 STANDARD_DEVIATION 5.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 30-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THEM | 30-Day Readmission (Any) | 4 Participants |
| Control | 30-Day Readmission (Any) | 2 Participants |
Primary
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.
Time frame: 30-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THEM | 30-day Wound Readmission | 1 Participants |
| Control | 30-day Wound Readmission | 1 Participants |
Primary
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.
Time frame: 30-day
Population: Percentage of patients with access site infections.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THEM | Access Site/Wound Infections. | 5 Participants |
| Control | Access Site/Wound Infections. | 1 Participants |
Secondary
Death
Yes/No Did patient die? Patients for monitored for 30 days for death.
Time frame: 30-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THEM | Death | 0 Participants |
| Control | Death | 0 Participants |
Secondary
Myocardial Infarction
Yes/No did patient have myocardial infarction. Patients were monitored for 30 days for myocardial infarction.
Time frame: 30-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THEM | Myocardial Infarction | 0 Participants |
| Control | Myocardial Infarction | 0 Participants |
Secondary
Number of Participants With Home Nursing Visits
Yes/No did the patient have (any) home nursing visits during the 30-day follow-up period.
Time frame: 30-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THEM | Number of Participants With Home Nursing Visits | 3 Participants |
| Control | Number of Participants With Home Nursing Visits | 3 Participants |
Secondary
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.
Time frame: 30-day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| THEM | Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18) | 4.0 units on a scale |
| Control | Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18) | 3.75 units on a scale |
Secondary
Stroke
Yes/No did patient have a stroke. Patients were monitored for 30 days for stroke.
Time frame: 30-day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THEM | Stroke | 0 Participants |
| Control | Stroke | 0 Participants |
Secondary
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.
Time frame: 30-day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| THEM | The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score | Baseline Physical Summary Score | 27.76 T-scores | Standard Deviation 7.38 |
| THEM | The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score | 30-day Physical Summary Score | 36.83 T-scores | Standard Deviation 8.58 |
| THEM | The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score | Difference (30-day - baseline) Summary Score | 9.07 T-scores | Standard Deviation 6.02 |
| Control | The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score | Baseline Physical Summary Score | 30.14 T-scores | Standard Deviation 11.28 |
| Control | The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score | 30-day Physical Summary Score | 34.61 T-scores | Standard Deviation 10.69 |
| Control | The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score | Difference (30-day - baseline) Summary Score | 4.47 T-scores | Standard Deviation 7.63 |