Coronary Artery Disease
Conditions
Keywords
Telemedicine, Surgery, Cardiac
Brief summary
Telemedicine has been widely used in managing patients with neurologic disorders or mental illness. Telemedicine is defined as the use of medical information exchanged from one site to another via electronic communications for the health and education of the patient or healthcare provider and for the purpose of improving patient care. According to our knowledge, it has not been used to manage cardiac patients who need postoperative care after discharge from hospitals. The use of telemedicine has the potential to reduce the cost of unnecessary travel by assessing the patient's postoperative status prior to making decisions as to whether or not a face-to-face consultation is necessary. In this pilot study we will compare the accuracy of surgeons' decisions during follow-up visits via video-teleconference (V-Visit) to surgeons' decisions during traditional face-to-face follow-up visits (FTF-Visits). Both the V-Visit and the FTF-Visit will take place at the Houston Michael E DeBakey VA Medical Center on the same day. We will also ask both patients and providers to complete short questionnaires after each V-Visit regarding their acceptability of using telemedicine for these post-operative follow-up visits. Information collected as part of this pilot study will be used to design a future full randomized controlled trial (RCT) on the use of telemedicine in evaluating post-operative cardiac surgical patients.
Detailed description
The specific aims are: 1. To compare surgeons' decisions on patient disposition between V-visits and FTF-visits (gold standard). 2. To assess the acceptability to patients and surgeons of using V-visits in the postoperative care of cardiac surgical patients; 3. To assess the technical feasibility of using community-based outpatient clinics (CBOCs) for delivery of postoperative cardiac surgical care; 4. To determine the recruitment rate for eligible subjects. We plan to conduct this pilot study at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) in Houston, Texas, along with satellite CBOC facilities in Lufkin and Conroe. Once the accuracy, acceptability, and feasibility of the use of video conferencing (VC) in the postoperative care for cardiac surgical patients are established, we will submit a full proposal to conduct a two-arm RCT in future.
Interventions
OTHEREvaluate video clinic visit prior to Face-to-Face usual care visit
Evaluate video clinic visit prior to Face-to-Face usual care visit
Sponsors
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients older than 18 years of age 2. Patients who have undergone one of the following cardiac surgical procedures: Coronary artery bypass grafting (CABG) and/or Cardiac valvular operations
Exclusion criteria
1. Patients who have undergone aortic dissection/aneurysm operations 2. Patients who have been diagnosed with atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition) | 1 month | Using CVT software and desktop webcams on the VA private network, Virtual CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits. Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions. Accuracy was assessed by comparing the 2 reviewers' CVT decisions to the FTF decision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 1 month | Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree). |
| Feasibility | 1 month | — |
Countries
United States
Participant flow
Recruitment details
Patients were recruited after coronary artery bypass or cardiac valvular surgery.
Pre-assignment details
All participants were assigned to both the intervention (post-surgical evaluation by video-teleconference) and control (face-to-face visit) groups.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - Evaluate Video Clinic Visit Evaluate video clinic visit prior to Face-to-Face usual care visit | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Tech barriers to videoteleconference vis | 12 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Arm 1 - Evaluate Video Clinic Visit |
|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 8.3 |
| Race/Ethnicity, Customized African American | 4 participants |
| Race/Ethnicity, Customized Hispanic | 4 participants |
| Race/Ethnicity, Customized White | 16 participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)
Using CVT software and desktop webcams on the VA private network, Virtual CVT visits were conducted immediately prior to usual care of Face-to-Face (FTF) postoperative visits. Two independent surgeons reviewed the CVT recordings and made recommendations on patient dispositions. Accuracy was assessed by comparing the 2 reviewers' CVT decisions to the FTF decision.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 - Evaluate Video Conferencing | Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition) | 89 percentage of agreement |
Secondary
Acceptability
Acceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Evaluate Video Conferencing | Acceptability | 68 units on a scale | Standard Deviation 6.7 |
Secondary
Feasibility
Time frame: 1 month
Population: Data for this outcome are no longer available.