Trial Outcomes & Findings for Telemedicine in Cardiac Surgery: A Pilot Study (NCT NCT01163474)
NCT ID: NCT01163474
Last Updated: 2019-08-06
Results Overview
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.
COMPLETED
EARLY_PHASE1
40 participants
1 month
2019-08-06
Participant Flow
Patients were recruited after coronary artery bypass or cardiac valvular surgery.
All participants were assigned to both the intervention (post-surgical evaluation by video-teleconference) and control (face-to-face visit) groups.
Participant milestones
| Measure |
Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua
Evaluate video clinic visit prior to Face-to-Face usual care visit
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua
Evaluate video clinic visit prior to Face-to-Face usual care visit
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Tech barriers to videoteleconference vis
|
12
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Telemedicine in Cardiac Surgery: A Pilot Study
Baseline characteristics by cohort
| Measure |
Arm 1 - Evaluate Video Clinic Visit
n=24 Participants
Evaluate video clinic visit prior to Face-to-Face usual care visit
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 monthUsing 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.
Outcome measures
| Measure |
Arm 1 - Evaluate Video Conferencing
n=24 Participants
Evaluate virtual video conference follow-up clinic visit
Evaluative process: Evaluative process using video conferencing
|
|---|---|
|
Accuracy (FTF Decision on Patient Disposition vs. V-visit Decision on Patient Disposition)
|
89 percentage of agreement
|
SECONDARY outcome
Timeframe: 1 monthAcceptability was assessed using a the Demeris 17-item Likert-scale questionnaire. Scale from 1 to 5 (1 = strongly disagree; 5 = strongly agree).
Outcome measures
| Measure |
Arm 1 - Evaluate Video Conferencing
n=23 Participants
Evaluate virtual video conference follow-up clinic visit
Evaluative process: Evaluative process using video conferencing
|
|---|---|
|
Acceptability
|
68 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Data for this outcome are no longer available.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 - Evaluate Video Conferencing
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place