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Trial Outcomes & Findings for Utilizing Telemedicine for Delivery of Postoperative Care (NCT NCT04348357)

NCT ID: NCT04348357

Last Updated: 2020-07-07

Results Overview

General satisfaction component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

1 month after surgery (1-2 weeks after postoperative visit)

Results posted on

2020-07-07

Participant Flow

Participant milestones

Participant milestones
Measure
Traditional Visit
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
Overall Study
STARTED
25
28
Overall Study
COMPLETED
25
16
Overall Study
NOT COMPLETED
0
12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
Total
n=41 Participants
Total of all reporting groups
Age, Continuous
41.4 years
STANDARD_DEVIATION 7.6 • n=25 Participants
43.3 years
STANDARD_DEVIATION 8.3 • n=16 Participants
42.1 years
STANDARD_DEVIATION 7.9 • n=41 Participants
Sex: Female, Male
Female
25 Participants
n=25 Participants
16 Participants
n=16 Participants
41 Participants
n=41 Participants
Sex: Female, Male
Male
0 Participants
n=25 Participants
0 Participants
n=16 Participants
0 Participants
n=41 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
25 participants
n=25 Participants
16 participants
n=16 Participants
41 participants
n=41 Participants
BMI
31.9 kg/m^2
STANDARD_DEVIATION 6.1 • n=25 Participants
30.6 kg/m^2
STANDARD_DEVIATION 6.1 • n=16 Participants
31.4 kg/m^2
STANDARD_DEVIATION 6.0 • n=41 Participants
Distance from clinic
12.7 miles
STANDARD_DEVIATION 7.3 • n=25 Participants
12.5 miles
STANDARD_DEVIATION 6.2 • n=16 Participants
12.6 miles
STANDARD_DEVIATION 6.8 • n=41 Participants

PRIMARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

General satisfaction component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable).

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
PSQ-18 General Satisfaction
4.0 score on a scale
Interval 4.0 to 4.5
4.5 score on a scale
Interval 4.5 to 5.0

PRIMARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

Technical Quality component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
PSQ-18 Technical Quality
4.0 score on a scale
Interval 3.8 to 4.5
4.5 score on a scale
Interval 3.9 to 5.0

PRIMARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

Interpersonal manner component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
PSQ-18 Interpersonal Manner
4.0 score on a scale
Interval 4.0 to 4.5
4.5 score on a scale
Interval 4.0 to 5.0

PRIMARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

Communication component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
PSQ-18 Communication
4.5 score on a scale
Interval 4.0 to 4.5
4.5 score on a scale
Interval 4.3 to 5.0

PRIMARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

"Time spent with doctor" component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
PSQ-18 Time Spent With Doctor
4.0 score on a scale
Interval 4.0 to 4.5
4.5 score on a scale
Interval 4.0 to 5.0

PRIMARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

"Accessibility and convenience" component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
PSQ-18 Accessibility and Convenience
4.0 score on a scale
Interval 3.5 to 4.5
4.0 score on a scale
Interval 3.6 to 4.5

SECONDARY outcome

Timeframe: Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery

Time that the actual postoperative encounter took, originally to be measured in seconds, and then rounded to the nearest minute for reporting. This is measured at the time of visit by research staff using a stop-watch.

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
Actual Visit Time
9.2 minutes
Standard Deviation 4.0
9.1 minutes
Standard Deviation 2.6

SECONDARY outcome

Timeframe: 30 days after surgery

Number of visits to the emergency department occurring after the postoperative visit, within 30 days of the surgery

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
Visits to Emergency Department
1 number of ER visits
0 number of ER visits

SECONDARY outcome

Timeframe: 30 days after surgery

Number of phone-calls made to office for postoperative complaints occurring after postoperative visit, within 30 days of the surgery

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
Phone-calls to Office
6 Number of phonecalls
5 Number of phonecalls

SECONDARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

Patient estimate of the time it took them to complete the postoperative visit, including transportation to and from the clinic (if randomized to office visit group). Measured in minutes (increments of 5)

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
Time Dedicated by Patient to Complete Visit
60.8 minutes
Standard Deviation 45.8
14.7 minutes
Standard Deviation 11.9

SECONDARY outcome

Timeframe: 1 month after surgery (1-2 weeks after postoperative visit)

Participants who responded YES when asked during the final interview (1-2 weeks after postoperative visit) if they would've switched groups if given the chance.

Outcome measures

Outcome measures
Measure
Traditional Visit
n=25 Participants
Patients come to the office for a traditional postoperative visit Office visit: Patient comes to the office to receive routine postoperative care
Tele-medicine
n=16 Participants
Patients receive postoperative care via telemedicine Telemedicine: A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
Number of Patients Who Desired to Switch Groups
2 Participants
0 Participants

Adverse Events

Traditional Visit

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Tele-medicine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Steven Radtke

Texas Tech University Health and Science Center El Paso

Phone: 2177254940

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place