Trial Outcomes & Findings for Virtual Visits for Postoperative Care Following Urogynecologic Surgery (NCT NCT05641077)
NCT ID: NCT05641077
Last Updated: 2024-09-26
Results Overview
Patient satisfaction will be measured by the Patient Satisfaction Questionnaire-18 (PSQ-18) at the 6-week postoperative visit. The PSQ-18 is a validated 18-item questionnaire. Responses to each question are scored on a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score for the questionnaire ranges from 18 (dissatisfaction with medical care) to 90 (highest satisfaction with medical care).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-09-26
Participant Flow
Participant milestones
| Measure |
Virtual Visit
Patients randomized to the experimental arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
Virtual Visit: Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
|
Office Visit
Patients randomized to the active comparator arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
Office Visit: Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Visits for Postoperative Care Following Urogynecologic Surgery
Baseline characteristics by cohort
| Measure |
Virtual Visit
n=50 Participants
Patients randomized to the experimental arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
Virtual Visit: Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
|
Office Visit
n=50 Participants
Patients randomized to the active comparator arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
Office Visit: Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Continuous
|
58.4 Years
n=5 Participants
|
55.5 Years
n=7 Participants
|
57 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPatient satisfaction will be measured by the Patient Satisfaction Questionnaire-18 (PSQ-18) at the 6-week postoperative visit. The PSQ-18 is a validated 18-item questionnaire. Responses to each question are scored on a five-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The total score for the questionnaire ranges from 18 (dissatisfaction with medical care) to 90 (highest satisfaction with medical care).
Outcome measures
| Measure |
Virtual Visit
n=50 Participants
Patients randomized to the experimental arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
Virtual Visit: Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via a virtual visit using videoconference technology at 6 weeks after the anticipated date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
|
Office Visit
n=50 Participants
Patients randomized to the active comparator arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
Office Visit: Patients randomized to this arm will be scheduled for and follow up with the surgeon or an advanced practice provider via an in-office visit at 6 weeks after the planned date of surgery. If the surgery were to be rescheduled to a future date, the postoperative visit will be moved accordingly to ensure follow-up occurs at the 6-week postoperative period.
|
|---|---|---|
|
Patient Satisfaction
|
75.18 score on a scale
Standard Deviation 8.15
|
75.14 score on a scale
Standard Deviation 8.7
|
Adverse Events
Virtual Visit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Office Visit
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place