18 and older, female only, with Telemedicine. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient Preoperative PreparednessPrimary· 1-7 days
To determine whether preoperative telemedicine appointments are non-inferior to in-office visits based on patient preoperative preparedness in women undergoing pelvic surgery as measured by a preoperative preparedness survey.
Preoperative Preparedness Questionnaire ranges from 11 to 66 points with higher scores equaling greater patient preparedness.
Patients will complete the preoperative portion of the Consumer Assessment of Healthcare Providers and Systems Surgical Care Survey (S-CAHPS) at the 2-week postoperative visit. S-CAHPS is a validated standardized questionnaire for adults developed by the American College of Surgeons (ACS). There are various ways to score. We elected to measure total composite scores of the perioperative SCAHPS subsection ranging from 12 to 36, with greater scores equating to higher patient satisfaction. The minimum value is 0 and maximum is 33.
Group
Value
95% CI
In Office
30.5
± 2.1
Virtual Visit
31.3
± 1.5
Duration of VisitSecondary· at preoperative visit (1-30 days prior to surgery)
Each visit will be timed to evaluate patient and provider visit duration. Timing will begin for the Telemedicine group upon connection to the virtual waiting room and will conclude after all counseling is completed and the virtual visit is disconnected. The duration of virtual visit counseling time with the provider will also be calculated. Timing for the in-office group will begin at time of patient check-in at the front desk and will conclude with patient check-out.
Group
Value
95% CI
In Office
55.9
± 18.9
Virtual Visit
39.3
± 14.0
Round Trip Travel DistanceSecondary· at preoperative visit (1-30 days prior to surgery)
Round trip travel distance from patient's home address to office will be evaluated via a HIPPA compliant map-based search engine for each participant.
Group
Value
95% CI
In Office
28
20.0 – 46.0
Virtual Visit
0
0 – 0
Office Contacts, Total Scheduled In-person VisitsSecondary· perioperative time period, up to approximately 10 weeks
The total number of scheduled in-person visits in the perioperative time period including preoperative and postoperative visits..
Group
Value
95% CI
In Office
3.0
2.00 – 3.00
Virtual Visit
2.0
2.00 – 2.00
Postoperative Add on In-person Visits.Secondary· 6 weeks postoperatively
Clinical visits added in the six week postoperative time period.
Number of patient initiated postoperative telephone calls to the office in the six week postoperative time period.
Group
Value
95% CI
In Office
1
0.0 – 2.0
Virtual Visit
1
1.0 – 3.0
Travel TimeSecondary· 1 day of a preoperative visit.
Patient round-trip travel time in minutes from home to preoperative visits.
Group
Value
95% CI
In Office
66.0
50.0 – 80.0
Virtual Visit
0
0 – 0
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 weeks postoperatively.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a randomized controlled trial evaluating in office versus telemedicine preoperative counseling visits based on patient preparedness for surgery and patient satisfaction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 24 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04023175.