NCT03791697

Telehealth Postop Follow up RCT

Preferred Method of Postoperative Follow Up After Pelvic Reconstructive Surgery. (Phone Call Versus Clinic Visit): A Non-Inferiority Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Jackson, Elisha · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A randomized controlled trial that will evaluate whether telephone two-week postoperative follow up visits are an acceptable and safe alternative to traditional face-to-face-clinic two-week postoperative visits.

Detailed description

This is a two group, parallel randomized non-inferiority clinical trial at one institution evaluating telephone postoperative visits as non-inferior in patient satisfaction, patient preference, and patient safety, when compared with clinic postoperative visits. This protocol was written in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines 2011.

Conditions

• Patient Satisfaction

Interventions

Type	Name	Description
OTHER	Telehealth 2 week postoperative visit	The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits. Vital signs and physical examination will be deferred for the patients in the telephone follow up group. Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. (Intent to treat)

Timeline

• Start date: 2018-07-09
• Primary completion: 2019-07-01
• Completion: 2019-07-31
• First posted: 2019-01-03
• Last updated: 2019-01-03

Locations

1 site across 1 country: United States