Telehealth Postop Follow up RCT

Not Applicable

• Conditions: Patient Satisfaction
• Interventions: Other: Telehealth 2 week postoperative visit

• Registration Number: NCT03791697
• Lead Sponsor: Jackson, Elisha

Brief 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.

Study Timeline

• Study Start: 2018-07-09
• Status Verified: 2018-12
• Study First Submitted: 2018-12-30
• Study First Submitted QC: 2019-01-02
• Last Update Submitted: 2019-01-02
• Study First Posted: 2019-01-03
• Last Update Posted: 2019-01-03
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 142

Inclusion Criteria

• Women >18 desiring surgical management of prolapse or incontinence
• English speaking
• Willing and able to provide written and informed consent without assistance from medical surrogate or interpreter
• Immediate access to telephone services (landline, mobile phone, office phone)

Exclusion Criteria

• Women <18
• Non-English speaking
• Unwilling and unable to provide written and informed consent without assistance from surrogate or interpreter
• Hearing impairment
• No access to telephone services (landline, mobile phone, office phone)
• Grade 3 complication- a complication requiring surgical, endoscopic, or radiological intervention. [3]
• Patient who did not attend any postoperative follow up visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone Group	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.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction (questionnaire)	Survey will be provided at the six-week follow up visit.	Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.

Secondary Outcome Measures

Name	Time	Method
Patient safety (adverse events)	Postoperative period up to 6 weeks	• Comparison of adverse events and Emergency Department (ED) visits between the two groups. Will be determined by reviewing the patient's record to identify adverse events as defined below
Time Spent (post op telephone follow up compared to clinic follow up [minutes])	Calculated from time spent at the two week follow up visit	• Actual time spent on phone call during postoperative telephone follow up compared to time spent in clinic follow up measured in minutes.

Trial Locations

Locations (1)

University of Florida Health; 🇺🇸 Tampa, Florida, United States