Telehealth Postop Follow up RCT

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791697
• Other study ID #: Telehealth Study
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2018
• Source: Jackson, Elisha
• Contact: Elisha J Jackson, MD
• Phone: 8166860222
• Email: elisha.jackson815[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: July 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

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)

Locations

Country	Name	City	State
United States	University of Florida Health	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Jackson, Elisha	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction (questionnaire)	Comparison of patient satisfaction as determined by completion of a non-validated, treatment non-specific satisfaction questionnaire between the two groups.	Survey will be provided at the six-week follow up visit.
Secondary	Patient safety (adverse events)	• 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	Postoperative period up to 6 weeks
Secondary	Time Spent (post op telephone follow up compared to clinic follow up [minutes])	• Actual time spent on phone call during postoperative telephone follow up compared to time spent in clinic follow up measured in minutes.	Calculated from time spent at the two week follow up visit