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

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.

Study Overview

• Status: Unknown
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Telehealth 2 week postoperative visit

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 Type: Interventional
• Enrollment (Anticipated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisha J Jackson, MD; Phone Number: 8166860222; Email: elisha.jackson815@gmail.com

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of Florida Health
      • Contact: Elisha Jackson, MD; Phone Number: 816-686-0222; Email: elisha.jackson815@gmail.com
      • Sub-Investigator: Renee Bassaly, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Telephone Group; 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.	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)
NO_INTERVENTION: In Person Clinic Visit Group; For the patient randomized into the clinic group, the clinic visit will entail questions about common postoperative complications (including fever, nausea/vomiting, pain, urinary symptoms, constipation, etc.). As per usual, vital signs and a focused physical examination will be completed at the clinic visit. All clinic visits will be performed by an FPRMS fellow and/or attending physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jackson, Elisha
• Collaborators: University of South Florida
• Investigators: Principal Investigator: Elisha J Jackson, MD, University of South Florida Morsani School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2018
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): July 31, 2019

Study Registration Dates

• First Submitted: December 30, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (ACTUAL): January 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative patient satisfaction
• Other Study ID Numbers: Telehealth Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No