Postoperative Virtual Clinical Encounters

Assessment of Video-conference Technology for Post-operative Follow up in a Urogynecologic Population

Postoperative follow up is necessary following any surgical procedure and has been conducted in the same manner since the field of surgery began. The study will determine feasibility and patient satisfaction of innovative postoperative virtual clinical encounters utilizing mobile video conference technology for women undergoing pelvic reconstructive surgery through a randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: VCE; Other: Survey

Detailed Description

This will be a prospective randomized control study comparing postoperative virtual clinical encounters versus traditional in-office postoperative visits in women undergoing pelvic reconstructive surgery. The postoperative experiences of both groups will be assessed via surveys. Virtual Clinical Encounter Group: - Receive video-conference call from office nurse 48-72 hours post discharge from hospital - Receive video-conference call from fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit Traditional Office Group: - Receive telephone call from office nurse 48-72 hours post discharge from hospital - Have in-office postoperative visit with fellow and/or attending physician approximately 30 days (4-6 weeks) from surgery -- Complete telephone survey one day later - Have in-office postoperative visit with fellow and/or attending physician approximately 90 days (10-12 weeks) from surgery -- Fill out surveys after office visit

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Undergoing surgery for pelvic organ prolapse
• Age greater than 18
• Access to a smartphone
• Access to high speed internet access (via 4G or 3G on their smartphone or high speed Wi-Fi)
• Signed up for MyPennMedicine web portal
• Ability to download MyChart mobile application
• Pennsylvania Hospital Subject: NJ or PA resident, HUP & Presbyterian Hospital Subject: PA resident

Exclusion Criteria:

• Pregnancy
• Inability to read, speak or understand English
• Isolated midurethral sling procedure
• Extraperitoneal vaginal colpopexy with Uphold mesh

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: post-op VCE; As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The VCE group will conduct their encounter via the videoconference section of the MyChart mobile applications. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.	Other: VCE; Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.; Other: Survey; Measure of satisfaction regarding post-op visit.
Active Comparator: Office post-operative visits; As per standard of care, all subjects will be scheduled for a nursing clinical encounter 48-72 hours following discharge from the hospital from their surgery. The traditional follow up group will receive a telephone call from the office nurse as is current standard of care. At the end of this nursing encounter, the office nurse will schedule the patient for a 30 day postoperative visit within 4 to 6 weeks after their surgery.	Other: Survey; Measure of satisfaction regarding post-op visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Via the Patient Satisfaction Questionnaire -18	PSQ-18 is a validated eighteen item patient satisfaction questionnaire that has been utilized across diverse healthcare settings. It measures satisfaction across the following domains: general satisfaction, technical quality of care, interpersonal manner of healthcare provider, communication, financial aspects of care, time spent with healthcare provider and accessibility/convenience of care. Total scores range from 18 to 90, with higher scores indicating higher patient satisfaction.	30 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General Publications

• Lee DD, Arya LA, Andy UU, Harvie HS. Video Virtual Clinical Encounters Versus Office Visits for Postoperative Care After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):432-438. doi: 10.1097/SPV.0000000000000909.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 830273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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