Postoperative Virtual Clinical Encounters

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138810
• Other study ID #: 830273
• Status: Completed
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• Survey
Measure of satisfaction regarding post-op visit.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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