search
Back to results

Postoperative Virtual Clinical Encounters

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VCE
Survey
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

post-op VCE

Office post-operative visits

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2019
Last Updated
August 11, 2020
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT04138810
Brief Title
Postoperative Virtual Clinical Encounters
Official Title
Assessment of Video-conference Technology for Post-operative Follow up in a Urogynecologic Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
post-op VCE
Arm Type
Experimental
Arm Description
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.
Arm Title
Office post-operative visits
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
VCE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Survey
Intervention Description
Measure of satisfaction regarding post-op visit.
Primary Outcome Measure Information:
Title
Patient Satisfaction Via the Patient Satisfaction Questionnaire -18
Description
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.
Time Frame
30 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32604202
Citation
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.
Results Reference
derived

Learn more about this trial

Postoperative Virtual Clinical Encounters

We'll reach out to this number within 24 hrs