Postoperative Virtual Clinical Encounters

NCT04138810 | Completed Results

• 1 other identifier: 830273
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

post-op VCE

EXPERIMENTAL

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; Other: Survey

Office post-operative visits

ACTIVE COMPARATOR

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

Interventions

VCE OTHER

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.

post-op VCE

Survey OTHER

Measure of satisfaction regarding post-op visit.

Office post-operative visits; post-op VCE

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 32604202 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Lily Arya
• Organization: University of Pennsylvania, Department of Urogynecology

larya@pennmedicine.upenn.edu

215-662-4147

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: July 17, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 24, 2020
• Results First Posted: August 24, 2020

Record last verified: 2020-08

Locations

US (1)