Utilizing Telemedicine for Delivery of Postoperative Care

NCT04348357 | Completed Results

• 1 other identifier: E19110
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a pilot project in which enrolled patients undergoing major gynecologic surgery will be randomized to either a traditional office postoperative visit or a telemedicine postoperative visit. The two groups will then be compared on a variety of metrics including clinical outcomes, patient satisfaction and time.

Conditions

Laparoscopic Gynecologic Surgery

Outcome Measures

Primary Outcomes (6)

• PSQ-18 General Satisfaction

  General satisfaction component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable).

  1 month after surgery (1-2 weeks after postoperative visit)

• PSQ-18 Technical Quality

  Technical Quality component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

  1 month after surgery (1-2 weeks after postoperative visit)

• PSQ-18 Interpersonal Manner

  Interpersonal manner component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

  1 month after surgery (1-2 weeks after postoperative visit)

• PSQ-18 Communication

  Communication component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

  1 month after surgery (1-2 weeks after postoperative visit)

• PSQ-18 Time Spent With Doctor

  "Time spent with doctor" component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

  1 month after surgery (1-2 weeks after postoperative visit)

• PSQ-18 Accessibility and Convenience

  "Accessibility and convenience" component from PSQ-18 (Patient Satisfaction Questionnaire-18). Ranges from 1 to 5, with 5 being the maximum score (favorable), and 1 being the minimum score (unfavorable)

  1 month after surgery (1-2 weeks after postoperative visit)

Secondary Outcomes (5)

• Actual Visit Time

  Measured at the time of postoperative visit, which occurred 2-3 weeks after surgery

• Visits to Emergency Department

  30 days after surgery

• Phone-calls to Office

  30 days after surgery

• Time Dedicated by Patient to Complete Visit

  1 month after surgery (1-2 weeks after postoperative visit)

• Number of Patients Who Desired to Switch Groups

  1 month after surgery (1-2 weeks after postoperative visit)

Study Arms (2)

Traditional Visit

ACTIVE COMPARATOR

Patients come to the office for a traditional postoperative visit

Other: Office visit

Tele-medicine

EXPERIMENTAL

Patients receive postoperative care via telemedicine

Other: Telemedicine

Interventions

Telemedicine OTHER

A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)

Tele-medicine

Office visit OTHER

Patient comes to the office to receive routine postoperative care

Traditional Visit

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients between ages 18-60
• Have access to smart-phone with video/audio and internet capabilities
• Undergoing laparoscopic gynecologic surgery that requires a postoperative visit
• Total laparoscopic hysterectomy
• Laparoscopic removal of adnexal structures
• Laparoscopic excision of endometriosis

You may not qualify if:

• Patient unwilling to participate
• The patient is unwilling to install and utilize the telemedicine app on their smartphone.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Scince Center El Paso

El Paso, Texas, 79905, United States

Location

MeSH Terms

Interventions

Telemedicine; Office Visits

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Professional Practice; Organization and Administration

Results Point of Contact

• Title: Dr Steven Radtke
• Organization: Texas Tech University Health and Science Center El Paso

dr.radtke@gmail.com

2177254940

Study Officials

• Steven Radtke, MD

  TTUHSCEP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 16, 2020
• Study Start: June 21, 2019
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)