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Clinical Trials/NCT04023175
NCT04023175CompletedNot Applicable

In Office Versus Telemedicine Preoperative Visit: a Randomized Controlled Trial

Wake Forest University Health Sciences1 site in 1 country118 target enrollmentStarted: July 27, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
118
Locations
1
Primary Endpoint
Patient Preoperative Preparedness

Study Overview

Brief Summary

This is a randomized controlled trial evaluating in office versus telemedicine preoperative counseling visits based on patient preparedness for surgery and patient satisfaction.

Detailed Description

PRIMARY OBJECTIVE To determine whether preoperative telemedicine appointments are non-inferior to in-office visits based on patient preoperative preparedness in women undergoing pelvic surgery as measured by a preoperative preparedness survey.

SECONDARY OBJECTIVES

  1. Evaluate patient satisfaction using the S-CAHPS survey

  2. Calculate the duration of visit for patient (minutes)

  3. Calculate the duration of visit for provider (minutes)

  4. Estimate round trip travel distance from patient home to clinic (miles)

  5. Evaluate the number of office contacts from date of preoperative counseling to 6 weeks postoperatively.

  6. Patient initiated calls

  7. Nurse initiated calls

  8. Scheduled office visits

  9. Add on office visits

  10. Evaluate canceled, no-show, and late visits

  11. Calculate value proposition metrics for Atrium Health System

PREOPERATIVE PERIOD All consecutive patients planning to undergo pelvic surgery who require a preoperative visit will be identified, screened, and approached for participation in the study. Participants who do not meet the inclusion and exclusion criteria will be considered screen failures. Screen failures will be captured and the cause for screen failure will be documented.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Females age 18 and greater
  • •Visit location in North Carolina
  • •Planning to undergo pelvic surgery at Mercy Hospital or One Day Surgery Center
  • •Scheduled for enhanced recovery perioperative protocol
  • •Require a preoperative visit
  • •Access to internet and a virtual visit capable device
  • •Telephone access

Exclusion Criteria

  • •Non-English speaking
  • •Inability to provide consent/decisionally impaired
  • •Auditory impairment
  • •Required preoperative in-office procedure such as endometrial biopsy

Arms & Interventions

In office

Active Comparator

Patients will undergo our standard in office preoperative counseling.

Intervention: In office preoperative counseling (Other)

Virtual visit

Experimental

Patients will undergo preoperative counseling using telemedicine virtual visits.

Intervention: Telemedicine preoperative counseling (Other)

Outcomes

Primary Outcomes

Patient Preoperative Preparedness

Time Frame: 1-7 days

To determine whether preoperative telemedicine appointments are non-inferior to in-office visits based on patient preoperative preparedness in women undergoing pelvic surgery as measured by a preoperative preparedness survey. Preoperative Preparedness Questionnaire ranges from 11 to 66 points with higher scores equaling greater patient preparedness.

Secondary Outcomes

  • Patient Satisfaction(2 week postoperative visit)
  • Round Trip Travel Distance(at preoperative visit (1-30 days prior to surgery))
  • Postoperative Add on In-person Visits.(6 weeks postoperatively)
  • Travel Time(1 day of a preoperative visit.)
  • Office Contacts, Total Scheduled In-person Visits(perioperative time period, up to approximately 10 weeks)
  • Postoperative Patient Initiated Phone Calls.(6 weeks postoperatively)
  • Duration of Visit(at preoperative visit (1-30 days prior to surgery))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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