NCT04855708

Brief Summary

This study aims to evaluate the safety and efficacy of virtual postoperative visits as compared to in-office postoperative visits for patients undergoing minimally invasive hysterectomy. The investigators hypothesize that virtual visits will be non-inferior to in-person visits in terms of patient satisfaction. The primary objective for this study is to evaluate patient satisfaction of the postoperative visit experience, as measured by the Press Ganey Medical Practice Survey and Medical Practice Telemedicine Survey. The secondary objectives include evaluating the incidence of a new diagnosis of a postoperative complication requiring medical treatment (e.g. calling in of a prescription), an office visit with CNP or MIGS surgeon, or an urgent care or ER visit. Post-operative complications include infection (urinary, pulmonary, wound, pelvic abscess, and bloodstream), thromboembolic events, bleeding; and issues with wound healing, such as dehiscence. The investigators will record no-show rates, visit times, and estimated travel distance as measured by distance of home to clinic site.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2024

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

2.9 years

First QC Date

February 17, 2021

Last Update Submit

September 4, 2024

Conditions

Keywords

GynecologyVirtual visitPost-operativePatient satisfaction

Outcome Measures

Primary Outcomes (2)

  • Patient satisfaction at 2-weeks

    The Press Ganey Medical Practice Survey is used to provide feedback on improving aspects of the clinic experience. It measures access, moving through the visit, nurse/assistant, care provider, personal issues and overall assessment. The scale exists from 1-5 (1=very poor, 5=very good)

    2-weeks

  • Patient satisfaction at 2-weeks

    The Press Ganey Medical Practice Telemedicine Survey is used to provide feedback on utilizing remote delivery of healthcare services. It measures access, care provider, telemedicine technology and overall access. The scale exists from 1-5 (1=very poor, 5=very good)

    2-weeks

Study Arms (2)

Virtual visit

EXPERIMENTAL

Patients will have 2-week post-operative virtual visit

Other: Virtual visit

Office visit

ACTIVE COMPARATOR

Patients will return to the office for a 2-week post-operative visit

Other: Office visit

Interventions

Patients randomized to this group will have a virtual 2-week post-operative visit

Virtual visit

Patients randomized to this group will have a in-person 2-week post-operative visit

Office visit

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGynecological post-operative study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18
  • Able to provide informed consent without assistance
  • English speaking
  • Access to phone or device equipped for virtual visit

You may not qualify if:

  • Surgeon determines participant is not a good candidate for virtual follow-up visit
  • Suspicion of malignancy
  • Unable to provide informed consent
  • No access to technology for virtual visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Office Visits

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Lindsey Valentine, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2021

First Posted

April 22, 2021

Study Start

February 5, 2021

Primary Completion

January 12, 2024

Study Completion

January 12, 2024

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations