Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery

November 2, 2020 updated by: University of California, San Francisco
The investigators propose utilizing a simple telemedical protocol to allow patients to substitute the first post-operative visit with a remote survey that includes essential post-operative history, vision measurement, and photographs, all of which can be provided using a personal computer, tablet, or smart phone. The investigators have selected for this purpose a subset of oculoplastic procedures involving the eyelid and lacrimal system that have well-reported low rates of serious complications, since high-risk procedures will likely always require close, in-person care. The investigators hypothesize that telemedicine follow-up for the first post-operative week after low-risk oculoplastic surgery will decrease the time burden on patients without compromising their satisfaction or increase the risk of late post-operative complications.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Davin C Ashraf, MD
        • Sub-Investigator:
          • M Reza Vagefi, MD
        • Sub-Investigator:
          • Robert C Kersten, MD
        • Sub-Investigator:
          • Bryan J Winn, MD
        • Sub-Investigator:
          • Seanna Grob, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are age 18 years or older
  • Are fluent in English
  • Own or have ready access to a smart phone, tablet, or personal computer with high speed internet
  • Participate in an informed consent process with the surgeon(s) including documentation of written informed consent
  • Are undergoing a low-risk* eyelid procedure in a clinic, ambulatory surgery center, or hospital operating room setting, including but not limited to:

    • upper eyelid blepharoplasty repair
    • ectropion repair
    • entropion repair
    • external levator resection
    • internal levator resection
    • eyelid lesion removal and/or biopsy
    • eyelid reconstruction and defect repair including after Mohs' surgery
    • eyelid tightening procedures for Floppy Eyelid Syndrome
    • tarsorrhaphy
    • dacryocystorhinostomy

(*)These listed procedures have a low reported rate of serious complications including vision loss, infection, severe bleeding, or death; however, surgical risk is ultimately determined by the surgeon on a per-patient basis, except in those cases specifically excluded in the subsequent section.

Exclusion Criteria:

  • Are under the age of 18 years
  • Are incarcerated
  • Are pregnant or plan to become pregnant during the period of surgery and 3 month recovery (however these patients are not eligible for elective eyelid surgery)
  • Are not fluent in English
  • Do not have access to or do not feel comfortable using a smart phone, tablet, or personal computer
  • Lack personal capacity for consent (i.e. those patients requiring consent for the surgery by a legal representative are excluded)
  • Experience a serious intra-operative complication (this criterion is assessed after initial consent)
  • Are undergoing eyelid or other oculoplastic procedures that are deemed greater than low-risk for serious complications, including but not limited to:

    • orbital surgery
    • lower eyelid blepharoplasty
    • repair of extensive eyelid defects following Mohs' surgery (roughly >33%)
    • procedures requiring skin grafting
    • procedures requiring extensive tissue rearrangement
    • procedures involving an implant (e.g. frontalis sling, gold weight implantation; except dacryocystorhinostomy due to the low-risk nature of the lacrimal stent)
    • procedures requiring in-person care at the first post-operative week (e.g. suture removal, bolster removal, patch removal)

Notably, patients undergoing greater than low risk procedures listed here are absolutely excluded from this trial. Surgeon assessment of individual patient surgical risk only applies to those typically low-risk procedures listed in the previous section on inclusion criteria; reasons for escalation of risk level include patient characteristics (e.g. frailty, previous infection or wound dehiscence), re-operation/revision status, or other factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine
Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.
No Intervention: Routine
Patient in the routine arm will have their post-operative week one visit in clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACE-Q 'Satisfaction with Outcome'
Time Frame: Approximately 3 months post-operatively
A patient-reported outcome measure assessing satisfaction with the surgical outcome.
Approximately 3 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACE-Q 'Early Life Impact'
Time Frame: Approximately 1 week post-operatively
A patient-reported outcome measure assessing early life impact of facial plastic surgery.
Approximately 1 week post-operatively
FACE-Q 'Satisfaction with Doctor'
Time Frame: Approximately 3 months post-operatively
A patient-reported outcome measure assessing satisfaction with the surgeon.
Approximately 3 months post-operatively
Late post-operative complications
Time Frame: Between the first and second post-operative visits (approximately 1 week to 3 months)
Investigator-reported post-operative complications.
Between the first and second post-operative visits (approximately 1 week to 3 months)
Time burden
Time Frame: Approximately 1 week post-operatively
Patient-reported time spent on the first post-operative visit, including waiting, travel, the visit, and all forms.
Approximately 1 week post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Davin C Ashraf, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only plan to share in the event that journal requests de-identified data to be released.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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