Comparing Pre-Anesthesia Evaluation Via Telemedicine Versus in Person for Surgical Patients at Moffitt Cancer Center

NCT ID: NCT05065944

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2024-08-09

Brief Summary

This is a randomized controlled trial of patients scheduled for hysterectomy or prostatectomy surgeries who undergo a pre-anesthesia evaluation at Moffitt Cancer Center PreAnesthesia Testing (PAT) clinic. Traditionally, patients who met certain criteria based on type of surgery or comorbidities would undergo an in-person evaluation in our clinic. In order to make our patient's care more convenient and accessible, investigators have introduced telemedicine evaluation for a certain subset of patients meeting specific criteria. Investigators aim with this randomized trial to investigate the hypothesis that telemedicine pre-anesthesia evaluation is non-inferior to in-person evaluation from the standpoint of day of surgery cancellation rate.

Conditions

Gynecologic Cancer; Prostate Cancer; Patient Satisfaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre-Anesthesia Evaluation: Telemedicine

Pre-Anesthesia evaluation conducted remotely via video conferencing

Telemedicine

Intervention Type: BEHAVIORAL

Pre-anesthesia assessment (history and physical examination) via telemedicine. Intervention is a one-time telemedicine clinic visit for approximately 30 minutes to 1 hour. Individual patients will be randomized to telemedicine and that visit will be scheduled via the Zoom video conferencing platform.

Pre-Anesthesia Evaluation: In person

Pre-Anesthesia evaluation conducted in person

In Person Visit

Intervention Type: BEHAVIORAL

Pre-anesthesia assessment (history and physical examination) in person at Moffitt Cancer Center (usual care)

Interventions

Telemedicine

Pre-anesthesia assessment (history and physical examination) via telemedicine. Intervention is a one-time telemedicine clinic visit for approximately 30 minutes to 1 hour. Individual patients will be randomized to telemedicine and that visit will be scheduled via the Zoom video conferencing platform.

Intervention Type: BEHAVIORAL

In Person Visit

Pre-anesthesia assessment (history and physical examination) in person at Moffitt Cancer Center (usual care)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Able to speak and read English
• Able to provide signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Presurgical patients at Moffitt Cancer Center scheduled to undergo any type of hysterectomy/salpingo-oophorectomy or prostatectomy surgeries.
• Possesses appropriate equipment (i.e., computer, tablet, smartphone) to undergo telemedicine evaluation.

Exclusion Criteria

• Patients with documented or observable significant cognitive barriers, hearing, or speech impairment. Examples include a patient who is not alert or oriented, who is unable to sign his or her own surgical consent due to cognitive issues or who cannot understand and repeat back to study coordinator reason for study. If these barriers will not be an issue for a video phone call and can be reasonably accommodated, we will do so. However, our telemedicine technology is still very basic, and these patients may be more comfortable communicating with providers and expressing their needs during an in-person visit
• Surgery 3 days or less away from clinic visit. As in-person assessment is the gold standard, we need to allow some time in case a patient cannot work the technology for a telemedicine visit or an issue comes up where visit needs to be converted to in-person.
• Out of state patients as there are currently medical licensing concerns with conducting telemedicine on patients physically located out of state during the visit.
• Determined to be ineligible for surgery during evaluation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasrin N Aldawoodi, MD

Role: PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-21353

Identifier Type: -

Identifier Source: org_study_id