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NCT Number: NCT05065944

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

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.

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Key information

Conditions

Gynecologic Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Health Behavior Male Urogenital Diseases Neoplasms Neoplasms by Site Patient Satisfaction Prostate Cancer Prostatic Diseases Prostatic Neoplasms Treatment Adherence and Compliance Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

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.

In Person Visit

Behavioral

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

Primary outcomes

  1. Number of eligible patients that elect to participate

    Time frame: Up to day 26

    Acceptability of pre-anesthesia telemedicine evaluation will be measured as ≥ 50% of eligible patients consent to participate and ≥ 70% submit exit survey.

  2. Percentage of participants satisfied with telemedicine visit

    Time frame: Up to day 26

    Acceptability will be measured as ≥ 70% strongly agreeing or agreeing with the statement that they were satisfied with their telemedicine visit on an exit survey.

Secondary outcomes

  1. Evaluation of pre-anesthesia evaluation via telemedicine vs in-person

    Time frame: Up to day 30

    Efficacy of pre-anesthesia evaluation via telemedicine will be determined by day of surgery and 48 hours before surgery cancellation rate (number of cancelled appointments divided by number of scheduled appointments).

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

A Prospective Randomized Trial Comparing Pre-Anesthesia Evaluation Remotely Via Telemedicine Versus in Person for Surgical Patients at H. Lee Moffitt Cancer Center

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Oct 4, 2021
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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