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Clinical Trial 21353

Cancer Type: Genitourinary
Study Type: Health Services Research
NCT#: NCT05065944

Phase: N/A
Prinicipal Investigator: Nasrin Aldawoodi

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Overview

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

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.

Objective

Demonstrate telemedicine evaluation in the PAT Clinic does not increase DOS cancellations due to incomplete assessment compared with in-person evaluation while being beneficial to patients. 2. Demonstrate that telemedicine premedicine evaluation offers some benefits over in-person evaluation.3. Conduct a pilot study using the Eko DUOTM digital stethoscope for telemedicine heart and lung examination and assess concordance with an in-person examination.

Treatments

Therapies

Medications

Inclusion 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

    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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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