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

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05065944
Collaborator
(none)
106
Enrollment
1
Location
24
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Telemedicine
  • Behavioral: In Person Visit

Study Design

Study Type:
Observational
Anticipated Enrollment :
106 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Randomized Trial Comparing Pre-Anesthesia Evaluation Remotely Via Telemedicine Versus in Person for Surgical Patients at H. Lee Moffitt Cancer Center
Actual Study Start Date :
Sep 22, 2021
Anticipated Primary Completion Date :
Sep 22, 2023
Anticipated Study Completion Date :
Sep 22, 2023

Arms and Interventions

ArmIntervention/Treatment
Pre-Anesthesia Evaluation: Telemedicine

Pre-Anesthesia evaluation conducted remotely via video conferencing

Behavioral: 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.

Pre-Anesthesia Evaluation: In person

Pre-Anesthesia evaluation conducted in person

Behavioral: In Person Visit
Pre-anesthesia assessment (history and physical examination) in person at Moffitt Cancer Center (usual care)

Outcome Measures

Primary Outcome Measures

  1. Number of eligible patients that elect to participate [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 [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Moffitt Cancer CenterTampaFloridaUnited States33612

Sponsors and Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Nasrin N Aldawoodi, MD, Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT05065944
Other Study ID Numbers:
  • MCC-21353
First Posted:
Oct 4, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021