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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05065944
• Other study ID #: MCC-21353
• Status: Active, not recruiting
• Start date: November 16, 2021
• Est. completion date: August 19, 2024

Study information

• Verified date: February 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Patient Satisfaction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of eligible patients that elect to participate	Acceptability of pre-anesthesia telemedicine evaluation will be measured as = 50% of eligible patients consent to participate and = 70% submit exit survey.	Up to day 26
Primary	Percentage of participants satisfied with telemedicine visit	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.	Up to day 26
Secondary	Evaluation of pre-anesthesia evaluation via telemedicine vs in-person	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).	Up to day 30

External Links

•   Moffitt Cancer Center Clinical Trials website