A Prospective Randomized Trial Comparing Pre-Anesthesia Evaluation Remotely Via Telemedicine Versus in Person for Surgical Patients at H. Lee Moffitt Cancer Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Number of eligible patients that elect to participate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number of eligible patients that elect to participate
时间窗: 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.
Percentage of participants satisfied with telemedicine visit
时间窗: 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.
次要结局
- Evaluation of pre-anesthesia evaluation via telemedicine vs in-person(Up to day 30)