Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- FACE-Q 'Satisfaction with Outcome'
研究概览
简要总结
The investigators propose utilizing a simple telemedical protocol to allow patients to substitute the first post-operative visit with a remote survey that includes essential post-operative history, vision measurement, and photographs, all of which can be provided using a personal computer, tablet, or smart phone. The investigators have selected for this purpose a subset of oculoplastic procedures involving the eyelid and lacrimal system that have well-reported low rates of serious complications, since high-risk procedures will likely always require close, in-person care. The investigators hypothesize that telemedicine follow-up for the first post-operative week after low-risk oculoplastic surgery will decrease the time burden on patients without compromising their satisfaction or increase the risk of late post-operative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Are age 18 years or older
- •Are fluent in English
- •Own or have ready access to a smart phone, tablet, or personal computer with high speed internet
- •Participate in an informed consent process with the surgeon(s) including documentation of written informed consent
- •Are undergoing a low-risk* eyelid procedure in a clinic, ambulatory surgery center, or hospital operating room setting, including but not limited to:
- •upper eyelid blepharoplasty repair
- •ectropion repair
- •entropion repair
- •external levator resection
- •internal levator resection
- •eyelid lesion removal and/or biopsy
- •eyelid reconstruction and defect repair including after Mohs' surgery
- •eyelid tightening procedures for Floppy Eyelid Syndrome
- •tarsorrhaphy
- •dacryocystorhinostomy
- •(*)These listed procedures have a low reported rate of serious complications including vision loss, infection, severe bleeding, or death; however, surgical risk is ultimately determined by the surgeon on a per-patient basis, except in those cases specifically excluded in the subsequent section.
排除标准
- •Are under the age of 18 years
- •Are incarcerated
- •Are pregnant or plan to become pregnant during the period of surgery and 3 month recovery (however these patients are not eligible for elective eyelid surgery)
- •Are not fluent in English
- •Do not have access to or do not feel comfortable using a smart phone, tablet, or personal computer
- •Lack personal capacity for consent (i.e. those patients requiring consent for the surgery by a legal representative are excluded)
- •Experience a serious intra-operative complication (this criterion is assessed after initial consent)
- •Are undergoing eyelid or other oculoplastic procedures that are deemed greater than low-risk for serious complications, including but not limited to:
- •orbital surgery
- •lower eyelid blepharoplasty
- •repair of extensive eyelid defects following Mohs' surgery (roughly >33%)
- •procedures requiring skin grafting
- •procedures requiring extensive tissue rearrangement
- •procedures involving an implant (e.g. frontalis sling, gold weight implantation; except dacryocystorhinostomy due to the low-risk nature of the lacrimal stent)
- •procedures requiring in-person care at the first post-operative week (e.g. suture removal, bolster removal, patch removal)
- •Notably, patients undergoing greater than low risk procedures listed here are absolutely excluded from this trial. Surgeon assessment of individual patient surgical risk only applies to those typically low-risk procedures listed in the previous section on inclusion criteria; reasons for escalation of risk level include patient characteristics (e.g. frailty, previous infection or wound dehiscence), re-operation/revision status, or other factors.
研究组 & 干预措施
Telemedicine
Patients in the telemedicine arm will have their post-operative week one visit via a telemedicine portal.
干预措施: Telemedicine follow-up (Other)
Routine
Patient in the routine arm will have their post-operative week one visit in clinic.
结局指标
主要结局
FACE-Q 'Satisfaction with Outcome'
时间窗: Approximately 3 months post-operatively
A patient-reported outcome measure assessing satisfaction with the surgical outcome.
次要结局
- FACE-Q 'Early Life Impact'(Approximately 1 week post-operatively)
- FACE-Q 'Satisfaction with Doctor'(Approximately 3 months post-operatively)
- Late post-operative complications(Between the first and second post-operative visits (approximately 1 week to 3 months))
- Time burden(Approximately 1 week post-operatively)