Feasibility Trial for Postoperative Wound Surveillance Using Smartphones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Protocol completion
研究概览
简要总结
The proposed trial is a pilot to test a smartphone application (app) that will ultimately allow patients to take and transmit photos of their postoperative wounds from home and relay other symptom information. This protocol covers the single-institution pilot study of the app's use in the period between hospital discharge and a patient's first follow-up clinic visit. The investigators will recruit vascular surgery patients either preoperatively in clinic or in the post-operative, pre-discharge period following surgery to participate in the pilot. Using a training protocol refined in the usability-testing phase of the project, patients will be trained to use the smartphone and the wound surveillance app prior to discharge. Patients will use the app from home to take send digital images of their postoperative wounds and answer a short survey, all of which will be transmitted to a secure database maintained by the University of Wisconsin (UW) Department of Surgery and accessible only to UW-employed study personnel. These data will be evaluated by one of three vascular surgery service nurse practitioners (NPs) daily and entered into the medical record. Patients who have concerning findings either in their images or in their survey answers will be contacted for further evaluation. Smartphones will be provided to patients who do not have one of their own, through a partnership with AT&T. Sociodemographic and comorbidity data collected from the medical record will be kept at UW Department of Surgery on a secure server and accessible only to UW employed study personnel.
详细描述
Study duration: 3 years
Population Description:
Patients are typically older adults with multiple comorbid conditions and low health literacy. Caregivers may have a similar profile or may be younger with some technological experience (adult son or daughter).
Recruitment and Consent Screening for eligibility: On the outpatient side, study personnel will identify eligible participants from the vascular surgery clinic schedule. On the inpatient side, study personnel will identify eligible participants from the service inpatients with the assistance of service NPs and residents. Eligible patients will be approached by study personnel and the operating surgeon or service NP to discuss the project and obtain consent.
Enrollment/baseline: Research personnel will introduce the study, obtain consent, and perform the training to teach a patient or caregiver how to take a picture of a wound.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Vascular surgery patient capable of independently completing protocol or who has an identifiable competent caregiver
- •Incision >3 cm in length
排除标准
- •No decisional capacity and absence of competent caregiver
- •Identifying mark in area of the wound that would be capture in digital image of the wound
- •Under age 18 years
研究组 & 干预措施
Smartphone monitoring
Intervention arm
干预措施: Smartphone monitoring (Device)
结局指标
主要结局
Protocol completion
时间窗: Assessed at 2 weeks from enrollment of each participant
The percentage of participants who completed the app for the full length of the protocol (from the day of discharge to the day of scheduled clinic follow-up) without requiring a reminder phone call.
次要结局
- Patient willingness to participate(Assessed at consent/enrollment of eligible patients)
- Participant satisfaction(Assessed at 2 weeks from enrollment for each participant)
- Time needed to successfully complete the training module(Assessed at enrollment for each participant)
- Burden of protocol on clinical workflow(Through study completion, an average of 6 months)
- Wound complication detection(Assessed daily through 2 weeks from enrollment for each participant)