Analysis of the Accuracy of Telemedicine-guided Orthopedic Self-examination Compared to Face-to-face Assessment in an Emergency Care Unit: a Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy of telemedicine diagnosis in adult patients with orthopedic complaints
研究概览
简要总结
Adult patients with acute complaints related to the musculoskeletal system are prevalent and correspond to a large percentage of visits to Emergency Care Units (UPA), often performed by general practitioners. These patients, in most cases, present complaints associated with low-complexity trauma, which can be diagnosed through targeted physical examination and treated with basic guidelines (behavioral/medicinal). The diagnosis of a more complex fracture or injury requires an assessment by an orthopedist. Currently, patients with orthopedic complaints are often seen by telemedicine, but there are no studies that have compared the diagnostic accuracy of remote assessment with standard face-to-face assessment. Telemedicine is a recognized medical care strategy used for various situations, including as a virtual emergency service. Despite the current widespread use, there are few studies that have evaluated the diagnostic accuracy of telemedicine compared to face-to-face evaluation, and there are no specific studies in patients with orthopedic symptoms. Scientific evidence of high diagnostic accuracy in telemedicine care can support the investment and expansion of this modality, expanding and facilitating the access of patients to the health service, with a reduction in costs and the rational use of resources. The objective of the study is to analyze the diagnostic accuracy of telemedicine-guided self-examination compared to a face-to-face medical evaluation at the UPA in adult patients with orthopedic complaints. Secondary objectives are: evaluation of medical care time, indication of additional tests, guidance, medical prescription, proposed destination after completion of care, cost and patient satisfaction. It is a a randomized, prospective, single-center study carried out in the telemedicine and UPA sectors of Hospital Israelita Albert Einstein. Randomization will be 1:1 and patients will be allocated in the Tele group (evaluation by telemedicine followed by face-to-face evaluation) or in the Standard group (in-person evaluation). The sample calculated for non-inferiority was 50 patients in each group.
详细描述
Randomized, prospective, single-center study carried out in the telemedicine sectors and emergency care unit of Hospital Israelita Albert Einstein, Ibirapuera Unit. The randomization will be 1:1, from the commercial application Randomizer ®, by the member of the project Renata Vidigal Correia.
After randomization, patients will be included in one of two possible groups:
- TELE Group: first care will be provided via telemedicine with a clinical physician, guiding self-examination guided by telemedicine. After the remote consultation, a face-to-face evaluation will be carried out with an orthopedist, according to institutional protocol.
- GrupoSTANDARD: Face-to-face care with an orthopedist, according to institutional protocol.
The face-to-face evaluation will be carried out by the local UPA medical and orthopedic care team and the telemedicine evaluation by the fixed medical team of the HIAE service responsible for urgency/emergency care.
The study will be of non-inferiority with evaluation of accuracy in both groups, since the telemedicine group, after completion of care, will pass the face-to-face consultation (gold standard).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years;
- •Patient with orthopedic complaints according to the above diagnostic criteria, by the triage nurse.
- •Signing the informed consent form.
排除标准
- •Return to the UPA for maintenance or aggravation of the complaint;
- •Age > 65 years;
- •Patient with emergency room criteria by the evaluation of the triage nursing.
- •Postoperative period of orthopedic surgery < 3 months
结局指标
主要结局
Accuracy of telemedicine diagnosis in adult patients with orthopedic complaints
时间窗: through study completion, an average of 1 year
The patient will be evaluated by telemedicine and / or face-to-face consultation and at the end will receive the diagnosis, which will be assigned the ICD code for orthopedic complaints. At the end, these ICDs will be grouped by the same clinical significance (M54: Neck pain and Low back pain; T11-T13: Extremity contusion; S93: Ankle Sprain) and will be compared between the two consultation methods (telemedicine versus face-to-face consultation).
次要结局
- Time of medical care(through study completion, an average of 1 year)
- Rate of indication for complementary exams(through study completion, an average of 1 year)
- Types of requested exams(through study completion, an average of 1 year)
- Medical prescription(through study completion, an average of 1 year)
- Proposed destination after completion of the service(through study completion, an average of 1 year)
- Total hospital cost after completion of care(through study completion, an average of 1 year)
- Patient satisfaction(through study completion, an average of 1 year)