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Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Orthopedic Patients

NCT04981002 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-09

No results posted yet for this study

Summary

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.

Conditions

  • Orthopedic Patients

Interventions

OTHER

Telemedicine Consultation with self orthopedic exam

Brief telemedicine consultation, with self orthopedic exam,blinded to subsequent face-to-face evaluation.

OTHER

Face-to-face Consultation

Direct face-to-face evaluation (without telemedicine consultation before).

Sponsors & Collaborators

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Noel HS Oizerovici Foni, MD · Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-05
Primary Completion
2022-04-30
Completion
2022-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04981002 on ClinicalTrials.gov