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

NCT04981002 | Unknown

• 1 other identifier: 46603821.9.0000.0071
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Telemedicine; Orthopedics; Trauma; Emergency Room

Outcome Measures

Primary Outcomes (1)

• Accuracy of telemedicine diagnosis in adult patients with orthopedic complaints

  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).

  through study completion, an average of 1 year

Secondary Outcomes (7)

• 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

Study Arms (2)

Adult patients with orthopedic complaints - telemedicine self exam before face-to-face evaluation

ACTIVE COMPARATOR

First care will be performed via telemedicine with a clinical physician, guiding self-examination guided by telemedicine. After the remote consultation, a face-to-face evaluation will be performed with an orthopedist, according to institutional protocol.

Other: Telemedicine Consultation with self orthopedic exam; Other: Face-to-face Consultation

Adult patients with orthopedic complaints - only face-to-face evaluation

ACTIVE COMPARATOR

Face-to-face care with an orthopedist, according to institutional protocol.

Other: Face-to-face Consultation

Interventions

Telemedicine Consultation with self orthopedic exam OTHER

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

Adult patients with orthopedic complaints - telemedicine self exam before face-to-face evaluation

Face-to-face Consultation OTHER

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

Adult patients with orthopedic complaints - only face-to-face evaluation; Adult patients with orthopedic complaints - telemedicine self exam before face-to-face evaluation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• Patient with orthopedic complaints according to the above diagnostic criteria, by the triage nurse.
• Signing the informed consent form.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Abert Einstein

São Paulo, Brazil

RECRUITING

Related Publications (1)

• Foni NO, Accorsi TAD, Correia RFV, Moreira FT, Lima KA, Morbeck RA, Souza JL Jr, Pedrotti CHS, Wolosker N; TeleORTHOPEDICS Trial. Guideline-Based Telemedicine Assessment of Orthopedic Low-Risk Conditions by General Practitioners is Not Inferior to that of Face-to-Face Consultations with Specialists in the Emergency Department: A Randomized Trial. Telemed J E Health. 2024 Dec;30(12):2859-2869. doi: 10.1089/tmj.2024.0312. Epub 2024 Aug 21.

  PMID: 39166332 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Noel HS Oizerovici Foni, MD

  Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noel Oizerovici Foni, MD

CONTACT

+55 11 99697-0529; noel.foni@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 28, 2021
• Study Start: November 5, 2021
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 9, 2022

Record last verified: 2021-07

Locations

BR (1)