Clinical trial NCT04981002: Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Orthopedic Patients
Official title: Analysis of the Accuracy of Telemedicine-guided Orthopedic Self-examination Compared to Face-to-face Assessment in an Emergency Care Unit: a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Patients
Keywords: Telemedicine
Orthopedics
Trauma
Emergency Room
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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:

1. 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.
2. 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).

Both in face-to-face and telemedicine assessments, clinical data, final diagnosis, destination, total time of care, guidance, complementary exams and prescription will be computed. In the face-to-face evaluation, additional exams and medications received in situ will also be computed. The final diagnoses will receive nomenclature according to the International Statistical Classification of Diseases and Related Health Problems - ICD 10 (requirement of institutional records - Cerner) and will be grouped according to the equivalence of the syndromic diagnosis. The diagnosis of the face-to-face evaluation is made following institutional protocols based on extensive medical literature and approved by the institutional clinical staff, being representative of current medical practice and will be considered the gold standard diagnosis.

The total service time in minutes will be evaluated, verifying if telemedicine can change the total medical service time. The fee for complementary exams will be counted in the number of exams requested and their categorization (laboratory exam or imaging exam); the quantification in number and its categorization (behavioral measures, cryotherapy guidelines and new medical evaluation if necessary) of the guidelines; categorization of prescription (only symptomatic or medication in the UPA); destination categorization (high - item valid for both services, hospitalization - valid item for face-to-face care, search for the ER - valid item for telemedicine care), hospital cost (measured by the need for immobilization/complementary tests), and indication of additional tests .

The final diagnosis will be considered by the official report of the radiologist based on the imaging exams performed.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Accuracy of telemedicine diagnosis in adult patients with orthopedic complaints
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Time of medical care
timeFrame: through study completion, an average of 1 year
measure: Rate of indication for complementary exams
timeFrame: through study completion, an average of 1 year
measure: Types of requested exams
timeFrame: through study completion, an average of 1 year
measure: Medical prescription
timeFrame: through study completion, an average of 1 year
measure: Proposed destination after completion of the service
timeFrame: through study completion, an average of 1 year
measure: Total hospital cost after completion of care
timeFrame: through study completion, an average of 1 year
measure: Patient satisfaction
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Abert Einstein
Study officials:
affiliation: Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
name: Noel HS Oizerovici Foni, MD
role: PRINCIPAL_INVESTIGATOR
References: