Orthopedic PatientsNCT04981002
Telemedicine and Face-to-face Consultations Diagnostic Accuracy Comparison in Orthopedic Patients
A study testing Telemedicine Consultation with self orthopedic exam and Face-to-face Consultation in people with Orthopedic Patients, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Patients
- What is being tested?
- Telemedicine Consultation with self orthopedic exam and Face-to-face Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Nov 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years;
- Patient with orthopedic complaints according to the above diagnostic criteria, by the triage nurse.
- Signing the informed consent form.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Abert Einstein
São Paulo
Noel Foni
About this study
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
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.
Read the 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:
- 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).
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.
- Conditions
- Orthopedic Patients
- Being tested
- Telemedicine Consultation with self orthopedic exam, Face-to-face Consultation
- Keywords
- Telemedicine, Orthopedics, Trauma, Emergency Room
- Medical subject headings
- Wounds and Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine Consultation with self orthopedic examOther
Brief telemedicine consultation, with self orthopedic exam,blinded to subsequent face-to-face evaluation.
Face-to-face ConsultationOther
Direct face-to-face evaluation (without telemedicine consultation before).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Face-to-face Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Time of medical care
Comparison of time (minutes) of medical care between telemedicine and face-to-face consultation.
Measured: through study completion, an average of 1 year
Rate of indication for complementary exams
Comparison of rate (percentage) of indication for complementary exams between telemedicine and face-to-face consultation.
Measured: through study completion, an average of 1 year
Types of requested exams
Comparison of types of requested exams (percentage) between telemedicine and face-to-face consultation.
Measured: through study completion, an average of 1 year
Medical prescription
Comparison of medical prescription after completion of the service between telemedicine and face-to-face consultation.
Measured: through study completion, an average of 1 year
Proposed destination after completion of the service
Comparison of proposed destination (percentage of discharge or hospitalization) after completion of the service between telemedicine and face-to-face consultation.
Measured: through study completion, an average of 1 year
Total hospital cost after completion of care
Comparison of total hospital cost after completion of care (Real and Dollar) between telemedicine and face-to-face consultation.
Measured: through study completion, an average of 1 year
Patient satisfaction
Comparison of patient satisfaction (percentage) between telemedicine and face-to-face consultation.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start5 Nov 2021
- Primary completionApr 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel HS Oizerovici Foni, MD, Principal investigator, Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981002
- Sponsor's protocol ID
- 46603821.9.0000.0071
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39166332
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04981002
- Acronym / sponsor ID
- 46603821.9.0000.0071
- Conditions
- Orthopedic Patients
- Keywords
- Telemedicine, Orthopedics, Trauma, Emergency Room
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult patients with orthopedic complaints - telemedicine self exam before face-to-face evaluation | Active comparator | Other: Telemedicine Consultation with self orthopedic exam, Other: Face-to-face ConsultationFirst 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. |
| Adult patients with orthopedic complaints - only face-to-face evaluation | Active comparator | Other: Face-to-face ConsultationFace-to-face care with an orthopedist, according to institutional protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years;
- Patient with orthopedic complaints according to the above diagnostic criteria, by the triage nurse.
- Signing the informed consent form.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine Consultation with self orthopedic examBrief telemedicine consultation, with self orthopedic exam,blinded to subsequent face-to-face evaluation. | Other | Adult patients with orthopedic complaints - telemedicine self exam before face-to-face evaluation |
| Face-to-face ConsultationDirect face-to-face evaluation (without telemedicine consultation before). | Other | Adult patients with orthopedic complaints - only face-to-face evaluation, Adult patients with orthopedic complaints - telemedicine self exam before face-to-face evaluation |
Primary outcome
Accuracy of telemedicine diagnosis in adult patients with orthopedic complaints
Time frame: 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).
7 secondary outcomes
Time of medical care
Time frame: through study completion, an average of 1 year
Rate of indication for complementary exams
Time frame: through study completion, an average of 1 year
Types of requested exams
Time frame: through study completion, an average of 1 year
Medical prescription
Time frame: through study completion, an average of 1 year
Proposed destination after completion of the service
Time frame: through study completion, an average of 1 year
Total hospital cost after completion of care
Time frame: through study completion, an average of 1 year
Patient satisfaction
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 39166332Foni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel HS Oizerovici Foni, MD principal investigator
Telemedicine Department, Hospital Israelita Albert Einstein, Sao Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Consultation with self orthopedic exam and Face-to-face Consultation in people with Orthopedic Patients, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noel Oizerovici Foni, MD (+55 11 99697-0529, noel.foni@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of telemedicine diagnosis in adult patients with orthopedic complaints (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.