<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20171031037138N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-27</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Stroke Triage scale (Researcher) on timing indicators and triage errors among patients with neuro sensory deficit referred to emergency department</public_title>
      <acronym>ESI</acronym>
      <scientific_title>Camparison of Stroke Triage scale (Researcher) and Emergency Severity Index    scale (ESI) on timing indicators and triage errors among patients with neuro sensory deficit referred to emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28138</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Other design features: Introduction of Triage Stroke Scale (Researcher):                                                 It has five levels.                                                                                                                First level: Patients referred with signs of neuro-sensory deficit accompanied by a decrease in the level of consciousness that requires advanced life-saving measures.                                                                                                        Second Level: Patients referred with symptoms of neuro-sensory deficit  without loss of consciousness.                                                                            The next three levels of researcher's scale are the same as the three levels of ABCD2 scale, so patients with transient ischemic attack that may not be properly diagnosed or may be undertriaged , are identified by the researcher's scale.                                                                                                                   Third level: people who score from the scoreboard ABCD2 score 6-7 will be on this level.                                                                                                                 Level 4: Individuals who score from the Scoreboard Score ABCD2 score of 4-5 will be on this level.                                                                                                                            Level 5: Individuals who score from the Scoreboard score of ABCD2 score 0-3 will be placed at this level, Randomization description: After the patient enters to the triage room, if there is a suspicion that there is a sensory impairment, using random allocation method (using SPSS software),  they are divided into two groups: intervention and control, Blinding description: The Nurse using emergency severity index  Scale will stay blind to the researcher's triage process and will not share the decision information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients who are in the intervention group fall into five classes using the stroke triage scale. Intervention 2: Control group: Patients who are in the control group fall into five classes using the emergency severity index scale.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because of secondery data analysis</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Reza Mazlom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>َAhmad abad Avenue</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>12345678</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>MazlomR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Reza Mazloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahmad abad Avenue</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>656314-99817</zip>
        <telephone>+98 513605484</telephone>
        <email>MazlomR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfied to participate in the study.
If they are over 18 years old.
Ability to speak Persian.
Referring to the emergency department is at least one of the most common symptoms of sensory neural impairment:    •Severe Headache  •Weakness or paralysis on one side of the body •Sudden, severe numbness in any part of the body •Visual disturbance (sudden loss of vision) •Difficulty walking (staggering or veering) •Coordination problems in the arms and hands •Slurred speech or inability to speak</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Incomplete or corrupted patient records
Sending the patient to other treatment centers
At the end of the study, patients that their neuro-sensory defects (diagnosed by a specialist physician) are diagnosed for reasons except central nervous system impairment are excluded from the study , and Patients who do not have an emergency file are excluded
Patients who do not want to continue to participate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>163.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients who are in the intervention group fall into five classes using the stroke triage scale.</i_keyword>
      <i_keyword>Control group: Patients who are in the control group fall into five classes using the emergency severity index scale.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1.The length of time elapsed from the exit of the triage room until each of the following measures and comparing them based on two methods of stroke triage scale and the emergency severity index scale (ESI):             CT Scan                                                                                                          doctor appiontment                                                                                   Checks the orders by the nurse                                                                   2.The mean of the triage score of patients hospitalized in ICU in two methods of  stroke triage scale and the emergency severity index scale (ESI).                                                                                                            3.The mean of the triage score of patients admitted to the neurology department in two methods of stroke triage scale and the emergency severity index scale (ESI).                                                                         4.The mean of the triage score of discharged patients in two methods of  stroke triage scale and the emergency severity index scale (ESI). 5.Measurement of triage error and sensitivity and specificity in two methods of  stroke triage scale and the emergency severity index scale (ESI).                                                                                             6.thrombolytic therapy. Timepoint: The final outcome of the patient is determined from the patients leaves the triage room to 6 hours later. Method of measurement: The level of triage of patients entering the study is determined using the items available at each scale.                                                                        To measure time indicators, the hours recorded in the patient file are used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-16</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Ahmad abad Ave, Faculty of Nursing and Midwifery of Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
