<?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>IRCT20211205053284N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-26</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Education of using IMIST-AMBO protocol in delivering patients from pre-hospital staff on patient safety in hospital emergency department</public_title>
      <acronym></acronym>
      <scientific_title>The effect of education of using IMIST-AMBO protocol in delivering patients from pre-hospital staff on patient safety in hospital emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>400</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60455</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is done in a simple and individual way using Randomizer random allocation software. Emergency medical personnel are listed according to the national code and then divided into group 1 (intervention) and group 2 (control) using random allocation software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients transferred by pre-hospital emergency..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pre-hospital emergency staff                                     Step 1 (before intervention): For all patients (traumatic and non-traumatic) who are delivered to the emergency department by pre-hospital emergency staff and delivered as usual, the safety standards checklist by the researcher is up to six hours (4 to 6 hours). ) Will be completed later. The reason for the period of four to six hours is the stabilization of the patient's condition and the initial stages of care and treatment, which is done faster in some patients and later in others. Also, according to the laws of the Ministry of Health, each patient in the emergency department must be assigned within six hours and a final decision must be made regarding the patient's hospitalization or discharge.                                Step 2 (Intervention): In this step, all pre-hospital emergency staff of the IMIST-AMBO protocol intervention group will be trained in two face-to-face sessions. The validity of the educational content is confirmed by 4 emergency medicine specialists and nursing faculty members. The training will be presented by the researcher using PowerPoint in person for two hours. It should be noted that the objectives of the research will be explained to all participants and all of them will be informed.         Stage 3 (after intervention): In this stage, the safety checklist of patients admitted to the emergency department for all trauma and non-trauma patients who have been transferred to the hospital by pre-hospital emergency staff trained in the IMIST-AMBO protocol, until Six hours (4 to 6 hours) will be completed later. Then the patient's safety in the stage before and after the study will be compared with each other and the results will be prepared for statistical analysis. Intervention 2: Control group: Pre-hospital emergency staff did not intervene in the control group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Safety measured before and after the intervention

When:
Access to the study will be after the publication of the article

To whom:
The data will be available to all medical researchers

Conditions:
If the principles of research ethics are observed, it will be provided to researchers.

Where to obtain:
Refer to the registration email address in the published article and request.

How to obtain:
The article will be provided to the requesting researchers immediately after approval and publication.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Chiman Ebrahimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amirabad - Keshavarz Boulevard - next to Bisotoun Alley 5</address>
        <city>Bukan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5951112374</zip>
        <telephone>+98 44 4625 2160</telephone>
        <email>chiman.ebrahimian@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Monjazebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 8865 5366</telephone>
        <email>fmonjazebi@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient enters the emergency room by the pre-hospital emergency department
Criteria for admission of pre-hospital emergency staff and nurses to work experience research for at least six months in the emergency department or pre-hospital</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient leaves before 6 hours by completing and signing the personal consent form
Patient dies before 6 hours
Need emergency surgery or immediate transfer to other wards
Exclusion criteria for pre-hospital emergency staff and nurses Lack of regular attendance at training classes</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N98.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Safety</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pre-hospital emergency staff                                     Step 1 (before intervention): For all patients (traumatic and non-traumatic) who are delivered to the emergency department by pre-hospital emergency staff and delivered as usual, the safety standards checklist by the researcher is up to six hours (4 to 6 hours). ) Will be completed later. The reason for the period of four to six hours is the stabilization of the patient's condition and the initial stages of care and treatment, which is done faster in some patients and later in others. Also, according to the laws of the Ministry of Health, each patient in the emergency department must be assigned within six hours and a final decision must be made regarding the patient's hospitalization or discharge.                                Step 2 (Intervention): In this step, all pre-hospital emergency staff of the IMIST-AMBO protocol intervention group will be trained in two face-to-face sessions. The validity of the educational content is confirmed by 4 emergency medicine specialists and nursing faculty members. The training will be presented by the researcher using PowerPoint in person for two hours. It should be noted that the objectives of the research will be explained to all participants and all of them will be informed.         Stage 3 (after intervention): In this stage, the safety checklist of patients admitted to the emergency department for all trauma and non-trauma patients who have been transferred to the hospital by pre-hospital emergency staff trained in the IMIST-AMBO protocol, until Six hours (4 to 6 hours) will be completed later. Then the patient's safety in the stage before and after the study will be compared with each other and the results will be prepared for statistical analysis.</i_keyword>
      <i_keyword>Control group: Pre-hospital emergency staff did not intervene in the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient safety                                                                                                The meaning of patient safety is the score obtained from the checklist of safety assessment of patients admitted to the emergency room, which measures patient safety in the areas of 1) attention to drugs with similar forms and pronunciation, 2) correct patient identification, 3) communication Effective health workers at the time of patient delivery, 4) Performing the correct procedure in the correct location of the patient's body, 5) Controlling high concentration electrolyte solutions, 6) Ensuring drug accuracy in the delivery of care services, 7) Avoiding incorrect connections of catheters and tubes, 8 ) Measures the immediate use of injection equipment. 9) Improves hand hygiene to prevent infections. Timepoint: Before intervention and after intervention. Method of measurement: Questionnaire nine WHO patient safety solutions.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-02</approval_date>
        <contact_name>Ethics Committee in Research Schools of Pharmacy, Nursing and Midwifery - Shahid Beheshti University</contact_name>
        <contact_address>In front of Shahid Rajaei Heart Hospital.,Niayesh Intersection.,Valiasr St.,School of Nursing and Midwifery.,Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
