<?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>IRCT20150919024080N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-26</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of person-centered care on the triage accuracy, pain control and patient experience of trauma patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of person-centered care on the triage accuracy, pain control and patient experience of trauma patients in the emergency department: a randomized controlled trial(RCT)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58238</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: According to the inclusion and exclusion criteria, people enter the study in an accessible way. In order to equalize the distribution of two important confounders of age and sex, a class based on these two variables is created as age group 18 to 45 years / age group 46 to 65 years and men / women and then by Random blocks are placed in balance between intervention and control groups. The size of each block is 4 items, so that 6 different combinations of 4 blocks are created and are selected randomly by placing the blocks.</study_design>
      <phase>N/A</phase>
      <hc_freetext>trauma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention The intervention in the present study will include a person-centered care package focusing on three components: a) specialized triage, b: pain management, c: communication therapy / conscious trauma care. Considering that the triage unit is the first service center for trauma victims, first the intervention group, as soon as it is accepted and enters the triage unit, by the main researcher (nurse trained in the field of triage) with a special triage scale that fits the needs, priorities and The condition of trauma patients is triage. This scale is the "Adjusted Emergency Medicine Score (mREMS)"The variables used in this scale include: patient age, systolic blood pressure, heart rate, respiration rate, blood oxygen saturation level and level of consciousness. The sum of the scores of these parameters determines the level of triage of patients. The degree of agreement between the scorers (reliability between the evaluators) is used to perform triage (nurse and emergency physician) to determine the accuracy of triage and the nurse and emergency physician simultaneously triage the patient according to the new criteria and the opinion of the specialist Emergency medicine is the standard gold.After determining the level of triage, pain management begins with a person-centered approach. In this way, the patient's pain is first assessed using the Numerical Pain Rating Scale (NRS), then if the patient needs pain medication based on a pain management protocol previously designed by the current research director and implemented in a previous study. Is . Patient pain management is done with the prescription of a nurse. In this protocol, the nurse is allowed to prescribe analgesics to the patient independently without first examining the patient by a physician.Paracetamol is the first treatment of choice and may be given non-steroidal anti-inflammatory drugs (NSAIDs) such as ketorolac and injectable or morphine suppositories if needed. Depending on the study approach, other options for analgesics such as fentanyl may be considered. Also, according to this protocol, the nurse is obliged to record and evaluate the pain during analgesic administration and re-examine it at intervals of 15 minutes, 30 minutes and one hour after analgesic administration. Allergies, medications, and vital signs, as well as pain assessment, are performed by a triage nurse using the NRS tool, which is color-coded on A4 paper.After determining the pain score, and according to the pain management protocol, for the injured, analgesics are prescribed by the nurse according to the algorithm. After prescribing the drugs based on the method of administration and the amount of pain, the patient's pain is re-examined by the nurse and in case of no pain relief (pain score greater than 4) or side effects and drug reactions due to analgesics, the appropriate decision to re-prescribe anti-pain drug Pain or cessation is taken in consultation with an emergency medicine specialist. For patients with known allergies to analgesics, consult a physician for alternative medicine. Oral analgesics are prescribed with the expectation that the patient will not vomit and will be able to tolerate oral medications orally.In order to provide person-centered care, the third component of the current intervention will be a combination of patient-centered communication and conscious trauma care, which will be performed simultaneously and in parallel with triage and pain management in order to provide a supportive environment for the patient. To achieve this goal, during triage or pain management, the nurse has a dynamic, direct, and continuous presence at the patient's bedside and asks the patient to briefly describe their life situation (such as stress, social life, social support), and possible related experiences. Describe the diagnosis and treatment and previous experience related to hospitalization and pain management.If necessary, other risk factors related to trauma (such as drug use, alcohol use, mental health, etc.) are discussed. During the patient's admission to the emergency room, the patient and the nurse share information about the patient's management of pain, treatment plan and diagnosis, such as blood tests, examinations, imaging, and the use of analgesics, by reviewing the medical record. The nurse also acknowledges symptoms such as pain and fatigue and encourages the patient to describe the problems and barriers associated with managing their pain, and the treatment strategies, benefits, and risks of these treatments will be recommended and discussed.In this exchange of information and participation, factors such as pain, bruising and even emotional stress that are identified in patients' narratives are considered very important for managing emergency care problems and are planned for them. In this supportive context, the patient's participation in planning is emphasized so that the treatment process tailored to each individual's condition is discussed as part of the health care program.This intervention is a flexible intervention, but in the current study, based on the framework of this study, we pursue the same goals such as: patient satisfaction, patient respect, patient pain control, patient participation in the treatment program for all participants. Intervention 2: Control group : In this group, the routine care method of the emergency department is generally performed. In this study, the research environment is the same for the intervention and control groups. Triage of patients in the research environment is with the ESI system. The ESI system is a 5-level triage system that divides patients based on the severity of the disease and the facilities needed by the patient in the emergency room.No special tools are used to assess patients' pain and according to the patients themselves, pain assessment is performed and analgesics are prescribed according to the routine ward by the treating physician and emergency medicine if necessary and the nurse plays an active role in deciding to prescribe anti-pain drugs. There is no pain. Also, the patient-centered communication structure is not implemented in this group, and at the end, patients' experiences will be examined with a questionnaire for the intervention group.Before and during the study, nurses did not use any other standard pain management protocol and there was no structured measurement and recording of pain by nurses. In order to prevent contamination of the samples, we ask the patients in the intervention group to avoid sharing their experiences with other patients during the intervention, and try to keep the intervention and control groups in separate units.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not decided yet and I do not have a plan</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nesa.Khademi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorramabad, Enghelab St., Arasteh Alley, No. 3, No. 97</address>
        <city>KhorramAbad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6816847175</zip>
        <telephone>+98 66 3324 1473</telephone>
        <email>Nesa.Khademi71126@gmail.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Gholami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>km 5 Road of Khorram Abad - Boroujerd - Opposite to the Kahrizak Village- Integrated Lorestan Medica</address>
        <city>khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6814993165</zip>
        <telephone>+98 66 3312 0139</telephone>
        <email>gholami.m@lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>(age 18-60 years)
Abdominal, chest and orthopedic trauma (musculoskeletal)
Having triage level 3 or 4 according to the ESI triage system
Having acute pain means that the pain  started 6 hours ago
Having a minimum score of mild pain based on NRS
having the ability to communicate
The patient is alert and aware
Injury Severity Score (ISS) in terms of anatomical area in the mild to moderate range
No history of admission to the emergency room for 6 months
Absence of sleeping pills, herbal medicines and other complementary medicine treatments from one month ago
All injured transported by 115 emergency</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Mental illness or cognitive impairment
Unstable hemodynamic status
Drug and alcohol abuse
Serious diseases such as advanced liver disease, acute infectious diseases and chronic pain syndrome
Active bleeding
Transfer to the ICU or operating room
Traumas of the face, head and neck and spinal cord
Pregnancy
Allergy to analgesics used in the present study
Being treated with other pain and restlessness management protocols
Participate in other emergency service enhancement interventions affecting experience
Being admitted in an emergency department for less than 90 minutes
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain due to trauma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Intervention The intervention in the present study will include a person-centered care package focusing on three components: a) specialized triage, b: pain management, c: communication therapy / conscious trauma care. Considering that the triage unit is the first service center for trauma victims, first the intervention group, as soon as it is accepted and enters the triage unit, by the main researcher (nurse trained in the field of triage) with a special triage scale that fits the needs, priorities and The condition of trauma patients is triage. This scale is the "Adjusted Emergency Medicine Score (mREMS)"The variables used in this scale include: patient age, systolic blood pressure, heart rate, respiration rate, blood oxygen saturation level and level of consciousness. The sum of the scores of these parameters determines the level of triage of patients. The degree of agreement between the scorers (reliability between the evaluators) is used to perform triage (nurse and emergency physician) to determine the accuracy of triage and the nurse and emergency physician simultaneously triage the patient according to the new criteria and the opinion of the specialist Emergency medicine is the standard gold.After determining the level of triage, pain management begins with a person-centered approach. In this way, the patient's pain is first assessed using the Numerical Pain Rating Scale (NRS), then if the patient needs pain medication based on a pain management protocol previously designed by the current research director and implemented in a previous study. Is . Patient pain management is done with the prescription of a nurse. In this protocol, the nurse is allowed to prescribe analgesics to the patient independently without first examining the patient by a physician.Paracetamol is the first treatment of choice and may be given non-steroidal anti-inflammatory drugs (NSAIDs) such as ketorolac and injectable or morphine suppositories if needed. Depending on the study approach, other options for analgesics such as fentanyl may be considered. Also, according to this protocol, the nurse is obliged to record and evaluate the pain during analgesic administration and re-examine it at intervals of 15 minutes, 30 minutes and one hour after analgesic administration. Allergies, medications, and vital signs, as well as pain assessment, are performed by a triage nurse using the NRS tool, which is color-coded on A4 paper.After determining the pain score, and according to the pain management protocol, for the injured, analgesics are prescribed by the nurse according to the algorithm. After prescribing the drugs based on the method of administration and the amount of pain, the patient's pain is re-examined by the nurse and in case of no pain relief (pain score greater than 4) or side effects and drug reactions due to analgesics, the appropriate decision to re-prescribe anti-pain drug Pain or cessation is taken in consultation with an emergency medicine specialist. For patients with known allergies to analgesics, consult a physician for alternative medicine. Oral analgesics are prescribed with the expectation that the patient will not vomit and will be able to tolerate oral medications orally.In order to provide person-centered care, the third component of the current intervention will be a combination of patient-centered communication and conscious trauma care, which will be performed simultaneously and in parallel with triage and pain management in order to provide a supportive environment for the patient. To achieve this goal, during triage or pain management, the nurse has a dynamic, direct, and continuous presence at the patient's bedside and asks the patient to briefly describe their life situation (such as stress, social life, social support), and possible related experiences. Describe the diagnosis and treatment and previous experience related to hospitalization and pain management.If necessary, other risk factors related to trauma (such as drug use, alcohol use, mental health, etc.) are discussed. During the patient's admission to the emergency room, the patient and the nurse share information about the patient's management of pain, treatment plan and diagnosis, such as blood tests, examinations, imaging, and the use of analgesics, by reviewing the medical record. The nurse also acknowledges symptoms such as pain and fatigue and encourages the patient to describe the problems and barriers associated with managing their pain, and the treatment strategies, benefits, and risks of these treatments will be recommended and discussed.In this exchange of information and participation, factors such as pain, bruising and even emotional stress that are identified in patients' narratives are considered very important for managing emergency care problems and are planned for them. In this supportive context, the patient's participation in planning is emphasized so that the treatment process tailored to each individual's condition is discussed as part of the health care program.This intervention is a flexible intervention, but in the current study, based on the framework of this study, we pursue the same goals such as: patient satisfaction, patient respect, patient pain control, patient participation in the treatment program for all participants.</i_keyword>
      <i_keyword>Control group : In this group, the routine care method of the emergency department is generally performed. In this study, the research environment is the same for the intervention and control groups. Triage of patients in the research environment is with the ESI system. The ESI system is a 5-level triage system that divides patients based on the severity of the disease and the facilities needed by the patient in the emergency room.No special tools are used to assess patients' pain and according to the patients themselves, pain assessment is performed and analgesics are prescribed according to the routine ward by the treating physician and emergency medicine if necessary and the nurse plays an active role in deciding to prescribe anti-pain drugs. There is no pain. Also, the patient-centered communication structure is not implemented in this group, and at the end, patients' experiences will be examined with a questionnaire for the intervention group.Before and during the study, nurses did not use any other standard pain management protocol and there was no structured measurement and recording of pain by nurses. In order to prevent contamination of the samples, we ask the patients in the intervention group to avoid sharing their experiences with other patients during the intervention, and try to keep the intervention and control groups in separate units.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Triage score: It is measured according to the specialized triage criteria of trauma patients. Timepoint: Patients' triage score is measured at the time of admission to the emergency room. Method of measurement: Using the specialized triage criteria of mREMS trauma patients.</prim_outcome>
      <prim_outcome>Pain intensity: Measured using the NRS criterion. Timepoint: Pain intensity is assessed upon arrival, 15, 30, and 60 minutes after analgesia according to the pain control protocol. Method of measurement: Using the NRS criterion.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Triage accuracy: comes from the degree of agreement between the scorers, which includes the principal investigator and the emergency physician. Timepoint: Upon arrival of patients to the emergency room. Method of measurement: comes from the degree of agreement between the scorers, which includes the principal investigator and the emergency physician.</sec_outcome>
      <sec_outcome>Pain control and management. Timepoint: At the onset and at 15, 30 and 60 minutes after the implementation of the pain control protocol. Method of measurement: It is measured in patients using the NRS system.</sec_outcome>
      <sec_outcome>Satisfaction with pain control. Timepoint: When leaving the emergency department. Method of measurement: Using a questionnaire to assess patient satisfaction with pain control.</sec_outcome>
      <sec_outcome>Patients' experiences. Timepoint: When leaving the emergency department. Method of measurement: Using the AEDQ questionnaire.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-10</approval_date>
        <contact_name>Lorestan Medical Sciences Ethics Committee</contact_name>
        <contact_address>Lorestan, Khorramabad, Lorestan University of Medical Sciences, Campus Kamalvand, Vice Chancellor for Research and Technology khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
