<?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>IRCT201107187053N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using critical care service team on mortality of acutely ill patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of using critical care service team in comparison to routine care on mortality of acutely ill patients in general wards</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-07-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7484</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research, Other design features: Assigning the participating wards to the intervention was at random.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acutely Ill Patients.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group: In this study the intervention group will receive the critical care service (CCS). The steps of intervention will be  training of ward nurses, admitting acutly ill patients (AIPs) under the care of CCS and management and follow up of CCS patients. These steps explain in detail as below: 1- Training of ward nurses : Because ward nurses are the first step in the CCS process, an additional 8-week period of training is provided for them before starting the intervention on each ward. During this stage identifying the acutely ill patients , the process of CCS  and patients  care will explained to ward staff.  2- Admitting AIPs under the care of CCS:  Patients can come under the care of the CCS in one of three ways: a) patients who met the criteria (for example: high blood presssure (  are referred by the ward staff to the CCS team; b) patients will discharge from ICU; and c) the CCS team can actively identify patients in the wards. Ward nurses will identify patients requiring intervention by the CCS based on the standard criteria. The ward nursing staff will report any changes in systolic blood pressure, respiratory rate, heart rate, urinary output, body temperature, level of consciousness and any other general concerns about the patient’s condition to the shift’s head nurse. They will continue to observe the patients for 30 minutes, and if there is no improvement; they will inform the CCS team. Then the CCS team will attend the patient’s bedside. The patient’s care is taken over by the CCS team if the patient has a acute condition. If the patient is assess and find not to need CCS (those with  no acute condition), they are given the same treatments as other patients in wards. Also,  list of patients, who are transfer from ICUs to general wards, is taken from supervisors in each shift and pass to the CCS team. Following these patients are visit by CCS team members and place in CCS team service.  3- Management and follow up of CCS patients: After admitting patients to CCS, immediate evaluations are carried out and decisions are made for their management. Methods for patients’ management are applied to CCS patients, as will describe below: a) Active intervention: In these situations, team members are responsible for patients’ critical care, such as airway suction, changes in patients’ position, oxygen therapy, and consultation with physicians about patient care.  b) Training of ward staff:  Medical staffs, particularly wards nurses, are trained in patient care. This include appropriate airway management, suction, oxygen therapy, changing the patient’s position, endotracheal tube care, working with a ventilator and regulating its settings based on the patient’s needs. The team members give practical tutoring to the staff on the correct performance of these procedures. c) Training and active intervention: This method is a combination of previous methods. After intervention, haemodynamically stable patients are observed for 72hours and then discharge from CCS if they recover. If not, another intervention is decided upon. Patients who remain ill and unstable, or whose conditions cause concern, are transferred to ICU if there are any empty beds available. If not, the intervention is continued on general wards. Intervention 2: Control group: This group will recieve routine ward care and usual practices vis-a-vis urgent patient situaions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Jeddian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8490 2101</telephone>
        <email>jeddian@mohme.gov.ir</email>
        <affiliation>Tehran University of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Jeddian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8490 2101</telephone>
        <email>jeddian@mohme.gov.ir</email>
        <affiliation>Tehran university of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The role of CCS is to deliver care in the non-critical care units of general hospital wards  and all patients who will admit to these wards were included in the trial. Exclusion criteria are burn;cardiac surgery; pediatric and neonatal patients .</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>120 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group: In this study the intervention group will receive the critical care service (CCS). The steps of intervention will be  training of ward nurses, admitting acutly ill patients (AIPs) under the care of CCS and management and follow up of CCS patients. These steps explain in detail as below: 1- Training of ward nurses : Because ward nurses are the first step in the CCS process, an additional 8-week period of training is provided for them before starting the intervention on each ward. During this stage identifying the acutely ill patients , the process of CCS  and patients  care will explained to ward staff.  2- Admitting AIPs under the care of CCS:  Patients can come under the care of the CCS in one of three ways: a) patients who met the criteria (for example: high blood presssure (  are referred by the ward staff to the CCS team; b) patients will discharge from ICU; and c) the CCS team can actively identify patients in the wards. Ward nurses will identify patients requiring intervention by the CCS based on the standard criteria. The ward nursing staff will report any changes in systolic blood pressure, respiratory rate, heart rate, urinary output, body temperature, level of consciousness and any other general concerns about the patient’s condition to the shift’s head nurse. They will continue to observe the patients for 30 minutes, and if there is no improvement; they will inform the CCS team. Then the CCS team will attend the patient’s bedside. The patient’s care is taken over by the CCS team if the patient has a acute condition. If the patient is assess and find not to need CCS (those with  no acute condition), they are given the same treatments as other patients in wards. Also,  list of patients, who are transfer from ICUs to general wards, is taken from supervisors in each shift and pass to the CCS team. Following these patients are visit by CCS team members and place in CCS team service.  3- Management and follow up of CCS patients: After admitting patients to CCS, immediate evaluations are carried out and decisions are made for their management. Methods for patients’ management are applied to CCS patients, as will describe below: a) Active intervention: In these situations, team members are responsible for patients’ critical care, such as airway suction, changes in patients’ position, oxygen therapy, and consultation with physicians about patient care.  b) Training of ward staff:  Medical staffs, particularly wards nurses, are trained in patient care. This include appropriate airway management, suction, oxygen therapy, changing the patient’s position, endotracheal tube care, working with a ventilator and regulating its settings based on the patient’s needs. The team members give practical tutoring to the staff on the correct performance of these procedures. c) Training and active intervention: This method is a combination of previous methods. After intervention, haemodynamically stable patients are observed for 72hours and then discharge from CCS if they recover. If not, another intervention is decided upon. Patients who remain ill and unstable, or whose conditions cause concern, are transferred to ICU if there are any empty beds available. If not, the intervention is continued on general wards.</i_keyword>
      <i_keyword>Control group: This group will recieve routine ward care and usual practices vis-a-vis urgent patient situaions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Number of deaths. Timepoint: during three phases of recieving routtine care, while on training and while recieving intervention. Method of measurement: Physician’s certification of death.</prim_outcome>
      <prim_outcome>Number of Cardio-pulmonary resucitations. Timepoint: during three phases of recieving routtine care, while on training and while recieving intervention. Method of measurement: A CPR call that was made for the patient (was called code 145 in study setting) and completed CPR forms in the medical records of the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Length of stay. Timepoint: during three phases of recieving routtine care, while on training and while recieving intervention. Method of measurement: Total days of patients hospitalization according to the hospital information system.</sec_outcome>
      <sec_outcome>Admission to ICU. Timepoint: during three phases of recieving routtine care, while on training and while recieving intervention. Method of measurement: Number of patient who will admit to the ICU from general wards (medical and surgical).</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>Vice chancellor for research, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethics committee of Tehran university of medical sciences</contact_name>
        <contact_address>Ghods St., Keshavarz Blvd, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
