<?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>IRCT20100531004062N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the‏ designed ‏transitional care plan from the Open Heart Intensive Care Unit to the general ward in patients undergoing coronary artery bypass graft surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the‏ designed ‏transitional care plan from the Open Heart Intensive Care Unit to the general ward in patients undergoing coronary artery bypass graft surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57664</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: This study is part of a mixed-method study that aims to design, implement and  evaluation of the‏ ‏transitional care plan‏ ‏from OH-‏ICU to general ward; The result of the doctoral dissertation of Nursing, Tehran University of Medical Sciences, School of Nursing and Midwifery, Number: 961199997. In order to design a transitional care program, while examining the concept of transitional care from the perspective of stakeholders (patients, patient companions, physician, and nurse responsible for patient transfer), the needs of patients undergoing CABG surgery eligible for transfer to the general ward have been identified (qualitative study). The program takes into account the preferences and needs of patients and stakeholders, using the best available evidence (systematic review of literature, guidelines, protocols, programs, and models of transitional care over the past 10 years), and the opinions of the Experts panel (Focus group) to be designed. Finally, the transitional care program was designed and developed in four dimensions: 1- Transfer expectation 2- Support, gradual reduction of dependence and increase of independence 3- Communication and strengthening of Care triangle 4- continuity of Integrated and need-based care.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Transitional care program for patients undergoing coronary artery bypass graft surgery from the open heart intensive care unit to the general ward.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: after the necessary explanations to the ‎research samples and obtaining informed consent, before ‎transferring the patient from the open heart surgery-intensive ‎care unit, questionnaires related to the expected outcomes ‎‎(anxiety and perceived social support) are completed. Patients ‎then have a transitional care program that includes measures ‎designed to transfer the patient from the physician's decision ‎to transfer the patient from the open heart surgery-intensive ‎care unit to discharge from the general ward, which is ‎designed to maintain the continuity of the integrated care while ‎transferring the patient. It is performed in a multidisciplinary ‎manner and with the cooperation of the patient, the patient ‎care nurses from the open heart intensive care unit and ‎general care, and the physician with the participation of the ‎patient companions (friend, spouse, or relatives). Interventions ‎are performed by trained nurses to implement this program in ‎the intensive care unit and the general ward. The researcher ‎monitors and tracks the patient and the implementation of the ‎program during the course and records how the program is ‎implemented in the registration forms of the transitional care ‎program. On the day of the patient's discharge, questionnaires ‎related to the expected outcomes (perceived anxiety and social ‎support, patient satisfaction, and family satisfaction) are ‎completed. ‎. Intervention 2: Control group: after the necessary explanations to the research samples and obtaining informed consent, before transferring the patient from the open heart surgery-intensive care unit of , questionnaires related to the expected outcomes (anxiety and perceived social support) are completed. Patients then receive routine care during the transfer to the general ward until the day of discharge. The researcher follows the patient throughout the course to be excluded from the study if they meet the exclusion criteria.On the day of the patient's discharge, questionnaires related to the expected outcomes (perceived anxiety and social support, patient satisfaction and family satisfaction) arecompleted.</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:
The data file, participants' details, information about the outcomes, and the study protocol  with the designed program will be published as an articles

When:
6 months after publishing the results

To whom:
For researchers working in academic institutions with the approval of supervisors and advisors

Conditions:
Only for use  of the designed  program with cited  to the source

Where to obtain:
The main researcher, Ms. Sahar Khoshkasht

How to obtain:
Send email to supervisors Dr. Masoumeh ZakeriMoghadam and Dr. Shahrzad Ghiyasvandian

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Khoshkesht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>‎1419733171‎</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>khoshkesht@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Zakerimoghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4000</telephone>
        <email>zakerimo@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients undergoing Coronary artery bypass graft(CABG) surgery who are candidates for transfer from the Open Heart Intensive Care Unit  (OH-ICU) to the general ward at least two days after surgery as directed by the physician
Level of consciousness 15 according to Glasgow Coma Scale (GCS)
No chronic progressive disease or acute unpredicted complications of surgery
No history of diagnosed psychological disorders</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to continue participating in the study during the intervention
Death of the patient
The occurrence of an unpredictable accident that interferes with the implementation of the program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: after the necessary explanations to the ‎research samples and obtaining informed consent, before ‎transferring the patient from the open heart surgery-intensive ‎care unit, questionnaires related to the expected outcomes ‎‎(anxiety and perceived social support) are completed. Patients ‎then have a transitional care program that includes measures ‎designed to transfer the patient from the physician's decision ‎to transfer the patient from the open heart surgery-intensive ‎care unit to discharge from the general ward, which is ‎designed to maintain the continuity of the integrated care while ‎transferring the patient. It is performed in a multidisciplinary ‎manner and with the cooperation of the patient, the patient ‎care nurses from the open heart intensive care unit and ‎general care, and the physician with the participation of the ‎patient companions (friend, spouse, or relatives). Interventions ‎are performed by trained nurses to implement this program in ‎the intensive care unit and the general ward. The researcher ‎monitors and tracks the patient and the implementation of the ‎program during the course and records how the program is ‎implemented in the registration forms of the transitional care ‎program. On the day of the patient's discharge, questionnaires ‎related to the expected outcomes (perceived anxiety and social ‎support, patient satisfaction, and family satisfaction) are ‎completed. ‎</i_keyword>
      <i_keyword>Control group: after the necessary explanations to the research samples and obtaining informed consent, before transferring the patient from the open heart surgery-intensive care unit of , questionnaires related to the expected outcomes (anxiety and perceived social support) are completed. Patients then receive routine care during the transfer to the general ward until the day of discharge. The researcher follows the patient throughout the course to be excluded from the study if they meet the exclusion criteria.On the day of the patient's discharge, questionnaires related to the expected outcomes (perceived anxiety and social support, patient satisfaction and family satisfaction) arecompleted.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patients Satisfaction. Timepoint: After the intervention. Method of measurement: Patients Satisfaction Instrument.</prim_outcome>
      <prim_outcome>Family Satisfaction. Timepoint: After the intervention. Method of measurement: Family Satisfaction Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after the intervention. Method of measurement: Speilberger State – Trait Anxiety Inventory (STAI-Y)‎.</prim_outcome>
      <prim_outcome>Relocation Stress Syndrome. Timepoint: After the intervention. Method of measurement: Relocation Stress Syndrome Scale.</prim_outcome>
      <prim_outcome>Total Comfort Score. Timepoint: Before and after the intervention. Method of measurement: Visual Analog Scale to Total Comfort.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-19</approval_date>
        <contact_name>‎ ‎Joint institutional research ‎ethics Committee of School of Nursing and Midwifery ‎&amp; ‎Rehabilitat</contact_name>
        <contact_address>Nosrat St., Tohid Sq., School of Nursing &amp; Midwifery, Tehran University of Medical Sciences, Tehra, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
