xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038266</url>
    </required_header>
    <id_info>
      <org_study_id>PHR for Cardiac Surgery</org_study_id>
      <nct_id>NCT06038266</nct_id>
    </id_info>
    <brief_title>Predictors of Hospital Readmission for Patients Undergoing Cardiac Surgeries</brief_title>
    <official_title>Predictors of Hospital Readmission for Patients Undergoing Cardiac Surgeries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aimed to identify the predictors of hospital readmission for patients undergoing&#xD;
        cardiac surgeries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular diseases (CVDs) are conditions of the heart and blood vessels that lead to&#xD;
        significant morbidity and mortality, burden the global public health system, and are the main&#xD;
        cause of death worldwide. CVD accounted for approximately 19.05 million global deaths in&#xD;
        2020. CVD is listed as the first underlying cause of death, with more than 800000 deaths in&#xD;
        the United States in 2019. Between 2015 and 2018, 126.9 million US adults had some form of&#xD;
        CVD. Between 2017 and 2018, direct and indirect costs of total CVD were $378.0 billion&#xD;
        ($226.2. billion in direct costs and $151.8 billion in lost productivity/mortality).&#xD;
  &#xD;
        Cardiac surgery continues to play an important role in the management of various&#xD;
        cardiovascular disorders, including the treatment of seriously and critically ill patients.&#xD;
        The most frequently performed procedures include coronary artery bypass graft (CABG) and&#xD;
        valvular surgery. According to the Society of Thoracic Surgeons, the number of cardiac&#xD;
        surgeries exceeds 300000 procedures in 2019 in the United States. Despite tremendous&#xD;
        advancements in cardiac surgery over the past few years, postoperative hospital readmissions&#xD;
        after cardiac surgeries still present significant challenges.&#xD;
  &#xD;
        Readmission occurs when a patient is admitted to the same or a different hospital after being&#xD;
        discharged from the relevant hospital and placed in a non-acute setting, such as his home,&#xD;
        within a predetermined amount of time. Readmission within 30 days of adult cardiac surgery is&#xD;
        a difﬁcult and costly problem, with rates ranging from 8% to 21%. In addition to delayed&#xD;
        return to activities of daily living and reduced quality of life, readmission is associated&#xD;
        with a ﬁnancial cost for patients and healthcare facilities. Increased facility costs can be&#xD;
        substantial, especially when combined with reimbursement penalties, the cost of skilled care,&#xD;
        and potential legal expenses.&#xD;
  &#xD;
        Readmission after cardiac surgery is common and moderately predictable. According to a study&#xD;
        done in a multi-institutional hospital in Ontario, Canada on patients who underwent CABG&#xD;
        and/or valve surgery from 2008 to 2016, the 30-day readmission rate was 11.5% overall.&#xD;
        Patients who were readmitted were older with higher incidences of cardiac comorbidities&#xD;
        compared with non-readmitted patients. Signiﬁcant risk factors for readmission from the ﬁnal&#xD;
        model were the prolonged length of stay, isolated valve surgery, in-hospital complications of&#xD;
        sepsis, acute myocardial infarction, diabetes mellitus, gastrointestinal problems wound&#xD;
        infection, postoperative acute renal failure, atrial ﬁbrillation (AF), chronic lung disease,&#xD;
        obesity, hematocrit &lt;35% before surgery, cardiopulmonary bypass, especially bypass durations&#xD;
        of more than 100 minutes.&#xD;
  &#xD;
        Perioperative nurses may positively affect reducing readmission rates at different stages of&#xD;
        the perioperative continuum of care. All nursing interventions play an important role in&#xD;
        minimizing patient risk and preventing or reducing the number of readmissions. Nursing&#xD;
        strategies to reduce postoperative cardiac surgery readmission include central line and&#xD;
        urinary catheter insertion, cardiopulmonary bypass circuit maintenance, temperature&#xD;
        regulation, hair removal, and skin preparation, glycemic control, care of the incision site,&#xD;
        treatment and prevention of dysrhythmia, pleural effusion and retained blood syndrome,&#xD;
        appropriate discharge teaching, following up with the patients after discharge through&#xD;
        telephone conversations and post-discharge care.&#xD;
  &#xD;
        Reducing readmission after cardiac surgery remains a quality improvement priority. most&#xD;
        readmission risk models examine only coronary artery bypass grafting (CABG). So, this study&#xD;
        will be carried out to identify predictors of patients' postoperative readmission after&#xD;
        cardiac surgery, including CABG &amp; valvular surgeries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>detect perioperative risk factors for hospital readmission in patients whose undergoing cardiac surgeries</measure>
      <time_frame>baseline</time_frame>
      <description>analysis of pre, intra and postoperative risk factors that may cause readmission for patients undergoing Valvular surgery or Coronary artery bypass grafting (CABG)</description>
    </primary_outcome>
    <enrollment type="Anticipated">121</enrollment>
    <condition>Cardiac Surgery, Readmission</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cardiac surgeries</intervention_name>
      <description>predict perioperative risk factors for readmission after cardiac surgeries</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will include a sample of 121 adult patients (male and female) who are undergoing&#xD;
          CABG or Cardiac Valvular surgeries and whose age is from 18 to 65 years old.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The study will include a sample of 121 adult patients (male and female) who are&#xD;
               undergoing CABG or Cardiac Valvular surgeries and whose age is from 18 to 65 years&#xD;
               old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Failed surgery&#xD;
  &#xD;
            -  Psychiatric patient&#xD;
  &#xD;
            -  Patient refusal to participate in the study&#xD;
  &#xD;
            -  Aortic surgeries&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Marwa Ali Almasry, Ass.Prof</last_name>
      <role>Study Director</role>
      <affiliation>Assistant professor of medical surgical nursing</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mahmoud FathI Abdelhafeez Soliman, BSN</last_name>
      <phone>+201006579808</phone>
      <email>mahmoud808@aun.edu.eg</email>
    </overall_contact>
    <reference>
      <citation>Iribarne A, Chang H, Alexander JH, Gillinov AM, Moquete E, Puskas JD, Bagiella E, Acker MA, Mayer ML, Ferguson TB, Burks S, Perrault LP, Welsh S, Johnston KC, Murphy M, DeRose JJ, Neill A, Dobrev E, Baio KT, Taddei-Peters W, Moskowitz AJ, O'Gara PT. Readmissions after cardiac surgery: experience of the National Institutes of Health/Canadian Institutes of Health research cardiothoracic surgical trials network. Ann Thorac Surg. 2014 Oct;98(4):1274-80. doi: 10.1016/j.athoracsur.2014.06.059. Epub 2014 Aug 28.</citation>
      <PMID>25173721</PMID>
    </reference>
    <reference>
      <citation>Seifert PC. Reducing Readmissions After Coronary Artery Bypass Grafting. AORN J. 2017 Oct;106(4):332-337. doi: 10.1016/j.aorn.2017.08.009. No abstract available.</citation>
      <PMID>28958319</PMID>
    </reference>
    <reference>
      <citation>Ferraris VA, Ferraris SP, Harmon RC, Evans BD. Risk factors for early hospital readmission after cardiac operations. J Thorac Cardiovasc Surg. 2001 Aug;122(2):278-86. doi: 10.1067/mtc.2001.114776.</citation>
      <PMID>11479500</PMID>
    </reference>
    <reference>
      <citation>Demissie, D. B., Doge, G., &amp; Werba, T. B. (2023). The Magnitude of 30-Day Readmission and Factors Associated with Patients Underwent Cardiac Surgery in Tikur Anbessa Specialized Hospital Cardiac Center, Ethiopia. Research Reports in Clinical Cardiology, Volume 14, 35-48. https://doi.org/10.2147/rrcc.s407183</citation>
    </reference>
    <reference>
      <citation>Stephens RS, Whitman GJ. Postoperative Critical Care of the Adult Cardiac Surgical Patient. Part I: Routine Postoperative Care. Crit Care Med. 2015 Jul;43(7):1477-97. doi: 10.1097/CCM.0000000000001059.</citation>
      <PMID>25962078</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mahmoud Fathy Abdelhafeez Soliman</investigator_full_name>
      <investigator_title>Mr.</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038266
  org study id: PHR for Cardiac Surgery
  nct id: NCT06038266
  lead sponsor: 
  has dmc: Yes
  is fda regulated device: No
  This study aimed to identify the predictors of hospital readmission for patients undergoing
        cardiac surgeries.
  Cardiovascular diseases (CVDs) are conditions of the heart and blood vessels that lead to
        significant morbidity and mortality, burden the global public health system, and are the main
        cause of death worldwide. CVD accounted for approximately 19.05 million global deaths in
        2020. CVD is listed as the first underlying cause of death, with more than 800000 deaths in
        the United States in 2019. Between 2015 and 2018, 126.9 million US adults had some form of
        CVD. Between 2017 and 2018, direct and indirect costs of total CVD were $378.0 billion
        ($226.2. billion in direct costs and $151.8 billion in lost productivity/mortality).
  
        Cardiac surgery continues to play an important role in the management of various
        cardiovascular disorders, including the treatment of seriously and critically ill patients.
        The most frequently performed procedures include coronary artery bypass graft (CABG) and
        valvular surgery. According to the Society of Thoracic Surgeons, the number of cardiac
        surgeries exceeds 300000 procedures in 2019 in the United States. Despite tremendous
        advancements in cardiac surgery over the past few years, postoperative hospital readmissions
        after cardiac surgeries still present significant challenges.
  
        Readmission occurs when a patient is admitted to the same or a different hospital after being
        discharged from the relevant hospital and placed in a non-acute setting, such as his home,
        within a predetermined amount of time. Readmission within 30 days of adult cardiac surgery is
        a difﬁcult and costly problem, with rates ranging from 8% to 21%. In addition to delayed
        return to activities of daily living and reduced quality of life, readmission is associated
        with a ﬁnancial cost for patients and healthcare facilities. Increased facility costs can be
        substantial, especially when combined with reimbursement penalties, the cost of skilled care,
        and potential legal expenses.
  
        Readmission after cardiac surgery is common and moderately predictable. According to a study
        done in a multi-institutional hospital in Ontario, Canada on patients who underwent CABG
        and/or valve surgery from 2008 to 2016, the 30-day readmission rate was 11.5% overall.
        Patients who were readmitted were older with higher incidences of cardiac comorbidities
        compared with non-readmitted patients. Signiﬁcant risk factors for readmission from the ﬁnal
        model were the prolonged length of stay, isolated valve surgery, in-hospital complications of
        sepsis, acute myocardial infarction, diabetes mellitus, gastrointestinal problems wound
        infection, postoperative acute renal failure, atrial ﬁbrillation (AF), chronic lung disease,
        obesity, hematocrit <35% before surgery, cardiopulmonary bypass, especially bypass durations
        of more than 100 minutes.
  
        Perioperative nurses may positively affect reducing readmission rates at different stages of
        the perioperative continuum of care. All nursing interventions play an important role in
        minimizing patient risk and preventing or reducing the number of readmissions. Nursing
        strategies to reduce postoperative cardiac surgery readmission include central line and
        urinary catheter insertion, cardiopulmonary bypass circuit maintenance, temperature
        regulation, hair removal, and skin preparation, glycemic control, care of the incision site,
        treatment and prevention of dysrhythmia, pleural effusion and retained blood syndrome,
        appropriate discharge teaching, following up with the patients after discharge through
        telephone conversations and post-discharge care.
  
        Reducing readmission after cardiac surgery remains a quality improvement priority. most
        readmission risk models examine only coronary artery bypass grafting (CABG). So, this study
        will be carried out to identify predictors of patients' postoperative readmission after
        cardiac surgery, including CABG & valvular surgeries.
  observational model: Cohort
  time perspective: Prospective
  measure: detect perioperative risk factors for hospital readmission in patients whose undergoing cardiac surgeries
  time frame: baseline
  description: analysis of pre, intra and postoperative risk factors that may cause readmission for patients undergoing Valvular surgery or Coronary artery bypass grafting (CABG)
  intervention type: Procedure
  intervention name: cardiac surgeries
  description: predict perioperative risk factors for readmission after cardiac surgeries
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: Marwa Ali Almasry, Ass.Prof
  role: Study Director
  affiliation: Assistant professor of medical surgical nursing
  last name: Mahmoud FathI Abdelhafeez Soliman, BSN
  phone: +201006579808
  email: mahmoud808@aun.edu.eg
  citation: Iribarne A, Chang H, Alexander JH, Gillinov AM, Moquete E, Puskas JD, Bagiella E, Acker MA, Mayer ML, Ferguson TB, Burks S, Perrault LP, Welsh S, Johnston KC, Murphy M, DeRose JJ, Neill A, Dobrev E, Baio KT, Taddei-Peters W, Moskowitz AJ, O'Gara PT. Readmissions after cardiac surgery: experience of the National Institutes of Health/Canadian Institutes of Health research cardiothoracic surgical trials network. Ann Thorac Surg. 2014 Oct;98(4):1274-80. doi: 10.1016/j.athoracsur.2014.06.059. Epub 2014 Aug 28.
  PMID: 25173721
  citation: Seifert PC. Reducing Readmissions After Coronary Artery Bypass Grafting. AORN J. 2017 Oct;106(4):332-337. doi: 10.1016/j.aorn.2017.08.009. No abstract available.
  PMID: 28958319
  citation: Ferraris VA, Ferraris SP, Harmon RC, Evans BD. Risk factors for early hospital readmission after cardiac operations. J Thorac Cardiovasc Surg. 2001 Aug;122(2):278-86. doi: 10.1067/mtc.2001.114776.
  PMID: 11479500
  citation: Demissie, D. B., Doge, G., & Werba, T. B. (2023). The Magnitude of 30-Day Readmission and Factors Associated with Patients Underwent Cardiac Surgery in Tikur Anbessa Specialized Hospital Cardiac Center, Ethiopia. Research Reports in Clinical Cardiology, Volume 14, 35-48. https://doi.org/10.2147/rrcc.s407183
  citation: Stephens RS, Whitman GJ. Postoperative Critical Care of the Adult Cardiac Surgical Patient. Part I: Routine Postoperative Care. Crit Care Med. 2015 Jul;43(7):1477-97. doi: 10.1097/CCM.0000000000001059.
  PMID: 25962078
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mahmoud Fathy Abdelhafeez Soliman
  investigator title: Mr.
  sharing ipd: No