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/NCT06036264</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN132022/CHUSTE</org_study_id>
      <nct_id>NCT06036264</nct_id>
    </id_info>
    <brief_title>Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient</brief_title>
    <acronym>IPASIRC</acronym>
    <official_title>Monocentric Retrospective Cohort Study of the Impact of Advanced Nursing Practice on the Follow-up of the End Stage Chronic Renal Disease Patient: Influence on the Implementation of an Arteriovenous Fistula Prior to Dialysis and on Access to Renal Transplantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        With regard to the fields of competence of advanced practice defined by the Order of October&#xD;
        22, 2021 amending the Order of July 18, 2018 on the system of studies for the State diploma&#xD;
        of advanced practice nurse mentioning renal disease, dialysis and renal transplantation&#xD;
        (MRDT) and the latest recommendations of the French National Authority for Health (HAS) of&#xD;
        July 1 2021 on the monitoring of patients with Chronic Kidney Disease (CKD), the Advanced&#xD;
        Practice Nurse (APN) has its place in improving practices and the care pathway of patients&#xD;
        suffering from end-stage chronic renal failure (CKD).&#xD;
  &#xD;
        In the literature, there are a number of studies arguing the benefits of advanced practice&#xD;
        nurse follow-up with patients suffering from chronic renal failure (CKD) in terms of&#xD;
        improving their psycho-social and self-care skills. However, few studies, particularly in&#xD;
        France, demonstrate its role in the coordination of care. By virtue of their training,&#xD;
        advanced practice nurse with an disease, dialysis and renal transplantation (MRDT)&#xD;
        specialization acquire skills in managing pretransplant assessment files and in planning the&#xD;
        creation of arteriovenous fistula (AVF), which enable them to be autonomous and relevant&#xD;
        professionals in the coordination of these processes. This is why it seems appropriate to&#xD;
        look at the added value that advanced nursing practice can bring to the follow-up of these&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To this end, a study of the practices and social representations of healthcare professionals&#xD;
        involved in the management of Chronic Kidney Disease (CKD) patients can allow us to - To&#xD;
        explore current practices under the focus of follow-up by a nephrologist and an advanced&#xD;
        nurse on access to renal transplantation and on the implementation of arteriovenous fistula&#xD;
        (AVF) versus follow-up by a nephrologist only.&#xD;
  &#xD;
          -  To perceive the &quot;reading grids&quot; that health professionals in transplant centers assign&#xD;
             to the management of this type of patient by an Advanced Practice Nurse (APN).&#xD;
  &#xD;
          -  To question the identity issues associated with the actors by taking into account their&#xD;
             status and roles in the institution and in interdisciplinaritý.&#xD;
  &#xD;
        This study should produce initial results on the changes induced by advanced nursing practice&#xD;
        on access to care and on the improvement of complex care pathways and more particularly for&#xD;
        the Chronic Kidney Disease (CKD) patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2016</start_date>
    <completion_date type="Actual">December 31, 2021</completion_date>
    <primary_completion_date type="Actual">December 31, 2021</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the impact of the implementation of an Advanced Practice Nurse (APN) dedicated to the nephrology care pathway on the creation of arteriovenous fistula before dialysis sessions.</measure>
      <time_frame>Year: 1</time_frame>
      <description>Rate of patients arriving with a functional arteriovenous fistula (AVF) at dialysis start. This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-Advanced Practice Nurse (APN) follow-up and patients starting dialysis who received usual follow-up (control group).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of patients on the transplant list.</measure>
      <time_frame>Year: 1</time_frame>
      <description>This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-IP follow-up and patients starting dialysis who received usual follow-up (control group).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To explore the beliefs and attitudes of healthcare professionals in transplant centers regarding the management of patients by an Advanced Practice Nurse (APN).</measure>
      <time_frame>Year: 1</time_frame>
      <description>Analysis semi-structured interviews results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identify the strengths and areas for improvement of this system.</measure>
      <time_frame>Year: 1</time_frame>
      <description>Analysis semi-structured interviews results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of patients on the transplant list</measure>
      <time_frame>Year: 1</time_frame>
      <description>This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-Advanced Practice Nurse (APN) follow-up and patients starting dialysis who received usual follow-up (control group).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To explore the &quot;reading grids&quot; that healthcare professionals in transplant centers assign to the intervention of the Advanced Practice Nurse (APN) in the management of chronic renal failure (CKD) patients.</measure>
      <time_frame>Year: 1</time_frame>
      <description>Analysis semi-structured interviews results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Isolate the obstacles and facilitators to the intervention of Advanced Practice Nurse (APN) in this care pathway</measure>
      <time_frame>Year: 1</time_frame>
      <description>Analysis semi-structured interviews results.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Renal Disease</condition>
    <arm_group>
      <arm_group_label>Exposed subject group</arm_group_label>
      <description>Patients, starting dialysis, eligible for arteriovenous fistula (AVF) creation and/or renal transplantation who received pre-Advanced Practice Nurse (APN) intervention in their care pathway will be included Datas will be collected of medical record.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comparable unexposed subject group</arm_group_label>
      <description>All patients starting dialysis sessions eligible for arteriovenous fistula (AVF) creation and/or renal transplantation will be included.&#xD;
  Datas will be collected of medical record.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>professional working with the pre-Advanced Practice Nurse (APN)</arm_group_label>
      <description>professional working with the pre-Advanced Practice Nurse (APN) will be included.&#xD;
  Semi-structured interview will be performed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Collected of Datas</intervention_name>
      <description>age, sex, mode of dialysis, emergency context, approach, date of creation of the arteriovenous fistula (if concerned), date of start of dialysis, transplant status, date of registration on the renal transplant waiting list (if concerned), nephrologist, date of first consultation with the pre-nurse in advanced practice (APN) (if concerned)</description>
      <arm_group_label>Comparable unexposed subject group</arm_group_label>
      <arm_group_label>Exposed subject group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>semi-structured interview</intervention_name>
      <description>Semi-structured interviews will be realized. The goal is to establish a qualitative analysis of the relevance and organization of pre-transplant assessments, of the reactivity in the adjustment of requests and assessments, and to identify the strong points or areas for improvement.</description>
      <arm_group_label>professional working with the pre-Advanced Practice Nurse (APN)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient eligible for arteriovenous fistula (AVF) and/or renal transplantation who started&#xD;
          dialysis sessions between January 1st 2016 and December 31st 2021 at the Roanne Hospital&#xD;
          will be included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients starting dialysis sessions&#xD;
  &#xD;
            -  Patient eligible for arteriovenous fistula (AVF) and/or renal transplantation who&#xD;
               started dialysis sessions between January 1st 2016 and December 31st 2021 at the&#xD;
               Roanne Hospital.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient starting dialysis in emergency without prior nephrological followup.&#xD;
  &#xD;
            -  Patients who started dialysis in other dialysis centers (transfer: no knowledge of&#xD;
               their previous nephrological follow-up)&#xD;
  &#xD;
            -  Patients starting dialysis at dates earlier or later than those determined in the&#xD;
               study.&#xD;
  &#xD;
            -  Patients with missing data at the time of data collection.&#xD;
  &#xD;
            -  Patients under legal protection (guardianship, curatorship) or with cognitive&#xD;
               impairment preventing informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Françoise RAY, Nurse</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Hospitalier de Roanne</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>CH de Roanne</name>
        <address>
          <city>Roanne</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>advanced practice nurse</keyword>
    <keyword>kidney transplantation</keyword>
    <keyword>renal disease</keyword>
    <keyword>arteriovenous fistula</keyword>
    <keyword>Chronic Kidney Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
      <mesh_term>Kidney Failure, Chronic</mesh_term>
      <mesh_term>Arteriovenous Fistula</mesh_term>
    </condition_browse>
    <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/NCT06036264
  org study id: IRBN132022/CHUSTE
  nct id: NCT06036264
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  With regard to the fields of competence of advanced practice defined by the Order of October
        22, 2021 amending the Order of July 18, 2018 on the system of studies for the State diploma
        of advanced practice nurse mentioning renal disease, dialysis and renal transplantation
        (MRDT) and the latest recommendations of the French National Authority for Health (HAS) of
        July 1 2021 on the monitoring of patients with Chronic Kidney Disease (CKD), the Advanced
        Practice Nurse (APN) has its place in improving practices and the care pathway of patients
        suffering from end-stage chronic renal failure (CKD).
  
        In the literature, there are a number of studies arguing the benefits of advanced practice
        nurse follow-up with patients suffering from chronic renal failure (CKD) in terms of
        improving their psycho-social and self-care skills. However, few studies, particularly in
        France, demonstrate its role in the coordination of care. By virtue of their training,
        advanced practice nurse with an disease, dialysis and renal transplantation (MRDT)
        specialization acquire skills in managing pretransplant assessment files and in planning the
        creation of arteriovenous fistula (AVF), which enable them to be autonomous and relevant
        professionals in the coordination of these processes. This is why it seems appropriate to
        look at the added value that advanced nursing practice can bring to the follow-up of these
        patients.
  To this end, a study of the practices and social representations of healthcare professionals
        involved in the management of Chronic Kidney Disease (CKD) patients can allow us to - To
        explore current practices under the focus of follow-up by a nephrologist and an advanced
        nurse on access to renal transplantation and on the implementation of arteriovenous fistula
        (AVF) versus follow-up by a nephrologist only.
  
          -  To perceive the "reading grids" that health professionals in transplant centers assign
             to the management of this type of patient by an Advanced Practice Nurse (APN).
  
          -  To question the identity issues associated with the actors by taking into account their
             status and roles in the institution and in interdisciplinaritý.
  
        This study should produce initial results on the changes induced by advanced nursing practice
        on access to care and on the improvement of complex care pathways and more particularly for
        the Chronic Kidney Disease (CKD) patient.
  observational model: Cohort
  time perspective: Retrospective
  measure: To evaluate the impact of the implementation of an Advanced Practice Nurse (APN) dedicated to the nephrology care pathway on the creation of arteriovenous fistula before dialysis sessions.
  time frame: Year: 1
  description: Rate of patients arriving with a functional arteriovenous fistula (AVF) at dialysis start. This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-Advanced Practice Nurse (APN) follow-up and patients starting dialysis who received usual follow-up (control group).
  measure: Rate of patients on the transplant list.
  time frame: Year: 1
  description: This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-IP follow-up and patients starting dialysis who received usual follow-up (control group).
  measure: To explore the beliefs and attitudes of healthcare professionals in transplant centers regarding the management of patients by an Advanced Practice Nurse (APN).
  time frame: Year: 1
  description: Analysis semi-structured interviews results.
  measure: Identify the strengths and areas for improvement of this system.
  time frame: Year: 1
  description: Analysis semi-structured interviews results.
  measure: Rate of patients on the transplant list
  time frame: Year: 1
  description: This rate will be compared between patients starting dialysis who received alternating nephrologist/pre-Advanced Practice Nurse (APN) follow-up and patients starting dialysis who received usual follow-up (control group).
  measure: To explore the "reading grids" that healthcare professionals in transplant centers assign to the intervention of the Advanced Practice Nurse (APN) in the management of chronic renal failure (CKD) patients.
  time frame: Year: 1
  description: Analysis semi-structured interviews results.
  measure: Isolate the obstacles and facilitators to the intervention of Advanced Practice Nurse (APN) in this care pathway
  time frame: Year: 1
  description: Analysis semi-structured interviews results.
  arm group label: Exposed subject group
  description: Patients, starting dialysis, eligible for arteriovenous fistula (AVF) creation and/or renal transplantation who received pre-Advanced Practice Nurse (APN) intervention in their care pathway will be included Datas will be collected of medical record.
  arm group label: Comparable unexposed subject group
  description: All patients starting dialysis sessions eligible for arteriovenous fistula (AVF) creation and/or renal transplantation will be included.
  Datas will be collected of medical record.
  arm group label: professional working with the pre-Advanced Practice Nurse (APN)
  description: professional working with the pre-Advanced Practice Nurse (APN) will be included.
  Semi-structured interview will be performed.
  intervention type: Other
  intervention name: Collected of Datas
  description: age, sex, mode of dialysis, emergency context, approach, date of creation of the arteriovenous fistula (if concerned), date of start of dialysis, transplant status, date of registration on the renal transplant waiting list (if concerned), nephrologist, date of first consultation with the pre-nurse in advanced practice (APN) (if concerned)
  arm group label: Comparable unexposed subject group
  arm group label: Exposed subject group
  intervention type: Other
  intervention name: semi-structured interview
  description: Semi-structured interviews will be realized. The goal is to establish a qualitative analysis of the relevance and organization of pre-transplant assessments, of the reactivity in the adjustment of requests and assessments, and to identify the strong points or areas for improvement.
  arm group label: professional working with the pre-Advanced Practice Nurse (APN)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Françoise RAY, Nurse
  role: Principal Investigator
  affiliation: Centre Hospitalier de Roanne
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Kidney Failure, Chronic
  mesh term: Arteriovenous Fistula
  sharing ipd: No