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/NCT05980741</url>
    </required_header>
    <id_info>
      <org_study_id>TJ-IRB20220940</org_study_id>
      <nct_id>NCT05980741</nct_id>
    </id_info>
    <brief_title>Exploration of New Nursing Models for Urological Surgery</brief_title>
    <official_title>Exploration of New Nursing Models for Urological Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>YaNi Peng</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</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>
        Patients undergoing urological surgery often need to be provided with targeted nursing care&#xD;
        to ensure that the therapeutic effects can be fully realized, however, the traditional&#xD;
        nursing cannot reach the expect effect.both patient outcome and nurse satisfaction have been&#xD;
        reported with high levels of dissatisfaction in the traditional nursing. Therefore, exploring&#xD;
        a new, patient-centered and effective nursing mode is needed. In 2010, the Chinese Ministry&#xD;
        of Health proposed a project named the High-Quality Care Project to improve nurse and patient&#xD;
        outcomes through the transformation of the nursing care delivery system in hospitals. This&#xD;
        study aims to compare the new nursing model and the traditional nursing, and to explore a&#xD;
        more effective nursing model for urological surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who underwent urological disease diagnosed and treated in our department were&#xD;
        included in this study. The patients were randomly divided into two groups through the random&#xD;
        number table method, with a 1:1 ratio. The control group received traditional urological&#xD;
        care. The study group comprised 3 subgroups, and each subgroup received different nursing&#xD;
        model. All the three new nursing models, including high-quality nursing (primary nursing),&#xD;
        Clinical care pathway, and Roy adaptation model.were given to the subgroups respectively.&#xD;
  &#xD;
        High-quality nursing refers to effective nursing measures in multiple aspects and dimensions,&#xD;
        provided to patients according to their actual conditions by centering on the patients&#xD;
        throughout their ongoing treatment, strengthening the primary nursing care, and fully&#xD;
        implementing the nursing responsibility including managing complications and providing&#xD;
        long-term support and information, to ensure patient satisfaction and to improve the&#xD;
        patient's quality of life. Clinical care pathway includes multidisciplinary care plans that&#xD;
        provides detailed guidelines for patients with specific clinical problems, and the Roy&#xD;
        adaptation model (RAM), proposed by nursing scientist Sister Callista Roy in 1970, offers a&#xD;
        comprehensive framework to guide nursing care for patients with chronic diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">May 31, 2023</completion_date>
    <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>High-quality nursing will be provided to the study group based on primary nursing</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patients' quality of life after surgery</measure>
      <time_frame>3 months</time_frame>
      <description>the 36-Item Short Form Health Survey (SF-36)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>3 months</time_frame>
      <description>The patient satisfaction was evaluated by means of an adapted version of Press-Ganey PS scores, which included physician-specific questions and hospital performance questions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>3 months</time_frame>
      <description>Postoperative complications include hemorrhage, infection, and anuria</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The postoperative time to flatus</measure>
      <time_frame>1 month</time_frame>
      <description>postoperative recovery 1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the time for first bowel movement</measure>
      <time_frame>1 month</time_frame>
      <description>postoperative recovery 2</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the length of hospital stay</measure>
      <time_frame>1 month</time_frame>
      <description>postoperative recovery 3</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">300</enrollment>
    <condition>Urological Nursing</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Traditional nursing services are provided to the control group, based on functional nursing. The nurses in the ward are assigned to complete different tasks according to their responsibilities, technical knowledge and skills. These tasks are including carrying out health education to the patients, introducing the admission guidelines and ward conditions, informing patients of basic knowledge on diseases, treatment, and nursing, monitoring patient vital signs and so on. The basic medical inspection and care are conducted appropriately. The patients are instructed on the compliance and precautions required during the perioperative period. The wound and drainage are checked regularly after the operation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>study group High-quality nursing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High-quality nursing is provided to the study group based on primary nursing. Nurses in primary nursing take responsibility for the total care of a patient and are accountable for his/her care over 24 h a day from the patient's admission to discharge. In this case, nurses have more time to communicate with patients and to establish the nurse-patient relationship. In addition, high-quality nursing offers effective nursing measures to patients in terms of multiple aspects and dimensions through planning patient-centered nursing care, strengthening the perioperative nursing since admission, and fully implementing the nursing responsibility system.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>study group Clinical Care Pathway</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The clinical care pathway will be implemented immediately after admission. With the patient as the center of the nursing intervention, a flowable form is chosen to ensure that patients could receive effective nursing interventions throughout the entire hospitalization from the day of admission to the final discharge. In addition to primary care, the present program also unifies the management of nursing resources with the establishment of a highly qualified and professionally competent nursing team. The team members would cooperate with each other and give full play to their respective initiatives, with the common goal of improving the quality of care. The severity of illness, psychological status, and family and social environment in each patient differ, so individualized care plans are developed for each case.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>study group Roy Adaptation Model</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>the Roy Adaptation Model (RAM) offers a comprehensive framework to guide nursing care for patients with chronic diseases. The RAM group receives standard care supplemented with interventions based on the RAM model. Negative emotions measured by the Hospital Anxiety and Depression Scale (HADS), pain intensity by the Visual Analog Scale (VAS), and HRQoL by the 36-Item Short Form Health Survey (SF-36) are measured at the preoperative visit (T0), at 30 days (T1), and at 3 months of (T2) follow-up.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>high-quality nursing</intervention_name>
      <description>High-quality nursing</description>
      <arm_group_label>study group High-quality nursing</arm_group_label>
      <other_name>primary nursing</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Clinical Care Pathway</intervention_name>
      <description>Clinical Care Pathway</description>
      <arm_group_label>study group Clinical Care Pathway</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Roy Adaptation Model</intervention_name>
      <description>Roy Adaptation Model</description>
      <arm_group_label>study group Roy Adaptation Model</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patients with a definite diagnosis of urological disease confirmed by pathological&#xD;
               examination or imaging;&#xD;
  &#xD;
            2. patients with definite surgical indications;&#xD;
  &#xD;
            3. patients with complete follow-up information.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with hepatic or renal dysfunction or serious organic lesions in other organs;&#xD;
  &#xD;
            2. patients with associated lymph node and distant metastases;&#xD;
  &#xD;
            3. patients who withdrew during the study;&#xD;
  &#xD;
            4. patients with incomplete case and follow-up data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>E-Jun Peng, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tong Ji Hospital, Tong Medical College, Huazhong University of Science and Technology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>YaNi Peng</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>High-quality nursing, Primary nursing, Roy Adaptation Model, Urological surgery</keyword>
    <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/NCT05980741
  org study id: TJ-IRB20220940
  nct id: NCT05980741
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients undergoing urological surgery often need to be provided with targeted nursing care
        to ensure that the therapeutic effects can be fully realized, however, the traditional
        nursing cannot reach the expect effect.both patient outcome and nurse satisfaction have been
        reported with high levels of dissatisfaction in the traditional nursing. Therefore, exploring
        a new, patient-centered and effective nursing mode is needed. In 2010, the Chinese Ministry
        of Health proposed a project named the High-Quality Care Project to improve nurse and patient
        outcomes through the transformation of the nursing care delivery system in hospitals. This
        study aims to compare the new nursing model and the traditional nursing, and to explore a
        more effective nursing model for urological surgery.
  Patients who underwent urological disease diagnosed and treated in our department were
        included in this study. The patients were randomly divided into two groups through the random
        number table method, with a 1:1 ratio. The control group received traditional urological
        care. The study group comprised 3 subgroups, and each subgroup received different nursing
        model. All the three new nursing models, including high-quality nursing (primary nursing),
        Clinical care pathway, and Roy adaptation model.were given to the subgroups respectively.
  
        High-quality nursing refers to effective nursing measures in multiple aspects and dimensions,
        provided to patients according to their actual conditions by centering on the patients
        throughout their ongoing treatment, strengthening the primary nursing care, and fully
        implementing the nursing responsibility including managing complications and providing
        long-term support and information, to ensure patient satisfaction and to improve the
        patient's quality of life. Clinical care pathway includes multidisciplinary care plans that
        provides detailed guidelines for patients with specific clinical problems, and the Roy
        adaptation model (RAM), proposed by nursing scientist Sister Callista Roy in 1970, offers a
        comprehensive framework to guide nursing care for patients with chronic diseases.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: High-quality nursing will be provided to the study group based on primary nursing
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  measure: Patients' quality of life after surgery
  time frame: 3 months
  description: the 36-Item Short Form Health Survey (SF-36)
  measure: Patient satisfaction
  time frame: 3 months
  description: The patient satisfaction was evaluated by means of an adapted version of Press-Ganey PS scores, which included physician-specific questions and hospital performance questions
  measure: Postoperative complications
  time frame: 3 months
  description: Postoperative complications include hemorrhage, infection, and anuria
  measure: The postoperative time to flatus
  time frame: 1 month
  description: postoperative recovery 1
  measure: the time for first bowel movement
  time frame: 1 month
  description: postoperative recovery 2
  measure: the length of hospital stay
  time frame: 1 month
  description: postoperative recovery 3
  arm group label: control group
  arm group type: No Intervention
  description: Traditional nursing services are provided to the control group, based on functional nursing. The nurses in the ward are assigned to complete different tasks according to their responsibilities, technical knowledge and skills. These tasks are including carrying out health education to the patients, introducing the admission guidelines and ward conditions, informing patients of basic knowledge on diseases, treatment, and nursing, monitoring patient vital signs and so on. The basic medical inspection and care are conducted appropriately. The patients are instructed on the compliance and precautions required during the perioperative period. The wound and drainage are checked regularly after the operation.
  arm group label: study group High-quality nursing
  arm group type: Experimental
  description: High-quality nursing is provided to the study group based on primary nursing. Nurses in primary nursing take responsibility for the total care of a patient and are accountable for his/her care over 24 h a day from the patient's admission to discharge. In this case, nurses have more time to communicate with patients and to establish the nurse-patient relationship. In addition, high-quality nursing offers effective nursing measures to patients in terms of multiple aspects and dimensions through planning patient-centered nursing care, strengthening the perioperative nursing since admission, and fully implementing the nursing responsibility system.
  arm group label: study group Clinical Care Pathway
  arm group type: Experimental
  description: The clinical care pathway will be implemented immediately after admission. With the patient as the center of the nursing intervention, a flowable form is chosen to ensure that patients could receive effective nursing interventions throughout the entire hospitalization from the day of admission to the final discharge. In addition to primary care, the present program also unifies the management of nursing resources with the establishment of a highly qualified and professionally competent nursing team. The team members would cooperate with each other and give full play to their respective initiatives, with the common goal of improving the quality of care. The severity of illness, psychological status, and family and social environment in each patient differ, so individualized care plans are developed for each case.
  arm group label: study group Roy Adaptation Model
  arm group type: Experimental
  description: the Roy Adaptation Model (RAM) offers a comprehensive framework to guide nursing care for patients with chronic diseases. The RAM group receives standard care supplemented with interventions based on the RAM model. Negative emotions measured by the Hospital Anxiety and Depression Scale (HADS), pain intensity by the Visual Analog Scale (VAS), and HRQoL by the 36-Item Short Form Health Survey (SF-36) are measured at the preoperative visit (T0), at 30 days (T1), and at 3 months of (T2) follow-up.
  intervention type: Procedure
  intervention name: high-quality nursing
  description: High-quality nursing
  arm group label: study group High-quality nursing
  other name: primary nursing
  intervention type: Procedure
  intervention name: Clinical Care Pathway
  description: Clinical Care Pathway
  arm group label: study group Clinical Care Pathway
  intervention type: Procedure
  intervention name: Roy Adaptation Model
  description: Roy Adaptation Model
  arm group label: study group Roy Adaptation Model
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: E-Jun Peng, Dr.
  role: Principal Investigator
  affiliation: Tong Ji Hospital, Tong Medical College, Huazhong University of Science and Technology
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: YaNi Peng
  investigator title: Principal Investigator
  sharing ipd: No