<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/NCT04504084</url>
  </required_header>
  <id_info>
    <org_study_id>N202003100</org_study_id>
    <nct_id>NCT04504084</nct_id>
  </id_info>
  <brief_title>Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial</brief_title>
  <official_title>Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Shuang Ho Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University Shuang Ho Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Ureteral stone is a common disease with high prevalence and recurrence rate in Taiwan. Taiwan&#xD;
      is located in subtropical zone, where urolithiasis is commonly seen. A national survey in&#xD;
      Taiwan determined that 9.6% of the population suffered stones throughout their lifetime.&#xD;
      Symptoms of ureteral stone include renal colic, hematuria, and urinary tract infection.&#xD;
      Without proper treatment, ureteral stone could lead to renal function impairment such as&#xD;
      acute kidney injury (AKI) or chronic kidney disease (CKD). There are several treatment&#xD;
      options for ureteral stone, such as ureteroscopic lithotripsy (URSL), flexible urteroscopic&#xD;
      lithotripsy (F-URSL), percutaneous nephrolithotomy (PCNL), extracorporeal shock wave&#xD;
      lithotripsy (ESWL), and Medical expulsive therapy (MET).&#xD;
&#xD;
      However, there are only few minutes from diagnosis of ureteral stone to possible treatment&#xD;
      options explanation. It's difficult for patients to well understand all the details of&#xD;
      possible treatments under such circumstances.&#xD;
&#xD;
      Therefore, we design a patient decision aid (PDA) for unilateral ureteral stone to help&#xD;
      patients understand all the treatment options. The PDA is standardized, written in plain&#xD;
      language and patient-centered, with pictures attached.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Shared decision making (SDM) has been defined as: 'an approach where clinicians and patients&#xD;
      share the best available evidence when faced with the task of making decisions, and where&#xD;
      patients are supported to consider options, to achieve informed preferences&quot;. To conduct SDM,&#xD;
      a PDA was developed to be administered for patients with ureteral stone to choose treatment&#xD;
      options. We expect the PDA would benefit the intervention group in the aspects of knowledge&#xD;
      and communication in choosing treatment.The aim of this study is to conduct a single center&#xD;
      randomized controlled trial (RCT ) to evaluate the benefit of PDAs on decision making.&#xD;
&#xD;
      Patients and Methods:&#xD;
&#xD;
      Decision aids are interventions designed to help patients with ureteral stone to choose their&#xD;
      treatment options for unilateral ureteral stone and any potential outcome relevant to&#xD;
      treatment options. Patients with unilateral ureteral stone are randomly assigned to receive a&#xD;
      PDA (PDA group) or the standard oral information (control group) during consultation.&#xD;
&#xD;
      In control group, patients will receive standard oral information. In PDA group group, PDA&#xD;
      will be used as a tool to explain the benefits and harms between ureteroscopic lithotripsy&#xD;
      (URSL), flexible urteroscopic lithotripsy (F-URSL), extracorporeal shock wave lithotripsy&#xD;
      (ESWL). And by following SDM principles, the patients are guided to consider their individual&#xD;
      values and preferences and helped to make a choice that best meet their needs. This study&#xD;
      will be conducted in a single center (Shuang Ho Hospital). The outcomes are decision&#xD;
      conflicts and decision-making and SURE test before treatment.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      We expect that the PDA would promote communications between doctors and patients, to further&#xD;
      help the patient to make a proper decision for his/her own.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Parallel Assignment</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decision conflicts</measure>
    <time_frame>For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.</time_frame>
    <description>Total score of decisional conflict scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SURE test</measure>
    <time_frame>For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.</time_frame>
    <description>Total score of SURE test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Patient Decision Aids</condition>
  <condition>Ureteral Stone</condition>
  <condition>Shared Decision Making</condition>
  <arm_group>
    <arm_group_label>Decision aid group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shared decision making using decision aid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controlled group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard oral explanation the details of treament options</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision aid</intervention_name>
    <description>Patient Decision Aid is a tool that helps patient with ureteral stone become involved in decision making on choosing treatment for ureteral stone. Patient Decision Aid provides information about the options and outcomes, and by clarifying personal values.</description>
    <arm_group_label>Decision aid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 18 and 75&#xD;
&#xD;
          -  Ureteral stone diagnosed with KUB, IVP or CT&#xD;
&#xD;
          -  Stone size between 0 to 2 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stone passage spontaneously&#xD;
&#xD;
          -  Patients who do not speak Mandarian&#xD;
&#xD;
          -  Patients with dementia&#xD;
&#xD;
          -  Nationality not Republic of China&#xD;
&#xD;
          -  Patients with bilateral ureteral stone&#xD;
&#xD;
          -  Patients with staghorn stone&#xD;
&#xD;
          -  Patients with bladder stone&#xD;
&#xD;
          -  Patients with severe infection&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Others patients could not communicate with&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Te Chiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi-Te Chiang, MD</last_name>
    <phone>+886988261275</phone>
    <email>11229@s.tmu.edu.tw</email>
  </overall_contact>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ureteral Calculi</mesh_term>
    <mesh_term>Ureterolithiasis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04504084
org study id: N202003100
nct id: NCT04504084
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ureteral stone is a common disease with high prevalence and recurrence rate in Taiwan. Taiwan
      is located in subtropical zone, where urolithiasis is commonly seen. A national survey in
      Taiwan determined that 9.6% of the population suffered stones throughout their lifetime.
      Symptoms of ureteral stone include renal colic, hematuria, and urinary tract infection.
      Without proper treatment, ureteral stone could lead to renal function impairment such as
      acute kidney injury (AKI) or chronic kidney disease (CKD). There are several treatment
      options for ureteral stone, such as ureteroscopic lithotripsy (URSL), flexible urteroscopic
      lithotripsy (F-URSL), percutaneous nephrolithotomy (PCNL), extracorporeal shock wave
      lithotripsy (ESWL), and Medical expulsive therapy (MET).

      However, there are only few minutes from diagnosis of ureteral stone to possible treatment
      options explanation. It's difficult for patients to well understand all the details of
      possible treatments under such circumstances.

      Therefore, we design a patient decision aid (PDA) for unilateral ureteral stone to help
      patients understand all the treatment options. The PDA is standardized, written in plain
      language and patient-centered, with pictures attached.
Background:

      Shared decision making (SDM) has been defined as: 'an approach where clinicians and patients
      share the best available evidence when faced with the task of making decisions, and where
      patients are supported to consider options, to achieve informed preferences". To conduct SDM,
      a PDA was developed to be administered for patients with ureteral stone to choose treatment
      options. We expect the PDA would benefit the intervention group in the aspects of knowledge
      and communication in choosing treatment.The aim of this study is to conduct a single center
      randomized controlled trial (RCT ) to evaluate the benefit of PDAs on decision making.

      Patients and Methods:

      Decision aids are interventions designed to help patients with ureteral stone to choose their
      treatment options for unilateral ureteral stone and any potential outcome relevant to
      treatment options. Patients with unilateral ureteral stone are randomly assigned to receive a
      PDA (PDA group) or the standard oral information (control group) during consultation.

      In control group, patients will receive standard oral information. In PDA group group, PDA
      will be used as a tool to explain the benefits and harms between ureteroscopic lithotripsy
      (URSL), flexible urteroscopic lithotripsy (F-URSL), extracorporeal shock wave lithotripsy
      (ESWL). And by following SDM principles, the patients are guided to consider their individual
      values and preferences and helped to make a choice that best meet their needs. This study
      will be conducted in a single center (Shuang Ho Hospital). The outcomes are decision
      conflicts and decision-making and SURE test before treatment.

      Hypothesis:

      We expect that the PDA would promote communications between doctors and patients, to further
      help the patient to make a proper decision for his/her own.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Decision conflicts
time frame: For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.
description: Total score of decisional conflict scale
measure: SURE test
time frame: For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.
description: Total score of SURE test
arm group label: Decision aid group
arm group type: Experimental
description: Shared decision making using decision aid
arm group label: Controlled group
arm group type: No Intervention
description: Standard oral explanation the details of treament options
intervention type: Other
intervention name: Decision aid
description: Patient Decision Aid is a tool that helps patient with ureteral stone become involved in decision making on choosing treatment for ureteral stone. Patient Decision Aid provides information about the options and outcomes, and by clarifying personal values.
arm group label: Decision aid group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yi-Te Chiang, MD
role: Principal Investigator
affiliation: No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital
last name: Yi-Te Chiang, MD
phone: +886988261275
email: 11229@s.tmu.edu.tw
responsible party type: Sponsor
mesh term: Ureteral Calculi
mesh term: Ureterolithiasis