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Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial

Primary Purpose

Patient Decision Aids, Ureteral Stone, Shared Decision Making

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decision aid
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Decision Aids

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages between 18 and 75
  • Ureteral stone diagnosed with KUB, IVP or CT
  • Stone size between 0 to 2 cm

Exclusion Criteria:

  • Stone passage spontaneously
  • Patients who do not speak Mandarian
  • Patients with dementia
  • Nationality not Republic of China
  • Patients with bilateral ureteral stone
  • Patients with staghorn stone
  • Patients with bladder stone
  • Patients with severe infection
  • Pregnant women
  • Others patients could not communicate with

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Decision aid group

    Controlled group

    Arm Description

    Shared decision making using decision aid

    Standard oral explanation the details of treament options

    Outcomes

    Primary Outcome Measures

    Decision conflicts
    Total score of decisional conflict scale

    Secondary Outcome Measures

    SURE test
    Total score of SURE test

    Full Information

    First Posted
    August 5, 2020
    Last Updated
    August 5, 2020
    Sponsor
    Taipei Medical University Shuang Ho Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04504084
    Brief Title
    Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial
    Official Title
    Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University Shuang Ho Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patient Decision Aids, Ureteral Stone, Shared Decision Making

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Decision aid group
    Arm Type
    Experimental
    Arm Description
    Shared decision making using decision aid
    Arm Title
    Controlled group
    Arm Type
    No Intervention
    Arm Description
    Standard oral explanation the details of treament options
    Intervention Type
    Other
    Intervention Name(s)
    Decision aid
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Decision conflicts
    Description
    Total score of decisional conflict scale
    Time Frame
    For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.
    Secondary Outcome Measure Information:
    Title
    SURE test
    Description
    Total score of 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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ages between 18 and 75 Ureteral stone diagnosed with KUB, IVP or CT Stone size between 0 to 2 cm Exclusion Criteria: Stone passage spontaneously Patients who do not speak Mandarian Patients with dementia Nationality not Republic of China Patients with bilateral ureteral stone Patients with staghorn stone Patients with bladder stone Patients with severe infection Pregnant women Others patients could not communicate with
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi-Te Chiang, MD
    Phone
    +886988261275
    Email
    11229@s.tmu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yi-Te Chiang, MD
    Organizational Affiliation
    No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial

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