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
About this trial
This is an interventional health services research trial for Patient Decision Aids
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
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
NCT ID
NCT04504084
First Posted
August 5, 2020
Last Updated
August 5, 2020
Sponsor
Taipei Medical University Shuang Ho Hospital
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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