Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504084
Status:
UNKNOWN
Last Update Posted:
2020-08-07
First Post:
2020-08-05
Brief Title:
Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone A Randomized-Controlled Trial
Sponsor:
Taipei Medical University Shuang Ho Hospital
Organization:
Taipei Medical University Shuang Ho Hospital
Study Overview
Official Title:
Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone A Randomized-Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 96 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 Its 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
However there are only few minutes from diagnosis of ureteral stone to possible treatment options explanation Its 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 treatmentThe 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 hisher own
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 treatmentThe 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 hisher own
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None