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

NCT ID: NCT04504084

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-31

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.

Conditions

Patient Decision Aids; Ureteral Stone; Shared Decision Making

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Decision aid group

Shared decision making using decision aid

Group Type: EXPERIMENTAL

Decision aid

Intervention Type: OTHER

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.

Controlled group

Standard oral explanation the details of treament options

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Decision aid

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Te Chiang, MD

Role: PRINCIPAL_INVESTIGATOR

No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital

Central Contacts

Yi-Te Chiang, MD

Role: CONTACT

11229@s.tmu.edu.tw

+886988261275

Other Identifiers

N202003100

Identifier Type: -

Identifier Source: org_study_id