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

NCT04504084 | Unknown DMC

• 1 other identifier: N202003100
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Decision Aids; Ureteral Stone; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• Decision conflicts

  Total score of decisional conflict scale

  For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.

Secondary Outcomes (1)

• SURE test

  For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.

Study Arms (2)

Decision aid group

EXPERIMENTAL

Shared decision making using decision aid

Other: Decision aid

Controlled group

NO INTERVENTION

Standard oral explanation the details of treament options

Interventions

Decision aid 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.

Decision aid group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

MeSH Terms

Conditions

Ureterolithiasis

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Yi-Te Chiang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Te Chiang, MD

CONTACT

+886988261275; 11229@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 7, 2020

Record last verified: 2020-08