Patient Decision AidsNCT04504084
Influence of Patient Decision-Making Aids for Patients With Unilateral Ureteral Stone: A Randomized-Controlled Trial
A study testing Decision aid in people with Patient Decision Aids and Ureteral Stone, run by Taipei Medical University Shuang Ho Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patient Decision Aids, Ureteral Stone, Shared Decision Making
- What is being tested?
- Decision aid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Dec 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18 and 75
- Ureteral stone diagnosed with KUB, IVP or CT
- Stone size between 0 to 2 cm
Who cannot join
- 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
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- Patients with bladder stone
- Patients with severe infection
- Pregnant women
- Others patients could not communicate with
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Decision aid
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid group | Experimental | Shared decision making using decision aid Receives: Other: Decision aid |
| Controlled group | No intervention | Standard oral explanation the details of treament options |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision conflicts
Total score of decisional conflict scale
Measured: 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
Total score of SURE test
Measured: For patients choose URSL or F-URSL, one day before the operation. For patients choose ESWL, half an hour before the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Decision AidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Te Chiang, MD, Principal investigator, No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504084
- Sponsor's protocol ID
- N202003100
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No