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Shared Decision-Making Aids for Kidney Stones (ED-KSS Trial)
ED-KSS Trial Summary
This trial found that a shared approach to diagnostic decision-making reduced radiation exposure and improved engagement and the quality of Emergency Department care.
ED-KSS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ED-KSS Trial Design
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Who is running the clinical trial?
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- You might not be able to be reached for follow-up calls (for example, if you are homeless or do not have a phone).The doctor is thinking about using scans or x-rays to check for kidney stones.I have ongoing severe stomach pain that doesn't get better with pain medication.I have had recent surgery on my abdomen or pelvis.I have a fever over 101, low blood pressure, or a heart rate over 120.My condition is not getting better and hospital admission is being considered.The doctor thinks you might have a different condition like appendicitis and wants to do a CT scan to check.This is my second visit for the same pain episode, with no similar visits in the last 30 days.You are pregnant, or you find out you are pregnant during the study.Gave birth in the last 30 daysI have a known kidney issue or only one kidney.I have had cancer or received cancer treatment in the last year.I am between 18-55 years old and have sudden side pain that might be from a kidney stone.I am unable to make medical decisions for myself.I had a procedure related to my urinary system in the last 30 days.I am currently taking blood thinners.I have experienced pain from a recent injury, even if it was minor.You are experiencing a mental health crisis or are behaving aggressively.I have a weakened immune system due to chronic illness or medication.The doctor thinks you have a low risk of having a different serious illness.
- Group 1: Shared Decision-Making (via Decision Aid)
- Group 2: standardized educational intervention (pamphlet +usual care)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What conclusions is this research seeking to reach?
"Over the course of 12 months, this medical trial will monitor CT scan rate as its principal metric. Secondary outcomes include patient satisfaction (as measured through HCAHPS scores ranging from 0 to 10), occurrence of shared decision-making according to OPTION-5 scoring (where higher marks reflect more SDM involvement) and an overall assessment of radiation burden as reported in numeric DLP values extracted from CT reports."
Is it possible for me to register as a participant in this medical experiment?
"In order to participate in this medical study, individuals must be between 18 and 55 years old and able to make informed decisions about their care. Upwards of 250 patients are being accepted for the trial."
Is enrollment to this trial still open?
"Clinicaltrials.gov reports that this trial is actively looking for test subjects, with the original posting occuring on December 11th 2019 and most recent update taking place on February 28th 2022."
What is the upper limit of participants in this medical experiment?
"Affirmative. Per the information on clinicaltrials.gov, this research study is currently recruiting volunteers. It was initially published on December 11th 2019 and up to date as of February 28th 2022. The investigation seeks 250 participants from a single medical location."
Does this clinical investigation accept volunteers who are octogenarians?
"This study welcomes those aged 18 to 55 who want to participate."
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