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Shared Decision-Making Aids for Kidney Stones (ED-KSS Trial)
N/A
Recruiting
Led By Elizabeth Schoenfeld, MD, MS
Research Sponsored by Baystate Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Signs of Systemic Infection: Fever >100.9 (101 and up), SBP <90, HR>120
Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 18-55 who have acute flank pain possibly due to kidney stones and are at low risk for other serious conditions. They must be capable of making medical decisions and not have signs of systemic infection, recent surgeries, or certain health complications like a history of one kidney.Check my eligibility
What is being tested?
The study tests if shared decision-making between patients and doctors about imaging for suspected kidney stones can reduce unnecessary CT scans. It compares this approach with the usual physician-directed decision-making process.See study design
What are the potential side effects?
Since the interventions involve decision aids and educational materials rather than medications, there are no direct side effects. However, choosing less imaging could miss other diagnoses or delay treatment.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a fever over 101, low blood pressure, or a heart rate over 120.
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I have ongoing severe stomach pain that doesn't get better with pain medication.
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I have a known kidney issue or only one kidney.
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I am currently taking blood thinners.
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I am unable to make medical decisions for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CT scan rate
Feasibility
Fidelity
+2 moreSecondary outcome measures
ED Length of Stay
ED revisits
Implementation Outcomes
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Shared Decision-Making (via Decision Aid)Experimental Treatment2 Interventions
The intervention is a decision aid, which both encourages and facilitates a shared decision-making conversation between the clinician and the patient. The decision aid educates patients regarding evidence-based approaches to the management of suspected kidney stones in the ED. Clinicians will receive training specific to this decision aid, though the decision aid is designed to be used with no additional training.
Group II: standardized educational intervention (pamphlet +usual care)Active Control1 Intervention
The control arm will receive Usual Care and a standardized educational intervention (pamphlet). This intervention (pamphlet) contains information about kidney stones. Usual care for this clinical scenario generally involves the clinician choosing the management plan. Clinicians of subjects assigned to the usual care group will be asked to practice usual, evidence-based medical care, without shared decision-making.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decision Aid
2008
Completed Phase 3
~4150
Find a Location
Who is running the clinical trial?
Agency for Healthcare Research and Quality (AHRQ)FED
402 Previous Clinical Trials
6,821,346 Total Patients Enrolled
1 Trials studying Shared Decision Making
176 Patients Enrolled for Shared Decision Making
Baystate Medical CenterLead Sponsor
64 Previous Clinical Trials
44,024 Total Patients Enrolled
Elizabeth Schoenfeld, MD, MSPrincipal Investigator - University of Massachusetts Medical School - Baystate
Baystate Children�s Hospital, Baystate Medical Center
Brown University Program In Medicine (Medical School)
Geo Washington University School Medicine (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Shared Decision-Making (via Decision Aid)
- Group 2: standardized educational intervention (pamphlet +usual care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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