Baystate Medical Center
Springfield, Massachusetts, 01199, United States
NCT Number: NCT04234035
Although a CT scan is required for some Emergency Department patients with signs and symptoms of a kidney stone, recent evidence has shown that routine scanning is unnecessary and may expose young patients to significant cumulative radiation, increasing their risk of future cancers. Shared Decision-Making may facilitate diagnostic imaging decisions that are more inline with patients' values and preferences. By comparing a shared approach to diagnostic decision-making to a traditional, physician-directed approach, this study lays the foundation for a future randomized trial that will reduce radiation exposure, improve engagement, and improve the quality and patient-centeredness of Emergency Department care.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Springfield, Massachusetts, 01199, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Decision aid to facilitated shared decision-making
Pamphlet with information about kidney stones
Time frame: Up to 12 months
Is this study feasible? Investigators will record number of patients enrolled. An enrollment of at least three patients per month will indicate feasibility.
Time frame: Up to 12 months
Does the DA do what we think it is doing? Fidelity will be examined after 50 patients are enrolled: conversations between patients and clinicians will be scored for whether shared decision-making occurred. If SDM is NOT occurring in the intervention group (>75% of interactions) or IS occurring in the usual care group (>50% of interactions), fidelity will not be considered met.
Time frame: Measured at the end of the index visit. (Day 0)
We hypothesize that the intervention group will have increased knowledge regarding radiation exposure and diagnostic options. This will be tested with a 10 question Knowledge Test developed by stakeholders for this study and delivered at the end of the index visit. The scores for this test range from 0-10 with 10 indicating higher knowledge (more correct answers)
Time frame: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
We hypothesize that SDM will lead to a change in CT scans performed at the index visits and in the first 60 days
Time frame: Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
We hypothesize that SDM will lead to a change in exposure to radiation. We will record radiation exposure for each CT done between day 0 and day 60, as indicated by DLP on CT reports.
Time frame: Day 0, end of visit
Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible)
Time frame: Day 0, end of visit
Measure of engagement: CollaboRATE 3-question measure (where 10/10 for all three is the highest score possible, and 0/0 is the lowest possible, with highest indicating better patient engagement)
Time frame: Day 0, end of visit
Measure of engagement: modified CPS (Scale from 1-5, where 1 indicates the doctor made the decision, 5 indicates the patient made the decision, and 2,3, and 4 indicate levels of shared decision-making)
Time frame: Day 0, end of visit
Measure of engagement: direct SDM question (Measures patients' perception of "Did SDM occur" on a likert scale of 1-7 with 1 = no and 7 = yes, and higher scores = more SDM)
Time frame: Day 0, end of visit
"As involved" question: "Were you as involved in today's decisions as you would have liked to be?" With three response options: Yes, No, and "There were no decisions for me to be involved in" Greater proportion of patients choosing "yes" indicates more SDM.
Time frame: Day 0, end of visit
Whether SDM took place from a third party observer's perspectives: OPTION-5 Score (where scale goes from 0-5, and is re-scaled to 0-100, where higher score indicates more SDM)
Time frame: within 60 days from index ED visit
Radiation burden from diagnostic imaging (numeric DLP from CT reports)
Time frame: Day 0, end of visit
Trust in physician scale (0-25 with 25 indicating higher trust in the physician)
Time frame: 60 days
Repeat visits to any Emergency Department
Time frame: 60 days from index ED visit
High Risk Diagnoses with Complications, as previously described by Smith-Bindman.
Time frame: Day 0, end of visit
Total minutes of ED stay
Time frame: Day 0, end of visit
Clinician's perceptions of the conversation/intervention. We will ask about whether the clinician found the decision aid helpful, whether they would recommend it to another clinician, and whether they would use it again (likert scale 1-7 for each, with higher number indicating more acceptance/helpfulness)
Time frame: Day 0, end of visit
We will ask open ended questions to providers about their interaction, to ask about what went well, what did not, how else could SDM be facilitated, how this intervention would work outside of a study, what other feedback they have. This will be collected via recorded interview and open ended questions.
Baystate Medical Center
Other
Shared Decision-Making for the Promotion of Patient-Centered Imaging in the Emergency Department: Suspected Kidney Stones
Acronym: ED-KSS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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