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Feasibility and Impact of a Decision Rule for Imaging of Emergency Department Patients With Suspected Kidney Stone

Feasibility and Impact of a Decision Rule for Imaging of Emergency Department Patients With Suspected Kidney Stone

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01869647
Enrollment
264
Registered
2013-06-05
Start date
2013-04-30
Completion date
2014-07-31
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stones

Keywords

kidney stones

Brief summary

This is the third phase (feasibility and impact) of a three-phase project designed to derive, validate and test the feasibility and impact of implementing clinical decision support to safely limit the use of Computerized Tomography (CT) and its accompanying radiation and cost in emergency department patients with suspected renal colic. Hypothesis: Using a before and after model, integration of a clinical prediction rule into decisions about imaging in patients with suspected renal colic will result in a reduction of between 25-50% of radiation received from CT scanning in this population, without adverse affects on patient-centered outcomes.

Detailed description

Patients that a clinician deems a CT Flank Pain Protocol for suspected kidney stone is warranted based on their usual practice will be eligible for enrollment. Clinicians will be encouraged to page the Research Associate (RA) prior to ordering the CT, and an automatic page will go out for all CT flank pain protocols that are ordered via EPIC. RAs will approach eligible subjects for written informed consent. Subjects who are incapable or unwilling to provide informed consent, including non-English speaking patients will be excluded. Following written informed consent, eligibility for the S.T.O.N.E. score will be determined. Subjects that consent to enrollment but have exclusion criteria will be enrolled observationally to determine the performance of the S.T.O.N.E. score and outcomes in these groups, but will not be eligible for alternate imaging pathways. Subjects who do not have any of the above exclusion criteria will be placed in one of three groups based on the S.T.O.N.E. score (which may be supplemented by gestalt clinician pre-test probability and/or point-of-care ultrasound for hydronephrosis). The groups are low, moderate, or high and correspond to the likelihood of the patient having a kidney stone as described in results from phases I and II.Subjects in the high likelihood of stone group will be eligible to get either Ultra Low Dose Computerized Tomography (ULDCT) or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone. We will attempt to contact these patients at \ 1 week after their ED visit, and they will also have the option to contact our study team. If symptoms are persistent for a week or more, subjects may of course pursue further clinical care with the clinician of their choice and this will not be billed to the study. Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient. In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol. All subjects will be followed during their Emergency Department (ED) course and follow-up care (records in EPIC), with an attempt to contact the patient at \ 90 days after the initial ED visit. Outcomes will include the number of eligible patients that receive regular dose CT, ULDCT, or the expectant management option. Radiation dose received will be measured with comparison of both the expected radiation dose if regular CT had been performed in all eligible patients and using a before and after model from phases I and II. We will also follow all patients to determine the prevalence and timing of diagnosis and/or intervention for kidney stone or other pathology. We will qualitatively compare the prevalence of alternative causes of symptoms and incidental findings (and follow-up) for regular and low dose CTs.

Interventions

RADIATIONUltra low dose CT scan

Ultra low dose CT scan

RADIATIONRegular CT or Low Dose CT scan

Regular CT or Low Dose CT scan

RADIATIONNo imaging

No imaging

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Yale University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients 18 or older who present to the adult YNHH ED, Saint Raphael Campus ED or SMC ED in whom renal colic is suspected upon presentation, and the physician intends to order a CT FPP study for suspicion of a kidney stone. Members of all ethnic and racial groups are eligible.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Radiation Exposure (Dose-Length-Product) at BaselineBaseline (at enrollment)Radiation exposure at baseline was collected using the mean dose length product mGy\*cm.

Secondary

MeasureTime frameDescription
Prevalence of Urological Intervention90 daysThis measure presents the prevalence of participants needing urological intervention in each arm within 90 days.

Countries

United States

Participant flow

Participants by arm

ArmCount
High Likelihood of Stone Group
Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone. high likelihood of stone group: Ultra low dose CT scan
66
Moderate Likelihood of Stone Group
Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient. moderate likelihood of stone group: Regular CT or Low Dose CT scan
136
Low Likelihood of Stone Group
In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol. low likelihood of stone group: No imaging
62
Total264

Baseline characteristics

CharacteristicModerate Likelihood of Stone GroupLow Likelihood of Stone GroupHigh Likelihood of Stone GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
7 Participants8 Participants4 Participants19 Participants
Age, Categorical
Between 18 and 65 years
129 Participants54 Participants62 Participants245 Participants
Age, Continuous44.0 years
STANDARD_DEVIATION 13.7
46.1 years
STANDARD_DEVIATION 14.7
42.2 years
STANDARD_DEVIATION 14.1
44.0 years
STANDARD_DEVIATION 14
Region of Enrollment
United States
136 participants62 participants66 participants264 participants
Sex: Female, Male
Female
58 Participants45 Participants15 Participants118 Participants
Sex: Female, Male
Male
78 Participants17 Participants51 Participants146 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 660 / 1360 / 62
serious
Total, serious adverse events
0 / 660 / 1360 / 62

Outcome results

Primary

Radiation Exposure (Dose-Length-Product) at Baseline

Radiation exposure at baseline was collected using the mean dose length product mGy\*cm.

Time frame: Baseline (at enrollment)

ArmMeasureValue (MEAN)
High Likelihood of Stone GroupRadiation Exposure (Dose-Length-Product) at Baseline293.5 mGy*cm
Moderate Likelihood of Stone GroupRadiation Exposure (Dose-Length-Product) at Baseline482.1 mGy*cm
Low Likelihood of Stone GroupRadiation Exposure (Dose-Length-Product) at Baseline915.99 mGy*cm
Secondary

Prevalence of Urological Intervention

This measure presents the prevalence of participants needing urological intervention in each arm within 90 days.

Time frame: 90 days

ArmMeasureValue (NUMBER)
High Likelihood of Stone GroupPrevalence of Urological Intervention19 participants
Moderate Likelihood of Stone GroupPrevalence of Urological Intervention24 participants
Low Likelihood of Stone GroupPrevalence of Urological Intervention3 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026