Communication, Emergencies, Kidney Stone, Radiation Exposure, Shared Decision-making
Conditions
Brief summary
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.
Interventions
BEHAVIORALDecision Aid
Decision aid to facilitated shared decision-making
OTHERStandardized Educational Material (informational pamphlet)
Pamphlet with information about kidney stones
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Baystate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-55, 2. with acute flank pain - for whom clinician believes acute flank pain may be from renal colic 3. who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses. 4. Clinician is considering imaging patient for kidney stones (any imaging)
Exclusion criteria
1. Recent trauma related to pain (including minor such as lifting/turning) 2. Pregnancy (previous or discovered during ED visit) 3. Recent surgical procedure on abdomen or pelvis (30d) 4. Recent urologic procedure (30d) 5. Recent childbirth (30d) 6. Signs of Systemic Infection: Fever \>100.9 (101 and up), SBP \<90, HR\>120 7. Moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication) 8. Second doctor's visit (ED, PCP, urgent care) for THIS episode of pain (previous similar visits ok if pain gone for \>30d in between episodes) (if seen at PCP or urgent care in same day or 24 hour period, this is not an exclusion, but if seen at PCP/urgent care or ED 1-30 days prior to index visit, with same pain, excluded) 9. Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US) 10. Known malignancy (any) within past year (or received treatment in the past 12 months) 11. Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically) 12. On anticoagulation 13. Crisis patient (behavioral health)/belligerent 14. Lacks capacity for medical decision-making 15. Unlikely to respond to follow-up calls (IVDA, homeless, no phone) 16. Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (\>5% likelihood by clinician gestalt) 17. Patient is not improving clinically and clinician is considering admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of study | 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. |
| Fidelity | 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. |
| Patient Knowledge | 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) |
| CT scan rate | 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 |
| Radiation exposure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ED revisits | 60 days | Repeat visits to any Emergency Department |
| Safety: missed diagnosis | 60 days from index ED visit | High Risk Diagnoses with Complications, as previously described by Smith-Bindman. |
| Patient Satisfaction | Day 0, end of visit | Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible) |
| Implementation Outcomes | 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) |
| Qualitative evaluation | 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. |
| ED Length of Stay | Day 0, end of visit | Total minutes of ED stay |
| Patient engagement | 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) |
| Occurrence of SDM | 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. |
| Overall Radiation Burden | within 60 days from index ED visit | Radiation burden from diagnostic imaging (numeric DLP from CT reports) |
| Trust in physician | Day 0, end of visit | Trust in physician scale (0-25 with 25 indicating higher trust in the physician) |
Countries
United States
Outcome results
None listed