Shared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones
- Conditions
- Kidney StoneEmergenciesCommunicationShared Decision-makingRadiation Exposure
- Interventions
- Behavioral: Decision AidOther: Standardized Educational Material (informational pamphlet)
- Registration Number
- NCT04234035
- Lead Sponsor
- Baystate Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- Age 18-55,
- with acute flank pain - for whom clinician believes acute flank pain may be from renal colic
- who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses.
- Clinician is considering imaging patient for kidney stones (any imaging)
- Recent trauma related to pain (including minor such as lifting/turning)
- Pregnancy (previous or discovered during ED visit)
- Recent surgical procedure on abdomen or pelvis (30d)
- Recent urologic procedure (30d)
- Recent childbirth (30d)
- 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)
- 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)
- Known history of one kidney or other urological/renal abnormality (including neurogenic bladder, ESRD and paraplegia; or if solitary kidney discovered on US)
- Known malignancy (any) within past year (or received treatment in the past 12 months)
- Immunocompromised (chronic steroids, HIV, crohns, immunomodulators or severely ill chronically)
- On anticoagulation
- Crisis patient (behavioral health)/belligerent
- Lacks capacity for medical decision-making
- Unlikely to respond to follow-up calls (IVDA, homeless, no phone)
- Clinician is concerned for alternative diagnosis requiring CT scan (appendicitis) (>5% likelihood by clinician gestalt)
- Patient is not improving clinically and clinician is considering admission
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Shared Decision-Making (via Decision Aid) Decision Aid 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. Shared Decision-Making (via Decision Aid) Standardized Educational Material (informational pamphlet) 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. standardized educational intervention (pamphlet +usual care) Standardized Educational Material (informational pamphlet) 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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)
- Secondary Outcome Measures
Name Time Method 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)
Occurrence of SDM 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)
ED revisits 60 days Repeat visits to any Emergency Department
Patient Satisfaction Day 0, end of visit Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible)
Overall Radiation Burden within 60 days from index ED visit Radiation burden from diagnostic imaging (numeric DLP from CT reports)
Safety: missed diagnosis 60 days from index ED visit High Risk Diagnoses with Complications, as previously described by Smith-Bindman.
Patient engagement 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)
Trust in physician Day 0, end of visit Trust in physician scale (0-25 with 25 indicating higher trust in the physician)
ED Length of Stay Day 0, end of visit Total minutes of ED stay
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.
Trial Locations
- Locations (1)
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States