Shared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones

Baystate Medical Center98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Shared Decision-making Kidney Stone Emergencies Radiation Exposure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of study

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

Fidelity

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: Up to 12 months

Patient Knowledge

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: Measured at the end of the index visit. (Day 0)

CT scan rate

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)

Radiation exposure

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 and Day 60 (Day 60 evaluation will include all days from 0-60)

Secondary Outcomes

Patient Satisfaction

Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible)

Time frame: Day 0, end of visit

Patient engagement

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

Patient engagement

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

Patient engagement

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

Occurrence of SDM

"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

Occurrence of SDM

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: Day 0, end of visit

Overall Radiation Burden

Radiation burden from diagnostic imaging (numeric DLP from CT reports)

Time frame: within 60 days from index ED visit

Trust in physician

Trust in physician scale (0-25 with 25 indicating higher trust in the physician)

Time frame: Day 0, end of visit

ED revisits

Repeat visits to any Emergency Department

Time frame: 60 days

Safety: missed diagnosis

High Risk Diagnoses with Complications, as previously described by Smith-Bindman.

Time frame: 60 days from index ED visit

ED Length of Stay

Total minutes of ED stay

Time frame: Day 0, end of visit

Implementation Outcomes

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

Qualitative evaluation

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.

Time frame: Day 0, end of visit

Shared Decision-Making for the Promotion of Patient-Centered Imaging in the ED: Suspected Kidney Stones

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes