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

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

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 Overview

• Status: Completed
• Conditions: Emergencies; Communication; Kidney Stone; Radiation Exposure; Shared Decision-making
• Intervention / Treatment: Behavioral: Decision Aid; Other: Standardized Educational Material (informational pamphlet)

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shared Decision-Making (via 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.	Behavioral: Decision Aid; Decision aid to facilitated shared decision-making; Other: Standardized Educational Material (informational pamphlet); Pamphlet with information about kidney stones
Active Comparator: standardized educational intervention (pamphlet +usual care); 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.	Other: Standardized Educational Material (informational pamphlet); Pamphlet with information about kidney stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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	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.	Day 0 and Day 60 (Day 60 evaluation will include all days from 0-60)
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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Measure of satisfaction (HCAHPS measure: Provider rating where 0 = worst provider possible and 10 = best provider possible)	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)	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)	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)	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.	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)	Day 0, end of visit
Overall Radiation Burden	Radiation burden from diagnostic imaging (numeric DLP from CT reports)	within 60 days from index ED visit
Trust in physician	Trust in physician scale (0-25 with 25 indicating higher trust in the physician)	Day 0, end of visit
ED revisits	Repeat visits to any Emergency Department	60 days
Safety: missed diagnosis	High Risk Diagnoses with Complications, as previously described by Smith-Bindman.	60 days from index ED visit
ED Length of Stay	Total minutes of ED stay	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)	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.	Day 0, end of visit

Collaborators and Investigators

• Sponsor: Baystate Medical Center
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Elizabeth Schoenfeld, MD, MS, University of Massachusetts Medical School - Baystate

Publications and helpful links

General Publications

• Schoenfeld EM, Poronsky KE, Westafer LM, DiFronzo BM, Visintainer P, Scales CD, Hess EP, Lindenauer PK. Feasibility and efficacy of a decision aid for emergency department patients with suspected ureterolithiasis: protocol for an adaptive randomized controlled trial. Trials. 2021 Mar 10;22(1):201. doi: 10.1186/s13063-021-05140-9.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Emergencies; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: BH-19-168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no current plan for data sharing. This could change.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No