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

NCT04234035 | Completed

• 1 other identifier: BH-19-168
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Shared Decision-making; Kidney Stone; Emergencies; Radiation Exposure; Communication

Outcome Measures

Primary Outcomes (5)

• 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

• 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)

Secondary Outcomes (13)

• Patient Satisfaction

  Day 0, end of visit

• Patient engagement

  Day 0, end of visit

• Patient engagement

  Day 0, end of visit

• Patient engagement

  Day 0, end of visit

• Occurrence of SDM

  Day 0, end of visit

Study Arms (2)

Shared Decision-Making (via Decision Aid)

EXPERIMENTAL

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; Other: Standardized Educational Material (informational pamphlet)

standardized educational intervention (pamphlet +usual care)

ACTIVE COMPARATOR

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)

Interventions

Decision Aid BEHAVIORAL

Decision aid to facilitated shared decision-making

Shared Decision-Making (via Decision Aid)

Standardized Educational Material (informational pamphlet) OTHER

Pamphlet with information about kidney stones

Shared Decision-Making (via Decision Aid); standardized educational intervention (pamphlet +usual care)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Baystate Medical Center: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (1)

• 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.

  PMID: 33691760 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Emergencies; Communication

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Elizabeth Schoenfeld, MD, MS

  University of Massachusetts Medical School - Baystate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 21, 2020
• Study Start: December 11, 2019
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)