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

NCT ID: NCT04234035

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2024-03-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Decision Aid

Intervention Type: BEHAVIORAL

Decision aid to facilitated shared decision-making

Standardized Educational Material (informational pamphlet)

Intervention Type: OTHER

Pamphlet with information about kidney stones

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.

Group Type: ACTIVE_COMPARATOR

Standardized Educational Material (informational pamphlet)

Intervention Type: OTHER

Pamphlet with information about kidney stones

Interventions

Decision Aid

Decision aid to facilitated shared decision-making

Intervention Type: BEHAVIORAL

Standardized Educational Material (informational pamphlet)

Pamphlet with information about kidney stones

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Baystate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Schoenfeld, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Schoenfeld, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Medical School - Baystate

Locations

Baystate Medical Center

Springfield, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33691760 (View on PubMed)

Other Identifiers

BH-19-168

Identifier Type: -

Identifier Source: org_study_id