NCT05410366

Brief Summary

Many patients who present to the emergency department (ED) receive a vast array of diagnostic tests, some of which might not be useful. Providers often feel obligated to order so many tests to protect themselves against the risk of being sued. The investigators believe if a standard of care providing legal protection for certain clinical conditions were agreed upon and followed, unnecessary testing would significantly decrease in the ED, which, in turn, would improve patient safety, augment the quality of care delivered, and increase patient satisfaction.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

March 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

June 2, 2022

Last Update Submit

March 9, 2023

Conditions

Low Back PainHeadacheHead Injury, Minor

Keywords

Safe harborsEmergency departmentLiability

Outcome Measures

Primary Outcomes (1)

  • Radiation exposure

    Aggregate ED radiologic imaging - X-ray or CT scan and MRI

    June 15, 2022 - March 31, 2024

Secondary Outcomes (1)

  • Length of stay

    June 15, 2022 - March 31, 2024

Other Outcomes (4)

  • Patient satisfaction

    June 15, 2022 - March 31, 2024

  • Patient cost

    June 15, 2022 - March 31, 2024

  • Patient charges

    June 15, 2022 - March 31, 2024

  • +1 more other outcomes

Study Arms (1)

Emergency department (ED) patients

Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.

Other: Safe harbor clinical practice guideline

Interventions

Safe harbor clinical practice guidelineOTHER

A safe harbor is a special type of clinical practice guideline which, under existing federal law, may serve as the legal standard of care, not just evidence of the standard of care. If a patient with a safe harbor condition satisfies all safe harbor inclusion criteria and does not meet any exclusion criteria, no imaging is required, and the patient may be discharged with specific instructions. If a patient is excluded from the safe harbor, then imaging decisions are per customary practice. The safe harbor clinical practice guidelines are provided to treating ED physicians, but they are not obligated to use them. The safe harbor pathways do not limit the diagnostic and therapeutic approach patients and physicians undertake during a clinical encounter. They have the liberty in this decision to proceed jointly down a clinical pathway most appropriate to the individual clinical circumstance.

Emergency department (ED) patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Vanderbilt University Medical Center emergency department patients. Comparator Northwestern University emergency department patients.

You may qualify if:

  • Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37027, United States

Location

Related Publications (1)

  • Blumstein JF, McMichael BJ, Storrow AB. Constraints on Medical Liability Through Malpractice Safe Harbors. JAMA Health Forum. 2020;1(8):e200961. doi: 10.1001/jamahealthforum.2020.0961. Epub 2020 Aug 14. No abstract available.

    PMID: 33728420BACKGROUND

MeSH Terms

Conditions

Low Back PainHeadacheCraniocerebral TraumaEmergencies

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesDisease AttributesPathologic Processes

Study Officials

  • Alan B Storrow, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 8, 2022

Study Start

September 30, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

March 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)