- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05410366
Safe Harbors in Emergency Medicine, Specific Aim 3
Safely Improving Emergency Diagnostic Testing Through Clinical Safe Harbors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Overutilization of healthcare resources often has negative implications. The Choosing Wisely campaign, an initiative of the American Board of Internal Medicine, was proposed to help patients and caregivers engage in shared conversations to reduce overuse of potentially harmful tests and procedures. However, the Choosing Wisely campaign's lack of linkage to medical liability considerations has substantially reduced its impact.
For instance, excessive medical imaging and its associated radiation exposure inflicts a measurably real and significant risk of carcinogenesis, drives costs, and therefore is a significant Choosing Wisely target. This is a particularly important consideration in the emergency care setting, frequently cited as an extremely utilization rich environment due to the higher inherent risk of missed pathology and the isolation of clinical care.
The investigators hypothesize a special type of predetermined standard of care (a "safe harbor") can be defined based upon medical evidence, and upon consultation among multiple experts and advisors, for a selected number of clinical conditions within the specialty of emergency medicine (EM). Furthermore, a state-based, federally-contracted and legally-recognized Quality Improvement Organization (QIO) could adopt the "safe harbor" and, in doing so, establish the standard of care in the context of a legal liability claim. Practitioners who meet such a standard and implement it appropriately satisfy their obligation under the law of medical malpractice.
Ultimately, defining provider liability through this predetermined, or ex ante, standard of care, may result in a significant reduction in healthcare resource utilization within EM. Through this reduction, the quality of care would not decrease and a measurable reduction in radiation exposure would occur. Moreover, these predefined standards of care would improve communication between patient and provider during the clinical transaction.
A team of Vanderbilt University medicine, law, economics, and clinical faculty will undertake this. The investigators have summoned a broad group of technical experts and advisors and defined safe harbors for a narrow set of distinct clinical conditions within EM. These safe harbors will be presented for review and approval by the appropriate QIO. Specific Aim 3 will advance the safe harbor demonstration to EM practitioners at Vanderbilt University Medical Center and determine the effects on radiation exposure, length of stay, patient satisfaction, patient costs, charges, and adverse event reporting.
Study Type
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37027
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.
Exclusion Criteria:
- Age < 18 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation exposure
Time Frame: June 15, 2022 - March 31, 2024
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Aggregate ED radiologic imaging - X-ray or CT scan and MRI
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June 15, 2022 - March 31, 2024
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: June 15, 2022 - March 31, 2024
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Aggregate ED length of stay defined as provider evaluation to disposition
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June 15, 2022 - March 31, 2024
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction
Time Frame: June 15, 2022 - March 31, 2024
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Press Ganey scores, Consumer Assessment of Healthcare Providers and Systems (CAHPS), aggregate number of patient complaints
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June 15, 2022 - March 31, 2024
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Patient cost
Time Frame: June 15, 2022 - March 31, 2024
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Aggregate out of pocket patient costs
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June 15, 2022 - March 31, 2024
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Patient charges
Time Frame: June 15, 2022 - March 31, 2024
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Aggregate patient charges
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June 15, 2022 - March 31, 2024
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Adverse event reporting
Time Frame: June 15, 2022 - March 31, 2024
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Aggregate number of reports per patient per condition
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June 15, 2022 - March 31, 2024
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alan B Storrow, MD, Vanderbilt University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHRQ R18HS025931
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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