Safe Harbors in Emergency Medicine, Specific Aim 3
- Conditions
- Low Back PainHead Injury, MinorHeadache
- Interventions
- Other: Safe harbor clinical practice guideline
- Registration Number
- NCT05410366
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.
- Age < 18 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Emergency department (ED) patients Safe harbor clinical practice guideline Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.
- Primary Outcome Measures
Name Time Method Radiation exposure June 15, 2022 - March 31, 2024 Aggregate ED radiologic imaging - X-ray or CT scan and MRI
- Secondary Outcome Measures
Name Time Method Length of stay June 15, 2022 - March 31, 2024 Aggregate ED length of stay defined as provider evaluation to disposition
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States