Clinical trial NCT05410366: Safe Harbors in Emergency Medicine, Specific Aim 3
Official title: Safely Improving Emergency Diagnostic Testing Through Clinical Safe Harbors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Low Back Pain
Headache
Head Injury, Minor
Keywords: Safe harbors
Emergency department
Liability
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vanderbilt University Medical Center emergency department patients. Comparator Northwestern University emergency department patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation exposure
timeFrame: June 15, 2022 - March 31, 2024
Secondary outcomes:
measure: Length of stay
timeFrame: June 15, 2022 - March 31, 2024
Other outcomes:
measure: Patient satisfaction
timeFrame: June 15, 2022 - March 31, 2024
measure: Patient cost
timeFrame: June 15, 2022 - March 31, 2024
measure: Patient charges
timeFrame: June 15, 2022 - March 31, 2024
measure: Adverse event reporting
timeFrame: June 15, 2022 - March 31, 2024
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alan B Storrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.