Safe Harbors in Emergency Medicine, Specific Aim 3

Low Back Pain Clinical Trial

Official title:

Safely Improving Emergency Diagnostic Testing Through Clinical Safe Harbors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05410366
• Other study ID #: AHRQ R18HS025931
• Status: Withdrawn
• Start date: September 30, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Emergencies
• Head Injury, Minor
• Headache
• Low Back Pain

Intervention

Other:
• Safe harbor clinical practice guideline
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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction	Press Ganey scores, Consumer Assessment of Healthcare Providers and Systems (CAHPS), aggregate number of patient complaints	June 15, 2022 - March 31, 2024
Other	Patient cost	Aggregate out of pocket patient costs	June 15, 2022 - March 31, 2024
Other	Patient charges	Aggregate patient charges	June 15, 2022 - March 31, 2024
Other	Adverse event reporting	Aggregate number of reports per patient per condition	June 15, 2022 - March 31, 2024
Primary	Radiation exposure	Aggregate ED radiologic imaging - X-ray or CT scan and MRI	June 15, 2022 - March 31, 2024
Secondary	Length of stay	Aggregate ED length of stay defined as provider evaluation to disposition	June 15, 2022 - March 31, 2024