Low Back PainNCT05410366
Safe Harbors in Emergency Medicine, Specific Aim 3
An observational study of Low Back Pain and Headache, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Headache, Head Injury, Minor
- What is being tested?
- Safe harbor clinical practice guideline
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vanderbilt University Medical Center emergency department patients. Comparator Northwestern University emergency department patients.
Who may be able to join
- Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37027
About this study
Official title: Safely Improving Emergency Diagnostic Testing Through Clinical Safe Harbors
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.
Read the 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.
- Conditions
- Low Back Pain, Headache, Head Injury, Minor
- Being tested
- Safe harbor clinical practice guideline
- Keywords
- Safe harbors, Emergency department, Liability
- Medical subject headings
- Low Back Pain, Headache, Craniocerebral Trauma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Safe harbor clinical practice guideline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure
Aggregate ED radiologic imaging - X-ray or CT scan and MRI
Measured: June 15, 2022 - March 31, 2024
Secondary outcomes (1)
Length of stay
Aggregate ED length of stay defined as provider evaluation to disposition
Measured: June 15, 2022 - March 31, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start30 Sep 2022 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Why it stopped: Pursuing an alternative clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Alan Storrow, Vanderbilt University Medical Center
- Investigators
- Alan B Storrow, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410366
- Sponsor's protocol ID
- AHRQ R18HS025931
- Status last verified
- Feb 2023
- First submitted
- 2 Jun 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33728420
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safely Improving Emergency Diagnostic Testing Through Clinical Safe Harbors
- ClinicalTrials.gov ID
- NCT05410366
- Acronym / sponsor ID
- AHRQ R18HS025931
- Conditions
- Low Back Pain, Headache, Head Injury, Minor
- Keywords
- Safe harbors, Emergency department, Liability
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Pursuing an alternative clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency department (ED) patients | – | Other: Safe harbor clinical practice guidelineAdult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vanderbilt University Medical Center emergency department patients. Comparator Northwestern University emergency department patients.
Key inclusion criteria (1 listed)
- Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe harbor clinical practice guidelineA 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. | Other | Emergency department (ED) patients |
Primary outcome
Radiation exposure
Time frame: June 15, 2022 - March 31, 2024
Aggregate ED radiologic imaging - X-ray or CT scan and MRI
1 secondary outcome
Length of stay
Time frame: June 15, 2022 - March 31, 2024
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Background: PubMed 33728420Blumstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan B Storrow, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Headache, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure (time frame: June 15, 2022 - March 31, 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.