Cervical Spine InjuryNCT05711134
CT C-spine Audit and Feedback
A study testing Audit and Feedback on Individual Practice Patterns in people with Cervical Spine Injury and Emergencies, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
This is a prospective quality improvement study to assess the effect of using an audit-and-feedback process for emergency providers on utilization of computed tomography of the cervical spine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Spine Injury, Emergencies, Trauma
- What is being tested?
- Audit and Feedback on Individual Practice Patterns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 31 Oct 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Emergency medicine physician, nurse practitioner, or physician assistant
- Ordered at least 5 CT scans of the cervical spine on adult patients in the two-month pre-intervention period
Who cannot join
- Non-emergency providers
- Ordered few than 5 studies in the pre-intervention period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Audit and Feedback for Computed Tomography of the Cervical Spine in the Emergency Department
This is a prospective quality improvement study to assess the effect of using an audit-and-feedback process for emergency providers on utilization of computed tomography of the cervical spine. The objective of this study is to determine whether providing repeated individualized feedback on CT C-spine utilization to emergency providers alters their practice pattern and reduces overutilization. The investigators hypothesize that emergency providers who receive individualized feedback regarding their CT C-spine utilization on a regular basis will alter their practice pattern to reduce overutilization of this imaging study.
- Conditions
- Cervical Spine Injury, Emergencies, Trauma
- Being tested
- Audit and Feedback on Individual Practice Patterns
- Keywords
- computed tomography, resource utilization, NEXUS, emergency medicine
- Medical subject headings
- Emergencies, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and Feedback on Individual Practice PatternsBehavioural
Providers are given feedback on their practice patterns of ordering computed tomography of the cervical spine.
| Study group | Role | What they receive |
|---|---|---|
| Serial In-Person Feedback | Experimental | Providers are given recurring individualized in-person feedback on their practice patterns. Receives: Behavioral: Audit and Feedback on Individual Practice Patterns |
| In-Person Feedback with Serial Electronic Feedback | Experimental | Providers are given one-time individualized in-person feedback on their practice patterns, followed by recurrent individualized electronic feedback. Receives: Behavioral: Audit and Feedback on Individual Practice Patterns |
| Control | No intervention | Providers are not given any feedback on their practice patterns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent NEXUS-Negative
Percentage of CT C-spine studies that an individual provider ordered on NEXUS-negative patients
Measured: 6 months
Secondary outcomes (3)
Number of Fractures
Number of cervical spine fractures identified on CT for patients who are NEXUS-negative
Measured: 6 months
Clinically Significant Fractures
Number of cervical spine fractures identified on CT for patients who are NEXUS-negative that required procedural intervention, hospitalization, or prolonged immobilization
Measured: 6 months
Number of CTs
Number of CT scans of the cervical spine ordered by each provider
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 May 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Chamberlin, University of Massachusetts, Worcester
- Investigators
- Karl T Chamberlin, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711134
- Sponsor's protocol ID
- STUDY00000533
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audit and Feedback for Computed Tomography of the Cervical Spine in the Emergency Department
- ClinicalTrials.gov ID
- NCT05711134
- Acronym / sponsor ID
- STUDY00000533
- Conditions
- Cervical Spine Injury, Emergencies, Trauma
- Keywords
- computed tomography, resource utilization, NEXUS, emergency medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 2 Feb 2023 (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.
This is a prospective quality improvement study to assess the effect of using an audit-and-feedback process for emergency providers on utilization of computed tomography of the cervical spine. The objective of this study is to determine whether providing repeated individualized feedback on CT C-spine utilization to emergency providers alters their practice pattern and reduces overutilization. The investigators hypothesize that emergency providers who receive individualized feedback regarding their CT C-spine utilization on a regular basis will alter their practice pattern to reduce overutilization of this imaging study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Serial In-Person Feedback | Experimental | Behavioral: Audit and Feedback on Individual Practice PatternsProviders are given recurring individualized in-person feedback on their practice patterns. |
| In-Person Feedback with Serial Electronic Feedback | Experimental | Behavioral: Audit and Feedback on Individual Practice PatternsProviders are given one-time individualized in-person feedback on their practice patterns, followed by recurrent individualized electronic feedback. |
| Control | No intervention | –Providers are not given any feedback on their practice patterns. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Emergency medicine physician, nurse practitioner, or physician assistant
- Ordered at least 5 CT scans of the cervical spine on adult patients in the two-month pre-intervention period
Key exclusion criteria (2 listed)
- Non-emergency providers
- Ordered few than 5 studies in the pre-intervention period
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 |
|---|---|---|
| Audit and Feedback on Individual Practice PatternsProviders are given feedback on their practice patterns of ordering computed tomography of the cervical spine. | Behavioural | In-Person Feedback with Serial Electronic Feedback, Serial In-Person Feedback |
Primary outcome
Percent NEXUS-Negative
Time frame: 6 months
Percentage of CT C-spine studies that an individual provider ordered on NEXUS-negative patients
3 secondary outcomes
Number of Fractures
Time frame: 6 months
Clinically Significant Fractures
Time frame: 6 months
Number of CTs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- 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.
Karl T Chamberlin, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback on Individual Practice Patterns in people with Cervical Spine Injury and Emergencies, run by University of Massachusetts, Worcester 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 9 Nov 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent NEXUS-Negative (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2023.