Back PainLBP-EDNCT03381885
Natural Experiment: "Gentle Nudge" Intervention, Eliminating Phone Call Requirement
A study testing Gentle Nudge and Usual Standard Procedure in people with Back Pain and X-rays, run by University of California, Los Angeles.
Trial summary
Back pain costs the U.S. over $100 billion annually, and much of this spending is wasteful due to the overuse of advanced diagnostic imaging. Despite prominent clinical guidelines and the nationally recognized Choosing Wisely campaign discouraging use of costly and low value imaging, magnetic resonance imaging (MRI)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Gentle Nudge and Usual Standard Procedure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with Lower Back Pain receiving treatment at Los Angeles Department of Health Services Facility (LAC-DHS)
- Adults whose physicians order Imaging Studies (CT SCANs and MRIs)
Who cannot join
- Non-LAC-DHS patients
- Patient without Lower Back Pain
About this study
Back pain costs the U.S. over $100 billion annually, and much of this spending is wasteful due to the overuse of advanced diagnostic imaging. Despite prominent clinical guidelines and the nationally recognized Choosing Wisely campaign discouraging use of costly and low value imaging, magnetic resonance imaging (MRI) and computed tomography (CT) studies remain frequently overused. Real-time electronic clinical decision support (CDS) at the point of care has been increasingly emphasized as an important strategy to improve the value of back pain management; however, studies suggest that CDS at best only modestly influences practice patterns. The aim is to implement a behavioral economic-based intervention in the ED to promote the use of CDS system.
Read the detailed description
Despite prominent clinical guidelines and the nationally recognized Choosing Wisely campaign discouraging use of costly and low value imaging, magnetic resonance imaging (MRI) and computed tomography (CT) studies remain frequently overused. Few studies have rigorously investigated the causes of CDS' limited influence on care as well as interventions to enhance CDS' impact on reducing low value imaging. The implementation of CDS to reduce low value MRI and CT imaging studies for back pain at a large safety net health system was monitored. The CDS systems was integrated into the electronic health record system. Clinicians answered several questions and select from a list of basic imaging indications and CDS provides an American College of Radiology Appropriateness Criteria score. Appropriate scores ranged from 7-9, borderline scores ranging from 4-6, and inappropriate scores ranging from 1-3 (clinicians are encouraged to cancel inappropriate orders).
Electronic order data on imaging studies was pulled using CPT billable data and imaging studies were categorized as appropriate, canceled, changed, and unscored orders. Early observation of CDS implementation revealed that LAC+USC Medical Center (one of 16 sites) had high percentages of unscored orders. At this intervention site, a "nudge" grounded in behavioral economic theory (nudge=gentle incentive, preserving freedom of choice) was provided where clinicians ordering medium or high scoring studies could bypass the usual mandatory phone call to radiology. This natural experiment was evaluated using a quasi-experimental difference-in-differences (DinD) analysis to measure whether high scores increased and unscored studies decreased at the intervention site vs. 15 control sites over time. Generalized linear regression models were used that accounted for clustering by practice site and adjusting for patient and clinician characteristics.
- Conditions
- Back Pain, X-rays, MRI, CT Scan, Clinical Decision Support Tool
- Being tested
- Gentle Nudge, Usual Standard Procedure
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle NudgeBehavioural
Clinicians ordering medium or high scoring imaging studies could bypass the usual mandatory phone call to radiology.
Usual Standard ProcedureBehavioural
Clinicians ordering imaging studies required mandatory phone to radiology
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A "nudge" grounded in behavioral economic theory (nudge=gentle incentive, preserving freedom of choice) Receives: Behavioral: Gentle Nudge |
| Control | Placebo comparator | No "nudge" Receives: Behavioral: Usual Standard Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Unscored Imaging Orders
Change in the percentage of Unscored Imaging Orders
Measured: 6 months from the date of intervention implementation
Secondary outcomes (1)
Percentage of Appropriate, Borderline and Inappropriate Imaging Orders
Change in the percentage of Appropriateness, Borderline and Inappropriate Imaging Orders
Measured: 6 months from the date of intervention implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study startFeb 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- LAC+USC Medical Center, Los Angeles Department of Health Services, American Board of Internal Medicine
- Responsible party
- Principal investigator, Catherine A. Sarkisian, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381885
- Sponsor's protocol ID
- UCLA IRB#16-000932-002
- Acronym
- LBP-ED
- Status last verified
- Dec 2017
- First submitted
- 12 Oct 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Experiment: "Gentle Nudge" Intervention, Eliminating Phone Call Requirement
- ClinicalTrials.gov ID
- NCT03381885
- Acronym / sponsor ID
- LBP-ED / UCLA IRB#16-000932-002
- Conditions
- Back Pain, X-rays, MRI, CT Scan, Clinical Decision Support Tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- LAC+USC Medical Center, Los Angeles Department of Health Services, American Board of Internal Medicine
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Dec 2017 (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.
Back pain costs the U.S. over $100 billion annually, and much of this spending is wasteful due to the overuse of advanced diagnostic imaging. Despite prominent clinical guidelines and the nationally recognized Choosing Wisely campaign discouraging use of costly and low value imaging, magnetic resonance imaging (MRI) and computed tomography (CT) studies remain frequently overused. Real-time electronic clinical decision support (CDS) at the point of care has been increasingly emphasized as an important strategy to improve the value of back pain management; however, studies suggest that CDS at best only modestly influences practice patterns. The aim is to implement a behavioral economic-based intervention in the ED to promote the use of CDS system.
Detailed description
Despite prominent clinical guidelines and the nationally recognized Choosing Wisely campaign discouraging use of costly and low value imaging, magnetic resonance imaging (MRI) and computed tomography (CT) studies remain frequently overused. Few studies have rigorously investigated the causes of CDS' limited influence on care as well as interventions to enhance CDS' impact on reducing low value imaging. The implementation of CDS to reduce low value MRI and CT imaging studies for back pain at a large safety net health system was monitored. The CDS systems was integrated into the electronic health record system. Clinicians answered several questions and select from a list of basic imaging indications and CDS provides an American College of Radiology Appropriateness Criteria score. Appropriate scores ranged from 7-9, borderline scores ranging from 4-6, and inappropriate scores ranging from 1-3 (clinicians are encouraged to cancel inappropriate orders).
Electronic order data on imaging studies was pulled using CPT billable data and imaging studies were categorized as appropriate, canceled, changed, and unscored orders. Early observation of CDS implementation revealed that LAC+USC Medical Center (one of 16 sites) had high percentages of unscored orders. At this intervention site, a "nudge" grounded in behavioral economic theory (nudge=gentle incentive, preserving freedom of choice) was provided where clinicians ordering medium or high scoring studies could bypass the usual mandatory phone call to radiology. This natural experiment was evaluated using a quasi-experimental difference-in-differences (DinD) analysis to measure whether high scores increased and unscored studies decreased at the intervention site vs. 15 control sites over time. Generalized linear regression models were used that accounted for clustering by practice site and adjusting for patient and clinician characteristics.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Gentle NudgeA "nudge" grounded in behavioral economic theory (nudge=gentle incentive, preserving freedom of choice) |
| Control | Placebo comparator | Behavioral: Usual Standard ProcedureNo "nudge" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with Lower Back Pain receiving treatment at Los Angeles Department of Health Services Facility (LAC-DHS)
- Adults whose physicians order Imaging Studies (CT SCANs and MRIs)
Key exclusion criteria (2 listed)
- Non-LAC-DHS patients
- Patient without Lower Back Pain
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 |
|---|---|---|
| Gentle NudgeClinicians ordering medium or high scoring imaging studies could bypass the usual mandatory phone call to radiology. | Behavioural | Intervention Group |
| Usual Standard ProcedureClinicians ordering imaging studies required mandatory phone to radiology | Behavioural | Control |
Primary outcome
Percentage of Unscored Imaging Orders
Time frame: 6 months from the date of intervention implementation
Change in the percentage of Unscored Imaging Orders
1 secondary outcome
Percentage of Appropriate, Borderline and Inappropriate Imaging Orders
Time frame: 6 months from the date of intervention implementation
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 22 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Nudge and Usual Standard Procedure in people with Back Pain and X-rays, run by University of California, Los Angeles.
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 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Percentage of Unscored Imaging Orders (time frame: 6 months from the date of intervention implementation). 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 22 Dec 2017.