- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381885
Natural Experiment: "Gentle Nudge" Intervention, Eliminating Phone Call Requirement (LBP-ED)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Non-LAC-DHS patients
- Patient without Lower Back Pain
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention Group
A "nudge" grounded in behavioral economic theory (nudge=gentle incentive, preserving freedom of choice)
|
Clinicians ordering medium or high scoring imaging studies could bypass the usual mandatory phone call to radiology.
|
|
PLACEBO_COMPARATOR: Control
No "nudge"
|
Clinicians ordering imaging studies required mandatory phone to radiology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Unscored Imaging Orders
Time Frame: 6 months from the date of intervention implementation
|
Change in the percentage of Unscored Imaging Orders
|
6 months from the date of intervention implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Appropriate, Borderline and Inappropriate Imaging Orders
Time Frame: 6 months from the date of intervention implementation
|
Change in the percentage of Appropriateness, Borderline and Inappropriate Imaging Orders
|
6 months from the date of intervention implementation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCLA IRB#16-000932-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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