Trial of Inserting Prevalence Information Into Lumbar Spine Imaging Reports
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 250000
Inclusion Criteria
- Imaging of lumbar spine requested by primary care provider
- Imaging of lumbar spine requested by primary care provider
Exclusion Criteria
- Age < 18years
- Age < 18years
Summary
- Conditions
- Back Pain
- Backache
- Low Back Pain
- Lumbar Pain
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The long-term public health significance is that a simple, inexpensive intervention has the potential to substantially reduce unnecessary and expensive care for back pain patients. Importantly, this approach could be applied to a wide range of other conditions and other diagnostic tests (e.g. other ...
The long-term public health significance is that a simple, inexpensive intervention has the potential to substantially reduce unnecessary and expensive care for back pain patients. Importantly, this approach could be applied to a wide range of other conditions and other diagnostic tests (e.g. other imaging tests, laboratory tests, genetic testing). If this study is positive, adding epidemiologic benchmarks to diagnostic test reporting could become the dominant paradigm for communicating all diagnostic information. To test this hypothesis, the investigators propose to conduct a pragmatic cluster, randomized controlled trial, randomly assigning primary care clinics at four large health systems to receive either standard lumbar spine imaging reports or reports containing epidemiological benchmarks for common imaging findings. The investigators will use a novel stepped wedge randomization scheme that temporally randomizes sites, allowing within-site before/after comparisons in addition to between-site comparisons, while assuring that all sites will eventually receive the intervention. The primary outcome will be a metric of back-related intervention intensity. The primary analysis will occur at the clinic level and not the patient level. This pragmatic trial will demonstrate both the feasibility of randomly assigning clinics within large health systems as well as the feasibility of passively collecting outcomes data up to two years after enrollment using the robust electronic medical records systems available at each health system.
Inclusion Criteria
- Imaging of lumbar spine requested by primary care provider
- Imaging of lumbar spine requested by primary care provider
Exclusion Criteria
- Age < 18years
- Age < 18years
Tracking Information
- NCT #
- NCT02015455
- Collaborators
- Mayo Clinic
- Henry Ford Health System
- Kaiser Permanente
- Oregon Health and Science University
- National Institutes of Health (NIH)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Principal Investigator: Jeffrey G Jarvik, MD, MPH University of Washington
- Jeffrey G Jarvik, MD, MPH University of Washington