Comparison of Active vs. Passive Surveillance to Collect Adverse Events
- Conditions
- Adverse Events
- Registration Number
- NCT02268331
- Lead Sponsor
- University of Alberta
- Brief Summary
This cluster randomized trial will be the first to specifically evaluate passive versus active surveillance methods collection of adverse events (AEs). The evaluation of these methods will be performed within the chiropractic healthcare profession, specifically among those who treat children. To date there is no mandatory reporting and learning as part of their profession. In Europe, a passive (voluntary) reporting and learning online system (CPiRLS) has been created and will be utilized in this study for the passive reporting and learning arm.
Manual therapy is the most common intervention provided by the chiropractic profession and is the most commonly sought provider-administrated complementary and alternative therapy in the United States pediatric population. This study will randomize participating doctors of chiropractic who often treat children, to of one of two arms (active vs. passive reporting and learning) to evaluate the quantity and quality of AE data collected.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- Licensed doctors of chiropractic who provide manual therapy in US or Canada
- Willing to collect data per protocol for 60 consecutive pediatric (13 years of age and younger) patients
- Doctors of chiropractic and patient participation will be limited to those that speak / read English.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Adverse event occurring after treatment Up to one week after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CARE
🇨🇦Edmonton, Alberta, Canada
CARE🇨🇦Edmonton, Alberta, Canada