NCT02268331

Comparison of Active vs. Passive Surveillance to Collect Adverse Events

Comparison of Active vs. Passive Surveillance to Collect Adverse Events After Chiropractic Manual Therapy in the Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Adverse Events

Interventions

Type	Name	Description
OTHER	Active Surveillance
OTHER	Passive Surveillance

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2014-10-20
• Last updated: 2017-10-25

Locations

1 site across 1 country: Canada