Comparison of Active vs. Passive Surveillance to Collect Adverse Events

Adverse Events Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adverse Events

• NCT number: NCT02268331
• Study type: Interventional
• Source: University of Alberta
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Completion date: July 2017