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Comparison of Active vs. Passive Surveillance to Collect Adverse Events

NCT02268331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-10-25

No results posted yet for this study

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

OTHER

Active Surveillance

OTHER

Passive Surveillance

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Sunita Vohra, MD, FRCPC, MSc · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02268331 on ClinicalTrials.gov