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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268331
• Other study ID #: Surveillance
• Status: Completed
• Phase: N/A
• First received: October 10, 2014
• Last updated: October 24, 2017
• Start date: October 2014
• Est. completion date: July 2017

Study information

• Verified date: September 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Doctors of chiropractic and patient participation will be limited to those that speak / read English.

Related Conditions & MeSH terms

• Adverse Events

Intervention

Other:
• Active Surveillance

• Passive Surveillance

Locations

Country	Name	City	State
Canada	CARE	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event occurring after treatment		Up to one week after treatment