Comparison of Active vs. Passive Surveillance to Collect Adverse Events
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|ClinicalTrials.gov Identifier: NCT02268331|
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : October 25, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Events||Other: Active Surveillance Other: Passive Surveillance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Active vs. Passive Surveillance to Collect Adverse Events After Chiropractic Manual Therapy in the Children|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Experimental: Active Surveillance
For 60 consecutive pediatric visits, patients will be asked to complete a PRE & POST form to capture adverse events (AEs) that occur up to 1 week after treatment. The PRE-treatment form will be completed prior to the start of the visit. The POST-treatment form will be completed after the treatment visit and mailed directly to the investigative team.
The providers will collect data on the treatment provided on the same 60 pediatric patients. The treatment provided is at the discretion of the doctors. If a moderate, serious, or severe AE occurs, the provider will complete the AE form with detailed information about potential risk factors and patient outcomes.
Other: Active Surveillance
Active Comparator: Passive Surveillance
All doctors allocated to this arm will be provided with a username and password with an established chiropractic passive surveillance reporting and learning online system (CPiRLS) in the UK. If a patient safety incident occurs in their office or an adverse event (AE), the provider will complete a report on the CPiRLS website. The providers can record events that occur during the time period of 60 pediatric visits.
Treatment provided during these treatments is at the doctor's discretion.
Other: Passive Surveillance
- Adverse event occurring after treatment [ Time Frame: Up to one week after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268331
|Edmonton, Alberta, Canada, T5K 0L4|
|Principal Investigator:||Sunita Vohra, MD, FRCPC, MSc||University of Alberta|