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Comparison of Active vs. Passive Surveillance to Collect Adverse Events

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02268331
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Adverse Events Other: Active Surveillance Other: Passive Surveillance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Adverse event occurring after treatment [ Time Frame: Up to one week after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02268331

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Canada, Alberta
Edmonton, Alberta, Canada, T5K 0L4
Sponsors and Collaborators
University of Alberta
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Principal Investigator: Sunita Vohra, MD, FRCPC, MSc University of Alberta
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Alberta Identifier: NCT02268331    
Other Study ID Numbers: Surveillance
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: September 2016