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Comparison of Active vs. Passive Surveillance to Collect Adverse Events

ClinicalTrials.gov ID NCT02268331
Sponsor University of Alberta
Information provided by University of Alberta (Responsible Party)
Last Update Posted 2017-10-25
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Study Overview

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.

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Official Title
Comparison of Active vs. Passive Surveillance to Collect Adverse Events After Chiropractic Manual Therapy in the Children
Conditions
Adverse Events
Intervention / Treatment
  • Other: Active Surveillance
  • Other: Passive Surveillance
  • Other: Active Surveillance
  • Other: Passive Surveillance
Other Study ID Numbers
  • Surveillance
Study Start (Actual)
2014-10
Primary Completion (Actual)
2017-07
Study Completion (Actual)
2017-07
Enrollment (Actual)
96
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
Canada
Alberta Locations
Edmonton, Alberta, Canada, T5K 0L4

CARE
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.

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Ages Eligible for Study
(ChildAdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Other
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm 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.

Intervention/Treatment Other: Active Surveillance
Participant Group/Arm 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.

Intervention/Treatment Other: Passive Surveillance
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Adverse event occurring after treatment Up to one week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
University of Alberta
Investigators
  • Principal Investigator:Sunita Vohra, MD, FRCPC, MSc,University of Alberta

Publications

From PubMed

These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2014-10-10
First Submitted that Met QC Criteria
2014-10-15
First Posted (Estimated)
2014-10-20
Study Record Updates
Last Update Submitted that met QC Criteria
2017-10-24
Last Update Posted
2017-10-25
Last Verified
2016-09

More Information