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Comparison of Active vs. Passive Surveillance to Collect Adverse Events

NCT ID: NCT02268331

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adverse Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Active Surveillance

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Passive Surveillance

Intervention Type OTHER

Interventions

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Active Surveillance

Intervention Type OTHER

Passive Surveillance

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sunita Vohra, MD, FRCPC, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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CARE

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Pohlman KA, Carroll L, Tsuyuki RT, Hartling L, Vohra S. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial. Trials. 2017 Dec 1;18(1):575. doi: 10.1186/s13063-017-2301-0.

Reference Type DERIVED
PMID: 29191232 (View on PubMed)

Other Identifiers

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Surveillance

Identifier Type: -

Identifier Source: org_study_id