Comparison of Active vs. Passive Surveillance to Collect Adverse Events

NCT02268331 | Completed

• 1 other identifier: Surveillance
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Events

Outcome Measures

Primary Outcomes (1)

• Adverse event occurring after treatment

  Up to one week after treatment

Study Arms (2)

Active Surveillance

EXPERIMENTAL

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

Passive Surveillance

ACTIVE COMPARATOR

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

Interventions

Active Surveillance OTHER

Active Surveillance

Passive Surveillance OTHER

Passive Surveillance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

CARE

Edmonton, Alberta, T5K 0L4, Canada

Location

Related Publications (1)

• 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.

  PMID: 29191232 DERIVED

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Sunita Vohra, MD, FRCPC, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2016-09

Locations

CA (1)