Adverse EventsNCT02268331
Comparison of Active vs. Passive Surveillance to Collect Adverse Events
A study testing Active Surveillance and Passive Surveillance in people with Adverse Events, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adverse Events
- What is being tested?
- Active Surveillance and Passive Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Doctors of chiropractic and patient participation will be limited to those that speak / read English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Active vs. Passive Surveillance to Collect Adverse Events After Chiropractic Manual Therapy in the Children
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
- Being tested
- Active Surveillance, Passive Surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceOther
Passive SurveillanceOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Passive Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event occurring after treatment
Measured: Up to one week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse EventsStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunita Vohra, MD, FRCPC, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268331
- Sponsor's protocol ID
- Surveillance
- Status last verified
- Sep 2016
- First submitted
- 10 Oct 2014
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29191232
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Active vs. Passive Surveillance to Collect Adverse Events After Chiropractic Manual Therapy in the Children
- ClinicalTrials.gov ID
- NCT02268331
- Acronym / sponsor ID
- Surveillance
- Conditions
- Adverse Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Experimental | Other: Active SurveillanceFor 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. |
| Passive Surveillance | Active comparator | Other: Passive SurveillanceAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Doctors of chiropractic and patient participation will be limited to those that speak / read English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Surveillance | Other | Active Surveillance |
| Passive Surveillance | Other | Passive Surveillance |
Primary outcome
Adverse event occurring after treatment
Time frame: Up to one week after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 29191232Pohlman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunita Vohra, MD, FRCPC, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Surveillance and Passive Surveillance in people with Adverse Events, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event occurring after treatment (time frame: Up to one week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02268331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.