HealthyNCT00468780
Standardized Comparison of Triage in EMS
An observational study of Healthy, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
The objective of this study is to evaluate the reliability and validity of acuity estimates by paramedics employing the Canadian Triage Acuity Scale (CTAS) in the out of hospital setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 928 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2003to Jul 2009
- Phase
- Observational
- 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
Study population: This study is taking place in 7 EMS systems in Ontario: Peterborough, Thunder Bay, Hamilton, Simcoe/Muskoka, Durham, Peel, and Toronto. The participants(Both Primary care paramedics and Advance Care Parmaeidcs)are riding as civilian observers under contract to the Sunnybrook and Women's College Health Sciences Centre Research Institute and have signed liability release forms. The main focus of the SCORE study is to determine how well paramedics in the field can correctly assign CTAS scores. By showing that it can be done reliably, decisions can be made on suitable destinations, especially for the low acuity patient.
Who may be able to join
- All patients
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton Health Sciences
Hamilton, Ontario, L8V 1C3
Sunnybrook-Osler Centre for Prehospital Care
Toronto, Ontario, M9W 7K6
About this study
Official title: Study to Evaluate the Safety and Efficacy of Redirecting Ambulance Patients to Destinations Based on Acuity
The objective of this study is to evaluate the reliability and validity of acuity estimates by paramedics employing the Canadian Triage Acuity Scale (CTAS) in the out of hospital setting. The study has the potential to help guide policy decisions pertaining to the safe transfer of ambulance patients to alternative destinations reducing ED overcrowding and ambulance off load time. Emergency Department triage nurses employ the same acuity scale and if this study is successful the emergency departments and the EMS services could communicate about capacity to handle patients based on acuity, volumes and waiting times.
Read the detailed description
CTAS stands for the Canadian Triage Acuity Scale. CTAS defines 5 levels of triage according to the perceived need for physician assessment. CTAS was developed to measure ED case mix and evaluate the potential effect of changes in the delivery of health care on patients seeking emergency care. Although the Canadian Institute of Health Information (CIHI) collects data on total visits, admissions, and ambulatory care visits, there are few standards for reporting data from Emergency Departments. The Canadian Association of Emergency Physicians endorsed CTAS as a standardized data element to assess and compare case mix and acuity.
At present there are no consistently utilized measures of patient acuity performed by paramedics in Ontario. Information on the interface between Prehospital Care and Emergency Departments would inform decision-making on the Emergency Health Care system. The introduction of CTAS provides a superb opportunity to evaluate its utility in providing this information on an accurate and consistent basis.
The use of an acuity scale common to the in-hospital and prehospital setting seems ideal. However, there are several questions to be answered regarding the feasibility, reliability, safety and validity of CTAS before widespread implementation. The Society for Academic Emergency Medicine's position clearly states, "Patients may be referred to other locations where they will receive care appropriate to the acuity of their problem only if the triage criteria, if any, are based on research that shows them to be safe and effective". In their prospective trial, Brillman et al. noted that 26-38% of emergency department patients who were admitted to hospital would not have been identified at triage even when the treating physician assessed them. If physicians are not capable of accurate triage decisions, one must consider the reliability of a paramedic under the challenges of the prehospital setting. Moreover, recent high-profile coroner cases suggest that liability is a significant concern. Paramedics are accustomed to point-of-care assessment and triage, and do not have access to some of the resources utilized by ED nurses. Because the environment, context, discriminating tools, resources and skill set differ between triage nurses and paramedics, it is essential to evaluate the use of paramedic assessment tools in the determination of an accurate and consistent CTAS score. Moreover there has not as yet been an emphasis on paramedic assessment interfacing with decision-making and time to care. It is important to ensure, therefore, that the prehospital application of CTAS is appropriate and safe.
The objectives of this study are to evaluate the criterion validity of CTAS assignment by paramedics at departure from scene and arrival at hospital compared to a CTAS expert (gold standard), to evaluate the inter-rater reliability of CTAS assignment by paramedics at arrival at hospital compared to triage nurses, to evaluate the predictive validity of CTAS level assignment with respect to patient outcomes and health care resource utilization and to describe the relationship and the use of the return priority code and the CTAS category.
A random sample of Advanced Care Paramedic crews and an equal number of randomly selected Basic Care Paramedic crews from five EMS systems (rural and urban) will be invited to participate. A paramedic observer (advanced and basic) with advanced CTAS skills will observe each crew, record the critical elements of each prehospital encounter on a data collection sheet and assign a CTAS level to the patient on departure from scene and arrival at hospital. The observer will also record the CTAS level and return priority code conveyed by the paramedic to the dispatch centre, and evaluate whether the use of both the return priority code (in which an urgent return is assigned a value of 4) and the CTAS score (in which an urgent call is assigned a value of 1 or 2) generates any difficulties in paramedic communication with dispatch on departure from the scene.
At the hospital, the observer will ensure that the triage nurse assigns the CTAS level without prior knowledge of the paramedic assignment. The observer will record the CTAS level assigned by the triage nurse as well as the CTAS level at departure from the scene and on arrival at the receiving hospital, return priority code and status change code recorded by the treating paramedic on the ambulance call report. The patient's health insurance number (HIN) will be collected for the purposes of linkage to outcome data. The observer will record the times of departure from scene and arrival at hospital to estimate the transport interval.
Validity will be measured by calculating a kappa statistic comparing the observer's (gold standard) CTAS score with the paramedic CTAS score at departure from scene and arrival at hospital.
Inter-rater reliability of CTAS between medics (as assigned at arrival at hospital) and triage nurses will be estimated using a kappa statistic. The same measure of agreement will be estimated between the triage nurse and the observer.
Agreement between the return priority code initially conveyed by the paramedic to dispatch and the code recorded on the ACR will be evaluated using the kappa statistic. The relationship between CTAS score and return priority code will be measured using descriptive statistics and non-parametric correlation. The frequency of calls in which problems in paramedic communication with dispatch arose with respect to the use of both CTAS and return priority will be calculated and the types of problems encountered described.
- Conditions
- Healthy
- Keywords
- Canadian Triage Acuity Scale, paramedics, triage nurse, triage levels, inter-rater reliability, health services outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
CTAS level assignment
Reliability and validity of CTAS level assignment by paramedics and EMS service implementation
Measured: At the time of departue from scene and arrival at hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startFeb 2003
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurie Morrison, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468780
- Sponsor's protocol ID
- 724180022
- Status last verified
- May 2014
- First submitted
- 1 May 2007
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety and Efficacy of Redirecting Ambulance Patients to Destinations Based on Acuity
- ClinicalTrials.gov ID
- NCT00468780
- Acronym / sponsor ID
- 724180022
- Conditions
- Healthy
- Keywords
- Canadian Triage Acuity Scale, paramedics, triage nurse, triage levels, inter-rater reliability, health services outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 May 2007 (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.
The objective of this study is to evaluate the reliability and validity of acuity estimates by paramedics employing the Canadian Triage Acuity Scale (CTAS) in the out of hospital setting. The study has the potential to help guide policy decisions pertaining to the safe transfer of ambulance patients to alternative destinations reducing ED overcrowding and ambulance off load time. Emergency Department triage nurses employ the same acuity scale and if this study is successful the emergency departments and the EMS services could communicate about capacity to handle patients based on acuity, volumes and waiting times.
Detailed description
CTAS stands for the Canadian Triage Acuity Scale. CTAS defines 5 levels of triage according to the perceived need for physician assessment. CTAS was developed to measure ED case mix and evaluate the potential effect of changes in the delivery of health care on patients seeking emergency care. Although the Canadian Institute of Health Information (CIHI) collects data on total visits, admissions, and ambulatory care visits, there are few standards for reporting data from Emergency Departments. The Canadian Association of Emergency Physicians endorsed CTAS as a standardized data element to assess and compare case mix and acuity.
At present there are no consistently utilized measures of patient acuity performed by paramedics in Ontario. Information on the interface between Prehospital Care and Emergency Departments would inform decision-making on the Emergency Health Care system. The introduction of CTAS provides a superb opportunity to evaluate its utility in providing this information on an accurate and consistent basis.
The use of an acuity scale common to the in-hospital and prehospital setting seems ideal. However, there are several questions to be answered regarding the feasibility, reliability, safety and validity of CTAS before widespread implementation. The Society for Academic Emergency Medicine's position clearly states, "Patients may be referred to other locations where they will receive care appropriate to the acuity of their problem only if the triage criteria, if any, are based on research that shows them to be safe and effective". In their prospective trial, Brillman et al. noted that 26-38% of emergency department patients who were admitted to hospital would not have been identified at triage even when the treating physician assessed them. If physicians are not capable of accurate triage decisions, one must consider the reliability of a paramedic under the challenges of the prehospital setting. Moreover, recent high-profile coroner cases suggest that liability is a significant concern. Paramedics are accustomed to point-of-care assessment and triage, and do not have access to some of the resources utilized by ED nurses. Because the environment, context, discriminating tools, resources and skill set differ between triage nurses and paramedics, it is essential to evaluate the use of paramedic assessment tools in the determination of an accurate and consistent CTAS score. Moreover there has not as yet been an emphasis on paramedic assessment interfacing with decision-making and time to care. It is important to ensure, therefore, that the prehospital application of CTAS is appropriate and safe.
The objectives of this study are to evaluate the criterion validity of CTAS assignment by paramedics at departure from scene and arrival at hospital compared to a CTAS expert (gold standard), to evaluate the inter-rater reliability of CTAS assignment by paramedics at arrival at hospital compared to triage nurses, to evaluate the predictive validity of CTAS level assignment with respect to patient outcomes and health care resource utilization and to describe the relationship and the use of the return priority code and the CTAS category.
A random sample of Advanced Care Paramedic crews and an equal number of randomly selected Basic Care Paramedic crews from five EMS systems (rural and urban) will be invited to participate. A paramedic observer (advanced and basic) with advanced CTAS skills will observe each crew, record the critical elements of each prehospital encounter on a data collection sheet and assign a CTAS level to the patient on departure from scene and arrival at hospital. The observer will also record the CTAS level and return priority code conveyed by the paramedic to the dispatch centre, and evaluate whether the use of both the return priority code (in which an urgent return is assigned a value of 4) and the CTAS score (in which an urgent call is assigned a value of 1 or 2) generates any difficulties in paramedic communication with dispatch on departure from the scene.
At the hospital, the observer will ensure that the triage nurse assigns the CTAS level without prior knowledge of the paramedic assignment. The observer will record the CTAS level assigned by the triage nurse as well as the CTAS level at departure from the scene and on arrival at the receiving hospital, return priority code and status change code recorded by the treating paramedic on the ambulance call report. The patient's health insurance number (HIN) will be collected for the purposes of linkage to outcome data. The observer will record the times of departure from scene and arrival at hospital to estimate the transport interval.
Validity will be measured by calculating a kappa statistic comparing the observer's (gold standard) CTAS score with the paramedic CTAS score at departure from scene and arrival at hospital.
Inter-rater reliability of CTAS between medics (as assigned at arrival at hospital) and triage nurses will be estimated using a kappa statistic. The same measure of agreement will be estimated between the triage nurse and the observer.
Agreement between the return priority code initially conveyed by the paramedic to dispatch and the code recorded on the ACR will be evaluated using the kappa statistic. The relationship between CTAS score and return priority code will be measured using descriptive statistics and non-parametric correlation. The frequency of calls in which problems in paramedic communication with dispatch arose with respect to the use of both CTAS and return priority will be calculated and the types of problems encountered described.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study is taking place in 7 EMS systems in Ontario: Peterborough, Thunder Bay, Hamilton, Simcoe/Muskoka, Durham, Peel, and Toronto. The participants(Both Primary care paramedics and Advance Care Parmaeidcs)are riding as civilian observers under contract to the Sunnybrook and Women's College Health Sciences Centre Research Institute and have signed liability release forms. The main focus of the SCORE study is to determine how well paramedics in the field can correctly assign CTAS scores. By showing that it can be done reliably, decisions can be made on suitable destinations, especially for the low acuity patient.
Key inclusion criteria (1 listed)
- All patients
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CTAS level assignment
Time frame: At the time of departue from scene and arrival at hospital
Reliability and validity of CTAS level assignment by paramedics and EMS service implementation
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 26 May 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Laurie Morrison, MD principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Unity Health Toronto at 2 sites 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 1 inclusion and 0 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
CTAS level assignment (time frame: At the time of departue from scene and arrival at hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2014.