Acute Coronary SyndromeASCENDNCT03463603
Ethnic Differences in Acute Coronary Syndromes Care in Emergency Departments.
An observational study of Acute Coronary Syndrome and Racial Bias, run by University of British Columbia at 3 sites in Canada.
Trial summary
When doctors and nurses use accepted guidelines for quickly treating patients who come to the emergency department (ED) with a possible heart attack, patients do better. Research shows that there are racial-identity- and ethnicity-based differences in the symptoms these patients have, when and why they seek care, the… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Racial Bias
- How many people
- 448 participants
- Where
- 3 sitesCanada
- Study dates
- 7 Oct 2013to 12 Apr 2017
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: Patients presenting to Emergency Departments with symptoms suggestive of an acute coronary syndrome.
Who may be able to join
- 20 years of age or older
- presented to the ED and are either referred for immediate cardiology consultation or managed according to a standardized protocol for continued observation and referral for follow-up (whether ultimately admitted or not);
- hemodynamically stable and free of ischemic discomfort for at least one hour
- spoke English, Mandarin, Cantonese, Punjabi
- able to provide informed consent.
Who cannot join
- being cared for by any of the Emergency physicians (3) who were co-investigators
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Richmond Hospital
Richmond, British Columbia, V6X 1A2
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
About this study
When doctors and nurses use accepted guidelines for quickly treating patients who come to the emergency department (ED) with a possible heart attack, patients do better. Research shows that there are racial-identity- and ethnicity-based differences in the symptoms these patients have, when and why they seek care, the treatments they receive, and how well they fare afterwards. There is also Canadian evidence that there may be racial-identity-based disparities in the care some patients receive, and it has been suggested that health professionals may unconsciously treat patients of different racial identities differently. But it is not known if there is racial-identity variation in the care given to Canadian patients with heart attack symptoms in the critical first hours after coming to an ED, or in their experiences of this care. The investigators collected information from the health records of patients who come to EDs with symptoms of heart attack. The investigators recorded events and times such as what provisional diagnosis was assigned to the patient, how often they received pain medication, how long until certain tests were performed and what treatments were offered. The investigators also collected information about things that might affect delivery of care, e.g., the number of doctors and nurses who were on duty. Participants also completed a short questionnaire about their reasons for coming to the hospital, how long they waited before coming and why, and what their experience in the ED was like. The investigators reviewed this information to see if there are racial-identity-based differences in the care received by patients with heart attack symptoms. The findings could identify important disparities, which could in turn inform future projects to correct these disparities, for example, education of health professionals about ethnic differences in ideas of health and illness.
Read the detailed description
The investigators conducted a prospective, observational study in which patients presenting to EDs who were subsequently diagnosed with acute coronary syndrome (ACS) or possible ACS were identified. The investigators collected data related to receiving the accepted standard of care for ACS patients. Information about the participants' initial symptoms, attribution of their symptoms, treatment-seeking choices, and perceptions of the care received in the ED was collected.
Setting and Sample: The investigators conducted the study at three sites: Hospital 1 is in an inner-city, quaternary care, university-affiliated hospital whose ED has approximately 71,000 patient visits annually, about 2,800 of which are patients with symptoms that are potentially due to myocardial ischemia. The medical and nursing staffing levels are staggered based on expected patient volumes, ranging from 15 to 18 registered nurses (RNs) and 1 to 6 physicians at a given time. There are also support staff, including licensed practical nurses, aides; clerks, ECG technicians, etc. There is a designated triage area, staffed continuously by at least one RN. Hospital 2's ED is in a large community hospital in a different health authority. It has 100,000 patient visits annually, approximately 6,500 of which are patients with potentially ischemic symptoms. The medical and nursing staffing levels are similar to the first site, ranging from 19 to 22 registered nurses (RNs) and 1 to 4 physicians at a given time. This site is in a community with a very high proportion of South Asian people (27.5%). Hospital 3 is also a community hospital with fewer ED visits annually, but similar nursing and medical staffing levels. This site is in a community with a very high proportion (52.5%) of people identifying as being of Chinese ancestry.
Procedures: Research assistants (RAs) fluent in English, Mandarin and Cantonese for the tertiary site and one fluent in English and Punjabi for the community site recruited participants.
Recruitment. The RAs identified potential participants, seven days per week, from one of three sources: (1) a list, obtained daily from the ED charge nurse, of all patients admitted to the hospital since the RA's last visit who were triaged with codes related to a possible ACS; (2) the current charge nurse, who identified any patient currently in the ED who met study criteria as signified by the ED physician ordering one of the following: (i) cardiology consult, (ii) cardiac computational tomography, or (iii) 2- or 6-hour repeat cardiac biomarker and ECG, followed by outpatient provocative stress testing; (3) a list, obtained from the stress-testing laboratory, of all patients who had been referred from the ED for urgent (within 48 hours) outpatient stress testing.
Recruitment occurred in the ED, the cardiology units (CCU or telemetry unit) and in the stress-testing laboratory. Potential participants were screened for general eligibility through discussion with the nurse or cardiology technologist. Those believed to be eligible were approached and invited to participate.
Data collection. Data regarding delivery of guideline-based care in the ED were collected from the health record (e.g., time to stretcher, time to ECG, time to first MD assessment, medications administered) and other processes (e.g., occurrence and timing of cardiology consultation, transfer from ED to a critical care area). Data regarding several patient-, environment- and system-related potential covariates were collected from the health record (e.g., mode of arrival at ED; language spoken; accompanied by family/friend; language ability of family/friend; symptoms reported) and ED staffing records (staffing levels). Data pertaining to the entire ED stay were captured.
Participants were asked to respond to a questionnaire, administered by the RA, regarding their decision to seek treatment and their perspectives on their ED care. Ethnicity, racial identity and other sociodemographic data were obtained during the interview.
For those admitted to the hospital, additional data regarding admission unit , procedures offered, refused and undergone, major adverse cardiac events, length of stay and final diagnosis were collected. For participants who were discharged from the ED with referral to outpatient stress testing, we tracked discharge diagnosis, attendance at, and interpretation of the test.
Measures: The primary outcome variable, door-to-ECG time, was defined as the time from triage to first ECG acquisition. The official triage time is the time entered by the triage nurse when the patient is initially evaluated. The time of the first ECG is an electronic time stamp appearing in the clinical information system, entered when the ECG is acquired.
The predictor variables ethnicity and racial identity were measured by self-report.
Other outcome variables and potential confounders:
- Time intervals: Several time intervals were measured, based on the official triage time.
- Location, nature and severity of reported symptoms: All symptoms reported by participant, as well as their intensity.
- Acuity at time of triage: measured using the Canadian Triage and Acuity Score. The participants' presenting complaint was measured using the Canadian Emergency Department Information System standardised codes, in use at the study sites.
- Other data: Mode of transport to hospital, accompanied versus alone, noted difficulty with English, presence of interpreter during care
- Number and frequency of physician and nurse assessments/interventions.
- Measured clinical parameters: All documented observations of ECG rhythm and vital signs.
- Medications: Agent, dose, route and time of administration
- Diagnostic testing: Timing and frequency of bloodwork and ECGs.
- Consultation: Consultation of other medical services.
- Patient Disposition.
- Patient perspectives: Time of onset, type of symptoms, decisions to seek treatment and reasons for delaying; participants' perspectives on care in ED; other socio-demographic variables
- Emergency department contextual factors: Staffing levels for each shift.
- Post-ED care: Diagnostic tests and interventions offered and completed after leaving ED, e.g., referral for / offer of / consent to / receipt of angiogram, percutaneous coronary intervention or cardiac surgery; discharge diagnosis; length of hospital stay.
- Conditions
- Acute Coronary Syndrome, Racial Bias
- Keywords
- ischemic heart disease, acute coronary syndrome, racial bias
- Medical subject headings
- Acute Coronary Syndrome, Racism, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asian racial identity | Those who self-report "Asian" or related terms as their racial identity. | |
| South Asian racial identity | Those who self-report "South Asian" or related terms as their racial identity. | |
| Other racial identity | All others, who self-report neither "Asian", "South Asian" or their related terms as their racial identity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door to ECG
time from Emergency triage to first ECG acquisition
Measured: from hour and minute of admission until the hour and minute of first documented ECG, up to 48 hours
Secondary outcomes (4)
Number of assessments by health professionals
The number of assessments by physicians and nurses during the ED stay.
Measured: from hour and minute of admission until the hour and minute of transfer to inpatient unit or discharge from Emergency Department, whichever comes first, up to 48 hours
Rate of being offered and consenting to coronary angiogram
Rate of being offered and consenting to coronary angiogram among those having a diagnosis of acute coronary syndrome or myocardial infarction.
Measured: from date of admission until the date of hospital discharge, up to 100 weeks
Rate of being offered and consenting to any revascularization procedure
Rate of being offered and consenting to any revascularization procedure among those having coronary atherosclerotic lesions >/= 70% in any vessel
Measured: from date of admission until the date of hospital discharge, up to 24 weeks
ethnic differences in treatment-seeking delay
the time between symptom onset and the decision to seek medical help
Measured: from hour and minute of first documented symptoms until the hour and minute of first documented help-seeking, up to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start7 Oct 2013
- Primary completion11 Jan 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research, Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Martha Mackay, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463603
- Sponsor's protocol ID
- H13-00617
- Acronym
- ASCEND
- Status last verified
- Mar 2018
- First submitted
- 5 Feb 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Iacoe E, Ratner PA, Wong ST, Mackay MH. A cross-sectional study of ethnicity-based differences in treatment seeking for symptoms of acute coronary syndrome. Eur J Cardiovasc Nurs. 2018 Apr;17(4):297-304. doi: 10.1177/1474515117741893. Epub 2017 Nov 15.
PubMed 29140107Mackay, M.H., Ratner, P.A., Scheuermeyer, F.X., Veenstra, G., Ramanathan, K.R., O'Sullivan, M.E., Grubisic, M., Murray, C., Humphries, K.H. (2017). Is racism a factor in emergency department care of patients with suspected acute coronary syndrome? Canadian Journal of Cardiology, 33 (10), s125-126.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Differences in Acute Coronary Syndromes Care in Emergency Departments.
- ClinicalTrials.gov ID
- NCT03463603
- Acronym / sponsor ID
- ASCEND / H13-00617
- Conditions
- Acute Coronary Syndrome, Racial Bias
- Keywords
- ischemic heart disease, acute coronary syndrome, racial bias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research, Heart and Stroke Foundation of Canada
- Study start
- 7 Oct 2013 (actual)
- Primary completion
- 11 Jan 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 13 Mar 2018 (actual)
- 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.
When doctors and nurses use accepted guidelines for quickly treating patients who come to the emergency department (ED) with a possible heart attack, patients do better. Research shows that there are racial-identity- and ethnicity-based differences in the symptoms these patients have, when and why they seek care, the treatments they receive, and how well they fare afterwards. There is also Canadian evidence that there may be racial-identity-based disparities in the care some patients receive, and it has been suggested that health professionals may unconsciously treat patients of different racial identities differently. But it is not known if there is racial-identity variation in the care given to Canadian patients with heart attack symptoms in the critical first hours after coming to an ED, or in their experiences of this care. The investigators collected information from the health records of patients who come to EDs with symptoms of heart attack. The investigators recorded events and times such as what provisional diagnosis was assigned to the patient, how often they received pain medication, how long until certain tests were performed and what treatments were offered. The investigators also collected information about things that might affect delivery of care, e.g., the number of doctors and nurses who were on duty. Participants also completed a short questionnaire about their reasons for coming to the hospital, how long they waited before coming and why, and what their experience in the ED was like. The investigators reviewed this information to see if there are racial-identity-based differences in the care received by patients with heart attack symptoms. The findings could identify important disparities, which could in turn inform future projects to correct these disparities, for example, education of health professionals about ethnic differences in ideas of health and illness.
Detailed description
The investigators conducted a prospective, observational study in which patients presenting to EDs who were subsequently diagnosed with acute coronary syndrome (ACS) or possible ACS were identified. The investigators collected data related to receiving the accepted standard of care for ACS patients. Information about the participants' initial symptoms, attribution of their symptoms, treatment-seeking choices, and perceptions of the care received in the ED was collected.
Setting and Sample: The investigators conducted the study at three sites: Hospital 1 is in an inner-city, quaternary care, university-affiliated hospital whose ED has approximately 71,000 patient visits annually, about 2,800 of which are patients with symptoms that are potentially due to myocardial ischemia. The medical and nursing staffing levels are staggered based on expected patient volumes, ranging from 15 to 18 registered nurses (RNs) and 1 to 6 physicians at a given time. There are also support staff, including licensed practical nurses, aides; clerks, ECG technicians, etc. There is a designated triage area, staffed continuously by at least one RN. Hospital 2's ED is in a large community hospital in a different health authority. It has 100,000 patient visits annually, approximately 6,500 of which are patients with potentially ischemic symptoms. The medical and nursing staffing levels are similar to the first site, ranging from 19 to 22 registered nurses (RNs) and 1 to 4 physicians at a given time. This site is in a community with a very high proportion of South Asian people (27.5%). Hospital 3 is also a community hospital with fewer ED visits annually, but similar nursing and medical staffing levels. This site is in a community with a very high proportion (52.5%) of people identifying as being of Chinese ancestry.
Procedures: Research assistants (RAs) fluent in English, Mandarin and Cantonese for the tertiary site and one fluent in English and Punjabi for the community site recruited participants.
Recruitment. The RAs identified potential participants, seven days per week, from one of three sources: (1) a list, obtained daily from the ED charge nurse, of all patients admitted to the hospital since the RA's last visit who were triaged with codes related to a possible ACS; (2) the current charge nurse, who identified any patient currently in the ED who met study criteria as signified by the ED physician ordering one of the following: (i) cardiology consult, (ii) cardiac computational tomography, or (iii) 2- or 6-hour repeat cardiac biomarker and ECG, followed by outpatient provocative stress testing; (3) a list, obtained from the stress-testing laboratory, of all patients who had been referred from the ED for urgent (within 48 hours) outpatient stress testing.
Recruitment occurred in the ED, the cardiology units (CCU or telemetry unit) and in the stress-testing laboratory. Potential participants were screened for general eligibility through discussion with the nurse or cardiology technologist. Those believed to be eligible were approached and invited to participate.
Data collection. Data regarding delivery of guideline-based care in the ED were collected from the health record (e.g., time to stretcher, time to ECG, time to first MD assessment, medications administered) and other processes (e.g., occurrence and timing of cardiology consultation, transfer from ED to a critical care area). Data regarding several patient-, environment- and system-related potential covariates were collected from the health record (e.g., mode of arrival at ED; language spoken; accompanied by family/friend; language ability of family/friend; symptoms reported) and ED staffing records (staffing levels). Data pertaining to the entire ED stay were captured.
Participants were asked to respond to a questionnaire, administered by the RA, regarding their decision to seek treatment and their perspectives on their ED care. Ethnicity, racial identity and other sociodemographic data were obtained during the interview.
For those admitted to the hospital, additional data regarding admission unit , procedures offered, refused and undergone, major adverse cardiac events, length of stay and final diagnosis were collected. For participants who were discharged from the ED with referral to outpatient stress testing, we tracked discharge diagnosis, attendance at, and interpretation of the test.
Measures: The primary outcome variable, door-to-ECG time, was defined as the time from triage to first ECG acquisition. The official triage time is the time entered by the triage nurse when the patient is initially evaluated. The time of the first ECG is an electronic time stamp appearing in the clinical information system, entered when the ECG is acquired.
The predictor variables ethnicity and racial identity were measured by self-report.
Other outcome variables and potential confounders:
- Time intervals: Several time intervals were measured, based on the official triage time.
- Location, nature and severity of reported symptoms: All symptoms reported by participant, as well as their intensity.
- Acuity at time of triage: measured using the Canadian Triage and Acuity Score. The participants' presenting complaint was measured using the Canadian Emergency Department Information System standardised codes, in use at the study sites.
- Other data: Mode of transport to hospital, accompanied versus alone, noted difficulty with English, presence of interpreter during care
- Number and frequency of physician and nurse assessments/interventions.
- Measured clinical parameters: All documented observations of ECG rhythm and vital signs.
- Medications: Agent, dose, route and time of administration
- Diagnostic testing: Timing and frequency of bloodwork and ECGs.
- Consultation: Consultation of other medical services.
- Patient Disposition.
- Patient perspectives: Time of onset, type of symptoms, decisions to seek treatment and reasons for delaying; participants' perspectives on care in ED; other socio-demographic variables
- Emergency department contextual factors: Staffing levels for each shift.
- Post-ED care: Diagnostic tests and interventions offered and completed after leaving ED, e.g., referral for / offer of / consent to / receipt of angiogram, percutaneous coronary intervention or cardiac surgery; discharge diagnosis; length of hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asian racial identity | – | –Those who self-report "Asian" or related terms as their racial identity. |
| South Asian racial identity | – | –Those who self-report "South Asian" or related terms as their racial identity. |
| Other racial identity | – | –All others, who self-report neither "Asian", "South Asian" or their related terms as their racial identity. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to Emergency Departments with symptoms suggestive of an acute coronary syndrome.
Key inclusion criteria (5 listed)
- 20 years of age or older
- presented to the ED and are either referred for immediate cardiology consultation or managed according to a standardized protocol for continued observation and referral for follow-up (whether ultimately admitted or not);
- hemodynamically stable and free of ischemic discomfort for at least one hour
- spoke English, Mandarin, Cantonese, Punjabi
- able to provide informed consent.
Key exclusion criteria (1 listed)
- being cared for by any of the Emergency physicians (3) who were co-investigators
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
Door to ECG
Time frame: from hour and minute of admission until the hour and minute of first documented ECG, up to 48 hours
time from Emergency triage to first ECG acquisition
4 secondary outcomes
Number of assessments by health professionals
Time frame: from hour and minute of admission until the hour and minute of transfer to inpatient unit or discharge from Emergency Department, whichever comes first, up to 48 hours
Rate of being offered and consenting to coronary angiogram
Time frame: from date of admission until the date of hospital discharge, up to 100 weeks
Rate of being offered and consenting to any revascularization procedure
Time frame: from date of admission until the date of hospital discharge, up to 24 weeks
ethnic differences in treatment-seeking delay
Time frame: from hour and minute of first documented symptoms until the hour and minute of first documented help-seeking, up to 168 hours
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 14 Mar 2018.
- Results publication: PubMed 29140107Iacoe E, Ratner PA, Wong ST, Mackay MH. A cross-sectional study of ethnicity-based differences in treatment seeking for symptoms of acute coronary syndrome. Eur J Cardiovasc Nurs. 2018 Apr;17(4):297-304. doi: 10.1177/1474515117741893. Epub 2017 Nov 15.
- Results publicationMackay, M.H., Ratner, P.A., Scheuermeyer, F.X., Veenstra, G., Ramanathan, K.R., O'Sullivan, M.E., Grubisic, M., Murray, C., Humphries, K.H. (2017). Is racism a factor in emergency department care of patients with suspected acute coronary syndrome? Canadian Journal of Cardiology, 33 (10), s125-126.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Racial Bias, run by University of British Columbia at 3 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 5 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Door to ECG (time frame: from hour and minute of admission until the hour and minute of first documented ECG, up to 48 hours). 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 NCT03463603, which also lists 2 linked publications.
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 14 Mar 2018.