Medical Emergency CallsNCT02649036
Social Inequalities in Emergency Call and Emergency Response Patterns
An observational study of Medical Emergency Calls, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
Trial summary
Background: Inequality in access to healthcare is a challenge internationally. Despite that medical emergency calls can be considered as access point to pre-hospital emergency care and hospital admission in emergency situations, no data on inequality in access to healthcare through emergency calls is reported in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Emergency Calls
- How many people
- 80,829 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2014to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In study part I the study population consists of all adult individuals with residence in the Capital Region of Denmark identified in a two-year period (December 2011-November 2013). In stydy part II the study population will be limited to individuals from the Capital Region of Denmark for whom a medical emergency call has been made in the study period.
Who may be able to join
- Medical emergency calls registered in the EMS database in the Capital region of Denmark, in which the individual patients live in the capital region of Denmark and have data from central registries (civil registration number and socioeconomic variables of interest)registered.
- Citizens ≥18 years of age
- Study part 1:
- All medical emergency calls in the period 12/1-2011-11/30-2013 with a civil registration number
- Study part 2:
- All medical emergency calls with a medical contact cause (chest pain, intoxication, breathing difficulties, abdominal pain/back pain, altered level of consciousness, seizures and unconscious/lifeless adult) in the period 12/1-2011-11/30-2013 with a civil registration number and a complete contact cause registered.
Who cannot join
- Calls from citizens with no civil registration number recorded
- Medical emergency calls from citizens <18 years old
- Emergency calls for citizens outside RegionH
- Non first time calls
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Inequality in access to healthcare is a challenge internationally. Despite that medical emergency calls can be considered as access point to pre-hospital emergency care and hospital admission in emergency situations, no data on inequality in access to healthcare through emergency calls is reported in the international literature.
Read more
Study aims:
The aim of this study is two-fold:
- to evaluate the association between socio-economic characteristics of citizens and first-time emergency call in the Capital Region of Denmark
- to evaluate the association between socio-economic characteristics of citizens with an emergency call and the priority level of the response provided by the emergency medical dispatch center in the Capital Region of Denmark.
Method: Observational register based study of adult citizens in the Capital Region of Denmark. Educational level, household income and employment are used as socioeconomic indicators. The unique civil registration number will be used to link data from the Emergency Medical Dispatch Center with data from the Civil Registration System, Danish registers on personal labor market affiliation, the Danish Populations Education Register, the Danish Income Statistics Registry and the national patient registry. Logistic regression models will be used for the association between socio economic indicators and first time emergency calls and the association between socioeconomic indicators and the priority level of the response provided.
Read the detailed description
Background:
In prehospital emergency medicine, emergency medical dispatchers play an essential role as gatekeepers to emergency care from the emergency medical services and possibly hospital admissions. Dispatching is the task of handling emergency calls in terms of appropriate triage, delivery of pre-arrival instructions and management of resources to citizens calling for help. Research within out-of-hospital cardiac arrest has shown that medical dispatchers can contribute to increased survival, if cardiac arrest is identified through the emergency call, and telephone assisted cardiopulmonary resuscitation is initiated. Optimal performance in the links of the chain of survival is not only dependent on good performance of healthcare professionals in the prehospital setting, but also on the persons initiating resuscitation and calling for help. This is not only true for OHCA but also other life-threatening situations and the outcome may be affected by the interaction between the person calling for help and the medical dispatcher responding to the call and providing advice and an adequate response from the emergency medical services. Research in this area is, however, at an early stage. Inequality in access to healthcare is a challenge internationally. Despite that medical emergency calls can be considered as access point to pre-hospital emergency care and hospital admission in emergency situations, no data on inequality in access to healthcare through emergency calls is reported in the international literature.
Study Objective:
The aim of the study is two-fold:
- To evaluate the association between socio-economic characteristics of citizens and first-time emergency call in the Capital Region of Denmark
- To evaluate the association between socio-economic characteristics of citizens with an emergency call and the emergency response provided by the emergency medical dispatch center in the Capital Region of Denmark.
Hypotheses:
- Low socioeconomic position (measured by educational level, employment, household income as social indicators) is associated with a high incidence of emergency calls, compared to high socioeconomic position.
- Within the most common medical contact causes (chest pain, intoxication, breathing difficulties, abdominal pain/back pain, altered level of consciousness, seizures and unconscious/lifeless adult), low socioeconomic position (measured by educational level, employment, household income as indicators) is associated with a lower level of emergency response, compared to high socioeconomic position.
Study design:
The study is an investigation of the population in the Capital Region of Denmark performed by combining data from the Emergency Medical Services and Danish central registries in a two-year period (December 2011-November 2013).
Setting:
The study is based on data from the Capital Region of Denmark with a population of 1.8 million. In Denmark, healthcare services are covered by income taxes. In case of an emergency, there is a single emergency phone number (1-1-2) to a call center that identifies the need for police, fire or medical assistance. In case of a medical problem, the caller is re-directed to an Emergency Medical Dispatch Center where medical dispatchers answer, process and respond to the call by activating the appropriate Emergency Medical Services. The medical dispatchers are specially trained nurses or paramedics with experience within emergency medicine. Their decision-making process is supported by a criteria-based, nationwide Emergency Medical Dispatch System (Danish Index for Emergency Care), which is a validated tool for managing emergency calls for the most urgent cases of emergencies.
Analysis, study part 1:
- Logistic regression models will be used with emergency call as outcome variable (yes/no) and socioeconomic indicators as explanatory variables, calculating odds ratios for the probability of a first-time emergency call for each socioeconomic indicator. The analysis will be performed unadjusted and adjusted for age, gender, civil status, country of origin, and comorbidity.
Analysis, study part 2:
- Ordinal logistic regression models will be used with emergency response as outcome variable (four levels) and socioeconomic indicators as explanatory variables to calculate the probability of each emergency response. The analysis will be performed unadjusted and adjusted for age, gender, civil status, country of origin and comorbidity.
- The analysis will primarily be performed as complete case analysis and secondarily as a weighted analysis according to the proportion of missing personal identification numbers within each response type in the original dataset.
- Conditions
- Medical Emergency Calls
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 |
|---|---|---|
| Emergency call population | Citizens over 18 years old from the Capital Region of Denmark with a first time emergency call within a two-year study period (1/12-2011-30/11-2013) | |
| Background population | Citizens over 18 years old from the Capital Region of Denmark with no emergency call within a two-year study period (1/12-2011-30/11-2013) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency call
First time emergency calls registered electronically at the EMS Copenhagen concerning citizens with recidence in the Capital Region of Denmark. The information will be obtained from the database at the EMS Copenhagen.
Measured: 12/1-2011 - 11/30-2013 (up to 24 months)
Emergency response level
Emergency response level provided by emergency medical dispatchers during emergency calls. This outcome will be divided into four levels: 1) Red (immediate response with lights and siren); 2) Orange (immediate response without lights and siren); 3) Yellow/green (non-urgent response with appropriate available resource); 4) Blue (medical advice). Information about emergency responce level is registered electronically and will be obtained from the database at the EMS Copenhagen.
Measured: 12/1-2011 - 11/30-2013 (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Emergency CallsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 80,829 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Collaborators
- The Danish National Institute of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649036
- Sponsor's protocol ID
- EMS-2015-TPM-02
- Status last verified
- Jan 2016
- First submitted
- 4 Jan 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Inequalities in Emergency Call and Emergency Response Patterns
- ClinicalTrials.gov ID
- NCT02649036
- Acronym / sponsor ID
- EMS-2015-TPM-02
- Conditions
- Medical Emergency Calls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80,829 participants (actual)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Collaborators
- The Danish National Institute of Public Health
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Jan 2016 (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.
Background:
Inequality in access to healthcare is a challenge internationally. Despite that medical emergency calls can be considered as access point to pre-hospital emergency care and hospital admission in emergency situations, no data on inequality in access to healthcare through emergency calls is reported in the international literature.
Study aims:
The aim of this study is two-fold:
- to evaluate the association between socio-economic characteristics of citizens and first-time emergency call in the Capital Region of Denmark
- to evaluate the association between socio-economic characteristics of citizens with an emergency call and the priority level of the response provided by the emergency medical dispatch center in the Capital Region of Denmark.
Method: Observational register based study of adult citizens in the Capital Region of Denmark. Educational level, household income and employment are used as socioeconomic indicators. The unique civil registration number will be used to link data from the Emergency Medical Dispatch Center with data from the Civil Registration System, Danish registers on personal labor market affiliation, the Danish Populations Education Register, the Danish Income Statistics Registry and the national patient registry. Logistic regression models will be used for the association between socio economic indicators and first time emergency calls and the association between socioeconomic indicators and the priority level of the response provided.
Detailed description
Background:
In prehospital emergency medicine, emergency medical dispatchers play an essential role as gatekeepers to emergency care from the emergency medical services and possibly hospital admissions. Dispatching is the task of handling emergency calls in terms of appropriate triage, delivery of pre-arrival instructions and management of resources to citizens calling for help. Research within out-of-hospital cardiac arrest has shown that medical dispatchers can contribute to increased survival, if cardiac arrest is identified through the emergency call, and telephone assisted cardiopulmonary resuscitation is initiated. Optimal performance in the links of the chain of survival is not only dependent on good performance of healthcare professionals in the prehospital setting, but also on the persons initiating resuscitation and calling for help. This is not only true for OHCA but also other life-threatening situations and the outcome may be affected by the interaction between the person calling for help and the medical dispatcher responding to the call and providing advice and an adequate response from the emergency medical services. Research in this area is, however, at an early stage. Inequality in access to healthcare is a challenge internationally. Despite that medical emergency calls can be considered as access point to pre-hospital emergency care and hospital admission in emergency situations, no data on inequality in access to healthcare through emergency calls is reported in the international literature.
Study Objective:
The aim of the study is two-fold:
- To evaluate the association between socio-economic characteristics of citizens and first-time emergency call in the Capital Region of Denmark
- To evaluate the association between socio-economic characteristics of citizens with an emergency call and the emergency response provided by the emergency medical dispatch center in the Capital Region of Denmark.
Hypotheses:
- Low socioeconomic position (measured by educational level, employment, household income as social indicators) is associated with a high incidence of emergency calls, compared to high socioeconomic position.
- Within the most common medical contact causes (chest pain, intoxication, breathing difficulties, abdominal pain/back pain, altered level of consciousness, seizures and unconscious/lifeless adult), low socioeconomic position (measured by educational level, employment, household income as indicators) is associated with a lower level of emergency response, compared to high socioeconomic position.
Study design:
The study is an investigation of the population in the Capital Region of Denmark performed by combining data from the Emergency Medical Services and Danish central registries in a two-year period (December 2011-November 2013).
Setting:
The study is based on data from the Capital Region of Denmark with a population of 1.8 million. In Denmark, healthcare services are covered by income taxes. In case of an emergency, there is a single emergency phone number (1-1-2) to a call center that identifies the need for police, fire or medical assistance. In case of a medical problem, the caller is re-directed to an Emergency Medical Dispatch Center where medical dispatchers answer, process and respond to the call by activating the appropriate Emergency Medical Services. The medical dispatchers are specially trained nurses or paramedics with experience within emergency medicine. Their decision-making process is supported by a criteria-based, nationwide Emergency Medical Dispatch System (Danish Index for Emergency Care), which is a validated tool for managing emergency calls for the most urgent cases of emergencies.
Analysis, study part 1:
- Logistic regression models will be used with emergency call as outcome variable (yes/no) and socioeconomic indicators as explanatory variables, calculating odds ratios for the probability of a first-time emergency call for each socioeconomic indicator. The analysis will be performed unadjusted and adjusted for age, gender, civil status, country of origin, and comorbidity.
Analysis, study part 2:
- Ordinal logistic regression models will be used with emergency response as outcome variable (four levels) and socioeconomic indicators as explanatory variables to calculate the probability of each emergency response. The analysis will be performed unadjusted and adjusted for age, gender, civil status, country of origin and comorbidity.
- The analysis will primarily be performed as complete case analysis and secondarily as a weighted analysis according to the proportion of missing personal identification numbers within each response type in the original dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency call population | – | –Citizens over 18 years old from the Capital Region of Denmark with a first time emergency call within a two-year study period (1/12-2011-30/11-2013) |
| Background population | – | –Citizens over 18 years old from the Capital Region of Denmark with no emergency call within a two-year study period (1/12-2011-30/11-2013) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In study part I the study population consists of all adult individuals with residence in the Capital Region of Denmark identified in a two-year period (December 2011-November 2013). In stydy part II the study population will be limited to individuals from the Capital Region of Denmark for whom a medical emergency call has been made in the study period.
Key inclusion criteria (6 listed)
- Medical emergency calls registered in the EMS database in the Capital region of Denmark, in which the individual patients live in the capital region of Denmark and have data from central registries (civil registration number and socioeconomic variables of interest)registered.
- Citizens ≥18 years of age
- All medical emergency calls in the period 12/1-2011-11/30-2013 with a civil registration number
- All medical emergency calls with a medical contact cause (chest pain, intoxication, breathing difficulties, abdominal pain/back pain, altered level of consciousness, seizures and unconscious/lifeless adult) in the period 12/1-2011-11/30-2013 with a civil registration number and a complete contact cause registered.
Key exclusion criteria (4 listed)
- Calls from citizens with no civil registration number recorded
- Medical emergency calls from citizens <18 years old
- Emergency calls for citizens outside RegionH
- Non first time calls
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
Emergency call
Time frame: 12/1-2011 - 11/30-2013 (up to 24 months)
First time emergency calls registered electronically at the EMS Copenhagen concerning citizens with recidence in the Capital Region of Denmark. The information will be obtained from the database at the EMS Copenhagen.
Emergency response level
Time frame: 12/1-2011 - 11/30-2013 (up to 24 months)
Emergency response level provided by emergency medical dispatchers during emergency calls. This outcome will be divided into four levels: 1) Red (immediate response with lights and siren); 2) Orange (immediate response without lights and siren); 3) Yellow/green (non-urgent response with appropriate available resource); 4) Blue (medical advice). Information about emergency responce level is registered electronically and will be obtained from the database at the EMS Copenhagen.
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 4 Aug 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Emergency Calls, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
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 6 inclusion and 4 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 4 Aug 2016. 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 Denmark. 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?
Emergency call (time frame: 12/1-2011 - 11/30-2013 (up to 24 months)). The study lists 2 primary outcomes in all. 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 4 Aug 2016.