Emergency Medical ServicesNCT04279262
Community First Responders' Role in the Current and Future Rural Health and Care Workforce
An observational study of Emergency Medical Services, run by University of Lincoln at 1 site in United Kingdom.
Trial summary
Community First Responders (CFRs) are trained members of the public, lay people or off-duty healthcare staff who volunteer to provide first aid. CFRs help ambulance services to provide care for people having health emergencies, from falls to road accidents to heart attacks, at home or in public places. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medical Services
- What is being tested?
- attendance by community first responders for medical emergencies
- How many people
- 83,995 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 3 Dec 2022
- 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: For the interview studies the investigators will purposively sample patients, relatives, and ambulance staff identified from records of patients who have been attended by a CFR in a rural location in the previous six months. Where possible the investigators will interview patients, relatives, CFRs and ambulance staff attending the same event. GPs will be purposively sampled from rural areas of the ambulance services involved. The investigators will recruit a maximum variation sample of patients (according to age, sex, condition, and ethnicity), ambulance staff (sex, experience, ethnicity and role), CFR (sex, ethnicity, length of experience, skill level) and CFR scheme leads (independent charity and ambulance trust overseen schemes).
Who may be able to join
- Adults capable of giving informed consent. The investigators will recruit a maximum variation sample of patients (according to age, sex, condition, and ethnicity), ambulance staff (sex, experience, ethnicity and role), CFR (sex, ethnicity, length of experience, skill level) and CFR scheme leads (independent charity and ambulance trust overseen schemes).
Who cannot join
- The investigators will exclude children and adults who are unable to give informed consent from this study.
- London Ambulance Service NHS Trust is not included as it is mainly urban; East of England Ambulance Service and North East Ambulance Service are not included because of lack of electronic data.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Community and Health Research Unit, University of Lincoln
Lincoln, Lincolnshire, LN5 7AY
About this study
Community First Responders (CFRs) are trained members of the public, lay people or off-duty healthcare staff who volunteer to provide first aid. CFRs help ambulance services to provide care for people having health emergencies, from falls to road accidents to heart attacks, at home or in public places. CFRs are particularly important in rural areas where it is more difficult to provide or access emergency care, and where they are an important part of the care workforce. CFRs are broadly perceived to be positive, however evidence is needed about how they contribute to rural health services, which patients/conditions they attend, what care they provide, how effective they are and at what cost, how they are perceived by patients and other health workers, and how they could be developed to improve care for rural communities.
The investigators aim to develop recommendations for rural CFRs, by exploring their contribution to rural care, evaluating their value for money, understanding experiences and views of patients, CFRs and other healthcare staff, and exploring the potential for CFRs to provide new services.
Read the detailed description
The project will involve the following steps:
- Analyse records from six ambulance services to see: how many people CFRs attended; the proportion of ambulance calls attended; age, sex and conditions of people attended; how quickly CFRs attended and what happened to the patient(s) when the ambulance arrived.
- Evaluate benefits and costs of CFRs attending rural emergencies.
- Interview patients/relatives, ambulance staff, GPs, funders, CFRs and CFR leads to obtain views on rural CFR current and potential future roles. Interviews will also explore with CFRs and CFR leads, challenges and solutions to recruiting, training, retaining rural CFRs and ensuring safe, high quality care.
- Combine this knowledge (gained in steps1-3 above) to develop recommendations for change; who will be involved and how services should change to solve the most pressing problems for the rural communities served.
- Present recommendations to a workshop of experts and public to agree priorities for future development.
- Conditions
- Emergency Medical Services
- Being tested
- attendance by community first responders for medical emergencies
- Keywords
- Community first responder, Rural health, Ambulance service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attendance by community first responders for medical emergenciesOther
The investigators will purposively sample patients, relatives, and ambulance staff identified from records of patients who have been attended by a CFR in a rural location in the previous six months. Where possible the investigators will interview patients, relatives, CFRs and ambulance staff attending the same event. GPs will be purposively sampled from rural areas of the ambulance services involved. Investigators will recruit a maximum variation sample of patients (according to age, sex, condition, and ethnicity), ambulance staff (sex, experience, ethnicity and role), CFR (sex, ethnicity, length of experience, skill level) and CFR scheme leads (independent charity and ambulance trust overseen schemes).
| Study group | Role | What they receive |
|---|---|---|
| Anonymised records from 6 ambulance services | The total available sample for analysis for this cohort is estimated to be at least 50,000 incidents across 6 ambulance trusts. The investigators will describe the epidemiology of CFR provision to rural health areas using an anonymised dataset. Receives: Other: attendance by community first responders for medical emergencies | |
| Interviews with patients (and/or relatives) | The investigators will interview about 15-20 patients (and/or relatives) who have been attended by CFRs. Receives: Other: attendance by community first responders for medical emergencies | |
| Interviews with CFRs | The investigators will interview about 15-20 CFRs/ CFR scheme leaders. | |
| Interviews with Ambulance staff | The investigators will interview about 15-20 ambulance staff who have experience of working with CFRs. | |
| Interviews with GPs and commisioners | The investigators will interview about 10-15 GPs and ambulance service commissioners. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ambulance calls that CFRs attend in one year
We will establish how many people CFRs attended and work out the proportion of ambulance calls attended.
Measured: we will evaluate all emergency attendances during one year
The type of cases treated by CFRs
characteristics of people (age, sex, condition) attended
Measured: we will evaluate all emergency attendances during one year
How quickly cases are dealt with
how quickly they attend
Measured: we will evaluate all emergency attendances during one year
Treatments given and transfer to hospital
we will evaluate the treatments provided and the number of cases transferred to hospital
Measured: we will evaluate all emergency attendances during one year
Locations
We will describe rurality and location (eg. at home or elsewhere) where CFRs give treatment.
Measured: we will evaluate all emergency attendances during one year
Secondary outcomes (1)
Perceptions of CFR schemes
We will interview different stakeholders (patients, CFRs, GPs, ambulance staff, CFR leads)
Measured: participants will have been involved in a CFR attendance in the previous 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Jun 2020
- Primary completion1 May 2022
- Study completion3 Dec 2022
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 Emergency Medical ServicesStudies 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
- 83,995 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niro Siriwardena, Principal investigator, University of Lincoln, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279262
- Sponsor's protocol ID
- 20002
- Status last verified
- May 2022
- First submitted
- 23 Jan 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siriwardena AN, Patel G, Botan V, Smith MD, Phung VH, Pattinson J, Trueman I, Ridyard C, Hosseini MP, Asghar Z, Orner R, Brewster A, Mountain P, Rowan E, Spaight R. Community First Responders' role in the current and future rural health and care workforce: a mixed-methods study. Health Soc Care Deliv Res. 2024 Jul;12(18):1-101. doi: 10.3310/JYRT8674.
PubMed 39054745
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community First Responders' Role in the Current and Future Rural Health and Care Workforce
- ClinicalTrials.gov ID
- NCT04279262
- Acronym / sponsor ID
- 20002
- Conditions
- Emergency Medical Services
- Keywords
- Community first responder, Rural health, Ambulance service
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83,995 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 21 Feb 2020 (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.
Community First Responders (CFRs) are trained members of the public, lay people or off-duty healthcare staff who volunteer to provide first aid. CFRs help ambulance services to provide care for people having health emergencies, from falls to road accidents to heart attacks, at home or in public places. CFRs are particularly important in rural areas where it is more difficult to provide or access emergency care, and where they are an important part of the care workforce. CFRs are broadly perceived to be positive, however evidence is needed about how they contribute to rural health services, which patients/conditions they attend, what care they provide, how effective they are and at what cost, how they are perceived by patients and other health workers, and how they could be developed to improve care for rural communities.
The investigators aim to develop recommendations for rural CFRs, by exploring their contribution to rural care, evaluating their value for money, understanding experiences and views of patients, CFRs and other healthcare staff, and exploring the potential for CFRs to provide new services.
Detailed description
The project will involve the following steps:
- Analyse records from six ambulance services to see: how many people CFRs attended; the proportion of ambulance calls attended; age, sex and conditions of people attended; how quickly CFRs attended and what happened to the patient(s) when the ambulance arrived.
- Evaluate benefits and costs of CFRs attending rural emergencies.
- Interview patients/relatives, ambulance staff, GPs, funders, CFRs and CFR leads to obtain views on rural CFR current and potential future roles. Interviews will also explore with CFRs and CFR leads, challenges and solutions to recruiting, training, retaining rural CFRs and ensuring safe, high quality care.
- Combine this knowledge (gained in steps1-3 above) to develop recommendations for change; who will be involved and how services should change to solve the most pressing problems for the rural communities served.
- Present recommendations to a workshop of experts and public to agree priorities for future development.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anonymised records from 6 ambulance services | – | Other: attendance by community first responders for medical emergenciesThe total available sample for analysis for this cohort is estimated to be at least 50,000 incidents across 6 ambulance trusts. The investigators will describe the epidemiology of CFR provision to rural health areas using an anonymised dataset. |
| Interviews with patients (and/or relatives) | – | Other: attendance by community first responders for medical emergenciesThe investigators will interview about 15-20 patients (and/or relatives) who have been attended by CFRs. |
| Interviews with CFRs | – | –The investigators will interview about 15-20 CFRs/ CFR scheme leaders. |
| Interviews with Ambulance staff | – | –The investigators will interview about 15-20 ambulance staff who have experience of working with CFRs. |
| Interviews with GPs and commisioners | – | –The investigators will interview about 10-15 GPs and ambulance service commissioners. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the interview studies the investigators will purposively sample patients, relatives, and ambulance staff identified from records of patients who have been attended by a CFR in a rural location in the previous six months. Where possible the investigators will interview patients, relatives, CFRs and ambulance staff attending the same event. GPs will be purposively sampled from rural areas of the ambulance services involved. The investigators will recruit a maximum variation sample of patients (according to age, sex, condition, and ethnicity), ambulance staff (sex, experience, ethnicity and role), CFR (sex, ethnicity, length of experience, skill level) and CFR scheme leads (independent charity and ambulance trust overseen schemes).
Key inclusion criteria (1 listed)
- Adults capable of giving informed consent. The investigators will recruit a maximum variation sample of patients (according to age, sex, condition, and ethnicity), ambulance staff (sex, experience, ethnicity and role), CFR (sex, ethnicity, length of experience, skill level) and CFR scheme leads (independent charity and ambulance trust overseen schemes).
Key exclusion criteria (2 listed)
- The investigators will exclude children and adults who are unable to give informed consent from this study.
- London Ambulance Service NHS Trust is not included as it is mainly urban; East of England Ambulance Service and North East Ambulance Service are not included because of lack of electronic data.
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 |
|---|---|---|
| attendance by community first responders for medical emergenciesThe investigators will purposively sample patients, relatives, and ambulance staff identified from records of patients who have been attended by a CFR in a rural location in the previous six months. Where possible the investigators will interview patients, relatives, CFRs and ambulance staff attending the same event. GPs will be purposively sampled from rural areas of the ambulance services involved. Investigators will recruit a maximum variation sample of patients (according to age, sex, condition, and ethnicity), ambulance staff (sex, experience, ethnicity and role), CFR (sex, ethnicity, length of experience, skill level) and CFR scheme leads (independent charity and ambulance trust overseen schemes). | Other | Anonymised records from 6 ambulance services, Interviews with patients (and/or relatives) |
Primary outcome
Number of ambulance calls that CFRs attend in one year
Time frame: we will evaluate all emergency attendances during one year
We will establish how many people CFRs attended and work out the proportion of ambulance calls attended.
The type of cases treated by CFRs
Time frame: we will evaluate all emergency attendances during one year
characteristics of people (age, sex, condition) attended
How quickly cases are dealt with
Time frame: we will evaluate all emergency attendances during one year
how quickly they attend
Treatments given and transfer to hospital
Time frame: we will evaluate all emergency attendances during one year
we will evaluate the treatments provided and the number of cases transferred to hospital
Locations
Time frame: we will evaluate all emergency attendances during one year
We will describe rurality and location (eg. at home or elsewhere) where CFRs give treatment.
1 secondary outcome
Perceptions of CFR schemes
Time frame: participants will have been involved in a CFR attendance in the previous 6 months
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 16 Dec 2024.
- Derived from this study: PubMed 39054745Siriwardena AN, Patel G, Botan V, Smith MD, Phung VH, Pattinson J, Trueman I, Ridyard C, Hosseini MP, Asghar Z, Orner R, Brewster A, Mountain P, Rowan E, Spaight R. Community First Responders' role in the current and future rural health and care workforce: a mixed-methods study. Health Soc Care Deliv Res. 2024 Jul;12(18):1-101. doi: 10.3310/JYRT8674.
- Individual participant dataSharing planned: No
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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.
Niro Siriwardena principal investigator
University of Lincoln, UK
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 Emergency Medical Services, run by University of Lincoln at 1 site in United Kingdom.
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 2 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 16 Dec 2024. 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 United Kingdom. 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?
Number of ambulance calls that CFRs attend in one year (time frame: we will evaluate all emergency attendances during one year). The study lists 5 primary outcomes in all. 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 NCT04279262, 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 16 Dec 2024.