Point of Care TestingPOCTParaNCT05054049
Point of Care Testing for Advanced Practitioners (Paramedics)
A study testing Interventional Diagnostic Device Arm in people with Point of Care Testing and Clinical Decision-Making, run by Yorkshire Ambulance Service NHS Trust.
Trial summary
Point of care testing (POCT) is described as a laboratory test conducted near the patient with a rapid result obtained through a portable analysing device, as opposed to the collection of a blood sample being transferred to a central laboratory for analysis and reporting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Point of Care Testing, Clinical Decision-Making, Community Urgent & Emergency Care
- What is being tested?
- Interventional Diagnostic Device Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paramedic Participants
- HCPC registered paramedics employed as advanced practitioners
- From the selected advanced practitioner team (Sheffield)
- Able to provide informed consent
- Willing to undergo training and to deliver intervention
- Willing to undergo training to participate in study measures and processes
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- Willing to take part in the focus group
- Patient Participants
- Adult patients aged 18 years old and over.
- Registered with a GP Surgery in the Sheffield CCG boundary.
- In their normal home environment, care home, nursing home or step up intermediate bed service, experiencing an ambulatory sensitive presentation related to falls, frailty, mild to moderate breathlessness, or non-specific general illness and receiving an ambulance service response from participating advanced practitioners (paramedics).
- Who do not require immediate life-saving intervention/immediate transfer to ED.
- Able to give written consent during the call-out.
Who cannot join
- -
- Paramedic Participants:
- Any HCPC registered advanced practitioner (paramedic) who is currently under investigation for fitness to practice.
- Patient Participants
- Patients requiring emergency intervention and immediate transfer to hospital.
- Patient does not have mental capacity.
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- Clinical presentations that should not have any delayed on scene time, meeting the criteria outlined in the YAS policy for the assessment, conveyance and referral of patients, for example detailing the NEWS2 score and other appropriate clinical screening tools that assist in the decision making regarding the decision to convey or refer for community management.
- Non-English speaking patients.
- End of life care patients.
- Patients residing in prison.
Trial locations and contacts
No sites are listed yet.
Bryan Lightowler contact
About this study
Official title: Point of Care Testing (POCT) for Advanced Practitioners (Paramedics) in Urgent and Emergency Care: a Single Site Feasibility Study
Point of care testing (POCT) is described as a laboratory test conducted near the patient with a rapid result obtained through a portable analysing device, as opposed to the collection of a blood sample being transferred to a central laboratory for analysis and reporting.
Over the past 15 years increasing emphasis has been placed upon the paramedic profession as a possible solution to addressing the increasing demands placed on emergency departments. This is largely viewed through the ability of paramedics to assess patients calling 999 and manage a patient's condition away from the emergency department, with sufficient evidence supporting the role of the paramedic to develop competencies to manage larger volumes of patients.
Read more
This feasibility study will seek to understand whether paramedics report that the use of POCT devices is useful in safe clinical decision making with patients in the community, and if it is possible to use the Abbott i-STAT device in the urgent and emergency care setting for those patients where management within the community is being considered.
Given that there is very little evidence in this subject area, the research should start to inform the potential for future innovations in paramedic and community practice, and build on the body of evidence regarding POCT by paramedics related to community management.
- Conditions
- Point of Care Testing, Clinical Decision-Making, Community Urgent & Emergency Care, Allied Health Professional
- Being tested
- Interventional Diagnostic Device Arm, Usual care
- Keywords
- Point of Care Testing, Clinical Decision Making, Paramedic, Community Urgent & Emergency
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional Diagnostic Device ArmDevice
Also called Abbott i-stat Allinity
Point of care testing venous blood diagnostic device.
Usual careOther
Usual care provided to patient without use of point of care testing device
| Study group | Role | What they receive |
|---|---|---|
| Abbott i-stat Allinity | Experimental | Randomised patients to this arm receive the application of the point of care testing device to provide further diagnostic information to assist clinical decision making. Receives: Device: Interventional Diagnostic Device Arm |
| Usual Care | Placebo comparator | Randomised patients to this arm receive usual care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported impact of using POCT device
Qualitative focus group data measuring perceived self-reported impact by advanced practitioner (paramedic).
Measured: 1.5 hours focus group at end of study
Secondary outcomes (9)
Non-conveyance rate
Proportion of cases not conveyed to hospital
Measured: Through study completion, expected to be 6 months
72 hour re-contact rate
Proportion of non-conveyed hospital where there was a re-contact to the ambulance service
Measured: Through study completion, expected to be 6 months
Type of POCT cartridges used.
Type of POCT cartridges used.
Measured: During the procedure
Number of POCT cartridges used.
Number of POCT cartridges used.
Measured: During the procedure
Number of successful and unsuccessful attempts in using the POCT device.
Number of successful and unsuccessful attempts in using the POCT device recorded as a measurement of failure rates
Measured: During the procedure
Length of time on scene.
Understanding any changes to time spent with patient
Measured: immediately after the patient care episode has ended
Number of patients who receive POCT.
Descriptive data to understand how many patients were eligible for the POCT device
Measured: Through study completion, expected to be 6 months
Patient demographics and presentations where POCT is applied - age, gender, NEWS2 score, clinical condition.
Descriptive data to understand patient characteristics of those patients enrolled into study
Measured: Through study completion, expected to be 6 months
Feasibility of patient randomisation process
Descriptive data to record number of successful and unsuccessful attempts at randomisation of eligible patients
Measured: Through study completion, expected to be 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Point of Care TestingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site feasibility study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yorkshire Ambulance Service NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Bradford
- Responsible party
- Principal investigator, Dr Fiona Bell, Yorkshire Ambulance Service NHS Trust
- Investigators
- Andrew Hodge, Principal investigator, Yorkshire Ambulance Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054049
- Sponsor's protocol ID
- YASRD148
- Acronym
- POCTPara
- Status last verified
- Sep 2021
- First submitted
- 6 Aug 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Testing (POCT) for Advanced Practitioners (Paramedics) in Urgent and Emergency Care: a Single Site Feasibility Study
- ClinicalTrials.gov ID
- NCT05054049
- Acronym / sponsor ID
- POCTPara / YASRD148
- Conditions
- Point of Care Testing, Clinical Decision-Making, Community Urgent & Emergency Care, Allied Health Professional
- Keywords
- Point of Care Testing, Clinical Decision Making, Paramedic, Community Urgent & Emergency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yorkshire Ambulance Service NHS TrustOther government
- Collaborators
- University of Bradford
- Study start
- Sep 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 23 Sep 2021 (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.
Point of care testing (POCT) is described as a laboratory test conducted near the patient with a rapid result obtained through a portable analysing device, as opposed to the collection of a blood sample being transferred to a central laboratory for analysis and reporting.
Over the past 15 years increasing emphasis has been placed upon the paramedic profession as a possible solution to addressing the increasing demands placed on emergency departments. This is largely viewed through the ability of paramedics to assess patients calling 999 and manage a patient's condition away from the emergency department, with sufficient evidence supporting the role of the paramedic to develop competencies to manage larger volumes of patients.
This feasibility study will seek to understand whether paramedics report that the use of POCT devices is useful in safe clinical decision making with patients in the community, and if it is possible to use the Abbott i-STAT device in the urgent and emergency care setting for those patients where management within the community is being considered.
Given that there is very little evidence in this subject area, the research should start to inform the potential for future innovations in paramedic and community practice, and build on the body of evidence regarding POCT by paramedics related to community management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single site feasibility study
| Arm | Type | Receives |
|---|---|---|
| Abbott i-stat Allinity | Experimental | Device: Interventional Diagnostic Device ArmRandomised patients to this arm receive the application of the point of care testing device to provide further diagnostic information to assist clinical decision making. |
| Usual Care | Placebo comparator | Other: Usual careRandomised patients to this arm receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Paramedic Participants
- HCPC registered paramedics employed as advanced practitioners
- From the selected advanced practitioner team (Sheffield)
- Able to provide informed consent
- Willing to undergo training and to deliver intervention
Key exclusion criteria (10 listed)
- -
- Any HCPC registered advanced practitioner (paramedic) who is currently under investigation for fitness to practice.
- Patient Participants
- Patients requiring emergency intervention and immediate transfer to hospital.
- Patient does not have mental capacity.
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 |
|---|---|---|
| Interventional Diagnostic Device ArmAlso: Abbott i-stat AllinityPoint of care testing venous blood diagnostic device. | Device | Abbott i-stat Allinity |
| Usual careUsual care provided to patient without use of point of care testing device | Other | Usual Care |
Primary outcome
Self-reported impact of using POCT device
Time frame: 1.5 hours focus group at end of study
Qualitative focus group data measuring perceived self-reported impact by advanced practitioner (paramedic).
9 secondary outcomes
Non-conveyance rate
Time frame: Through study completion, expected to be 6 months
72 hour re-contact rate
Time frame: Through study completion, expected to be 6 months
Type of POCT cartridges used.
Time frame: During the procedure
Number of POCT cartridges used.
Time frame: During the procedure
Number of successful and unsuccessful attempts in using the POCT device.
Time frame: During the procedure
Length of time on scene.
Time frame: immediately after the patient care episode has ended
Number of patients who receive POCT.
Time frame: Through study completion, expected to be 6 months
Patient demographics and presentations where POCT is applied - age, gender, NEWS2 score, clinical condition.
Time frame: Through study completion, expected to be 6 months
Feasibility of patient randomisation process
Time frame: Through study completion, expected to be 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- 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.
Bryan Lightowler contact
Andrew Hodge principal investigator
Yorkshire Ambulance Service
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Diagnostic Device Arm in people with Point of Care Testing and Clinical Decision-Making, run by Yorkshire Ambulance Service NHS Trust.
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 13 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Hodge (+447798640414, andrew.hodge1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported impact of using POCT device (time frame: 1.5 hours focus group at end of study). 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 23 Sep 2021.