Clinical trial NCT05054049: Point of Care Testing for Advanced Practitioners (Paramedics)
Official title: Point of Care Testing (POCT) for Advanced Practitioners (Paramedics) in Urgent and Emergency Care: a Single Site Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Yorkshire Ambulance Service NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Bradford
First posted: 2021-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single site feasibility study
Primary purpose: DIAGNOSTIC

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

- Paramedic Participants

Inclusion criteria:

* 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
* Willing to take part in the focus group

Patient Participants

Inclusion criteria:

* 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.

Exclusion Criteria:

-

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.
* 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.

Primary outcomes:
measure: Self-reported impact of using POCT device
timeFrame: 1.5 hours focus group at end of study
Secondary outcomes:
measure: Non-conveyance rate
timeFrame: Through study completion, expected to be 6 months
measure: 72 hour re-contact rate
timeFrame: Through study completion, expected to be 6 months
measure: Type of POCT cartridges used.
timeFrame: During the procedure
measure: Number of POCT cartridges used.
timeFrame: During the procedure
measure: Number of successful and unsuccessful attempts in using the POCT device.
timeFrame: During the procedure
measure: Length of time on scene.
timeFrame: immediately after the patient care episode has ended
measure: Number of patients who receive POCT.
timeFrame: Through study completion, expected to be 6 months
measure: Patient demographics and presentations where POCT is applied - age, gender, NEWS2 score, clinical condition.
timeFrame: Through study completion, expected to be 6 months
measure: Feasibility of patient randomisation process
timeFrame: Through study completion, expected to be 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Yorkshire Ambulance Service
name: Andrew Hodge
role: PRINCIPAL_INVESTIGATOR
References: