Point of Care Testing for Advanced Practitioners (Paramedics)

Not Applicable

• Conditions: Community Urgent & Emergency Care; Point of Care Testing; Clinical Decision-Making; Allied Health Professional
• Interventions: Device: Interventional Diagnostic Device Arm; Other: Usual care

• Registration Number: NCT05054049
• Lead Sponsor: Yorkshire Ambulance Service NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-06
• Status Verified: 2021-09
• Study Start: 2021-09
• Study First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Study First Posted: 2021-09-23
• Last Update Posted: 2021-09-23
• Primary Completion: 2022-03
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abbott i-stat Allinity	Interventional Diagnostic Device Arm	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.
Usual Care	Usual care	Randomised patients to this arm receive usual care.

Primary Outcome Measures

Name	Time	Method
Self-reported impact of using POCT device	1.5 hours focus group at end of study	Qualitative focus group data measuring perceived self-reported impact by advanced practitioner (paramedic).

Secondary Outcome Measures

Name	Time	Method
72 hour re-contact rate	Through study completion, expected to be 6 months	Proportion of non-conveyed hospital where there was a re-contact to the ambulance service
Length of time on scene.	immediately after the patient care episode has ended	Understanding any changes to time spent with patient
Feasibility of patient randomisation process	Through study completion, expected to be 6 months	Descriptive data to record number of successful and unsuccessful attempts at randomisation of eligible patients
Patient demographics and presentations where POCT is applied - age, gender, NEWS2 score, clinical condition.	Through study completion, expected to be 6 months	Descriptive data to understand patient characteristics of those patients enrolled into study
Non-conveyance rate	Through study completion, expected to be 6 months	Proportion of cases not conveyed to hospital
Type of POCT cartridges used.	During the procedure	Type of POCT cartridges used.
Number of POCT cartridges used.	During the procedure	Number of POCT cartridges used.
Number of successful and unsuccessful attempts in using the POCT device.	During the procedure	Number of successful and unsuccessful attempts in using the POCT device recorded as a measurement of failure rates
Number of patients who receive POCT.	Through study completion, expected to be 6 months	Descriptive data to understand how many patients were eligible for the POCT device