Point of Care Testing for Advanced Practitioners (Paramedics)

NCT ID: NCT05054049

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-05-31

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.

Conditions

Point of Care Testing; Clinical Decision-Making; Community Urgent & Emergency Care; Allied Health Professional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Abbott i-stat Allinity

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.

Group Type: EXPERIMENTAL

Interventional Diagnostic Device Arm

Intervention Type: DEVICE

Point of care testing venous blood diagnostic device.

Usual Care

Randomised patients to this arm receive usual care.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care provided to patient without use of point of care testing device

Interventions

Interventional Diagnostic Device Arm

Point of care testing venous blood diagnostic device.

Intervention Type: DEVICE

Usual care

Usual care provided to patient without use of point of care testing device

Intervention Type: OTHER

Other Intervention Names

Abbott i-stat Allinity

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bradford

OTHER

Sponsor Role: collaborator

Yorkshire Ambulance Service NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Fiona Bell

Head of Research & Development

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Hodge

Role: PRINCIPAL_INVESTIGATOR

Yorkshire Ambulance Service

Central Contacts

Andrew Hodge

Role: CONTACT

andrew.hodge1@nhs.net

+447798640414

Bryan Lightowler

Role: CONTACT

b.lightowler@bradford.ac.uk

Other Identifiers

YASRD148

Identifier Type: -

Identifier Source: org_study_id