Point of Care Testing for Advanced Practitioners (Paramedics)

NCT05054049 | Unknown DMC

• 1 other identifier: YASRD148
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

Point of Care Testing; Clinical Decision Making; Paramedic; Community Urgent & Emergency

Outcome Measures

Primary Outcomes (1)

• Self-reported impact of using POCT device

  Qualitative focus group data measuring perceived self-reported impact by advanced practitioner (paramedic).

  1.5 hours focus group at end of study

Secondary Outcomes (9)

• Non-conveyance rate

  Through study completion, expected to be 6 months

• 72 hour re-contact rate

  Through study completion, expected to be 6 months

• Type of POCT cartridges used.

  During the procedure

• Number of POCT cartridges used.

  During the procedure

• Number of successful and unsuccessful attempts in using the POCT device.

  During the procedure

Study Arms (2)

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.

Device: Interventional Diagnostic Device Arm

Usual Care

PLACEBO COMPARATOR

Randomised patients to this arm receive usual care.

Other: Usual care

Interventions

Interventional Diagnostic Device Arm DEVICE

Point of care testing venous blood diagnostic device.

Also known as: Abbott i-stat Allinity

Abbott i-stat Allinity

Usual care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yorkshire Ambulance Service NHS Trust: lead
• University of Bradford: collaborator

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Hodge

  Yorkshire Ambulance Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Hodge

CONTACT

+447798640414; andrew.hodge1@nhs.net

Bryan Lightowler

CONTACT

b.lightowler@bradford.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient is randomised to control or intervention arm after consent obtained.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research & Development

Model Details: Single site feasibility study

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: September 23, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share