Point of Care Testing for Advanced Practitioners (Paramedics) (POCTPara)

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Point of Care Testing; Clinical Decision-Making; Community Urgent & Emergency Care; Allied Health Professional
• Intervention / Treatment: Device: Interventional Diagnostic Device Arm; Other: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Hodge; Phone Number: +447798640414; Email: andrew.hodge1@nhs.net
• Study Contact Backup: Name: Bryan Lightowler; Email: b.lightowler@bradford.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Interventional Diagnostic Device Arm; Point of care testing venous blood diagnostic device.; Other Names: Abbott i-stat Allinity
Placebo Comparator: Usual Care; Randomised patients to this arm receive usual care.	Other: Usual care; Usual care provided to patient without use of point of care testing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-conveyance rate	Proportion of cases not conveyed to hospital	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	Through study completion, expected to be 6 months
Type of POCT cartridges used.	Type of POCT cartridges used.	During the procedure
Number of POCT cartridges used.	Number of POCT cartridges used.	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	During the procedure
Length of time on scene.	Understanding any changes to time spent with patient	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	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	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	Through study completion, expected to be 6 months

Collaborators and Investigators

• Sponsor: Yorkshire Ambulance Service NHS Trust
• Collaborators: University of Bradford
• Investigators: Principal Investigator: Andrew Hodge, Yorkshire Ambulance Service

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Point of Care Testing; Clinical Decision Making; Paramedic; Community Urgent & Emergency
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: YASRD148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No