Point of Care Testing for Advanced Practitioners (Paramedics)

Clinical Decision-Making Clinical Trial

— POCTPara  

Official title:

Point of Care Testing (POCT) for Advanced Practitioners (Paramedics) in Urgent and Emergency Care: a Single Site Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05054049
• Other study ID #: YASRD148
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: May 2022

Study information

• Verified date: September 2021
• Source: Yorkshire Ambulance Service NHS Trust
• Contact: Andrew Hodge
• Phone: +447798640414
• Email: andrew.hodge1[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Decision-Making
• Emergencies
• Point of Care Testing

Intervention

Device:
• Interventional Diagnostic Device Arm
Point of care testing venous blood diagnostic device.

Other:
• Usual care
Usual care provided to patient without use of point of care testing device

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yorkshire Ambulance Service NHS Trust	University of Bradford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Non-conveyance rate	Proportion of cases not conveyed to hospital	Through study completion, expected to be 6 months
Secondary	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
Secondary	Type of POCT cartridges used.	Type of POCT cartridges used.	During the procedure
Secondary	Number of POCT cartridges used.	Number of POCT cartridges used.	During the procedure
Secondary	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
Secondary	Length of time on scene.	Understanding any changes to time spent with patient	immediately after the patient care episode has ended
Secondary	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
Secondary	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
Secondary	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