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

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ClinicalTrials.gov Identifier: NCT05054049
Recruitment Status : Not yet recruiting
First Posted : September 23, 2021
Last Update Posted : September 23, 2021
Sponsor:
Collaborator:
University of Bradford
Information provided by (Responsible Party):
Dr Fiona Bell, Yorkshire Ambulance Service NHS Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Point of Care Testing Clinical Decision-Making Community Urgent & Emergency Care Allied Health Professional Device: Interventional Diagnostic Device Arm Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single site feasibility study
Masking: Single (Participant)
Masking Description: Patient is randomised to control or intervention arm after consent obtained.
Primary Purpose: Diagnostic
Official Title: Point of Care Testing (POCT) for Advanced Practitioners (Paramedics) in Urgent and Emergency Care: a Single Site Feasibility Study
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2022
Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Self-reported impact of using POCT device [ Time Frame: 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 :
  1. Non-conveyance rate [ Time Frame: Through study completion, expected to be 6 months ]
    Proportion of cases not conveyed to hospital

  2. 72 hour re-contact rate [ Time Frame: Through study completion, expected to be 6 months ]
    Proportion of non-conveyed hospital where there was a re-contact to the ambulance service

  3. Type of POCT cartridges used. [ Time Frame: During the procedure ]
    Type of POCT cartridges used.

  4. Number of POCT cartridges used. [ Time Frame: During the procedure ]
    Number of POCT cartridges used.

  5. Number of successful and unsuccessful attempts in using the POCT device. [ Time Frame: During the procedure ]
    Number of successful and unsuccessful attempts in using the POCT device recorded as a measurement of failure rates

  6. Length of time on scene. [ Time Frame: immediately after the patient care episode has ended ]
    Understanding any changes to time spent with patient

  7. Number of patients who receive POCT. [ Time Frame: Through study completion, expected to be 6 months ]
    Descriptive data to understand how many patients were eligible for the POCT device

  8. Patient demographics and presentations where POCT is applied - age, gender, NEWS2 score, clinical condition. [ Time Frame: Through study completion, expected to be 6 months ]
    Descriptive data to understand patient characteristics of those patients enrolled into study

  9. Feasibility of patient randomisation process [ Time Frame: Through study completion, expected to be 6 months ]
    Descriptive data to record number of successful and unsuccessful attempts at randomisation of eligible patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054049


Contacts
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Contact: Andrew Hodge +447798640414 andrew.hodge1@nhs.net
Contact: Bryan Lightowler b.lightowler@bradford.ac.uk

Sponsors and Collaborators
Yorkshire Ambulance Service NHS Trust
University of Bradford
Investigators
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Principal Investigator: Andrew Hodge Yorkshire Ambulance Service
More Information
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Responsible Party: Dr Fiona Bell, Head of Research & Development, Yorkshire Ambulance Service NHS Trust
ClinicalTrials.gov Identifier: NCT05054049    
Other Study ID Numbers: YASRD148
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Fiona Bell, Yorkshire Ambulance Service NHS Trust:
Point of Care Testing
Clinical Decision Making
Paramedic
Community Urgent & Emergency
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes