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

Sponsor
Yorkshire Ambulance Service NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05054049
Collaborator
University of Bradford (Other)
100
2
8

Study Details

Study Description

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
  • Device: Interventional Diagnostic Device Arm
  • Other: Usual care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single site feasibility studySingle 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
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Self-reported impact of using POCT device [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 [Through study completion, expected to be 6 months]

      Proportion of cases not conveyed to hospital

    2. 72 hour re-contact rate [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. [During the procedure]

      Type of POCT cartridges used.

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

      Number of POCT cartridges used.

    5. Number of successful and unsuccessful attempts in using the POCT device. [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. [immediately after the patient care episode has ended]

      Understanding any changes to time spent with patient

    7. Number of patients who receive POCT. [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. [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yorkshire Ambulance Service NHS Trust
    • University of Bradford

    Investigators

    • Principal Investigator: Andrew Hodge, Yorkshire Ambulance Service

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Sep 23, 2021
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Fiona Bell, Head of Research & Development, Yorkshire Ambulance Service NHS Trust
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 23, 2021