search
Back to results

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

Primary Purpose

Point of Care Testing, Clinical Decision-Making, Community Urgent & Emergency Care

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interventional Diagnostic Device Arm
Usual care
Sponsored by
Yorkshire Ambulance Service NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Point of Care Testing focused on measuring Point of Care Testing, Clinical Decision Making, Paramedic, Community Urgent & Emergency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Abbott i-stat Allinity

    Usual Care

    Arm Description

    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.

    Randomised patients to this arm receive usual care.

    Outcomes

    Primary Outcome Measures

    Self-reported impact of using POCT device
    Qualitative focus group data measuring perceived self-reported impact by advanced practitioner (paramedic).

    Secondary Outcome Measures

    Non-conveyance rate
    Proportion of cases not conveyed to hospital
    72 hour re-contact rate
    Proportion of non-conveyed hospital where there was a re-contact to the ambulance service
    Type of POCT cartridges used.
    Type of POCT cartridges used.
    Number of POCT cartridges used.
    Number of POCT cartridges used.
    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
    Length of time on scene.
    Understanding any changes to time spent with patient
    Number of patients who receive POCT.
    Descriptive data to understand how many patients were eligible for the POCT device
    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
    Feasibility of patient randomisation process
    Descriptive data to record number of successful and unsuccessful attempts at randomisation of eligible patients

    Full Information

    First Posted
    August 6, 2021
    Last Updated
    September 22, 2021
    Sponsor
    Yorkshire Ambulance Service NHS Trust
    Collaborators
    University of Bradford
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05054049
    Brief Title
    Point of Care Testing for Advanced Practitioners (Paramedics)
    Acronym
    POCTPara
    Official Title
    Point of Care Testing (POCT) for Advanced Practitioners (Paramedics) in Urgent and Emergency Care: a Single Site Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yorkshire Ambulance Service NHS Trust
    Collaborators
    University of Bradford

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Single site feasibility study
    Masking
    Participant
    Masking Description
    Patient is randomised to control or intervention arm after consent obtained.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Abbott i-stat Allinity
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    Placebo Comparator
    Arm Description
    Randomised patients to this arm receive usual care.
    Intervention Type
    Device
    Intervention Name(s)
    Interventional Diagnostic Device Arm
    Other Intervention Name(s)
    Abbott i-stat Allinity
    Intervention Description
    Point of care testing venous blood diagnostic device.
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Intervention Description
    Usual care provided to patient without use of point of care testing device
    Primary Outcome Measure Information:
    Title
    Self-reported impact of using POCT device
    Description
    Qualitative focus group data measuring perceived self-reported impact by advanced practitioner (paramedic).
    Time Frame
    1.5 hours focus group at end of study
    Secondary Outcome Measure Information:
    Title
    Non-conveyance rate
    Description
    Proportion of cases not conveyed to hospital
    Time Frame
    Through study completion, expected to be 6 months
    Title
    72 hour re-contact rate
    Description
    Proportion of non-conveyed hospital where there was a re-contact to the ambulance service
    Time Frame
    Through study completion, expected to be 6 months
    Title
    Type of POCT cartridges used.
    Description
    Type of POCT cartridges used.
    Time Frame
    During the procedure
    Title
    Number of POCT cartridges used.
    Description
    Number of POCT cartridges used.
    Time Frame
    During the procedure
    Title
    Number of successful and unsuccessful attempts in using the POCT device.
    Description
    Number of successful and unsuccessful attempts in using the POCT device recorded as a measurement of failure rates
    Time Frame
    During the procedure
    Title
    Length of time on scene.
    Description
    Understanding any changes to time spent with patient
    Time Frame
    immediately after the patient care episode has ended
    Title
    Number of patients who receive POCT.
    Description
    Descriptive data to understand how many patients were eligible for the POCT device
    Time Frame
    Through study completion, expected to be 6 months
    Title
    Patient demographics and presentations where POCT is applied - age, gender, NEWS2 score, clinical condition.
    Description
    Descriptive data to understand patient characteristics of those patients enrolled into study
    Time Frame
    Through study completion, expected to be 6 months
    Title
    Feasibility of patient randomisation process
    Description
    Descriptive data to record number of successful and unsuccessful attempts at randomisation of eligible patients
    Time Frame
    Through study completion, expected to be 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew Hodge
    Phone
    +447798640414
    Email
    andrew.hodge1@nhs.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bryan Lightowler
    Email
    b.lightowler@bradford.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Hodge
    Organizational Affiliation
    Yorkshire Ambulance Service
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Point of Care Testing for Advanced Practitioners (Paramedics)

    We'll reach out to this number within 24 hrs