The Pre-POCT-Non-Conveyance Trial: Prehospital Point-of-Care Testing to Support Non-Conveyance Decisions

Prehospital Point-of-Care Testing to Support Decision-Making in Alternative and Non-Conveyance Pathways: A Matched Parallel Cluster-Randomised Trial. The Pre-POCT-Non-Conveyance Trial

The goal of this clinical trial is to evaluate whether rapid blood tests performed in the ambulance can be implemented in routine prehospital assessment of adults who are initially considered for transport to hospital. Ambulance clinicians frequently assess adults who are transported to hospital but discharged shortly after arrival without requiring advanced diagnostic testing or treatment.

In this study, researchers will examine whether adding rapid point-of-care blood testing (POCT) at the scene supports ambulance clinicians and Emergency Medical Dispatch Centre (EMDC) physicians in making more informed decisions about hospital conveyance. POCT provides rapid measurements of biomarkers including infection markers, electrolytes, kidney function, blood counts, and total carbon dioxide, a proxy measure related to acid-base status.

Ten ambulance clusters will participate in a matched, cluster-randomized design. Half will provide standard care, and half will have access to POCT following consultation with an EMDC physician in patients who would otherwise be considered for hospital transport.

The main question is whether prehospital POCT can be performed, documented, and made available before the final conveyance decision in routine ambulance-based assessment. The study will also examine whether access to POCT is associated with a higher proportion of patients remaining at home rather than being transported to hospital.

Safety outcomes will include hospital admission within 24 hours among non-conveyed patients, short-stay hospitalization, intensive care unit (ICU) admission, and 30-day mortality.

This study will evaluate the implementation of POCT-supported decision-making in prehospital care and explore whether it may increase non-conveyance without compromising patient safety.

Study Overview

• Status: Recruiting
• Conditions: Point of Care Testing; Prehospital Emergency Medical Services; Prehospital Emergency Care
• Intervention / Treatment: Diagnostic test: Point-of-care testing (POCT)

Detailed Description

Many adults assessed by ambulance services are transported to hospital but discharged shortly after arrival without requiring advanced diagnostic testing or treatment. These potentially avoidable admissions contribute to emergency department crowding and increased healthcare utilization. Improving prehospital decision-making may reduce unnecessary hospital transports while maintaining patient safety. This study evaluates whether rapid point-of-care blood testing performed by ambulance clinicians can be implemented in routine prehospital assessment and support more informed decisions regarding hospital conveyance following an emergency call.

This is a prospective, matched, parallel, cluster-randomized trial conducted within the Prehospital Emergency Medical Services (EMS) of the Central Denmark Region, Denmark. Ten ambulance clusters are included and allocated in a 1:1 ratio to either an intervention strategy integrating point-of-care testing (POCT) into the prehospital assessment or to standard care. Prior to randomization, clusters are matched in pairs based on their historical non-conveyance rate during the preceding six months, overall case volume, and geographic characteristics to ensure balance in baseline practice patterns and workload and to reduce between-cluster heterogeneity. Each matched pair is then randomized to either the intervention or control group.

Participants are adults attended by participating ambulance clusters following an emergency call or GP-commissioned ambulance dispatch through the Emergency Medical Dispatch Centre (EMDC). In the intervention clusters, POCT may be performed in clinically stable patients who would otherwise be considered for hospital conveyance based on the initial on-scene ambulance assessment.

The intervention consists of on-scene biochemical testing using portable POCT devices. The iSTAT Alinity system with CHEM8+ cartridges measures sodium, potassium, chloride, calcium, urea, creatinine, glucose, and total carbon dioxide. QuickRead go is used to measure C-reactive protein and hemoglobin, and HemoCue WBC DIFF is used to measure leukocyte count. Control clusters follow existing assessment procedures without access to POCT. Apart from access to POCT devices and results, all other aspects of clinical management follow standard regional EMS practice.

The primary objective is to evaluate whether prehospital POCT can be implemented in routine ambulance-based assessment. The primary outcome is implementation of prehospital POCT, defined as the proportion of intervention-cluster attended patient encounters within the study population in which POCT was attempted, at least one valid POCT result was obtained and documented, and the result was available before the final conveyance decision.

Non-conveyance is retained as a key secondary clinical outcome and will be compared between randomized intervention and control clusters according to the intention-to-treat principle. Safety and clinical outcomes include hospital admission within 24 hours among non-conveyed patients, short-stay hospitalization, total hospital length of stay, intensive care unit admission, and 30-day mortality.

The trial is not powered to detect definitive differences in non-conveyance or safety outcomes. Instead, it is designed to estimate key implementation parameters, including the proportion of attended patient encounters in which POCT is attempted, the proportion of attempts yielding a valid result, documentation completeness, and availability of POCT results before the final conveyance decision. Clinical outcomes will be interpreted as secondary and exploratory and used to inform the design of a future definitive effectiveness trial.

Ethics and regulatory oversight:

The study has been assessed by the Central Denmark Region Committees on Health Research Ethics (Denmark) and determined not to constitute a health research study under Danish legislation (Consolidation Act on Research Ethics Review of Health Research Projects, Section 2(1)). Therefore, the study does not require approval from a research ethics committee, and formal ethics approval was not obtained.

In accordance with this determination, individual informed consent is not required, as the study is conducted at the cluster level within routine care without alteration of standard treatment pathways beyond the availability of point-of-care testing.

All data are handled in compliance with applicable data protection regulations. The determination is documented in a formal written statement from the Central Denmark Region Committees on Health Research Ethics. This documentation is included as an appendix to the Statistical Analysis Plan. No biological samples are stored for research purposes beyond immediate clinical analysis.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin F Gude, MD, PhD; Phone Number: 004525343621; Email: martgude@rm.dk
• Study Contact Backup: Name: Ulla Væggemose, PhD; Phone Number: 004578414912; Email: ulla.vaeggemose@ph.rm.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Recruiting
    • Prehospital Emergency Medical Services, Central Denmark Region, Denmark
    • Contact: Mille S Jensen, BSc; Phone Number: 004551164460; Email: misjns@rm.dk
    • Contact: Nicoline B Jensen, BSc; Phone Number: 004523261931; Email: nibuje@rm.dk
    • Principal Investigator: Martin F Gude, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged ≥18 years
• Emergency call or general practitioner-commissioned ambulance dispatch following telephone triage only, including video streaming triage, resulting in ambulance dispatch
• Initial on-scene assessments performed by the ambulance crew
• Patients initially considered for hospital conveyance based on clinical assessment
• Following telemedical consultation with an Emergency Medical Dispatch Centre (EMDC) physician, deemed eligible for point-of-care blood testing (POCT)
• Hemodynamically and clinically stable according to predefined operational stability criteria (including Glasgow Coma Scale, blood pressure, oxygen saturation, and heart rate), with final eligibility determined by the EMDC physician based on overall clinical assessment and the patient's baseline status

Exclusion Criteria:

• Non-emergency calls (e.g., interfacility transport or scheduled patient transport)
• General practitioner-commissioned ambulance dispatches where the patient has been physically assessed by a general practitioner or another physician before ambulance arrival
• Immediate need for emergency transport to hospital as determined by clinical assessment
• Persistent unstable vital signs outside predefined operational thresholds, except for known chronic baseline deviations (e.g., reduced oxygen saturation in patients with chronic obstructive pulmonary disease or chronic tachyarrhythmia in atrial fibrillation)
• Inability to obtain venous or capillary blood samples
• Prior participation in the study within 30 days (to ensure complete outcome follow-up)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POCT-supported assessment; Ambulance clusters in the intervention arm use prehospital point-of-care testing (POCT) integrated with telemedical consultation. For clinically stable patients in whom conveyance is uncertain, ambulance clinicians may perform on-scene biochemical testing (electrolytes, renal function, C-reactive protein, hemoglobin, leukocyte count) following approval from an Emergency Medical Dispatch Centre (EMDC) physician. Test results support clinical decision-making regarding hospital conveyance in addition to standard EMS assessment.	Diagnostic test: Point-of-care testing (POCT); On-scene biochemical testing performed using portable point-of-care devices. non-conveyance.
No Intervention: Standard care; Ambulance clusters in the control arm provide standard prehospital assessment and care according to regional EMS guidelines. Decisions regarding hospital conveyance or non-conveyance are based on clinical evaluation and telemedical consultation as needed, without access to point-of-care blood testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation of prehospital POCT	Implementation of prehospital POCT, defined as the proportion of intervention-cluster attended patient encounters within the study population in which POCT was attempted, at least one valid POCT result was obtained and documented, and the result was available before the final conveyance decision.	Day 1 (at completion of on-scene assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-conveyance rate	Proportion of patients not conveyed to hospital following ambulance assessment during the index EMS encounter	Day 1 (at completion of on-scene assessment)
Proportion of non-conveyed participants with hospital admission within 24 hours	Proportion of participants with hospital admission within 24 hours among patients not conveyed at the index EMS encounter	At 24 hours after the index EMS encounter
Proportion of participants with short-stay hospitalization (<6 hours without advanced hospital-based interventions)	Proportion of participants with short-stay hospitalization lasting less than 6 hours without documented advanced procedures, medication administration, or CT/MR imaging during the admission	At 6 hours after hospital admission
Total hospital length of stay	Time from initial hospital admission to hospital discharge to home or to care facility.	From hospital admission to hospital discharge (up to 30 days)
30-day mortality	Mortality within 30 days after the index EMS encounter	At 30 days after the index EMS encounter
ICU admission rates	Proportion of patients admitted to an intensive care unit during the index hospitalization related to the EMS encounter	From hospital admission to ICU admission during index hospitalization (up to 30 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day hospital admission rate	30-day hospital admission rate, defined as any hospital admission occurring within 30 days after the index EMS encounter.	At 30 days after the index EMS encounter
Emergency department (ED) visit or hospital admission within 72 hours after non-conveyance	Emergency department (ED) visit or hospital admission within 72 hours after non-conveyance, defined as any ED encounter or hospital admission occurring within 72 hours of the index non-conveyance encounter, regardless of referral pathway (e.g.,out-of-hours primary care (OOH-PC), EMS, general practitioner, or self-referred).	At 72 hours after the index non-conveyance encounter
Out-of-hour primary care (OOH-PC) contact within 72 hours after non-conveyance	OOH-PC contact within 72 hours after non-conveyance, defined as any registered out-of-hours primary care contact within 72 hours of the index non-conveyance encounter.	At 72 hours after the index non-conveyance encounter.
EMS recontact within 72 hours after non-conveyance	EMS recontact within 72 hours after non-conveyance, defined as any new emergency call resulting in ambulance dispatch within 72 hours of the index non-conveyance encounter.	At 72 hours after the index non-conveyance encounter.
Days alive and out of hospital at 30 days	Days alive and out of hospital at 30 days, defined as the number of days within 30 days after the index EMS encounter during which the patient is alive and not admitted to hospital.	At 30 days after the index EMS encounter
On-scene time	On-scene time, defined as time from ambulance arrival at scene to departure from scene, regardless of whether the patient is transported or not.	Day 1 (at completion of on-scene assessment)
Proportion of unsuccessful POCT measurements	The proportion of POCT attempts yielding no reportable result due to device-, cartridge-, or sampling-related error among all POCT attempts in intervention clusters. Reasons for unsuccessful measurements will be categorized when available (e.g., device error code, insufficient sample volume, clotting, or inability to obtain venous access). This outcome describes operational measurement performance during routine EMS use	Day 1 (at completion of on-scene assessment)
Intra-Cluster Correlation Coefficients (ICCs)	Estimated intra-cluster correlation coefficients (ICCs) for non-conveyance and selected key secondary outcomes (24-hour hospital admission among non-conveyed patients, 30-day hospital admission, 30-day mortality, and short-stay hospitalization), derived from the matched cluster-randomized design.	After completion of 30-day follow-up for all participants
Data linkage success rate	Proportion of participants successfully linked across relevant data sources, including prehospital records, hospital records, and research data (REDCap).	After completion of 30-day follow-up for all participants
Outcome data completeness	Proportion of participants with available data for key outcome measures, including primary and selected secondary endpoints.	After completion of 30-day follow-up for all participants

Collaborators and Investigators

• Sponsor: Central Denmark Region
• Investigators: Principal Investigator: Martin F Gude, MD, PhD, Prehospital Emergency Medical Services, Central Denmark Region. Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 7, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: POCT; point of care testing; decision-making; emergency medical services; Non-conveyance
• Other Study ID Numbers: 1234 (Department of Defense)

Drug and device information, study documents

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