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

NCT07503470 | Recruiting

• 1 other identifier: 1234
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prehospital Emergency Medical Services; Prehospital Emergency Care; Point of Care Testing

Keywords

emergency medical services; point of care testing; POCT; Non-conveyance; decision-making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Non-conveyance rate

  Day 1 (at completion of on-scene assessment)

• Proportion of non-conveyed participants with hospital admission within 24 hours

  At 24 hours after the index EMS encounter

• Proportion of participants with short-stay hospitalization (<6 hours without advanced hospital-based interventions)

  At 6 hours after hospital admission

• Total hospital length of stay

  From hospital admission to hospital discharge (up to 30 days)

• 30-day mortality

  At 30 days after the index EMS encounter

Other Outcomes (10)

• 30-day hospital admission rate

  At 30 days after the index EMS encounter

• Emergency department (ED) visit or hospital admission within 72 hours after non-conveyance

  At 72 hours after the index non-conveyance encounter

• Out-of-hour primary care (OOH-PC) contact within 72 hours after non-conveyance

  At 72 hours after the index non-conveyance encounter.

Study Arms (2)

POCT-supported assessment

EXPERIMENTAL

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)

Standard care

NO INTERVENTION

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.

Interventions

Point-of-care testing (POCT) DIAGNOSTIC_TEST

On-scene biochemical testing performed using portable point-of-care devices. non-conveyance.

POCT-supported assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Denmark Region: lead

Study Sites (1)

Prehospital Emergency Medical Services, Central Denmark Region, Denmark

Aarhus N, 8200, Denmark

RECRUITING

Study Officials

• Martin F Gude, MD, PhD

  Prehospital Emergency Medical Services, Central Denmark Region. Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin F Gude, MD, PhD

CONTACT

004525343621; martgude@rm.dk

Ulla Væggemose, PhD

CONTACT

004578414912; ulla.vaeggemose@ph.rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Personnel in the control (non-intervention) clusters are masked to study allocation. They are not informed that their ambulance cluster is serving as part of the control group in the trial.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomised pilot trial

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 31, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

DK (1)