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
Phase: NA
Conditions: Prehospital Emergency Medical Services, Prehospital Emergency Care, Point of Care Testing
Sponsor: Central Denmark Region

1. Original Title and general information 
 
Project name 
Prehospital Point-of-Care Testing to Support 
Decision-Making in Alternative and Non-
Conveyance Pathways: A Matched Parallel 
Cluster-Randomized Trial 
Project Acronym 
The pre-POCT–Non-Conveyance trial 
Sponsor 
Central Denmark Region, Denmark 
Principal Investigator 
Martin Faurholdt Gude, MD, PhD 
Prehospital Emergency Medical Services 
(Præhospitalet), Olof Palmes Allé 34, 8200 
Aarhus N 
Investigator signature 
 
 
Protocol version and date 
Version 1.0, 01.02.2026 
Study coordinators 
Mille Svenstrup Jensen, BSc 
Nicoline Buelund Jensen, BSc 
 
2. Purpose 
Rationale, background, problem formulation, hypothesis and 
endpoints 
Rationale 
A substantial proportion of patients transported by EMS are discharged shortly after hospital arrival 
without requiring advanced diagnostics or treatment. These short, low-value admissions contribute 
to ED crowding, inconvenience to patients, and increase healthcare costs. Improving prehospital 
decision-making may reduce avoidable admissions while maintaining patient safety. 

Point-of-care testing (POCT) may be a key component in this strategy. By providing rapid 
biochemical analyses directly on scene, POCT can support more informed decisions during 
telemedical consultation with the EMDC physician. This may help ambulance clinicians and 
physicians identify patients who can safely remain at home, thereby reducing unnecessary 
transports and optimizing resource utilization. 
Background 
Over the past decades, there has been an increase in the use of prehospital emergency medical 
services (EMS) and emergency departments (EDs).1–3  
In Denmark, EMS activity has grown considerably, with non-conveyance becoming a more frequent 
outcome of prehospital assessment.4–7  
This shift reflects broader international trends driven by ageing populations, limited access to 
primary care, and an increasing number of non-urgent patients entering the emergency healthcare 
system.2,5–8  
Non-conveyance can help reduce ED crowding, improve resource utilization, and maintain capacity 
for time-critical emergencies.6,7,9,10 However, patient safety must be ensured when discharging 
patients on scene. International studies show that within 24–48 hours, 2.5–6.1% of non-conveyed 
patients recontact EMS, 4.6–19.0% visit the ED, 1.0–3.3% are hospitalized, and mortality ranges 
from 0.2 to 3.5%.11  
A recent Danish register-based study in the Central Denmark Region, which included all EMS non-
conveyance cases over a two-year period, found that 4.7% of non-conveyed patients were 
reassessed by EMS, 4.9% were admitted to hospital, and 48-hour mortality was 0.08%.12 Increased 
risk for reassessment and readmission was observed in older patients, males, those with abnormal 
vital signs, and specific complaints such as ear, nose, and throat problems, seizures, non-traumatic 
bleeding, and psychiatric presentations.12 These findings indicate that current non-conveyance 

practice is relatively safe, yet most EMS patients are still transported to hospital.12 Whether more 
patients could safely remain at home remains an open question. 
POCT may improve patient selection for non-conveyance. Despite widespread hospital use, 
prehospital POCT has been insufficiently studied in this context. By providing rapid results on 
electrolytes, renal function, inflammatory markers, and hematology, POCT may support decisions 
that reduce unnecessary admissions while maintaining safety. This cluster randomized trial will 
evaluate whether adding POCT to ambulance-based assessment influences admission patterns, 
revisits, and safety outcomes. 
Hypothesis 
We hypothesize that integration of prehospital point-of-care testing (POCT) combined with 
telemedical consultation with an EMDC physician will increase the proportion of patients safely 
managed without hospital conveyance compared with standard care, without increasing short-term 
adverse outcomes. 
Specifically, we hypothesize that POCT-supported assessment will increase the non-conveyance 
proportion from 20% to 30% (absolute +10 percentage points; relative increase 50%) while 
maintaining comparable rates of hospital admission within 24 hours and 30-day mortality. 
Objectives 
Primary Objective 
To evaluate whether integration of prehospital point-of-care testing (POCT) into ambulance-based 
assessment increases the proportion of patients not conveyed to hospital compared with standard 
care. 
Secondary Objectives 
 To compare hospital admission within 24 hours among non-conveyed patients between 
intervention and control clusters. 

 To compare the proportion of short-stay hospitalizations (<6 hours without advanced 
intervention (procedures or medication) or CT/MR imaging). 
 To compare total hospital length of stay between groups. 
 To compare intensive care unit (ICU) admission rates. 
 To compare 30-day mortality between groups. 
To estimate the intra-cluster correlation coefficient (ICC) for non-conveyance in this EMS setting. 
Endpoint Definitions 
Primary Endpoint 
Non-conveyance, defined as completion of the ambulance encounter without transport to hospital 
following an emergency call and on-scene assessment. 
Secondary Endpoints 
 Hospital admission within 24 hours among patients not conveyed at the index encounter. 
 Short-stay hospitalization, defined as admission lasting less than 6 hours without advanced 
procedures or CT/MR imaging. 
 Total hospital length of stay within 30 days. 
 ICU admission within 30 days. 
 All-cause mortality within 30 days. 
3. Methods  
Study period and setting 
The study will be conducted from 1 April 2026 to 30 September 2027 within the Prehospital 
Emergency Medical Services of the Central Denmark Region. 
Study Design 
This is a prospective, matched, parallel, cluster-randomised trial conducted within a regional 
emergency medical services (EMS) system. A total of ten ambulances are included and randomly 
allocated in a 1:1 ratio to either an intervention strategy integrating point-of-care testing (POCT) 

into prehospital assessment or to standard care. Each ambulance constitutes a cluster and patient 
level allocation is determined by ambulance availability. 
Prior to randomization, clusters are matched in pairs based on their non-conveyance rate during the 
preceding six months, overall case volume, geographic coverage, and ambulance type to ensure 
balance in baseline practice patterns and workload. Matched pairs are then randomized to 
intervention or control. 
Practical Conduct 
Sampling Framework 
Five ambulances are allocated to the intervention arm and equipped with portable point-of-care 
testing (POCT) devices (iSTAT Alinity with CHEM8+ cartridges, QuickRead go C-reactive protein, 
and HemoCue WBC DIFF), and five ambulances serve as control units providing standard care 
without access to POCT. 
All eligible adult patients attended by these ambulances following an emergency call during the 
inclusion period may be enrolled. Ambulances are pair-matched prior to randomisation based on 
their non-conveyance rate during the preceding six months, overall case volume, geographic 
coverage, and ambulance type to ensure comparable baseline activity and patient mix between 
intervention groups. All participating ambulances operate within the same regional EMS system, 
follow identical dispatch procedures, and adhere to the same regional standard operating procedures 
for on-scene assessment, triage, telemedical consultation, and transport decisions. 
Clinical management, triage, and transport decisions follow standard regional practice. Control 
ambulances do not have access to POCT during patient assessment. Apart from access to POCT 
devices and test results, all other aspects of patient care are identical between groups. 
The sampling framework is designed to capture routine EMS patients initially considered for 
hospital conveyance and to evaluate whether integration of rapid biochemical testing with 

telemedical physician support influences conveyance decisions and short-term safety outcomes 
under real-world operational conditions. 
Study Procedures 
For each eligible patient in the intervention arm, the following procedures apply: 
1. Identification of eligible patients following an emergency call and initial on-scene 
ambulance assessment. 
2. Telemedical consultation with a doctor (EMDC physician) to confirm eligibility for POCT. 
3. Blood sampling using standard venous or capillary technique. 
4. Immediate on-scene analysis using the iSTAT Alinity CHEM8+ cartridge, QuickRead go C-
reactive protein, and HemoCue WBC DIFF as clinically indicated. 
5. Documentation of clinical findings, POCT results, and conveyance decision in REDCap. 
6. Continued standard EMS care, including transport or non-conveyance according to the final 
clinical decision. 
In control ambulances, patients undergo identification, telemedical consultation (if indicated), 
documentation in REDCap, and standard EMS care without POCT. 
No additional study-specific interventions beyond blood sampling in the intervention arm are 
introduced. All follow-up outcomes are obtained through routine registry linkage. 
Intervention 
The intervention consists of on-scene biochemical testing using portable point-of-care testing 
(POCT) devices: 
 iSTAT Alinity CHEM8+ (sodium, potassium, chloride, calcium, urea, creatinine, glucose 
and total carbon dioxide) 
 QuickRead go (C-reactive protein and hemoglobin) 
 HemoCue WBC DIFF (white blood cell count differentiated) is used for leukocyte count. 

These devices provide rapid biochemical results directly at the scene to support clinical assessment. 
 
POCT may be performed only after telemedical consultation with a doctor (EMDC physician), and 
only in patients who would otherwise be conveyed to hospital based on the initial on-scene 
ambulance assessment following an emergency call. The intervention therefore targets patients 
initially considered for hospital transport, in whom additional biochemical information may support 
reassessment of the conveyance decision. 
Control clusters continue usual care without POCT. All data will be recorded prospectively. 
 
Outcomes 
Primary and secondary outcomes will be reported in the primary trial publication. Additional 
prespecified outcomes will be analyzed and reported in separate methodological, safety, and 
implementation-focused publications. 
The primary outcome  
Proportion of non-conveyance (no transport to hospital) following an emergency call and on-scene 
assessment, analyzed according to the cluster randomization (10 ambulance clusters: 5 intervention 
and 5 control) under the intention-to-treat principle, regardless of whether POCT was performed in 
individual cases. 
Sensitivity analysis 
A per-protocol sensitivity analysis will be conducted, restricted to patients in whom POCT was 
performed in the intervention clusters. These will be compared with propensity-score–matched 
controls drawn from the control clusters. Matching will be based on patient characteristics, vital 
signs, and presenting problem to estimate the effect of POCT under conditions of actual use. 

Secondary outcomes: 
Secondary outcomes will be compared between the randomized intervention and control clusters 
under the intention-to-treat principle. Outcomes include: 
• Hospital admissions within 24 hours among non-conveyed patients 
• Short-stay hospitalization (<6 hours and without advanced interventions or CT/MR imaging) 
• Total hospital length of stay 
• ICU admission rates 
• 30-day mortality 
Prespecified Substudy and Implementation Outcomes 
The following additional outcomes are prespecified to support safety, operational, and 
methodological substudies. 
Safety and Health Services Outcomes 
 30-day hospital admission rate, defined as any hospital admission occurring within 30 days 
after the index encounter. 
 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., OOH-PC, 
EMS, general practitioner, or self-referred). 
 OOH-PC (out-of-hour primary care) 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. 
 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. 
 Days alive and out of hospital at 30 days, defined as the number of days within 30 days after 
the index encounter during which the patient is alive and not admitted to hospital. 

Operational and Process Outcomes 
 On-scene time, defined as time from ambulance arrival at scene to departure from scene, 
regardless of whether the patient is transported or not. 
 Rate of unsuccessful POCT measurements, defined as 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. 
Methodological Outcomes 
 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), to inform future 
matched cluster-randomized trials in comparable EMS settings. 
 Observed design effects for the primary outcome under the matched cluster-randomized 
design. 
 Pair-matching performance metrics, including within-pair correlation of baseline non-
conveyance rates and descriptive between-cluster variation prior to randomization. 
 Data linkage and outcome completeness, including the proportion of patients successfully 
linked across data sources and the availability of key endpoint data. 

Study Population 
Clusters 
The study will include 10 ambulance clusters, allocated 5 to the intervention arm and 5 to the 
control arm. Clusters will be matched prior to randomization based on their historical non-
conveyance rate during the preceding six months, overall case volume, geographic coverage, and 
ambulance type to ensure balance in baseline practice patterns, workload, and patient mix between 
groups. 
 
Urban eastern region: 3 intervention and 3 control ambulances 
 
Rural western region: 2 intervention and 2 control ambulances 
Patients 
Inclusion Criteria: 
 Adults aged ≥18 years 
 Emergency calls 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 Center (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 known baseline status 
Exclusion Criteria: 
 Non-emergency calls (interfacility or commissioned transport) 
 Immediate need for emergency transport to hospital based on 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) 
Data sources and data collection 
Only REDCap data will be entered prospectively. Prehospital operational and clinical data from the 
Prehospital Patient Record (PPJ) and Logis systems and in-hospital data from the electronical in-
hospital patient records will be collected following formal approval from the Legal Office of the 
Central Denmark Region in accordance with applicable data protection regulations.  
REDCap 
Blood sampling variables will be entered into REDCap by ambulance personnel. REDCap will 
contain study-specific variables including POCT timing, test results, and unique study identification 
numbers. 
Prehospital Patient Record (PPJ) and Logis (dispatch operational system) 
systems 
The following prehospital variables may be collected: 
• Time stamps (emergency call, dispatch, arrival on scene, departure from scene, hospital arrival 
where applicable) 
• Dispatch reference code (Danish Index of Emergency Care) 
• Ambulance cluster and EMS units involved 
• Demographics (age and sex) 
• Vital signs (GCS, oxygen saturation, blood pressure, pulse, and blood glucose where available) 
• Telemedical consultation with EMDC physician (yes/no and time) 
• Final prehospital decision (non-conveyance or hospital transport) 

The regional electronic patient record (EPJ)  
The following variables may be collected: 
 Hospital admission within 24 hours following non-conveyance 
 Total hospital length of stay 
 ICU admission and ICU length of stay 
 Discharge diagnoses (ICD-10) 
 Mortality data (date of death) 
 Historical ICD-10 data from a 10-year period to determine comorbidity 
Data linkage and access control 
Data linkage between REDCap, PPJ, Logis, and EPJ will be performed using the Danish civil 
registration number (CPR) within secure regional data environments in accordance with applicable 
data protection regulations.  
Only authorized research personnel will have access to identifiable data. Access will be role-based 
and logged. 
Data handling and storage 
The project will be registered in the Central Denmark Region’s internal registry of research projects 
and conducted in accordance with the General Data Protection Regulation (GDPR) and the Danish 
Data Protection Act. 
The sponsor and principal investigator are responsible for ensuring that all data processing complies 
with applicable data protection legislation. Study data will be stored in REDCap on secure regional 
servers approved for research use. Access will be restricted to authorised study personnel. 
Only data relevant to the research objectives will be collected and processed in accordance with 
data minimization principles. Identifiable data will be accessible only to authorized personnel 
involved in study conduct, data validation, or monitoring. 

Data will be stored in accordance with Danish regulatory requirements and institutional policies. 
After the required retention period, data will be deleted or fully anonymized as appropriate. 
Individual-level data will not be made publicly available. Aggregated and anonymized results may 
be shared upon reasonable request and subject to relevant approvals. 
Statistics 
All analyses will follow the intention-to-treat principle, with participants analyzed according to the 
allocation of their ambulance cluster regardless of whether POCT was performed. Statistical tests 
will be two-sided with a significance level of 0.05, and effect estimates will be presented with 95% 
confidence intervals. Analyses will account for clustering at the ambulance level and the matched-
pair design. 
Baseline characteristics will be summarized using descriptive statistics based on available (non-
missing) data. Continuous variables will be presented as mean (standard deviation) or median 
(interquartile range), as appropriate, and categorical variables as counts and percentages. No formal 
hypothesis testing of baseline differences will be performed. 
The primary outcome, non-conveyance (yes/no), will be analyzed using linear regression with 
cluster robust variance estimation to estimate the absolute risk difference and Poisson regression 
with cluster robust variance estimation to estimate the relative risk. Allocation group will be 
included as the main independent variable, and matched pair will be included as a fixed effect. 
Cluster-robust standard errors will be applied at the ambulance level. 
Binary secondary outcomes will be analyzed using the same modelling framework. Continuous 
outcomes will be analyzed using linear regression with cluster-robust variance estimation. 
A per-protocol sensitivity analysis will be conducted among patients in the intervention clusters in 
whom POCT was performed. These patients will be compared with propensity-score–matched 

controls from the control clusters. The same regression framework with cluster-robust variance 
estimation will be applied. 
The intra-cluster correlation coefficient (ICC) for the primary outcome will be estimated using a 
random effects analysis. 
Sample Size and Power Considerations 
The number of clusters is determined by the pre-specified organizational structure of the EMS 
system (10 ambulance clusters; 5 per arm). We anticipate inclusion of up to approximately 200 
eligible participants per ambulance, corresponding to approximately 1,000 participants per arm. 
With an expected baseline non-conveyance proportion of 20%, the trial is powered to detect an 
absolute increase in non-conveyance to 30% (+10 percentage points; relative increase 50%). Using 
Stata’s power twoproportions for a cluster randomized design (Pearson’s chi-squared test), 
assuming an intra-cluster correlation coefficient (ICC) of 0.01, equal cluster sizes, and 5 clusters per 
arm, approximately 141 participants per cluster (≈705 per arm) provide 80% power at a two-sided 
alpha level of 0.05. Cluster sizes may vary in practice, but the calculation assumes equal cluster 
sizes. With up to 200 participants per ambulance (≈1,000 per arm), the study provides additional 
precision around the estimated effect. 
The intra-cluster correlation is expected to be low because non-conveyance decisions are primarily 
driven by patient-level factors, and ambulances operate within similar dispatch pathways and shared 
clinical governance. In addition, clusters are pair-matched on historical non-conveyance rates, case 
volume, geography, and ambulance type to reduce between-group heterogeneity. The observed ICC 
will be estimated and reported as part of the analysis. The primary analysis will use methods 
appropriate for matched-pair cluster randomization and will focus on estimation of the intervention 
effect with corresponding confidence intervals. 

4. Ethics Approval 
The study has been reviewed and approved by the ethics committee in the Central Denmark Region 
(case no. 1-10-72-8-26). A waiver of informed consent was granted for registry-based follow-up. An 
English description of the ethical approval will be provided in the ClinicalTrials.gov registration. 
 
Limitations/Discussion 
Because POCT use must be approved by the EMDC physician, the intervention inevitably increases 
the frequency of telemedical consultations. Thus, any observed differences between groups reflect 
the combined effect of POCT and increased physician involvement. The study cannot isolate the 
independent effect of POCT alone, and findings should be interpreted as the impact of this 
integrated care model. 
 
References 
1.  
Andrew E, Nehme Z, Cameron P, Smith K. Drivers of Increasing Emergency Ambulance 
Demand. Prehosp Emerg Care. 2020;24(3):385.  
2.  
Lowthian JA, Cameron PA, Stoelwinder JU, Curtis A, Currell A, Cooke MW, et al. Increasing 
utilisation of emergency ambulances. Aust Health Rev Publ Aust Hosp Assoc. 2011 
Feb;35(1):63–9.  
3.  
Lowthian JA, Curtis AJ, Cameron PA, Stoelwinder JU, Cooke MW, McNeil JJ. Systematic 
review of trends in emergency department attendances: an Australian perspective. Emerg Med 
J EMJ. 2011 May;28(5):373–7.  
4.  
Christensen EF, Bendtsen MD, Larsen TM, Jensen FB, Lindskou TA, Holdgaard HO, et al. 
Trends in diagnostic patterns and mortality in emergency ambulance service patients in 2007-
2014: a population-based cohort study from the North Denmark Region. BMJ Open. 2017 Aug 
21;7(8):e014508.  
5.  
Booker MJ, Shaw ARG, Purdy S. Why do patients with ‘primary care sensitive’ problems 
access ambulance services? A systematic mapping review of the literature. BMJ Open. 2015 
May 19;5(5):e007726.  
6.  
Paulin J, Kurola J, Salanterä S, Moen H, Guragain N, Koivisto M, et al. Changing role of EMS 
-analyses of non-conveyed and conveyed patients in Finland. Scand J Trauma Resusc Emerg 
Med. 2020 May 29;28(1):45.  

7.  
Todd VF, Swain A, Howie G, Tunnage B, Smith T, Dicker B. Factors Associated with 
Emergency Medical Service Reattendance in Low Acuity Patients Not Transported by 
Ambulance. Prehosp Emerg Care. 2022;26(1):66–77.  
8.  
Hoikka M, Silfvast T, Ala-Kokko TI. A high proportion of prehospital emergency patients are 
not transported by ambulance: a retrospective cohort study in Northern Finland. Acta 
Anaesthesiol Scand. 2017 May;61(5):549–56.  
9.  
Fisher JD, Freeman K, Clarke A, Spurgeon P, Smyth M, Perkins GD, et al. Patient safety in 
ambulance services: a scoping review [Internet]. Southampton (UK): NIHR Journals Library; 
2015 [cited 2025 Dec 4]. (Health Services and Delivery Research). Available from: 
http://www.ncbi.nlm.nih.gov/books/NBK294028/ 
10.  Malm F, Elfström A, Ohlsson-Nevo E, Höglund E. Time consumption for non-conveyed 
patients within emergency medical services (EMS): A one-year prospective descriptive and 
comparative study in a region of Sweden. PloS One. 2021;16(5):e0251686.  
11.  Ebben RHA, Vloet LCM, Speijers RF, Tönjes NW, Loef J, Pelgrim T, et al. A patient-safety 
and professional perspective on non-conveyance in ambulance care: a systematic review. 
Scand J Trauma Resusc Emerg Med. 2017 Jul 17;25(1):71.  
12.  Møller FA, Gude MF, Nielsen RØ, Gehrt TB. Patient safety in non-conveyance within 
prehospital emergency medical services: a register-based study. Intern Emerg Med. 2025 May 
22;