PneumoniaNCT05654909
Prehospital Assessment Units - a Matched Cohort Study
An observational study of Pneumonia and Urinary Tract Infections, run by Prehospital Center, Region Zealand at 1 site in Denmark.
Trial summary
This study aimed to evaluate the prehospital assessment unit (PAU) by admission within 48 hours, 7 days, respectively and on survival. The PAU should increase focus on a patient-centered approach with the capability to make advanced assessments of patients to reduce unnecessary transportation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Urinary Tract Infections, Fall
- What is being tested?
- Prehospital assessment unit
- Type of treatment
- Surgery or procedure
- How many people
- 10,849 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients in the Region Zealand calling 1-1-2 during the study period
Who may be able to join
- expectations of undergoing an uncomplicated illness progression
- green or yellow level of triage based on the ABCDE approach (red, orange, yellow, green, blue levels of triage.
Who cannot join
- gynaecological disease
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the prehospital assessment unit (PAU) by admission within 48 hours, 7 days, respectively and on survival.
The PAU should increase focus on a patient-centered approach with the capability to make advanced assessments of patients to reduce unnecessary transportation. Further, this paramedic assessment program could positively impact the healthcare system by reducing admissions to emergency departments.
Read more
The PAU is operated by paramedics who have additional education, and they are capable of testing and monitoring certain conditions at the scene - in the home of the patients. The paramedics decide if the patient requires admission to the hospital or if the patient could stay at home. They are consulting physicians on call by phone.
This retrospective cohort study included data from patients assessed by the PAU between November 1st 2021, and October 1st 2022.
Non-PAU patients were selected from the 1-1-2 calls (the European version of 9-1-1) EMS and were collected based on the same criteria as the patients assessed by the PAU. The control ratio was 1:10 for cases to increase power. The non-PAU patients were matched on sex and age (within 5-year ranges). Matching was performed using incidence density sampling, where controls were selected for each case on the week of 1-1-2 call.
Read the detailed description
The demand for healthcare is increasing, stressing the need for adaptive Emergency Medical Services (EMS). This development was also illustrated in a Danish cohort study from 2017. The authors reported an increase in the annual number of patients assessed by EMS by 67% between 2007 and 2014.Thus, the traditional role of paramedics is changing to establish a bridge between the community and the hospital by offering primary care services. Paramedic assessment units (PAU) were implemented in Region Zealand, Denmark in 2021 to accommodate the increased demand. The PAU should increase focus on a patient-centered approach with the capability to make advanced assessments of patients to reduce unnecessary transportation. Further, this paramedic assessment program could positively impact the healthcare system by reducing admissions to emergency departments.
While this approach is new in Denmark, variations of the approach have been implemented internationally for more than two decades.The PAU can be compared with the community paramedic units. Different community paramedic programs have arisen to address the regional requirements; different regional and national operation environments explain this regarding the population density and level of healthcare service. No exact definition is present, but these assessment programs generally focus on frail elderly and other high-needs patients.
The PAU is operated by paramedics who have additional education, and they do have point-of-care test facilities (POCT). The paramedics can monitor saturation, blood pressure and electrocardiogram, all of which are standard equipment of ambulances in Region Zealand. Further, the paramedic can measure C-reactive protein, analyse urine test strips (pH, glucose, acetoacetate, leucocytes, nitrite, protein and erythrocytes), blood glucose and analyse blood gas (pH, pO2, pCO2, lactate, sodium, potassium, calcium and creatinine).
The patients assessed by the PAU had four possible destinations: admittance to the E-Hospital, a unique regional arrangement in which the patient stays at home but is under virtual surveillance by physicians and nurses. Alternatively, the patient was admitted to the E-hospital at local acute community-based facilities. Third, the patient was admitted to the emergency department at the hospital and finally, the PAU examined the patient at home without further follow-up. The decision was made between the physicians at the E-Hospital and the paramedic on the scene.
While the evidence supporting PAU is promising, convincing data from well-designed studies focusing on the impact of PAU on health outcomes and patient safety are still being determined.
This retrospective cohort study was conducted to compare individuals treated by PAU with a control group of matched individuals not treated by PAU. Thus, the primary objective of this study was:
- To identify patients among cases who were admitted to the emergency department within 48 hours and 7 days after consultation with the PAU, respectively.
- Secondary, to identify patients admitted to the emergency department within 6 hours from the initial call to the medical emergency number.
- Finally, to identify 30-day survival.
- Conditions
- Pneumonia, Urinary Tract Infections, Fall, Infections, GI Disorders, Orthopedic Disorder
- Being tested
- Prehospital assessment unit
- Medical subject headings
- Pneumonia, Urinary Tract Infections, Infections, Digestive System Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehospital assessment unitProcedure or surgery
The prehospital assessment unit was developed to provide a paramedic responding by car to 1-1-2 calls in the area of Region Zealand. Further details are mentioned in the description.
| Study group | Role | What they receive |
|---|---|---|
| PAU group | The PAU group were patients calling 1-1-2 assigned for the prehospital assessment unit, Receives: Procedure: Prehospital assessment unit | |
| non PAU group | The non PAU group were selected from the 1-1-2 calls (the European version of 9-1-1) EMS and were collected based on the same criteria as the patients assessed by the PAU. The control ratio was 1:10 for cases to increase power. Controls were matched on sex and age (within 5-year ranges). Matching was performed using incidence density sampling, where controls were selected for each case on the week of 1-1-2 call. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission within 48 hours
Dichotomous variable of admission within two days after intial call
Measured: 48 hours
Admission within 7 days
Dichotomous variable of admission within seven days after intial call
Measured: 7 dats
Secondary outcomes (2)
Admission within 6 hours
Dichotomous variable of admission within 6 hours from intial call
Measured: 6 hours
30-day survival
30-day survival from initial call
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Nov 2021
- Primary completion31 Oct 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prehospital Center, Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Amalie Wolthers, Prehospital Center, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654909
- Sponsor's protocol ID
- PHV_2022
- Status last verified
- Feb 2023
- First submitted
- 8 Dec 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen MS, Johnsen SP, Sorensen JN, Jepsen SB, Hansen JB, Christensen EF. Implementing a nationwide criteria-based emergency medical dispatch system: a register-based follow-up study. Scand J Trauma Resusc Emerg Med. 2013 Jul 9;21:53. doi: 10.1186/1757-7241-21-53.
PubMed 23835246Christensen EF, Bendtsen MD, Larsen TM, Jensen FB, Lindskou TA, Holdgaard HO, Hansen PA, Johnsen SP, Christiansen CF. 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. doi: 10.1136/bmjopen-2016-014508.
PubMed 28827233Wolthers SA, Blomberg SNF, Breindahl N, Anjum S, Hagi-Pedersen D, Ersboll A, Andersen LB, Christensen HC. Association between using a prehospital assessment unit and hospital admission and mortality: a matched cohort study. BMJ Open. 2023 Sep 22;13(9):e075592. doi: 10.1136/bmjopen-2023-075592.
PubMed 37739475
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Assessment Units - a Matched Cohort Study
- ClinicalTrials.gov ID
- NCT05654909
- Acronym / sponsor ID
- PHV_2022
- Conditions
- Pneumonia, Urinary Tract Infections, Fall, Infections, GI Disorders, Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,849 participants (actual)
- Lead sponsor
- Prehospital Center, Region ZealandUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the prehospital assessment unit (PAU) by admission within 48 hours, 7 days, respectively and on survival.
The PAU should increase focus on a patient-centered approach with the capability to make advanced assessments of patients to reduce unnecessary transportation. Further, this paramedic assessment program could positively impact the healthcare system by reducing admissions to emergency departments.
The PAU is operated by paramedics who have additional education, and they are capable of testing and monitoring certain conditions at the scene - in the home of the patients. The paramedics decide if the patient requires admission to the hospital or if the patient could stay at home. They are consulting physicians on call by phone.
This retrospective cohort study included data from patients assessed by the PAU between November 1st 2021, and October 1st 2022.
Non-PAU patients were selected from the 1-1-2 calls (the European version of 9-1-1) EMS and were collected based on the same criteria as the patients assessed by the PAU. The control ratio was 1:10 for cases to increase power. The non-PAU patients were matched on sex and age (within 5-year ranges). Matching was performed using incidence density sampling, where controls were selected for each case on the week of 1-1-2 call.
Detailed description
The demand for healthcare is increasing, stressing the need for adaptive Emergency Medical Services (EMS). This development was also illustrated in a Danish cohort study from 2017. The authors reported an increase in the annual number of patients assessed by EMS by 67% between 2007 and 2014.Thus, the traditional role of paramedics is changing to establish a bridge between the community and the hospital by offering primary care services. Paramedic assessment units (PAU) were implemented in Region Zealand, Denmark in 2021 to accommodate the increased demand. The PAU should increase focus on a patient-centered approach with the capability to make advanced assessments of patients to reduce unnecessary transportation. Further, this paramedic assessment program could positively impact the healthcare system by reducing admissions to emergency departments.
While this approach is new in Denmark, variations of the approach have been implemented internationally for more than two decades.The PAU can be compared with the community paramedic units. Different community paramedic programs have arisen to address the regional requirements; different regional and national operation environments explain this regarding the population density and level of healthcare service. No exact definition is present, but these assessment programs generally focus on frail elderly and other high-needs patients.
The PAU is operated by paramedics who have additional education, and they do have point-of-care test facilities (POCT). The paramedics can monitor saturation, blood pressure and electrocardiogram, all of which are standard equipment of ambulances in Region Zealand. Further, the paramedic can measure C-reactive protein, analyse urine test strips (pH, glucose, acetoacetate, leucocytes, nitrite, protein and erythrocytes), blood glucose and analyse blood gas (pH, pO2, pCO2, lactate, sodium, potassium, calcium and creatinine).
The patients assessed by the PAU had four possible destinations: admittance to the E-Hospital, a unique regional arrangement in which the patient stays at home but is under virtual surveillance by physicians and nurses. Alternatively, the patient was admitted to the E-hospital at local acute community-based facilities. Third, the patient was admitted to the emergency department at the hospital and finally, the PAU examined the patient at home without further follow-up. The decision was made between the physicians at the E-Hospital and the paramedic on the scene.
While the evidence supporting PAU is promising, convincing data from well-designed studies focusing on the impact of PAU on health outcomes and patient safety are still being determined.
This retrospective cohort study was conducted to compare individuals treated by PAU with a control group of matched individuals not treated by PAU. Thus, the primary objective of this study was:
- To identify patients among cases who were admitted to the emergency department within 48 hours and 7 days after consultation with the PAU, respectively.
- Secondary, to identify patients admitted to the emergency department within 6 hours from the initial call to the medical emergency number.
- Finally, to identify 30-day survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAU group | – | Procedure: Prehospital assessment unitThe PAU group were patients calling 1-1-2 assigned for the prehospital assessment unit, |
| non PAU group | – | –The non PAU group were selected from the 1-1-2 calls (the European version of 9-1-1) EMS and were collected based on the same criteria as the patients assessed by the PAU. The control ratio was 1:10 for cases to increase power. Controls were matched on sex and age (within 5-year ranges). Matching was performed using incidence density sampling, where controls were selected for each case on the week of 1-1-2 call. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients in the Region Zealand calling 1-1-2 during the study period
Key inclusion criteria (2 listed)
- expectations of undergoing an uncomplicated illness progression
- green or yellow level of triage based on the ABCDE approach (red, orange, yellow, green, blue levels of triage.
Key exclusion criteria (1 listed)
- gynaecological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehospital assessment unitThe prehospital assessment unit was developed to provide a paramedic responding by car to 1-1-2 calls in the area of Region Zealand. Further details are mentioned in the description. | Procedure or surgery | PAU group |
Primary outcome
Admission within 48 hours
Time frame: 48 hours
Dichotomous variable of admission within two days after intial call
Admission within 7 days
Time frame: 7 dats
Dichotomous variable of admission within seven days after intial call
2 secondary outcomes
Admission within 6 hours
Time frame: 6 hours
30-day survival
Time frame: 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Background: PubMed 23835246Andersen MS, Johnsen SP, Sorensen JN, Jepsen SB, Hansen JB, Christensen EF. Implementing a nationwide criteria-based emergency medical dispatch system: a register-based follow-up study. Scand J Trauma Resusc Emerg Med. 2013 Jul 9;21:53. doi: 10.1186/1757-7241-21-53.
- Background: PubMed 28827233Christensen EF, Bendtsen MD, Larsen TM, Jensen FB, Lindskou TA, Holdgaard HO, Hansen PA, Johnsen SP, Christiansen CF. 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. doi: 10.1136/bmjopen-2016-014508.
- Derived from this study: PubMed 37739475Wolthers SA, Blomberg SNF, Breindahl N, Anjum S, Hagi-Pedersen D, Ersboll A, Andersen LB, Christensen HC. Association between using a prehospital assessment unit and hospital admission and mortality: a matched cohort study. BMJ Open. 2023 Sep 22;13(9):e075592. doi: 10.1136/bmjopen-2023-075592.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Urinary Tract Infections, run by Prehospital Center, Region Zealand at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission within 48 hours (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654909, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.