Implementation of A Nurse Practitioner in Emergency Ambulance Care in The Netherlands: A Study Protocol for The IMPACT-Study

Background Ambulance care professionals face an increasing demand for ambulance care, which is caused by a changing patient population with more complex healthcare problems and comorbidities, accessibility of emergency care, repeated requests for ambulance care and the request of ambulance care for primary care problems. These changes might require an ambulance care professional at master level, such as the nurse practitioner (NP). The objective is to (1) determine characteristics of patients and ambulance runs in situations where NP care was provided, and to evaluate the effect of implementing the NP in Dutch ambulance on (2) patient safety and (3) patient experience compared to non-NP care. Methods/design A prospective mixed-methods implementation design will be used. The intervention is the implementation of a NP as solo ambulance unit within this EMS, to (1) determine characteristics of the patients and ambulance runs, and the effects on (2) patient safety and (3) patient, compared to regular ambulance care. Within this pilot the NP can apply additional diagnostic and therapeutic interventions in addition to regular ambulance care. Data will be collected through databases, additional apps, and questionnaires. performing surgical interventions; performing catheterization; giving injections; performing punctures; cardioversion debrillation;

Within this pilot the NP can apply additional diagnostic and therapeutic interventions in addition to regular ambulance care. Data will be collected through databases, additional apps, and questionnaires.

Background
Ambulance care in the Netherlands is provided by 25 regional emergency medical services (EMS). An EMS can be publicly or privately organized, or it can be a combination of public and private organizations [1]. Ambulance care is dispatched through the emergency medical dispatch center, and can be requested via the national emergency number 1-1-2, or by healthcare professionals (such as the general practitioner or medical specialist). The dispatch center is staffed by a dispatch nurse. Dispatch is either guided by the Advanced Medical Priority Dispatch System in its digital form of Professional Quality Assurance (ProQA), or the Dutch Triage Standard (NTS). The dispatch center can dispatch a fully equipped ambulance or a solo vehicle (car or motorcycle). Ambulance care can be dispatched with three priority levels: A1: an acute threat to the patient's vital functions or only to be excluded after an evaluation by the ambulance unit on site (response time < 15 minutes), A2: a request for care that does not entail an immediate threat to life, but may involve (serious) damage to health (response time < 30 minutes), or B: Planned patient transport.
Regular ambulances in the Netherlands are staffed with one driver and one ambulance care professional, being either a registered nurse or a bachelor of health. A registered nurse becomes quali ed as an ambulance nurse after following a speci c national training course at Dutch Quali cation Framework, NLQF-level 6. The position of a bachelor or health ambulance care is relatively new in the Dutch ambulance care system. A bachelor of health has followed a four-year educational program at bachelor level at NLQF-level 6. Both the nurse and the bachelor of health follow a national ambulance care course and are examined by the national ambulance care academy. Dutch ambulance care professionals have a functional autonomy within the framework of the national EMS standard. This standard covers 113 owcharts with decision making strategies on diagnosis and treatment of signs and symptoms of 15 diagnosis groups e.g. airway, cardiology, internal medicine and trauma care.
These ambulance care professionals face an increasing demand for ambulance care, which is caused by a changing patient population with more complex healthcare problems and comorbidities, accessibility of emergency care, repeated requests for ambulance care and the request of ambulance care for primary care problems [2][3][4][5][6]. This changes calls for different types of ambulance care, provided by different types of ambulance care professionals that have additional competencies and diagnostic and treatment options.
A possible solution to provide care to a changing prehospital patient population and limit the burden on the ambulance care system might be a professional at master level, such as a nurse practitioner (NP). The NP is a Master of Science educated nurse (NLQF/EQF level 7) who has completed the Master Advanced Nursing Practice [7]. NPs are quali ed and allowed to indicate and perform some of the so-called "reserved procedures", and combine nursing care with medical care. The NP comes to a differential diagnosis based on clinical reasoning.
Using; medical history, physical and/or psychiatric examination and/or additional diagnostics. Several reviews about the effect of NPs in primary, ambulatory or emergency department care showed positive effects on patient outcomes, patient satisfaction, and cost-effectiveness [8][9][10][11][12]. However, these studies did not focus on the effects of implementing a NP in ambulance care. Based on these studies it is hypothesized that the implementation of a NP within EMS care might positively affect patient safety and patient experience.

Objectives
The objective is to (1) determine characteristics of patients and ambulance runs in situations where NP care was provided, and to evaluate the effect of implementing the NP in Dutch ambulance on (2) patient safety and (3) patient experience compared to non-NP care.
Characteristics of the patient and ambulance runs 1. What are characteristics of the patients (demographics, initial complaints, on-scene diagnosis) and ambulance runs (timeframes and priority levels) when NP care was provided compared to non-NP care? Methods Design A prospective mixed-methods implementation design will be used. In concordance with Dutch legislation, a waiver of a medical ethical committee will be requested.

Intervention and setting
The intervention consists of the implementation of a NP as solo ambulance unit within this EMS. The NP is a Master of Science educated nurse (NLQF/EQF level 7) who has completed the Master Advanced Nursing Practice. The NP is registered in the specialists register of the Dutch Law. The NP can lawfully enter into an independent treatment relationship with a patient. The NP makes a differential diagnosis on basis of clinical reasoning, using; medical history, physical and/or psychiatric examination and additional diagnostics (14). Subsequently, the NP will apply evidence-based interventions, and indicate and perform reserved procedures. NPs are legally allowed to independently indicate and perform reserved procedures, like giving injections or prescribing medication.
Subsequently, he will apply evidence-based interventions, and indicate and perform reserved procedures. The nature of the reserved procedures are described as follows: performing surgical interventions; performing catheterization; giving injections; performing punctures; performing elective cardioversion or de brillation; performing endoscopies; prescribing medication.
The NP will be implemented in one EMS organization in the southern part of the Netherlands. Within this region reside approximately 1.8 million people, and the EMS preformed 153.000 ambulance runs in 2018. Within this EMS organization there are two emergency medical dispatch centers and 64 ambulances available. This EMS covers three main urban areas: Tilburg, Breda and Den Bosch. The NP will be deployed only in the Tilburg area (220.000 inhabitants) during daytimes starting at 07AM till 10PM. The rationale for this timeframe is to ensure on-scene safety of the NP as he attends the scene alone.
Within this pilot the NP can apply diagnostic and therapeutic interventions in addition to regular ambulance care.  Table 1.

Additional diagnostic interventions
Point-of-care testing (POCT) is de ned as an investigation taken at the time of the consultation with instant availability of results to make immediate and informed decisions about patient care. Within this pilot, the NP can apply 'urinalysis' ,'ultrasound' or otoscopies as POCT.
Urinalysis using multi-analytic dipsticks contain discrete reagent pads to semi-quantitatively test for the presence of bilirubin, blood, creatinine, glucose, ketones, leukocytes, nitrite, pH, protein, speci c gravity, and urobilinogen in a urine sample. The urinalysis is performed conform the guideline 'Urinary tract infections' of the Dutch College of General Practitioners [13]. Indication to apply urinalysis is any suspected pathology of the Urogenital Tract System, e.g. suspected urinary tract infections, trauma, kidney calculi, fever, unde ned abdominal complaints. Otoscopy is performed in concordance with the guideline 'Otitis Externa' of the Dutch College of General Practitioners [19]. Indication to apply the otoscope is any suspected pathology of the outer-and inner-ear canal and tympanic membrane, e.g. pain, trauma, (suspected) foreign body, vertigo and loss of hearing.

Additional therapeutic interventions
Procedural sedation and analgesia (PSA), commonly referred to as "conscious sedation" or "procedural sedation," is to alleviate anxiety, decrease pain, and provide amnesia to patients undergoing painful procedures or diagnostic imaging. Within this pilot, PSA is performed in concordance with the guideline 'sedation and/or analgesia (PSA) outside the operation room' of the Dutch Society of Anesthesiology and the Dutch Society of Pediatrics [21] . PSA is applied to make short, extremely painful procedures possible.
Surgical wound closure facilitates the biological event of healing by joining the wound edges and is performed in accordance with the guideline 'Traumatic and bite wounds' of the Dutch College of General Practitioners [23]. The guideline recommends to glue a wound if it is clean, super cial, non-gaping, and exists shorter than 12 hours. To stitch a wound, the wound should be clean, non-infected, created by a sharp object, the skin should be nonbruised, and should not exist longer than 18 hours, except wounds in the neck/head area (within 24 hours).
A prescription medication or prescription medicine is a pharmaceutical drug that legally requires a medical prescription to be dispensed. Within this pilot the NP can prescribe medication using the guidelines from the Dutch college of General Practitioners.
A thoracostomy is a small incision of the chest wall, with maintenance of the opening for drainage, and is most commonly used for the treatment of a pneumothorax. Indications to apply a thoracostomy are a tension pneumothorax, hemothorax, and a Traumatic out of hospital cardiac arrest.

Outcomes
To assess the effect of the implementation of the NP within the EMS-system three domains with outcomes are de ned: (1) patient and ambulance run characteristics, (2) patient safety, and (3) experience. All outcomes, data sources and analytical methods are displayed in Table 2.

Patient and ambulance run characteristics
For each ambulance run, dispatch data, demographics, initial reasons for care, and vital functions or observational scales are collected. The demographic variables include age, gender and geographical location.
Geographic location is divided in ve categories, based on home address per km 2 , from highly urban to highly telephone, or the consult is for cannula placement for euthanasia. If a patient consents to participate, he is contacted by telephone within one month after ambulance attendance to take the questionnaire.

Data collection
Data will be collected in the subregion were the NP is implemented (Tilburg) and one other subregion with regular ambulance care (Den Bosch). All ambulance runs in a one year period from September 2019 until September 2020 in the Tilburg and Den Bosch area will be included. The data will be collected from ve different (existing) data sources: (1) emergency medical dispatch center database, (2) regular ambulance runs sheets, (3) EMS database with complaints or incident reports (4) powerapps for each of the additional diagnostic and therapeutic interventions (5) telephone surveys about follow-up care patient experience with ambulance care. Each ambulance run is stored in an EMS database and has a unique identi cation number, which can be used to connect the ve data-sources on patient level but guarantees anonymity.

Data-analysis
Data will be analyzed with SPSS version 25.0 (or higher if available). To describe data from the NP and regular care group, measures of central tendency and variability, and percentages will be calculated. To compare data between the NP and regular care group, Chi-square tests and t-tests will be performed. Statistical signi cance will be set at p-value < 0.05.

Declarations
Ethics approval and consent to participate Not applicable

Consent for publication
We would like to state that all authors have read and approved the manuscript for submission.

Availability of data and materials
Not applicable