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 defibrillation; 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. The three additional diagnostic interventions are point of care tests (a) urinalysis and (b) ultrasound, and (c) otoscope. The four additional therapeutic interventions are (a) procedural sedation and analgesia, (b) surgical closure of wounds, (c) prescription of medication, and (d) thoracostomy. All additional interventions, their indications, options and evidence-based underpinning are described in Table 1.
Additional diagnostic interventions
Point-of-care testing (POCT) is defined 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, specific 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, undefined abdominal complaints.
Point of care ultrasound (POCUS) refers to the use of portable ultrasonography at a patient's side for diagnostic or therapeutic purposes. Indications to apply POCUS are abdominal trauma, thoracic trauma, out-of-hospital cardiac arrest, fascia iliac compartment block, intravenous cannula placement, intubation check, collapse, abdominal pains, and non-traumatic thoracic 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, superficial, 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 non-bruised, 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 defined: (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 five categories, based on home address per km2, from highly urban to highly rural. The variable ‘initial reason for care’ consists of the 22 different chapters of the International Statistical Classification of Diseases and Related Health Problems 10th revision ICD Version:2016 [27]. The vital signs and observation scales involved different variables based on the ABCDE-method, and are based on the national protocol which ambulance care professionals in the Netherlands use to make their treatment and conveyance decisions.
Safety
Safety is operationalized into three indicators:
- The number of complaints or major/minor incidents reported that are related to provided NP care
- Follow-up care within 24h, 48h or 72h after non-conveyance, categorized into emergency follow-up care (ambulance, ED and GP out-of-hours office) or regular care (GP, other)
- The degree of guideline adherence for each additional intervention, conform the legal guidelines
Patient experience
To collect data on patient experience a questionnaire was developed, based on the validated Consumer Quality Index Emergency Ambulance Care (CQI-index) [28]. This CQI-index is a 46-item validated questionnaire to measure patient experience on the domains (1) emergency number and dispatch center, (2) attitude and behavior of the ambulance professional, (3) treatment by the ambulance professional, (4) communication by the ambulance professional, (5) conveyance, and (6) emergency department. As this study focuses on on-scene and follow-up care by a solo ambulance care unit, we only used the questions from the three domains handling (attitude and behavior), treatment and communication. Patients could answer on a 4-point scale (‘no, not at all’, ‘yes, a little’, ‘yes, for the most part’, ‘yes, totally’), with an additional option for ‘can’t remember’ or ‘not applicable’.
After completing the ambulance consult, the NP asks the patient if he is willing to participate in the follow-up care and experience questionnaire. Patients are not eligible if the patient is <18 years, not able to speak Dutch, has no 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 five 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 identification number, which can be used to connect the five 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 significance will be set at p-value < 0.05.