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Nurse's Scope of PracticeNCT05230108

Implementation of Advanced Triage in the Emergency Department of Bellvitge University Hospital

A study testing Advanced Triage in people with Nurse's Scope of Practice, run by Hospital Universitari de Bellvitge at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the efficacy of advanced triage in improving the quality of care outcomes of patients attending the Emergency Department (ED) united care of high complexity hospital. There are four steps; Step 1 will consist of a concept analysis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nurse's Scope of Practice
What is being tested?
Advanced Triage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
547 participants
Where
1 siteSpain
Study dates
1 Sep 2022to 31 Dec 2025
Phase
Interventional
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • over 18 years of age, admitted to EDs classified with Emergency Severity Index (ESI) severity levels III, IV and V.

Who cannot join

  • patients over 70 years of age
  • pregnant women
  • patients with a Glasgow Glasgow score of less than 15
  • patients with more than 3 chronic pathologies and/or 1 complex chronic
  • disease or patients reconsulting the ED for the same reason for consultation.

Trial locations and contacts

1 site in 1 country.

Cristina Font Cabrera, Nurse contact

+34 687 235 773

cristinafont@ub.edu

Eva Maria Guix Comellas, Nurse. PHD contact

+34 609 310 430

evaguix@ub.edu

Spain1 site
  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

This study evaluates the efficacy of advanced triage in improving the quality of care outcomes of patients attending the Emergency Department (ED) united care of high complexity hospital.

There are four steps; Step 1 will consist of a concept analysis. Step 2 will include a mapping of advanced practice protocol terminologies. Step 3 will analyse the opinion of health professionals on advanced triage. In step 4: in retrospective phase, sociodemographic and clinical variables and quality indicators such as waiting time will be analysed. After that, in the prospective phase, advanced triage will be implemented and the two cohorts will be compared.

Read the detailed description

STEP 1:

Study design: a concept analysis will be carried out based on a systematic analysis method by which it details and specifies the element to be studied, in this case, the Advanced Triage (AT). This study is based on the method that was outlined by Wilson (Wilson, 1969) and later evolved by Avant (Walker \& Avant, 1989). This technique consists of eleven stages: 1) isolating questions concerning the concept; 2) finding suitable answers; 3-7) developing real or invented cases; 8) determining the social context; 9) identifying the underlying emotions; 10) establishing the practical results; 11) defining the results in language that facilitates the clarification of the controversial concept. The use of this methodology provides the construction of different definitions that reach all variants of the AT concept.

STEP 2:

Study design: Observational, descriptive, cross-sectional, retrospective, retrospective, observational study of interobserver concordance of bidirectional cross-mapping between Architecture Terminology Interface Knowledge (ATIC), Nursing Diagnoses: Definitions \& Classification (NANDA), Nursing Interventions Classification (NIC) and the International Classification of Diseases and Related Health Problems (ICD-10). Based on the protocols of the Nurse Demand Management (NDM) for primary health care (PHC) of the Catalan Institute of Health.

Data collection: The data collector will proceed to design a form that allows the collection and connection of the three terminologies in each concept (assessment, diagnosis and intervention). The identification of these equivalences will be carried out by the participation of three nurses independently of each of the researchers. Several interobserver consensus sessions will be held according to the results of the concordance. Discrepancies will be resolved, if appropriate, through the agreement processes. To make the equivalences of the concepts included in the NDM protocols with the different languages (ATIC, NANDA, NIC and ICD-10), with trichotomous variables: Yes /No/ Partially; and nominal quantitative variables, to facilitate the understanding of the mapping, the codes representing the type of equivalence are included.

Data analysis: The collected data will be processed and checked for processing errors and analysed with EXCEL. Interobserver reliability will be calculated by considering the ratio according to the results of the three investigators and using the kappa(K) index calculation, in which the agreement is considered to be: (1) low, if (k) ≤0.20; (2) moderate, if (k) 0.21-0.40; (3) acceptable, if (K) 0.61-0.80 and (5) excellent, if (k) ≤0.81.

STEP 3 Study design: observational, descriptive, cross-sectional and prospective study of the different protocols already existing in the PHC of the Catalan Institute of Health and assess whether they are suitable for the hospital setting

Study setting: The study will be carried out in the ED of a high complexity public hospital in the southern metropolitan area of Barcelona (Spain). This stage will consist of two phases:

Phase 1 (P1): a committee of experts will be formed, which will evaluate the existing protocols. Phase 2 (P2): surveys will be passed to several health professionals working in the ED of a high complexity hospital, in order to know their opinion about the AT.

Participants: In Phase 1, it will consist of 12 healthcare professionals (8 nurses and 4 doctors) who will work in the ED of a high complexity hospital. In Phase 2, the study population will be all healthcare professionals who work in the ED in an assisting or management capacity in a high complexity hospital.

Selection criteria:

Inclusion criteria: nurses and physicians, assistants and managers of the emergency departments of public hospitals in Catalonia.

Exclusion criteria: Auxiliary nursing care technicians, orderlies, nurses and administrative staff.

Sample size (phase 2):Starting from a maximum indeterminacy with an expected proportion (p)= 0.05, a 95% confidence interval (α=0.05) and a precision (y)=0.05. The number of professionals to be included will be 385. Assuming 15% of possible losses, the corrected sample formula will be applied, which gives a total sample of 490 individuals. The sampling technique in this phase will be non-probabilistic consecutive sampling.

Data collection: the variables for phase 1 and phase 2 of stpe 3 will be the usefulness and applicability of the NDM, protocols by the hospital AT and two lines will be considered: the first, the evaluation of the perception of usefulness and the second, of applicability by the healthcare professionals, from the two phases.

Perception of usefulness: (phases 1 and phases 2) professionals' impression and assessment of the correctness and advantages of each of the 33 protocols of the NDM by the AT. This variable is measured on a qualitative ordinal scale: 0 to 10, where 0 feels totally disagree and 10 feels totally agree.

Perception of applicability: (phases 1 and phases 2) practitioners' impression and assessment of the adaptability and feasibility of each of the 33 NDM protocols by AT. This variable is measured with an ordinal qualitative scale: 0 to 10, feeling 0 strongly disagree and 10 strongly agree.

Secondary variables: (phases 2) years of experience, professional groups, beliefs about nursing professional domains, knowledge about AT and opinion about AT.

The data collection in phase 1 will be carried out on the basis of grids, where the 33 protocols of the NDM will be analysed. In each protocol, 12 questions will have to be analysed. In phase 2, a questionnaire consisting of four blocks will be administered: (1) socio-demographic data will be asked; (2) knowledge of the AT will be asked; (3) the opinion held by the different health professionals will be asked; (4) nursing competences will be asked.

Data analysis: qualitative variables will be described by proportions, calculating 95% confidence intervals. Quantitative variables will be described with mean and median as measures of centrality, and standard deviation and interquartile range as measures of dispersion.The normality of the distribution of the quantitative variables will be checked with the Kolmogorov-Smirnov test pot, and the parametric and non-parametric pots indicated in each case in the bivariate analysis will be applied; normally, the most commonly used pots will be the Chi-square, the Mann-Whitney U, the Student's t and Pearson's correlation-regression pots. Finally, multivariate analysis will include logistic regression techniques. P-values of less than 0.05 will be considered statistically significant.

STEP 4:

Study design: quasi-experimental study consisting of 2 phases: phase 1 (retrospective control) and phase 2 (prospective intervention), where the AT will be implemented based on the advanced nurse practitioner's.

Study setting: the scope of the study will be the ED of a highly complex hospital in a centre in Catalonia (northeastern Spain), which serves as a community reference for 201,192 inhabitants of Hospitalet and Prat de Llobregat and is a reference centre for processes requiring high technology for more than 2 million inhabitants of the South Metropolitan area, Camp de Tarragona and Terres de l'Ebre. Outpatient ED of a tertiary-care centre in Catalonia (Northeast Spain), which serves as a referral centre for community reference of 201,192 people in the Southern Metropolitan Area of Barcelona.

In both phases, all adult patients (>18 years) who will visit the hospital ED and who will be classified with priority levels III, IV or V on the Emergency Severity Index (ESI) scale will be eligible to participate in the study.

Procedure and interventions:

Control group will apply the usual care of the service and will be analysed: (a) quality indicators specific to triage; (b) cluster; (c) satisfaction; (c) pain; (d) waiting time. This part of the study will allow us to gain a better understanding of the reality of ED care. In relation to the level of urgency and its complexity, allowing us to establish the digital footprint. In order to be able to compare them with each other.

Data analysis: qualitative variables will be described by proportions, calculating 95% confidence intervals. Quantitative variables will be described with mean and median as measures of centrality, and standard deviation and interquartile range as measures of dispersion. The normality of the distribution of quantitative variables will be checked with the Kolmogorov-Smirnov test, and the parametric and non-parametric pots indicated in each case in the bivariate analysis will be applied; normally, the most commonly used pots will be the Chi-square, the Mann-Whitney U, the Student's t and Pearson's correlation-regression pots. Finally, multivariate analysis will include logistic regression techniques. P-values of less than 0.05 will be considered statistically significant. All data will be analysed using Statistical Package for the Social Sciences (SPSS) v26.0 software.

The final results will be used to design the hospital ED TA implementation programme.

Being tested
Advanced Triage
Keywords
advanced practice nurse emergency, Advanced Interventions Nursing, Emergency Department.
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced TriageProcedure or surgery

    Also called Advanced triage is part of advanced practice nurse (APN).

    Advanced triage is an intervention that allows the emergency nurse to resolve health problems of low clinical complexity. All actions are aimed at resolving a health problem based on a protocol previously agreed upon by a multidisciplinary team.

Study groups in NCT05230108
Study groupRoleWhat they receive
Phase 1 (F1): retrospective control.No interventionPhase 1, retrospective, will include all patients who attended the ED from January 2018 to December 2022.
Phase (F2): prospective intervention of Advanced TriageExperimentalPhase 2, prospective, where advanced triage based on advanced practice nurse will be implemented. Will include patients from January 2023 to December 2024.
Receives: Procedure: Advanced Triage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality indicators specific to triage.

    Set of peculiar traits that characterise someone or something. This variable is a composite variable which is made up of quality indicators specific to triage, waiting time, and variables to inform the sample.

    • Arrival/registration-triage time: The time from patient arrival at the ED to triage classification. Quality indicators define this time as <= 10 minutes (min) over the total number of patients triaged.
    • Waiting time to be visited: It is established that at least 90% of patients must be visited by a medical team within <= 120 min from their classification, and 100% within <= 240 min

    Measured: Pre-intervention time as an initial reference.

Secondary outcomes (4)
  1. Cluster:

    This variable allows grouping several individuals in similar conditions. This variable is composed of:

    • Age (18-75 years)
    • Sex: Male/Female
    • Country of origin: Patient birth country.
    • Origin of the patient: Indicates whether a patient arrives at the emergency department referred from another health resource or not. The following values are coded: (a) home (b) residence, (c) primary care, (d) hospital, (e) hospitalisation at home, (f) other outpatient care.

    Measured: Throgh study completion, an average of 1 year.

  2. CatSalut-PLAENSA©

    This scale allows us to measure the satisfaction of patients who will be seen in the ED. The CatSalut-PLAENSA© satisfaction survey is based on an ordinal scale from 0 to 10. This variable will be measured on a qualitative ordinal scale; from 0 to 10, with 0 being totally disagree and 10 being totally agree.

    Measured: 12 months.

  3. Waiting times

    This will be analysed using the hospital's computer system. The following will be recorded: time of entry to the ED, time of triage, time of attendance (nurse or doctor), time of administration of analgesia, time of discharge from the ED and total time the patient has been in the emergency department.

    Measured: 12 months.

  4. The Visual Analog Scale (VAS or EVA)

    is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." This variable is measured on an ordinal qualitative scale; 0 to 10, with 0 being no pain and 10 being very intense pain.

    Measured: 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The fourth step is a quasi-experimental study consisting of two phases: the first, a retrospective control phase, and the second, a prospective intervention phase in which advanced triage will be implemented. In phase 1, control, quality of care indicators will be assessed, based on quality indicators in the emergency department, waiting time and satisfaction, and the level of pain. In addition, different epidemiological, socio-cultural and clinical variables will be measured. In phase 2, the intervention phase, advanced triage will be implemented based on advanced practices nurse and the indicators of quality of care and pain will be assessed.
Masking
None (open label)
Enrolment
547 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05230108
Sponsor's protocol ID
PR085/20
Status last verified
Feb 2022
First submitted
22 Dec 2021
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Austin EE, Blakely B, Tufanaru C, Selwood A, Braithwaite J, Clay-Williams R. Strategies to measure and improve emergency department performance: a scoping review. Scand J Trauma Resusc Emerg Med. 2020 Jun 15;28(1):55. doi: 10.1186/s13049-020-00749-2.

    PubMed 32539739
  • Bittencourt RJ, Stevanato AM, Braganca CTNM, Gottems LBD, O'Dwyer G. Interventions in overcrowding of emergency departments: an overview of systematic reviews. Rev Saude Publica. 2020;54:66. doi: 10.11606/s1518-8787.2020054002342. Epub 2020 Jul 3.

    PubMed 32638885
  • Butti L, Bierti O, Lanfrit R, Bertolini R, Chittaro S, Delli Compagni S, Del Russo D, Mancusi RL, Pertoldi F. Evaluation of the effectiveness and efficiency of the triage emergency department nursing protocol for the management of pain. J Pain Res. 2017 Oct 16;10:2479-2488. doi: 10.2147/JPR.S138850. eCollection 2017.

    PubMed 29081670
  • Hinson JS, Martinez DA, Schmitz PSK, Toerper M, Radu D, Scheulen J, Stewart de Ramirez SA, Levin S. Accuracy of emergency department triage using the Emergency Severity Index and independent predictors of under-triage and over-triage in Brazil: a retrospective cohort analysis. Int J Emerg Med. 2018 Jan 15;11(1):3. doi: 10.1186/s12245-017-0161-8.

    PubMed 29335793
  • Innes K, Jackson D, Plummer V, Elliott D. Emergency department waiting room nurse role: A key informant perspective. Australas Emerg Nurs J. 2017 Feb;20(1):6-11. doi: 10.1016/j.aenj.2016.12.002. Epub 2017 Jan 17.

    PubMed 28108139
  • Lauks J, Mramor B, Baumgartl K, Maier H, Nickel CH, Bingisser R. Medical Team Evaluation: Effect on Emergency Department Waiting Time and Length of Stay. PLoS One. 2016 Apr 22;11(4):e0154372. doi: 10.1371/journal.pone.0154372. eCollection 2016.

    PubMed 27104911
  • Sarria-Guerrero JA, Luaces-Cubells C, Jimenez-Fabrega FX, Villamor-Ordozgoiti A, Isla Pera P, Guix-Comellas EM. Pediatric televisits and telephone triage: impact on use of a hospital emergency department. Emergencias. 2019 Ago;31(4):257-260. English, Spanish.

    PubMed 31347806
  • Woo BFY, Lee JXY, Tam WWS. The impact of the advanced practice nursing role on quality of care, clinical outcomes, patient satisfaction, and cost in the emergency and critical care settings: a systematic review. Hum Resour Health. 2017 Sep 11;15(1):63. doi: 10.1186/s12960-017-0237-9.

    PubMed 28893270
  • Zachariasse JM, van der Hagen V, Seiger N, Mackway-Jones K, van Veen M, Moll HA. Performance of triage systems in emergency care: a systematic review and meta-analysis. BMJ Open. 2019 May 28;9(5):e026471. doi: 10.1136/bmjopen-2018-026471.

    PubMed 31142524
  • Font-Cabrera C, Juve-Udina ME, Galimany-Masclans J, Fabrellas N, Rosello-Novella A, Sancho-Agredano R, Adamuz J, Guix-Comellas EM. Implementation of advanced triage in the Emergency Department of high complexity public hospital: Research protocol. Nurs Open. 2023 Jun;10(6):4101-4110. doi: 10.1002/nop2.1622. Epub 2023 Jan 31.

    PubMed 36719704

Questions about this trial

What is this clinical trial studying?

A study testing Advanced Triage in people with Nurse's Scope of Practice, run by Hospital Universitari de Bellvitge at 1 site in Spain.

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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. 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 Spain. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristina Font Cabrera, Nurse (+34 687 235 773, cristinafont@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality indicators specific to triage. (time frame: Pre-intervention time as an initial reference.). 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 NCT05230108, which also lists 10 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 8 Feb 2022.

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