Impact of advanced practice nurses in hospital units on the implementation of clinical guidelines

ISRCTN ISRCTN18259923
DOI https://doi.org/10.1186/ISRCTN18259923
Secondary identifying numbers PI217/2019
Submission date
09/02/2022
Registration date
11/02/2022
Last edited
14/12/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The incorporation of best evidence into clinical practice is key for increasing the quality and efficacy of healthcare, though a continuous challenge for healthcare teams. Advanced practices nurses may facilitate this transference due to their influence on other professionals’ performance and attitudes.
This research aims to evaluate whether the inclusion of advanced practice nurses in hospitalization wards teams improves patient indicators and the adherence of other nurses to the best evidence, by monitoring variables related to pressure ulcer prevention and vascular access devices management.

Who can participate?
Adult inpatients aged 18 years and above, admitted to the participating hospital wards, except patients in terminal palliative care.

What does the study involve?
We will include advanced practice nurses in the intervention wards, who will provide support and education to health teams, motivating changes in attitude, skills, knowledge, and abilities regarding two clinical guidelines used in the Balearic Islands health system (pressure ulcer prevention and vascular access devices management). Control wards will continue their current protocols and practice.
We will measure clinical indicators related to both clinical guidelines, by bedside direct observation and review of nursing records.

What are the possible benefits and risks of participating?
The intervention is expected to reduce pressure ulcer and catheter-related complications in the intervention wards, compared to those in which the intervention is not provided. Due to the nature of the intervention (education and support), we do not expect any undesired effects in the patients attended in these units.

Where is the study run from?
The study is managed collaboratively by the Healthcare Office of the Balearic Islands Health Services and the Nursing and Physiotherapy Department of the University of the Balearic Islands (Spain)

When is the study starting and how long is it expected to run for?
February 2018 to September 2019

Who is funding the study?
The study is funded by the College of Nurses of the Balearic Islands (Spain)

Who is the main contact?
Dr Miguel Angel Rodriguez Calero, mianrodriguez@ibsalut.es

Contact information

Mrs Sandra Pol-Castañeda
Principal Investigator

Department of Nursing and Physiotherapy
University of the Balearic Islands (Gillem Cifre building)
Crta Valldemossa, Km 7,5
Palma
07122
Spain

ORCiD logoORCID ID 0000-0003-3962-4622
Phone +34 676090092
Email sandrapolcas@gmail.com
Mrs Palma Pol-Castañeda
Scientific

Department of Nursing and Physiotherapy
University of the Balearic Islands (Gillem Cifre building)
Crta Valldemossa, Km 7,5
Palma
07122
Spain

Phone 0034 676090092
Email sandrapolcas@gmail.com
Dr Miguel Angel Rodriguez-Calero
Public

Carrer de la Reina Esclaramunda
9. Piso 2
Palma
07003
Spain

ORCiD logoORCID ID 0000-0002-2468-5660
Phone +34 971170097 ext 76557
Email mianrodriguez@ibsalut.es

Study information

Study designProspective quasi-experimental study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request participant information sheet (originally in Spanish)
Scientific titleImpact of advanced practice nurses in hospital units on compliance with clinical practice guidelines: a quasi-experimental study
Study acronymEPAH
Study objectivesThe advanced practice nurses will increase the adherence of team nurses to guidelines recommendations regarding pressure lesions and peripheral catheterization. This will reduce complications and improve patient-related indicators.
Ethics approval(s)Approved 27/06/2018, Comité de ética en la investigación de las Islas Baleares [Balearic Islands Research Ethics Committee], (Calle del calçat, 2A, 2ª planta, Polígono de Son Valentí, 07011 Palma, Illes Balears, Spain; +34 971 177 378; ceic_ib@caib.es), ref: IB-3662/18-PI
Health condition(s) or problem(s) studiedPrevention of pressure ulcer and catheter-related complications in hospital care
InterventionThe intervention consists of the incorporation of an advanced practice nurse within each intervention unit involved, to participate in activities appropriate to the context in question, with a specific interest in providing support to health teams, motivating attitudinal change regarding skills, abilities, and knowledge and seeking to ensure the implementation of guidelines recommendations and the avoidance of low-value practices. Among other actions, the advanced practice nurses extend awareness of the project, assist in the implementation of the guidelines, work with the team to establish objectives, provide training for the health team, contribute to the planning of changes in circuits, materials, techniques, evaluate the results obtained, provide periodic feedback to the health team, adjust the interventions as necessary, and offer support and mentoring. Participating nurses hold monthly meetings with the research team, and took part in a specific training program, not provided to the control wards teams. The control wards do not receive any interventions, continuing with usual protocols and guideline implementation standards.

The process and outcome variables are measured once a month, in all inpatients admitted on that day.
Intervention typeBehavioural
Primary outcome measure1. Prevalence of pressure ulcer is measured by in-situ inspection at baseline and monthly during 1 year.
2. Prevalence of catheter-related adverse events s measured by in-situ inspection at baseline and monthly during 1 year.
Secondary outcome measures1. Overall adherence to pressure ulcer and catheter care recommendations are measured by in-situ follow-up of process indicators.
2. Mean number of recommendations fulfilled for each patient x100 / Total number of guideline recommendations
Overall study start date01/02/2018
Completion date30/09/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1198
Total final enrolment3742
Key inclusion criteriaHospitalised adults (>18 years old).
Key exclusion criteriaPatients in terminal care
Date of first enrolment01/04/2019
Date of final enrolment30/09/2019

Locations

Countries of recruitment

  • Spain

Study participating centres

Hospital Manacor
Ctra Manacor-Alcudia s/n
Manacor (Mallorca)
07500
Spain
Hospital Universitario Son Espases
Ctra Valldemossa, 79
Palma (Mallorca)
07210
Spain
Hospital Comarcal de Inca
Ctra Vieja de LLubí, s/n
Inca (Mallorca)
07300
Spain

Sponsor information

Balearic Islands Health Services
Government

Carrer de la Reina Esclaramunda, 9
Palma
07003
Spain

Phone +34 971 175600
Email cvillafafila@ibsalut.es
Website https://www.ibsalut.es/es/
University of the Balearic Islands
University/education

Ctra Valldemossa, Km 7,5
Palma
07122
Spain

Phone +34 971173000
Email depedro@uib.es
Website http://www.uib.cat/

Funders

Funder type

University/education

Nursing College of the Balearic Islands

No information available

Results and Publications

Intention to publish date01/03/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination planPlanned publication in a high-impact peer-reviwed journal
IPD sharing planThe datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 16/05/2020 11/02/2022 Yes No
Results article Outcome results 29/11/2022 14/12/2022 Yes No

Editorial Notes

14/12/2022: Publication reference added.
11/02/2022: Trial's existence confirmed by Balearic Islands Research Ethics Committee.