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
Not Applicable
Retrospectively registered
Protocol added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

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

Study website

Contact information

Type

Principal Investigator

Contact name

Mrs Sandra Pol-Castañeda

ORCID ID

http://orcid.org/0000-0003-3962-4622

Contact details

Department of Nursing and Physiotherapy
University of the Balearic Islands (Gillem Cifre building)
Crta Valldemossa
Km 7,5
Palma
07122
Spain
+34 676090092
sandrapolcas@gmail.com

Type

Scientific

Contact name

Mrs Palma Pol-Castañeda

ORCID ID

Contact details

Department of Nursing and Physiotherapy
University of the Balearic Islands (Gillem Cifre building)
Crta Valldemossa
Km 7,5
Palma
07122
Spain
0034 676090092
sandrapolcas@gmail.com

Type

Public

Contact name

Dr Miguel Angel Rodriguez-Calero

ORCID ID

http://orcid.org/0000-0002-2468-5660

Contact details

Carrer de la Reina Esclaramunda
9. Piso 2
Palma
07003
Spain
+34 971170097 ext 76557
mianrodriguez@ibsalut.es

Additional identifiers

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Protocol/serial number

PI217/2019

Study information

Scientific title

Impact of advanced practice nurses in hospital units on compliance with clinical practice guidelines: a quasi-experimental study

Acronym

EPAH

Study hypothesis

The 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

Study design

Prospective quasi-experimental study

Primary study design

Interventional

Secondary study design

Non randomised study

Study setting(s)

Hospital

Study type

Other

Patient information sheet

Not available in web format, please use contact details to request participant information sheet (originally in Spanish)

Condition

Prevention of pressure ulcer and catheter-related complications in hospital care

Intervention

The 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 type

Behavioural

Primary outcome measure

1. 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 measures

1. 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 date

01/02/2018

Overall study end date

30/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Hospitalised adults (>18 years old).

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

1198

Total final enrolment

3742

Participant exclusion criteria

Patients in terminal care

Recruitment start date

01/04/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

Spain

Study participating centre

Hospital Manacor
Ctra Manacor-Alcudia s/n
Manacor (Mallorca)
07500
Spain

Study participating centre

Hospital Universitario Son Espases
Ctra Valldemossa, 79
Palma (Mallorca)
07210
Spain

Study participating centre

Hospital Comarcal de Inca
Ctra Vieja de LLubí, s/n
Inca (Mallorca)
07300
Spain

Sponsor information

Organisation

Balearic Islands Health Services

Sponsor details

Carrer de la Reina Esclaramunda
9
Palma
07003
Spain
+34 971 175600
cvillafafila@ibsalut.es

Sponsor type

Government

Website

https://www.ibsalut.es/es/

Organisation

University of the Balearic Islands

Sponsor details

Ctra Valldemossa
Km 7,5
Palma
07122
Spain
+34 971173000
depedro@uib.es

Sponsor type

University/education

Website

http://www.uib.cat/

Funders

Funder type

University/education

Funder name

Nursing College of the Balearic Islands

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviwed journal

Intention to publish date

01/03/2022

Individual participant data (IPD) sharing plan

The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication

IPD sharing plan summary

Published as a supplement to the 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

Additional files

Editorial Notes

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