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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04199065
Other study ID # CEIm-PSMAR 2018/8087/I
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date April 21, 2022

Study information

Verified date April 2022
Source Parc de Salut Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evidence-based practice (EBP) has improved patient health outcomes. The work environment of nurses is a key element to improving the quality of care and to facilitate EBP, while also improving health outcomes. The CCEC® / BPSO® program consists of the implementation of Good Practice Guides in health organizations in the Spanish territory, and is carried out through a training and participatory methodology, actively involving nurses in the process. The present study tries to know if in the health organizations where the CCEC® / BPSO® program has been implemented, the perception of the nurses' working environment has improved, as well as their attitude towards evidence-based practice, with respect to organizations where this program has not been implemented.


Description:

Quasi-experimental pre-post multicentre study with a non-equivalent control group, within the framework of the third cohort of the RNAO Good Practice Guidelines Implementation Program in Centers Committed to Care Excellence (CCEC® / BPSO®). PARTICIPATING INSTITUTIONS: Intervention group(IG): (institutions included in the third cohort of CCEC®): Estructura de Gestión Integrada de Lugo, Cervo y Monforte de Lemos (Galicia), Hospital General Universitario Santa Lucía (Murcia), Xerencia de Xestión Integrada de A Coruña (Galicia), Hospital Guadarrama (Madrid), Hospital Universitari Germans Trias i Pujol (Cataluña), Hospital Regional Universitario de Málaga (Andalucía), Organización Sanitaria Integrada OSI Araba (Araba). Control group(CG): Hospital Son Espases (Mallorca), Hospital Son Llàtzer (Mallorca), Hospital de Granollers (Barcelona), Hospital de Puigcerdà (Girona), Hospital d'Igualada (Barcelona), Hospital General Universitario de Alicante (Alicante), Hospital Comarcal de Vinaròs de Castellón de la Plana (Castellón), Hospital Clínic de Barcelona (Barcelona), Hospital Universitario de Fuenlabrada (Madrid), Hospital de la Santa Creu i Sant Pau (Barcelona). To collect data, two validated questionnaires will be passed to all nurses in 7 health institutions where the RNAO Good Practice Guidelines Implementation Program begins (experimental group) and in 10 where it is not implemented (control group), both groups distributed throughout the Spanish territory. Basal data will be recorded before the beginning of the program and post intervention data will be recorded after one year. Then the results will be compared to determine whether there are differences between nurses who work in the group of hospitals that have started the program with respect to those who work in other centers. The total duration of the project will be three years.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date April 21, 2022
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria: Nurses Work in the institutions participating in the study Acceptance to participate in the study Exclusion Criteria: Not be active

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Good Practice Guidelines implementation
Implementation of Good Practice Guidelines on the framework of the Best Practice Spotlight Organization in Spain (CCEC® / BPSO®), that allows a standardized methodology for providing care and registering indicators.

Locations

Country Name City State
Spain Xerencia de Xestión Integrada de A Coruña A Coruña
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital Universitri Germans Tries i Pujol Badalona Barcelona
Spain Hospital Clínic Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Universitario de Fuenlabrada Fuenlabrada Madrid
Spain Hospital de Granollers Granollers Barcelona
Spain Hospital de Guadarrama Guadarrama Madrid
Spain Consorci Sanitari Anoia-Hospital Igualada Igualada Barcelona
Spain Hospital Lucus Augusti Lugo
Spain Hospital Regional Universitario de Málaga Málaga
Spain Hospital General Universitario Santa Lucía Murcia
Spain Hospital Son Llàtzer Palma De Mallorca
Spain Hospital Universitari Son Espases Palma De Mallorca
Spain Hospital de Puigcerdà Puigcerdà Girona
Spain Hospital Comarcal de Vinaròs Vinaròs Castelló
Spain Organización Sanitaria Integrada (OSI) Araba Vitoria Gasteiz Araba

Sponsors (4)

Lead Sponsor Collaborator
Parc de Salut Mar COIB, Col·legi d'Infermers i infermeres de Barcelona, Department of Health, Generalitat de Catalunya (PERIS), Hospital del Mar Research Institute (IMIM)

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Aiken LH, Sermeus W, Van den Heede K, Sloane DM, Busse R, McKee M, Bruyneel L, Rafferty AM, Griffiths P, Moreno-Casbas MT, Tishelman C, Scott A, Brzostek T, Kinnunen J, Schwendimann R, Heinen M, Zikos D, Sjetne IS, Smith HL, Kutney-Lee A. Patient safety, — View Citation

Aiken LH, Sloane DM, Clarke S, Poghosyan L, Cho E, You L, Finlayson M, Kanai-Pak M, Aungsuroch Y. Importance of work environments on hospital outcomes in nine countries. Int J Qual Health Care. 2011 Aug;23(4):357-64. doi: 10.1093/intqhc/mzr022. Epub 2011 — View Citation

Cho E, Chin DL, Kim S, Hong O. The Relationships of Nurse Staffing Level and Work Environment With Patient Adverse Events. J Nurs Scholarsh. 2016 Jan;48(1):74-82. doi: 10.1111/jnu.12183. Epub 2015 Dec 7. — View Citation

Fernández-Domínguez JC, de Pedro-Gómez JE, Morales-Asencio JM, Bennasar-Veny M, Sastre-Fullana P, Sesé-Abad A. Health Sciences-Evidence Based Practice questionnaire (HS-EBP) for measuring transprofessional evidence-based practice: Creation, development an — View Citation

Fuentelsaz-Gallego C, Moreno-Casbas MT, González-María E. Validation of the Spanish version of the questionnaire Practice Environment Scale of the Nursing Work Index. Int J Nurs Stud. 2013 Feb;50(2):274-80. doi: 10.1016/j.ijnurstu.2012.08.001. Epub 2012 S — View Citation

Heater BS, Becker AM, Olson RK. Nursing interventions and patient outcomes: a meta-analysis of studies. Nurs Res. 1988 Sep-Oct;37(5):303-7. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary change in Nurses' work environment self reported perceived current work environment through the Practice Environment Scale-Nursing Work Index (PES-NWI) questionaire, with 31 Likert type questions (1: "Strongly Disagree" -> 4 "Strongly Agree"), including 5 sub-scales: Nurse participation in hospital affairs (8 questions); nursing foundations for quality of care (10 questions); nurse manager ability, leadership and support of nurses (5 questions); staffing and resource adequacy (4 questions); and collegial nurse-physician relationships (3 questions) baseline and 1 year
Primary change in Beliefs- attitudes and behavior in front of EBP self-reported Beliefs- attitudes and behavior in front of EBP, through the 60 Likert type questions (from 1: minimum agreement to 10: maximum agreement) of the Health Sciences-Evidence Based Practice questionnaire (HS-EBP), that are classified in 5 dimensions: Beliefs and attitudes, (12 items); Results from scientific research (14 items); Development of professional practice (10 items); Evaluation of results (12 items) and Barriers / Facilitators (12 items). baseline and 1 year
Secondary change in Job satisfaction: Likert type question rating self-reported job satisfaction through a unique Likert type question rating 1: very unsatisfied; 5: very satisfied. baseline and 1 year
Secondary change in Institutional attitude perceived by nurses in relation to nursing research self-reported 4 question rating: yes, not, unknown. baseline and 1 year
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