Nurses' Work EnvironmentNCT04199065
Impact of Good Practice Guidelines on Evidence-based Practice and Nurses' Work Environment
A study testing Good Practice Guidelines implementation in people with Nurses' Work Environment and Committed Centers With Excellence in Care (CCEC®) Program, run by Parc de Salut Mar at 17 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nurses' Work Environment, Committed Centers With Excellence in Care (CCEC®) Program, Nurses' Evidence-based-practice Attitudes
- What is being tested?
- Good Practice Guidelines implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 17 sitesSpain
- Study dates
- 1 Mar 2018to 21 Apr 2022
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nurses Work in the institutions participating in the study Acceptance to participate in the study
Who cannot join
- Not be active
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Xerencia de Xestión Integrada de A Coruña
A Coruña, 15006
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitri Germans Tries i Pujol
Badalona, Barcelona, 08916
Hospital Clínic
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
Hospital de Granollers
Granollers, Barcelona, 08402
Hospital de Guadarrama
Guadarrama, Madrid, 28440
Consorci Sanitari Anoia-Hospital Igualada
Igualada, Barcelona, 08700
Hospital Lucus Augusti
Lugo, 27003
Hospital Regional Universitario de Málaga
Málaga, 29010
Hospital General Universitario Santa Lucía
Murcia, 30202
Hospital Universitari Son Espases
Palma de Mallorca, 07120
Hospital Son Llàtzer
Palma de Mallorca, 08198
Hospital de Puigcerdà
Puigcerdà, Girona, 17520
Hospital Comarcal de Vinaròs
Vinaròs, Castelló, 12500
Organización Sanitaria Integrada (OSI) Araba
Vitoria-Gasteiz, Araba, 01009
About this study
Official title: Impact of the Implementation of Good Practice Guidelines on Beliefs-attitudes and Behavior in the Face of Evidence-based Practice and on the Perception of the Nurses' Work Environment
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.
Read the detailed 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.
- Conditions
- Nurses' Work Environment, Committed Centers With Excellence in Care (CCEC®) Program, Nurses' Evidence-based-practice Attitudes, Nurse Physician Relations, Practice Nurse's Scope, Professional Stress
- Being tested
- Good Practice Guidelines implementation
- Keywords
- Evidence-Based Practice, nurses' Workplace, Good Practices Guides, Hospital
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good Practice Guidelines implementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Good Practice Guidelines group | Experimental | Implementation of Good Practice Guidelines Receives: Other: Good Practice Guidelines implementation |
| usual practices group | No intervention | Not Implementation of Good Practice Guidelines, so working as the usual way |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline and 1 year
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).
Measured: baseline and 1 year
Secondary outcomes (2)
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.
Measured: baseline and 1 year
change in Institutional attitude perceived by nurses in relation to nursing research
self-reported 4 question rating: yes, not, unknown.
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Mar 2018
- Primary completion30 Nov 2019
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nurses' Work EnvironmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), COIB, Col·legi d'Infermers i infermeres de Barcelona, Department of Health, Generalitat de Catalunya
- Responsible party
- Principal investigator, Silvia Esteban, Parc de Salut Mar
- Investigators
- Silvia Esteban-Sepúlveda, Principal investigator, IMIM (Hospital del Mar Medical Research Institute), Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199065
- Sponsor's protocol ID
- CEIm-PSMAR 2018/8087/I
- Status last verified
- Apr 2022
- First submitted
- 10 Dec 2019
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not considered, since the data processing will be done on an aggregate basis.
Publications
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, satisfaction, and quality of hospital care: cross sectional surveys of nurses and patients in 12 countries in Europe and the United States. BMJ. 2012 Mar 20;344:e1717. doi: 10.1136/bmj.e1717.
PubMed 22434089Aiken 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 May 11.
PubMed 21561979Cho 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.
PubMed 26642177Fernandez-Dominguez JC, de Pedro-Gomez JE, Morales-Asencio JM, Bennasar-Veny M, Sastre-Fullana P, Sese-Abad A. Health Sciences-Evidence Based Practice questionnaire (HS-EBP) for measuring transprofessional evidence-based practice: Creation, development and psychometric validation. PLoS One. 2017 May 9;12(5):e0177172. doi: 10.1371/journal.pone.0177172. eCollection 2017.
PubMed 28486533Fuentelsaz-Gallego C, Moreno-Casbas MT, Gonzalez-Maria 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 Sep 1.
PubMed 22944284Heater BS, Becker AM, Olson RK. Nursing interventions and patient outcomes: a meta-analysis of studies. Nurs Res. 1988 Sep-Oct;37(5):303-7.
PubMed 3047692
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Implementation of Good Practice Guidelines on Beliefs-attitudes and Behavior in the Face of Evidence-based Practice and on the Perception of the Nurses' Work Environment
- ClinicalTrials.gov ID
- NCT04199065
- Acronym / sponsor ID
- CEIm-PSMAR 2018/8087/I
- Conditions
- Nurses' Work Environment, Committed Centers With Excellence in Care (CCEC®) Program, Nurses' Evidence-based-practice Attitudes, Nurse Physician Relations, Practice Nurse's Scope, Professional Stress
- Keywords
- Evidence-Based Practice, nurses' Workplace, Good Practices Guides, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Hospital del Mar Research Institute (IMIM), COIB, Col·legi d'Infermers i infermeres de Barcelona, Department of Health, Generalitat de Catalunya
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good Practice Guidelines group | Experimental | Other: Good Practice Guidelines implementationImplementation of Good Practice Guidelines |
| usual practices group | No intervention | –Not Implementation of Good Practice Guidelines, so working as the usual way |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses Work in the institutions participating in the study Acceptance to participate in the study
Key exclusion criteria (1 listed)
- Not be active
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Good Practice Guidelines implementationImplementation 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. | Other | Good Practice Guidelines group |
Primary outcome
change in Nurses' work environment
Time frame: baseline and 1 year
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)
change in Beliefs- attitudes and behavior in front of EBP
Time frame: baseline and 1 year
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).
2 secondary outcomes
change in Job satisfaction: Likert type question rating
Time frame: baseline and 1 year
change in Institutional attitude perceived by nurses in relation to nursing research
Time frame: baseline and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Results publication: PubMed 22434089Aiken 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, satisfaction, and quality of hospital care: cross sectional surveys of nurses and patients in 12 countries in Europe and the United States. BMJ. 2012 Mar 20;344:e1717. doi: 10.1136/bmj.e1717.
- Results publication: PubMed 21561979Aiken 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 May 11.
- Results publication: PubMed 26642177Cho 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.
- Results publication: PubMed 28486533Fernandez-Dominguez JC, de Pedro-Gomez JE, Morales-Asencio JM, Bennasar-Veny M, Sastre-Fullana P, Sese-Abad A. Health Sciences-Evidence Based Practice questionnaire (HS-EBP) for measuring transprofessional evidence-based practice: Creation, development and psychometric validation. PLoS One. 2017 May 9;12(5):e0177172. doi: 10.1371/journal.pone.0177172. eCollection 2017.
- Results publication: PubMed 22944284Fuentelsaz-Gallego C, Moreno-Casbas MT, Gonzalez-Maria 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 Sep 1.
- Results publication: PubMed 3047692Heater BS, Becker AM, Olson RK. Nursing interventions and patient outcomes: a meta-analysis of studies. Nurs Res. 1988 Sep-Oct;37(5):303-7.
- Individual participant dataSharing planned: No. Not considered, since the data processing will be done on an aggregate basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Esteban-Sepúlveda principal investigator
IMIM (Hospital del Mar Medical Research Institute), Barcelona
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Good Practice Guidelines implementation in people with Nurses' Work Environment and Committed Centers With Excellence in Care (CCEC®) Program, run by Parc de Salut Mar at 17 sites 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 1 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: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Nurses' work environment (time frame: baseline and 1 year). The study lists 2 primary outcomes in all. 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 NCT04199065, which also lists 6 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 22 Apr 2022.