Healthy Work EnvironmentNCT06762015
Nursing Practice Environment and Patient Safety in Primary Health Care
A study testing Positive Nursing Practice Environments Promotion Program in people with Healthy Work Environment and Patient Safety, run by Cintia Silva Fassarella at 1 site in Portugal.
Trial summary
The goal of this study is to conduct an experimental, controlled, and randomized study, which will involve two data collection points - pre-intervention, post-intervention and a follow-up to asses the impact of the program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Work Environment, Patient Safety, Primary Health Care
- What is being tested?
- Positive Nursing Practice Environments Promotion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Sep 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nurses working in primary health care units
Who cannot join
- Nurses in primary health care who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practice Environment for Nursing and Patient Safety in Primary Health Care
The goal of this study is to conduct an experimental, controlled, and randomized study, which will involve two data collection points - pre-intervention, post-intervention and a follow-up to asses the impact of the program. The study will be carried out with two groups - an intervention group and a control group, consisting of nurses interested in participating in the Positive Nursing Practice Environments Promotion Program (PAPEP), a multi-component intervention program aimed at promoting positive nursing practice environments. Participant allocation will be conducted randomly, using software to ensure stratified randomization of participants between the two groups.
- Being tested
- Positive Nursing Practice Environments Promotion Program
- Keywords
- Healthy Work Environment, Patient Safety, Primary Health Care, Nurses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Nursing Practice Environments Promotion ProgramBehavioural
A multi-component intervention program aimed at promoting positive nursing practice environments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants who will undertake the Positive Nursing Practice Environments Promotion Program Receives: Behavioral: Positive Nursing Practice Environments Promotion Program |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Environment
Scale for the environments evaluation of professional nursing practice-shortened version.
The Scale for the Environment's Evaluation of Professional Nursing Practice-Shortened Version consists of 59 items across three subscales: Structure (29 items), Process (19 items), and Outcome (11 items). Participants rate each item on a five-point Likert scale (1: never to 5: always). Higher scores indicate a more favorable nursing practice environment for care quality and professional well-being. Scores are interpreted as follows: <35% (unfavorable), 35-55% (moderately favorable), 55-75% (favorable), and >75% (very favorable).
Measured: 6 months
Safety climate
Safety Attitudes Questionnaire - Short Form The Safety Attitudes Questionnaire (SAQ) - Short Form 2006 assesses healthcare professionals' perceptions of patient safety attitudes across various clinical areas and healthcare services. It has been validated and culturally adapted to the context in which the study will be conducted. The SAQ - Short Form 2006 comprises six dimensions, addressing organizational factors, work environment factors, and team factors, with a total of 30 items. Participants respond to each item using a five-point Likert scale: "strongly disagree," "partially disagree," "neutral," "partially agree," and "strongly agree." The final score ranges from 0 to 100, where 0 represents the worst perception and 100 the best perception of the safety climate.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start2 Sep 2024
- Primary completion31 Mar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cintia Silva Fassarella
- Sponsor type
- University, hospital or other
- Collaborators
- CINTESIS - Center for Health Technology and Services Research, Porto, Universidade do Porto
- Responsible party
- Sponsor-investigator, Cintia Silva Fassarella, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762015
- Sponsor's protocol ID
- CES n. 57_2024
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pereira SCA, Santos EJFD, Ferreira RA, Fassarella CS, Ribeiro OMPL. Promoting Positive Nursing Practice Environments: Outcomes of a Randomized Trial in Primary Care. J Nurs Manag. 2026;2026(1):e4139767. doi: 10.1155/jonm/4139767.
PubMed 41834150
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Environment for Nursing and Patient Safety in Primary Health Care
- ClinicalTrials.gov ID
- NCT06762015
- Acronym / sponsor ID
- CES n. 57_2024
- Keywords
- Healthy Work Environment, Patient Safety, Primary Health Care, Nurses
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cintia Silva FassarellaUniversity, hospital or other
- Collaborators
- CINTESIS - Center for Health Technology and Services Research, Porto, Universidade do Porto
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 7 Jan 2025 (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.
The goal of this study is to conduct an experimental, controlled, and randomized study, which will involve two data collection points - pre-intervention, post-intervention and a follow-up to asses the impact of the program. The study will be carried out with two groups - an intervention group and a control group, consisting of nurses interested in participating in the Positive Nursing Practice Environments Promotion Program (PAPEP), a multi-component intervention program aimed at promoting positive nursing practice environments. Participant allocation will be conducted randomly, using software to ensure stratified randomization of participants between the two groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Positive Nursing Practice Environments Promotion ProgramParticipants who will undertake the Positive Nursing Practice Environments Promotion Program |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses working in primary health care units
Key exclusion criteria (1 listed)
- Nurses in primary health care who refuse to participate in the study
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 |
|---|---|---|
| Positive Nursing Practice Environments Promotion ProgramA multi-component intervention program aimed at promoting positive nursing practice environments. | Behavioural | Intervention Group |
Primary outcome
Work Environment
Time frame: 6 months
Scale for the environments evaluation of professional nursing practice-shortened version. The Scale for the Environment's Evaluation of Professional Nursing Practice-Shortened Version consists of 59 items across three subscales: Structure (29 items), Process (19 items), and Outcome (11 items). Participants rate each item on a five-point Likert scale (1: never to 5: always). Higher scores indicate a more favorable nursing practice environment for care quality and professional well-being. Scores are interpreted as follows: <35% (unfavorable), 35-55% (moderately favorable), 55-75% (favorable), and >75% (very favorable).
Safety climate
Time frame: 6 months
Safety Attitudes Questionnaire - Short Form The Safety Attitudes Questionnaire (SAQ) - Short Form 2006 assesses healthcare professionals' perceptions of patient safety attitudes across various clinical areas and healthcare services. It has been validated and culturally adapted to the context in which the study will be conducted. The SAQ - Short Form 2006 comprises six dimensions, addressing organizational factors, work environment factors, and team factors, with a total of 30 items. Participants respond to each item using a five-point Likert scale: "strongly disagree," "partially disagree," "neutral," "partially agree," and "strongly agree." The final score ranges from 0 to 100, where 0 represents the worst perception and 100 the best perception of the safety climate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 41834150Pereira SCA, Santos EJFD, Ferreira RA, Fassarella CS, Ribeiro OMPL. Promoting Positive Nursing Practice Environments: Outcomes of a Randomized Trial in Primary Care. J Nurs Manag. 2026;2026(1):e4139767. doi: 10.1155/jonm/4139767.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Nursing Practice Environments Promotion Program in people with Healthy Work Environment and Patient Safety, run by Cintia Silva Fassarella at 1 site in Portugal.
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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2025. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
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?
Work Environment (time frame: 6 months). 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 NCT06762015, which also lists 1 linked publication.
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 7 Jan 2025.