NCT06762015

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

December 26, 2024

Last Update Submit

January 6, 2025

Conditions

Keywords

Healthy Work EnvironmentPatient SafetyPrimary Health CareNurses

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants who will undertake the Positive Nursing Practice Environments Promotion Program

Behavioral: Positive Nursing Practice Environments Promotion Program

Control Group

NO INTERVENTION

Interventions

A multi-component intervention program aimed at promoting positive nursing practice environments.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses working in primary health care units

You may not qualify if:

  • Nurses in primary health care who refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULS Entre Douro e Vouga

Santa Maria da Feira, Aveiro District, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Stratified random sample
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 7, 2025

Study Start

September 2, 2024

Primary Completion

March 31, 2025

Study Completion

April 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations