Nursing Practice Environment and Patient Safety in Primary Health Care

January 6, 2025 updated by: Cintia Silva Fassarella

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Aveiro
      • Santa Maria da Feira, Aveiro, Portugal
        • ULS Entre Douro e Vouga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Nurses working in primary health care units

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Intervention Group
Participants who will undertake the Positive Nursing Practice Environments Promotion Program
Behavioral: Positive Nursing Practice Environments Promotion Program
A multi-component intervention program aimed at promoting positive nursing practice environments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cintia Silva Fassarella

Collaborators

Universidade do Porto
CINTESIS - Center for Health Technology and Services Research, Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CES n. 57_2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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