NCT04576299

Brief Summary

Objective: Analyze health care workers' perception of patient safety during the COVID 19 pandemic. Methodology: Analytical cross-sectional observational study, with a quantitative focus on healthcare workers who are working on-site during the pandemic in the services of healthcare institutions that agree to participate in the countries where the study will be conducted, by applying a survey of patient safety perceptions in healthcare workers in times of pandemic. Analysis of the data will employ descriptive and inferential statistical techniques to meet the objectives of the study using IBM SPSS Statistics for Windows version 25.0 software. Expected results: The study seeks to generate evidence for the perception of patient safety in times of pandemic, for which it will generate the submission of an article with the results obtained to an indexed journal and presentation at a scientific event.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
4 countries

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

September 28, 2020

Last Update Submit

September 16, 2022

Conditions

Patient Safety

Keywords

Patient SafetyHealthcare PersonnelHospital Management

Outcome Measures

Primary Outcomes (1)

  • Patient Safety perception.

    Differences of patient safety perceptions among the participants from different countries. An ad-hoc survey questionnaire (not validated) has been developed by researchers using prior tools and personal experience by means of virtual conference consensus. The survey includes 32 questions about social networks, notification of adverse events, multidisciplinary teams, the doctor-patient relationship, the role of the ethics and patient safety committees, protocol compliance and suspension of outpatient procedures using a likert scale of 5 possible answers (totally disagree - totally agree).

    30 days

Study Arms (1)

Healthcare workers.

Survey developed specifically for the objective of this study: Healthcare worker perception of patient safety in times of pandemic. The application will be done through a digital questionnaire in the surveymonkey platform (Link of the instrument: https://es.surveymonkey.com/r/COVIDSP)

Other: Group 1

Interventions

Group 1OTHER

Survey about social networks, notification of adverse events, multidisciplinary teams, the doctor-patient relationship, the role of the ethics and patient safety committees, protocol compliance and suspension of outpatient procedures

Also known as: COVID-PS HW
Healthcare workers.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare workers and patient safety coordinators from the participant countries (Brazil, Chile, Colombia, Ecuador).

You may qualify if:

  • Healthcare professionals from all disciplines
  • Technicians from all disciplines (health related)
  • Working in a face-to-face manner during the pandemic in the services of health institutions
  • Professional or technical personnel in charge of the quality and patient safety processes in the institutions.

You may not qualify if:

  • Professional or technical staff from the administrative areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Universidad de Santander

Bucaramanga, Santander Department, Colombia

Location

Universidad Católica de Santiago de Guayaquil

Guayaquil, Guayas, Ecuador

Location

Miguel Hernández University

Elche, Alicante, 03202, Spain

Location

Related Publications (9)

  • Antino, M., Sanchez-Manzanares, M., & Ortega, A. (2020). The hospital survey on patient safety culture in Mexican hospitals: Assessment of psychometric properties. Safety Science, 128(May 2017), 104706. https://doi.org/10.1016/j.ssci.2020.104706

    BACKGROUND

  • Arias-Botero, J. H., & Gómez-Arias, R. D. (2017). La cultura de la seguridad del paciente: enfoques y metodologías para su medición. Ces Medicina, 31(2), 180-191. https://doi.org/10.21615/cesmedicina.31.2.7

    BACKGROUND

  • Camargo Tobias, G., Queiroz Bezerra, A. L., & Silvestre Branquinho, N. C. (2014). Cultura de la seguridad del paciente en la atención sanitaria: Un estudio bibliométrico. Enfermeria Global, 13(1), 336-361. https://doi.org/10.6018/eglobal.13.1.159931

    BACKGROUND

  • Huang L, Lei W, Xu F, Liu H, Yu L. Emotional responses and coping strategies in nurses and nursing students during Covid-19 outbreak: A comparative study. PLoS One. 2020 Aug 7;15(8):e0237303. doi: 10.1371/journal.pone.0237303. eCollection 2020.

    PMID: 32764825BACKGROUND

  • Pinheiro da Penha, M., Junior da Silva, O., da Penha Pinheiro, M., & da Silva Júnior, O. (2017). Evaluación de la cultura de seguridad del paciente en una organización hospitalaria de un hospital universitario. Enfermería Global: Revista Electrónica Semestral de Enfermería, 16(1), 309-352.

    BACKGROUND

  • Ramos, F., Coca, S. M., & Abeldaño, R. A. (2017). Percepción de la cultura de seguridad de pacientes en profesionales de una institución argentina. Enfermería Universitaria, 14(1), 47-53. https://doi.org/10.1016/j.reu.2016.12.004

    BACKGROUND

  • Singer S, Meterko M, Baker L, Gaba D, Falwell A, Rosen A. Workforce perceptions of hospital safety culture: development and validation of the patient safety climate in healthcare organizations survey. Health Serv Res. 2007 Oct;42(5):1999-2021. doi: 10.1111/j.1475-6773.2007.00706.x.

    PMID: 17850530BACKGROUND

  • University Johns Hopkins. (2020). COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

    BACKGROUND

  • Zhu Z, Xu S, Wang H, Liu Z, Wu J, Li G, Miao J, Zhang C, Yang Y, Sun W, Zhu S, Fan Y, Chen Y, Hu J, Liu J, Wang W. COVID-19 in Wuhan: Sociodemographic characteristics and hospital support measures associated with the immediate psychological impact on healthcare workers. EClinicalMedicine. 2020 Jun 24;24:100443. doi: 10.1016/j.eclinm.2020.100443. eCollection 2020 Jul.

    PMID: 32766545BACKGROUND

Related Links

Study Officials

  • Jose J Mira, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 6, 2020

Study Start

September 1, 2020

Primary Completion

December 30, 2021

Study Completion

June 15, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations

EC(1)CL(1)CO(1)ES(1)