NCT05422872

Brief Summary

Psychological safety refers to the shared belief that a work team can face complex challenges when there is an environment of mutual respect and trust. Thus, healthcare professionals provide safer care when causes and ways to avoid clinical errors can be discussed and analyzed without fear of criticism or sanctions. A psychological safety climate can be a determinant of patient safety. In this way, this provides safer care when it is possible to discuss and analyze the causes and how to avoid clinical errors without fear of criticism or sanctions. This study aims to explore the mentors' opinion on what psychological safety competencies are being acquired by future generations of healthcare professionals (students and residents, hereafter "trainees") through current training programs and what actions should be taken to promote such competencies in clinical settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

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

January 25, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

June 9, 2022

Last Update Submit

November 28, 2023

Conditions

Keywords

Psychological SafetyHealthcare studentsDelphi studyKnowledge, attitudes, skillsTrainee mentors

Outcome Measures

Primary Outcomes (16)

  • Psychological safety competencies - Degree of KNOWLEDGE acquisition (round 1)

    What knowledge in psychological safety is being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to knowledge. Participants (mentors of healthcare trainees) will have to assess each knowledge (competence component) according to its degree of acquisition (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety competencies - Degree of significance of KNOWLEDGE (round 1)

    What knowledge in psychological safety is being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to knowledge. Participants (mentors of healthcare trainees) will have to assess each knowledge (competence component) according to its degree of significance (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety competencies - Degree of ATTITUDE acquisition (round 1)

    What attitudes toward psychological safety are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 6 items referring to attitudes. Participants (mentors of healthcare trainees) will have to assess each attitude (competence component) according to its degree of acquisition (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety competencies - Degree of significance of the ATTITUDE (round 1)

    What attitudes toward psychological safety are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 6 items referring to attitudes. Participants (mentors of healthcare trainees) will have to assess each attitude (competence component) according to its degree of significance (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety competencies - Degree of SKILL acquisition (round 1)

    What psychological safety skills are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to skills. Participants (mentors of healthcare trainees) will have to assess each skill (competence component) according to its degree of acquisition (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety competencies - Degree of significance of the SKILL (round 1)

    What psychological safety skills are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to skills. Participants (mentors of healthcare trainees) will have to assess each skill (competence component) according to its degree of significance (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety INTERVENTIONS - Degree of implementation (round 1)

    What actions the healthcare institutions in which the trainees do their clinical internships should implement to promote the acquisition of these competencies. Participants (mentors of healthcare trainees) will have to assess each intervention according to its degree of implementation in their center (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety INTERVENTIONS - Degree of significance (round 1)

    What actions the healthcare institutions in which the trainees do their clinical internships should implement to promote the acquisition of these competencies. Participants (mentors of healthcare trainees) will have to assess each intervention according to its degree of significance (5-point Likert scale).

    Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.

  • Psychological safety competencies - Degree of KNOWLEDGE acquisition (round 2)

    What knowledge in psychological safety is being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to knowledge. Participants (mentors of healthcare trainees) will have to assess each knowledge (competence component) according to its degree of acquisition (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

  • Psychological safety competencies - Degree of significance of KNOWLEDGE (round 2)

    What knowledge in psychological safety is being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to knowledge. Participants (mentors of healthcare trainees) will have to assess each knowledge (competence component) according to its degree of significance (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

  • Psychological safety competencies - Degree of ATTITUDE acquisition (round 2)

    What attitudes toward psychological safety are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 6 items referring to attitudes. Participants (mentors of healthcare trainees) will have to assess each attitude (competence component) according to its degree of acquisition (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

  • Psychological safety competencies - Degree of significance of the ATTITUDE (round 2)

    What attitudes toward psychological safety are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 6 items referring to attitudes. Participants (mentors of healthcare trainees) will have to assess each attitude (competence component) according to its degree of significance (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

  • Psychological safety competencies - Degree of SKILL acquisition (round 2)

    What psychological safety skills are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to skills. Participants (mentors of healthcare trainees) will have to assess each skill (competence component) according to its degree of acquisition (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

  • Psychological safety competencies - Degree of significance of the SKILL (round 2)

    What psychological safety skills are being acquired by future generations of healthcare professionals (students and residents referred to as "trainees") through their clinical internships. The questionnaire contains 7 items referring to skills. Participants (mentors of healthcare trainees) will have to assess each skill (competence component) according to its degree of significance (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

  • Psychological safety INTERVENTIONS - Degree of implementation (round 2)

    What actions the healthcare institutions in which the trainees do their clinical internships should implement to promote the acquisition of these competencies. Participants (mentors of healthcare trainees) will have to assess each intervention according to its degree of implementation in their center (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

  • Psychological safety INTERVENTIONS - Degree of significance (round 2)

    What actions the healthcare institutions in which the trainees do their clinical internships should implement to promote the acquisition of these competencies. Participants (mentors of healthcare trainees) will have to assess each intervention according to its degree of significance (5-point Likert scale).

    Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.

Study Arms (11)

Croatia

Twenty to twenty-five professionals assigned to Croatian healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Estonia

Twenty to twenty-five professionals assigned to Estonian healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Finland

Twenty to twenty-five professionals assigned to Finnish healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Germany

Twenty to twenty-five professionals assigned to German healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Israel

Twenty to twenty-five professionals assigned to Israeli healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Lithuania

Twenty to twenty-five professionals assigned to Lithuanian healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Malta

Twenty to twenty-five professionals assigned to Maltese healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Portugal

Twenty to twenty-five professionals assigned to Portuguese healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Slovakia

Twenty to twenty-five professionals assigned to Slovakian healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Spain

Twenty to twenty-five professionals assigned to Spanish healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Serbia

Twenty to twenty-five professionals assigned to Serbian healthcare institutions (inpatient and outpatient settings, and community, and social care centers) who are responsible for mentoring and supervising residents and students during their clinical internships in the fields of family medicine, obstetrics, midwifery, pharmacy, surgery, and department of medicine.

Other: Delphi study

Interventions

A Delphi study will be conducted with several rounds up to expert consensus.

CroatiaEstoniaFinlandGermanyIsraelLithuaniaMaltaPortugalSerbiaSlovakiaSpain

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trainees' mentors who would be working in inpatient or outpatient settings or community or social care centers mentoring residents in the fields of family medicine, midwifery, pharmacy, surgery, and medicine department.

You may qualify if:

  • Trainees mentors in healthcare institutions (inpatient and outpatient settings, and community and social care centers) in Croatia, Estonia, Finland, Germany, Israel, Lithuania, Malta, Portugal, Serbia, Slovakia, and Spain.
  • Working in inpatient or outpatient settings or community or social care centers mentoring residents in the fields of family medicine, midwifery, pharmacy, surgery, and medicine department.

You may not qualify if:

  • Academic mentors. The study setting is social and health care centers, not academia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo ATENEA

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Related Publications (5)

  • O'Donovan R, McAuliffe E. A systematic review exploring the content and outcomes of interventions to improve psychological safety, speaking up and voice behaviour. BMC Health Serv Res. 2020 Feb 10;20(1):101. doi: 10.1186/s12913-020-4931-2.

    PMID: 32041595BACKGROUND
  • Richard A, Pfeiffer Y, Schwappach DDL. Development and Psychometric Evaluation of the Speaking Up About Patient Safety Questionnaire. J Patient Saf. 2021 Oct 1;17(7):e599-e606. doi: 10.1097/PTS.0000000000000415.

    PMID: 28858000BACKGROUND
  • Schwappach D, Sendlhofer G, Hasler L, Gombotz V, Leitgeb K, Hoffmann M, Jantscher L, Brunner G. Speaking up behaviors and safety climate in an Austrian university hospital. Int J Qual Health Care. 2018 Nov 1;30(9):701-707. doi: 10.1093/intqhc/mzy089.

    PMID: 29701770BACKGROUND
  • Schwappach D, Sendlhofer G, Kamolz LP, Kole W, Brunner G. Speaking up culture of medical students within an academic teaching hospital: Need of faculty working in patient safety. PLoS One. 2019 Sep 12;14(9):e0222461. doi: 10.1371/journal.pone.0222461. eCollection 2019.

    PMID: 31514203BACKGROUND
  • Derickson R, Fishman J, Osatuke K, Teclaw R, Ramsel D. Psychological safety and error reporting within Veterans Health Administration hospitals. J Patient Saf. 2015 Mar;11(1):60-6. doi: 10.1097/PTS.0000000000000082.

    PMID: 24583957BACKGROUND

Related Links

MeSH Terms

Conditions

Behavior

Study Design

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

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 21, 2022

Study Start

January 25, 2022

Primary Completion

December 7, 2022

Study Completion

October 15, 2023

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The databases, without identification and code registration, will be available at OSF (Center for Open Science) for access by the scientific community. the scientific community.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Six months after the data collecting.
Access Criteria
Data repository is available for the scientific community.

Locations