Psychological SafetyNCT05422872

Delphi Study on Psychological Safety Competencies in Healthcare Training Curricula

An observational study of Psychological Safety and Knowledge, Attitudes, Practice, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Psychological Safety, Knowledge, Attitudes, Practice
What is being tested?: Delphi study
How many people: 173 participants
Where: 1 siteSpain
Study dates: 25 Jan 2022to 15 Oct 2023
Phase: Observational
Are there results?: None posted in the registry

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 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Grupo ATENEA
Sant Joan d'Alacant, Alicante, 03550

Other trials in Spain

About this study

Official title: Exploring What Psychological Safety Competencies Are Being Acquired During the Training Period of Healthcare Students: A Delphi Study of Trainee Mentors

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.

Read the detailed description

Consensus study based on the Delphi technique. To develop the questionnaire 0 structured interviews will be conducted. This study step includes the development of a consultation instrument in questionnaire format to conduct the Delphi study. Only the legibility, face and content validity of the questionnaire will be assessed through interviews to ensure its correct completion by the participants.

One member of the research team for each participating country will act as national study coordinator in that country.

The study procedure will be structured in the following steps:

Research team constitution.
Request for study evaluation and approval by an Ethics Committee in each of the participating countries. This step is required only in the case of countries where ethical evaluation is mandatory to conduct this type of study. A common draft of the protocol will be available to support each national coordinator.
Collect preliminary information for the subsequent questionnaire re-define for the Delphi study. For this purpose, the available literature on the topic of the study and the WHO Global Patient Safety Action Plan 2021-2030 (more specifically, objective 5) has been reviewed beforehand. Once the first version of the questionnaire has been drafted from the information collected, interviews will be conducted with 3 mentors from each participating country to assess the legibility, face, and content validity of the draft questionnaire (readability, comprehension, clarity, coherence, relevance, and appropriateness). A template will be available to conduct it.
Revision and improvement of the initial version of the questionnaire based on the information gathered through the interviews to ensure the face and content validity of the instrument.
Approval of the questionnaire by the research team based on the information collected in steps 3 and 4. The questionnaire will be translated from English into the local languages of the participating countries by two native experts independently. Inconsistencies will be resolved with the participation of a third researcher.
Recruitment of participants. The national coordinator will be responsible for contacting the teaching units of healthcare institutions in their country to establish, through them, contact with trainees' mentors. A minimum of 20 participants from each country is expected. They will be working in family medicine, midwifery, pharmacy, surgery, and medicine departments.
Invitation to the study. The questionnaire will be designed on a web platform, property of the research team, hosted on a secure server, and specifically designed for conducting Delphi studies. The responses given to the questionnaire will be treated as fully confidential. However, given the nature of the study (Delphi with several rounds), each participant will access the web platform through personalized credentials to allow continuity in data collection and analysis. Personal information (username and password) will be deleted, and the responses of the same person to the different rounds will be linked by a unique double-blind code. The questionnaire will be disseminated by e-mail. Three reminders are foreseen to ensure an adequate response rate.
First round and successive rounds up to expert consensus. A minimum of two rounds will be carried out, and the maximum will be determined by reaching a consensus among the participants.
Data analysis and interpretation of the results. Preparation of an article for publication in a scientific journal.
Dissemination of the results. The results will be translated into practice to improve the training programs of next generations of health professionals through schools and faculties, ministries of health, and other agencies and scientific societies involved in curricula design. The results will also be disseminated through the usual scientific media (journals, conferences, etc.) and social networks.

Conditions: Psychological Safety, Knowledge, Attitudes, Practice
Being tested: Delphi study
Keywords: Psychological Safety, Healthcare students, Delphi study, Knowledge, attitudes, skills, Trainee mentors
Medical subject headings: Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05422872
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Delphi study

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 202215 Oct 2023

First posted21 Jun 2022
Study start25 Jan 2022
Primary completion7 Dec 2022
Study completion15 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Psychological SafetyStudies 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: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05422872
Sponsor's protocol ID: CA19113
Status last verified: Nov 2023
First submitted: 9 Jun 2022
Last updated: 30 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 32041595
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.
PubMed 28858000
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.
PubMed 29701770
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.
PubMed 31514203
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.
PubMed 24583957

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploring What Psychological Safety Competencies Are Being Acquired During the Training Period of Healthcare Students: A Delphi Study of Trainee Mentors
ClinicalTrials.gov ID: NCT05422872
Acronym / sponsor ID: CA19113
Conditions: Psychological Safety, Knowledge, Attitudes, Practice
Keywords: Psychological Safety, Healthcare students, Delphi study, Knowledge, attitudes, skills, Trainee mentors
Study type: Observational
Recruitment status: Completed
Enrolment: 173 participants (actual)
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
Collaborators: Universidad Miguel Hernandez de Elche, European Cooperation in Science and Technology, COST, RheinMain University of Applied Science, University of Tartu, Tartu Health Care College, LAB University of Applied Sciences, University of Haifa, Vilnius University Hospital Santaros Klinikos, University of Malta, Universidade Nova de Lisboa, Clinical Hospital Centre Zagreb, Pavol Jozef Safarik University, University of Belgrade
Study start: 25 Jan 2022 (actual)
Primary completion: 7 Dec 2022 (actual)
Study completion: 15 Oct 2023 (actual)
First posted: 21 Jun 2022 (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.

Detailed description

One member of the research team for each participating country will act as national study coordinator in that country.

The study procedure will be structured in the following steps:

Research team constitution.
Request for study evaluation and approval by an Ethics Committee in each of the participating countries. This step is required only in the case of countries where ethical evaluation is mandatory to conduct this type of study. A common draft of the protocol will be available to support each national coordinator.
Collect preliminary information for the subsequent questionnaire re-define for the Delphi study. For this purpose, the available literature on the topic of the study and the WHO Global Patient Safety Action Plan 2021-2030 (more specifically, objective 5) has been reviewed beforehand. Once the first version of the questionnaire has been drafted from the information collected, interviews will be conducted with 3 mentors from each participating country to assess the legibility, face, and content validity of the draft questionnaire (readability, comprehension, clarity, coherence, relevance, and appropriateness). A template will be available to conduct it.
Revision and improvement of the initial version of the questionnaire based on the information gathered through the interviews to ensure the face and content validity of the instrument.
Approval of the questionnaire by the research team based on the information collected in steps 3 and 4. The questionnaire will be translated from English into the local languages of the participating countries by two native experts independently. Inconsistencies will be resolved with the participation of a third researcher.
Recruitment of participants. The national coordinator will be responsible for contacting the teaching units of healthcare institutions in their country to establish, through them, contact with trainees' mentors. A minimum of 20 participants from each country is expected. They will be working in family medicine, midwifery, pharmacy, surgery, and medicine departments.
Invitation to the study. The questionnaire will be designed on a web platform, property of the research team, hosted on a secure server, and specifically designed for conducting Delphi studies. The responses given to the questionnaire will be treated as fully confidential. However, given the nature of the study (Delphi with several rounds), each participant will access the web platform through personalized credentials to allow continuity in data collection and analysis. Personal information (username and password) will be deleted, and the responses of the same person to the different rounds will be linked by a unique double-blind code. The questionnaire will be disseminated by e-mail. Three reminders are foreseen to ensure an adequate response rate.
First round and successive rounds up to expert consensus. A minimum of two rounds will be carried out, and the maximum will be determined by reaching a consensus among the participants.
Data analysis and interpretation of the results. Preparation of an article for publication in a scientific journal.
Dissemination of the results. The results will be translated into practice to improve the training programs of next generations of health professionals through schools and faculties, ministries of health, and other agencies and scientific societies involved in curricula design. The results will also be disseminated through the usual scientific media (journals, conferences, etc.) and social networks.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 11

Arm	Type	Receives
Croatia	–	Other: Delphi studyTwenty 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.
Estonia	–	Other: Delphi studyTwenty 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.
Finland	–	Other: Delphi studyTwenty 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.
Germany	–	Other: Delphi studyTwenty 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.
Israel	–	Other: Delphi studyTwenty 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.
Lithuania	–	Other: Delphi studyTwenty 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.
Malta	–	Other: Delphi studyTwenty 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.
Portugal	–	Other: Delphi studyTwenty 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.
Slovakia	–	Other: Delphi studyTwenty 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.
Spain	–	Other: Delphi studyTwenty 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.
Serbia	–	Other: Delphi studyTwenty 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.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

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

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
Delphi studyA Delphi study will be conducted with several rounds up to expert consensus.	Other	Croatia, Estonia, Finland, Germany, Israel, Lithuania, Malta, Portugal, Serbia, Slovakia, Spain

Primary outcome

Psychological safety competencies - Degree of KNOWLEDGE acquisition (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety competencies - Degree of significance of KNOWLEDGE (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety competencies - Degree of ATTITUDE acquisition (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety competencies - Degree of significance of the ATTITUDE (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety competencies - Degree of SKILL acquisition (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety competencies - Degree of significance of the SKILL (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety INTERVENTIONS - Degree of implementation (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety INTERVENTIONS - Degree of significance (round 1)
Time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
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).
Psychological safety competencies - Degree of KNOWLEDGE acquisition (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).
Psychological safety competencies - Degree of significance of KNOWLEDGE (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).
Psychological safety competencies - Degree of ATTITUDE acquisition (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).
Psychological safety competencies - Degree of significance of the ATTITUDE (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).
Psychological safety competencies - Degree of SKILL acquisition (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).
Psychological safety competencies - Degree of significance of the SKILL (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).
Psychological safety INTERVENTIONS - Degree of implementation (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).
Psychological safety INTERVENTIONS - Degree of significance (round 2)
Time frame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
Background: PubMed 32041595O'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.
Background: PubMed 28858000Richard 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.
Background: PubMed 29701770Schwappach 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.
Background: PubMed 31514203Schwappach 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.
Background: PubMed 24583957Derickson 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.
COST (European Cooperation in Science and Technology)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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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?

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 2 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: finished, as of the sponsor's last update on 30 Nov 2023. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Psychological safety competencies - Degree of KNOWLEDGE acquisition (round 1) (time frame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.). The study lists 16 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 NCT05422872, which also lists 5 linked publications.

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 30 Nov 2023.