Delphi Study on Psychological Safety Competencies in Healthcare Training Curricula

NCT ID: NCT05422872

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-25

Study Completion Date

2023-10-15

Brief Summary

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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.

Detailed Description

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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:

1. Research team constitution.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. Data analysis and interpretation of the results. Preparation of an article for publication in a scientific journal.
10. 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

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Psychological Safety Knowledge, Attitudes, Practice

Keywords

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Psychological Safety Healthcare students Delphi study Knowledge, attitudes, skills Trainee mentors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

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.

Delphi study

Intervention Type OTHER

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

Interventions

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Delphi study

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Miguel Hernández University of Elche

UNKNOWN

Sponsor Role collaborator

European Cooperation in Science and Technology, COST

UNKNOWN

Sponsor Role collaborator

RheinMain University of Applied Science

UNKNOWN

Sponsor Role collaborator

University of Tartu

OTHER

Sponsor Role collaborator

Tartu Health Care College

UNKNOWN

Sponsor Role collaborator

LAB University of Applied Sciences

UNKNOWN

Sponsor Role collaborator

University of Haifa

OTHER

Sponsor Role collaborator

Vilnius university hospital Sanatros klinikos

UNKNOWN

Sponsor Role collaborator

University of Malta

OTHER

Sponsor Role collaborator

Universidade Nova de Lisboa

OTHER

Sponsor Role collaborator

Clinical Hospital Centre Zagreb

OTHER

Sponsor Role collaborator

Pavol Jozef Safarik University

OTHER

Sponsor Role collaborator

University of Belgrade

OTHER

Sponsor Role collaborator

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role lead

Responsible Party

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José Joaquín Mira Solves

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Grupo ATENEA

Sant Joan d'Alacant, Alicante, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 32041595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28858000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29701770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31514203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24583957 (View on PubMed)

Related Links

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http://www.cost.eu

COST (European Cooperation in Science and Technology)

Other Identifiers

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CA19113

Identifier Type: -

Identifier Source: org_study_id