Delphi Study on Psychological Safety Competencies in Healthcare Training Curricula

Knowledge, Attitudes, Practice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422872
• Other study ID #: CA19113
• Status: Completed
• Start date: January 25, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: November 2023
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: October 15, 2023
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knowledge, Attitudes, Practice

Intervention

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

Locations

Country	Name	City	State
Spain	Grupo ATENEA	San Juan De Alicante	Alicante

Sponsors (14)

Lead Sponsor

Collaborator

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

Clinical Hospital Centre Zagreb, European Cooperation in Science and Technology, COST, LAB University of Applied Sciences, Miguel Hernández University of Elche, Pavol Jozef Safarik University, RheinMain University of Applied Science, Tartu Health Care College, Universidade Nova de Lisboa, University of Belgrade, University of Haifa, University of Malta, University of Tartu, Vilnius university hospital Sanatros klinikos

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.

External Links

•   COST (European Cooperation in Science and Technology)