Clinical trial NCT05422872: Delphi Study on Psychological Safety Competencies in Healthcare Training Curricula
Official title: Exploring What Psychological Safety Competencies Are Being Acquired During the Training Period of Healthcare Students: A Delphi Study of Trainee Mentors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Safety
Knowledge, Attitudes, Practice
Keywords: Psychological Safety
Healthcare students
Delphi study
Knowledge, attitudes, skills
Trainee mentors
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: Miguel Hernández University of Elche
name: European Cooperation in Science and Technology, COST
name: RheinMain University of Applied Science
name: University of Tartu
name: Tartu Health Care College
name: LAB University of Applied Sciences
name: University of Haifa
name: Vilnius university hospital Sanatros klinikos
name: University of Malta
name: Universidade Nova de Lisboa
name: Clinical Hospital Centre Zagreb
name: Pavol Jozef Safarik University
name: University of Belgrade
First posted: 2022-06-21
Enrollment: 173
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Psychological safety competencies - Degree of KNOWLEDGE acquisition (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety competencies - Degree of significance of KNOWLEDGE (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety competencies - Degree of ATTITUDE acquisition (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety competencies - Degree of significance of the ATTITUDE (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety competencies - Degree of SKILL acquisition (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety competencies - Degree of significance of the SKILL (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety INTERVENTIONS - Degree of implementation (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety INTERVENTIONS - Degree of significance (round 1)
timeFrame: Data collection for the first round of the Delphi study will extend from the start of the study for 20 days.
measure: Psychological safety competencies - Degree of KNOWLEDGE acquisition (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
measure: Psychological safety competencies - Degree of significance of KNOWLEDGE (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
measure: Psychological safety competencies - Degree of ATTITUDE acquisition (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
measure: Psychological safety competencies - Degree of significance of the ATTITUDE (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
measure: Psychological safety competencies - Degree of SKILL acquisition (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
measure: Psychological safety competencies - Degree of significance of the SKILL (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
measure: Psychological safety INTERVENTIONS - Degree of implementation (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
measure: Psychological safety INTERVENTIONS - Degree of significance (round 2)
timeFrame: Twenty-seven days after initiating the study, the second round of the Delphi study will extend for 20 days.
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan De Alicante
country: Spain
facility: Grupo ATENEA
state: Alicante
Study officials:
References:
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.
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.
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.
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.
citation: 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.