Sustainability of a Research Program in Risk Management (PeRENNITe)

NCT ID: NCT03966495

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-09-30

Brief Summary

Sustainability can be defined by several dimensions: the pursuit of program elements, the maintenance of its effectiveness, its integration into work processes, the adaptation of the program to the local context, its integration into the organizational culture, the dissemination of the program to other centres. Studies show that the continuation of the entire intervention is rare once the research stops.

The PRisM study (Pluriprofessionality and Risk Management through a Multifaceted Program in Primary Care) was a primary care risk management (RM) research project. Its purpose was to develop a safety culture within the participating multi-professional primary care structures. From 2015 to 2017, multi-professional primary care offices participated in the study, half of which implemented a RM program consisting of: 1) Training on RM in the context of primary care; 2) The appointment of a RM referent; 3) The conduct of six meetings of systematic analysis of incidents.

The PRisM study represents a favorable ground for the development of a methodology for evaluating the sustainability of a RM program in primary care.

Conditions

RM Program

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

PRisM program

Pluriprofessional primary care offices with the PRiSM RM program:

• Nine of the pluriprofessional primary care offices which implemented the RM program tested in the PRiSM study (2015-2017). The program consisted in: 1) Training on RM in the context of primary care; 2) The appointment of a RM referent in the office; 3) The conduct of six incident review meetings.
• All participating offices had to declare adverse events that occurred during the time frame of the PRiSM study.
• All participating offices had to fill in the safety climate survey MOSPS at the beginning and at the end of the PRiSM study.

Sustainability of a research program in risk management

Intervention Type: OTHER

No intervention will be implemented in the present study.

The investigators will evaluate of the sustainability of a research program in risk management in pluriprofessional primary care offices:

• Qualitatively assessed safety culture and Sustainability of the PRisM RM program in the offices by interviews of professional belonging to the offices.
• Quantitatively assessed safety climate in the offices measured by the Medical Office Survey on Patient Safety Culture (MOSPS) Questionnaire (fill in by the professionals of the offices)

Control

Pluriprofessional primary care offices without the PRiSM RM program:

• Nine of the offices pluriprofessional primary care offices which didn't implement the RM program tested in the PRiSM study (2015-2017). They belonged to the PRisM study control group.
• All participating offices had to declare adverse events that occurred during the time frame of the PRiSM study.
• All participating offices had to fill in the safety climate survey MOSPS at the beginning and at the end of the PRiSM study.

Sustainability of a research program in risk management

Intervention Type: OTHER

No intervention will be implemented in the present study.

The investigators will evaluate of the sustainability of a research program in risk management in pluriprofessional primary care offices:

• Qualitatively assessed safety culture and Sustainability of the PRisM RM program in the offices by interviews of professional belonging to the offices.
• Quantitatively assessed safety climate in the offices measured by the Medical Office Survey on Patient Safety Culture (MOSPS) Questionnaire (fill in by the professionals of the offices)

Interventions

Sustainability of a research program in risk management

No intervention will be implemented in the present study.

The investigators will evaluate of the sustainability of a research program in risk management in pluriprofessional primary care offices:

• Qualitatively assessed safety culture and Sustainability of the PRisM RM program in the offices by interviews of professional belonging to the offices.
• Quantitatively assessed safety climate in the offices measured by the Medical Office Survey on Patient Safety Culture (MOSPS) Questionnaire (fill in by the professionals of the offices)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volontary pluriprofessional primary care offices
• Having participated in the PRiSM study

Exclusion Criteria

• office that waived participation in the PRisM study course
• office with a participation rate in the first PRisM safety climate survey < 30%.
• office of the PRisM study intervention group that did not implement the program as planned

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pauline OCCELLI, MD

Role: STUDY_DIRECTOR

Hospices Civils de Lyon

Locations

Pôle de Santé publique des HCL

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Pauline OCCELLI, MD

Role: CONTACT

Phone: 04 78 86 19 73

Email: pauline.occelli@chu-lyon.fr

Karine POYAU, PhD

Role: CONTACT

Phone: 04 72 11 53 81

Email: karine.poyau@chu-lyon.fr

Facility Contacts

Pauline OCCELLI, MD

Role: primary

Karine POYAU, PhD

Role: backup

Other Identifiers

69HCL19_0043

Identifier Type: -

Identifier Source: org_study_id