Sustainability of a Research Program in Risk Management (PeRENNITe) (SUSTAIN)

Sustainability of a Research Program in Risk Management: Routine Implementation, Appropriation, Effectiveness, Development of the Safety Culture

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.

Study Overview

• Status: Recruiting
• Conditions: RM Program
• Intervention / Treatment: Other: Sustainability of a research program in risk management

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Pauline OCCELLI, MD; Phone Number: +33 04 78 86 19 73; Email: pauline.occelli@chu-lyon.fr
• Study Contact Backup: Name: Karine POYAU, PhD; Phone Number: +33 04 72 11 53 81; Email: karine.poyau@chu-lyon.fr

Study Locations

• France
  • Lyon, France
    • Recruiting
    • Pôle de Santé publique des HCL
    • Contact: Pauline OCCELLI, MD; Phone Number: 04 78 86 19 73; Email: pauline.occelli@chu-lyon.fr
    • Contact: Karine POYAU, PhD; Phone Number: 04 72 11 53 81; Email: karine.poyau@chu-lyon.fr
    • Principal Investigator: Pauline OCCELLI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pluriprofessional primary care offices in France (called "centre, pôle et maison de santé pluridisciplinaire")

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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)
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.	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient safety culture	- Qualitatively assessed through the model developed for health by Reiman, which apprehends the safety culture through organizational dimensions, social processes and psychological dimensions	24 months from the end of the PRiSM study in 2017 (2019)
patient safety culture	- Quantitatively assessed through 13 safetyclimate dimensions measured by the Medical Office Survey on Patient Safety Culture (MOSPS) Questionnaire	24 months from the end of the PRiSM study in 2017 (2019)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Study Director: Pauline OCCELLI, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (ACTUAL): May 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL19_0043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No