RM ProgramSUSTAINNCT03966495
Sustainability of a Research Program in Risk Management (PeRENNITe)
An observational study of RM Program, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RM Program
- What is being tested?
- Sustainability of a research program in risk management
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pluriprofessional primary care offices in France (called "centre, pôle et maison de santé pluridisciplinaire")
Who may be able to join
- Volontary pluriprofessional primary care offices
- Having participated in the PRiSM study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pôle de Santé publique des HCL
Lyon
Pauline OCCELLI, MD, 04 78 86 19 73, pauline.occelli@chu-lyon.fr
Karine POYAU, PhD, 04 72 11 53 81, karine.poyau@chu-lyon.fr
About this study
Official title: 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.
- Conditions
- RM Program
- Being tested
- Sustainability of a research program in risk management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustainability of a research program in risk managementOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sustainability of a research program in risk management | |
| 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. Receives: Other: Sustainability of a research program in risk management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 months from the end of the PRiSM study in 2017 (2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2020
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RM ProgramStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline OCCELLI, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966495
- Sponsor's protocol ID
- 69HCL19_0043
- Acronym
- SUSTAIN
- Status last verified
- Nov 2021
- First submitted
- 24 May 2019
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainability of a Research Program in Risk Management: Routine Implementation, Appropriation, Effectiveness, Development of the Safety Culture
- ClinicalTrials.gov ID
- NCT03966495
- Acronym / sponsor ID
- SUSTAIN / 69HCL19_0043
- Conditions
- RM Program
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- Sep 2022 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRisM program | – | Other: Sustainability of a research program in risk managementPluriprofessional 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. |
| Control | – | Other: Sustainability of a research program in risk managementPluriprofessional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pluriprofessional primary care offices in France (called "centre, pôle et maison de santé pluridisciplinaire")
Key inclusion criteria (2 listed)
- Volontary pluriprofessional primary care offices
- Having participated in the PRiSM study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustainability of a research program in risk managementNo 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) | Other | Control, PRisM program |
Primary outcome
patient safety culture
Time frame: 24 months from the end of the PRiSM study in 2017 (2019)
- Qualitatively assessed through the model developed for health by Reiman, which apprehends the safety culture through organizational dimensions, social processes and psychological dimensions
patient safety culture
Time frame: 24 months from the end of the PRiSM study in 2017 (2019)
- Quantitatively assessed through 13 safetyclimate dimensions measured by the Medical Office Survey on Patient Safety Culture (MOSPS) Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline OCCELLI, MD study director
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RM Program, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline OCCELLI, MD (04 78 86 19 73 ext. +33, pauline.occelli@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient safety culture (time frame: 24 months from the end of the PRiSM study in 2017 (2019)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.