Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care

Primary Health Care Clinical Trial

— PRisM  

Official title:

Implementation and Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care : the PRisM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02403388
• Other study ID #: 69HCL14_0265
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: April 9, 2018

Study information

• Verified date: September 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Avoidable care associated incidents are relatively frequent in primary care. In France for example, avoidable incidents rate is estimated to 22/1000 medical acts from general practitioners. Patient safety is now a growing issue in primary care. One tool to increase patient safety is incident reporting and analysis. It could reduce some important consequences for patients and could allow implementing substantial corrective actions.

The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk management program implemented in the french pluridisciplinary offices in primary care in association with a centralized incident reporting system, versus a centralized incident reporting system only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 9, 2018
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Voluntary multiprofessional primary care offices

• With at least 10 Full Time Equivalent (FTE)

• With at least general practitioners and 3 different occupations in care

Exclusion Criteria:

• Monoprofessional primary care offices

Related Conditions & MeSH terms

• Patient Safety
• Primary Health Care
• Risk Management

Intervention

Other:
• PRisM
A risk management program for each professional of care in multiprofessional primary care offices in France.

Locations

Country	Name	City	State
France	Pôle IMER - Hospices Civils de Lyon	LYON cedex 03

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual incident declaration rate by full-time equivalent in both groups.		18 months
Secondary	Declaration rate of incident associated with patient injury in both groups		18 months
Secondary	Repartition of patient injury in different classes in both groups.		18 months
Secondary	Repartition of incidents causes in different classes in both groups.		18 months
Secondary	Repartition of preventive actions in different classes in both groups.		18 months
Secondary	Repartition of correctives actions in different classes in both groups.		18 months
Secondary	A mean score of french version of Medical Office Survey on Patient Safety (MOSPS) in both groups, including a mean score for each dimension of the survey.		1 &18 months
Secondary	Identification of brakes and levers (qualitative assessment) of program implementation in intervention group.		after 18 months
Secondary	Psychometric analysis of Medical Office Survey on Patient Safety (french translation) for dimensional structuration of the survey.		1 month