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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Risk Management, Primary Health Care, Patient Safety

Intervention / Treatment
-----------------
* Other: PRisM


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiprofessional primary care offices with PRisM<br>25 multiprofessional primary care offices. Each professional of care of the offices (about 10 FTE / office) have to declare each adverse event that occurs in their office during 18 months. | Other: PRisM<br>* A risk management program for each professional of care in multiprofessional primary care offices in France.<br>|
| Multiprofessional primary care offices without PRisM<br>25 multiprofessional primary care offices. Each professional of care of the offices (about 10 FTE / office) have to declare each adverse event that occurs in their office during 18 months. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual incident declaration rate by full-time equivalent in both groups. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Declaration rate of incident associated with patient injury in both groups |  | 18 months | 
| Repartition of patient injury in different classes in both groups. |  | 18 months | 
| Repartition of incidents causes in different classes in both groups. |  | 18 months | 
| Repartition of preventive actions in different classes in both groups. |  | 18 months | 
| Repartition of correctives actions in different classes in both groups. |  | 18 months | 
| 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 | 
| Identification of brakes and levers (qualitative assessment) of program implementation in intervention group. |  | after 18 months | 
| Psychometric analysis of Medical Office Survey on Patient Safety (french translation) for dimensional structuration of the survey. |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Assessment, Patient safety, Primary care, Incident reporting, Pluridisciplinary care offices, Risk management