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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Health Care; Patient Safety; Risk Management
• Intervention / Treatment: Other: PRisM

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • LYON cedex 03, France, 69424
    • Pôle IMER - Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiprofessional primary care offices in France (MSP, SS, PS)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiprofessional primary care offices with PRisM; 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; A risk management program for each professional of care in multiprofessional primary care offices in France.
Multiprofessional primary care offices without PRisM; 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	Time Frame
Annual incident declaration rate by full-time equivalent in both groups.	18 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Marc CHANELIERE, MD, Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): April 9, 2018

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Primary care; Assessment; Patient safety; Risk management; Incident reporting; Pluridisciplinary care offices
• Other Study ID Numbers: 69HCL14_0265