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

Completed

• Conditions: Patient Safety; Risk Management; Primary Health Care
• Interventions: Other: PRisM

• Registration Number: NCT02403388
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Study Start: 2016-03-01
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09
• Status Verified: 2019-09
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• Monoprofessional primary care offices

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiprofessional primary care offices with PRisM	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.

Primary Outcome Measures

Name	Time	Method
Annual incident declaration rate by full-time equivalent in both groups.	18 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pôle IMER - Hospices Civils de Lyon; 🇫🇷 LYON cedex 03, France