Clinical trial NCT02403388: Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care
Official title: Implementation and Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care : the PRisM Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Management
Primary Health Care
Patient Safety
Keywords: Patient safety
Primary care
Incident reporting
Pluridisciplinary care offices
Risk management
Assessment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiprofessional primary care offices in France (MSP, SS, PS)

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.


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

Primary outcomes:
measure: Annual incident declaration rate by full-time equivalent in both groups.
timeFrame: 18 months
Secondary outcomes:
measure: Declaration rate of incident associated with patient injury in both groups
timeFrame: 18 months
measure: Repartition of patient injury in different classes in both groups.
timeFrame: 18 months
measure: Repartition of incidents causes in different classes in both groups.
timeFrame: 18 months
measure: Repartition of preventive actions in different classes in both groups.
timeFrame: 18 months
measure: Repartition of correctives actions in different classes in both groups.
timeFrame: 18 months
measure: 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.
timeFrame: 1 &18 months
measure: Identification of brakes and levers (qualitative assessment) of program implementation in intervention group.
timeFrame: after 18 months
measure: Psychometric analysis of Medical Office Survey on Patient Safety (french translation) for dimensional structuration of the survey.
timeFrame: 1 month
Other outcomes:
Locations:
city: LYON cedex 03
country: France
facility: Pôle IMER - Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche
name: Marc CHANELIERE, MD
role: PRINCIPAL_INVESTIGATOR
References: