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

August 11, 2020 updated by: Hospices Civils de Lyon

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 18 months
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 69HCL14_0265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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