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OpenTrials
Completed

NCT Number: NCT02403388

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

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.

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Key information

Conditions

Risk Management Patient Safety Primary Health Care

Sex eligibility

All sexes

Study type

Observational

Primary location

Pôle IMER - Hospices Civils de Lyon

Lyon, 69424, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRisM

Other

A risk management program for each professional of care in multiprofessional primary care offices in France.

Primary outcomes

  1. Annual incident declaration rate by full-time equivalent in both groups.

    Time frame: 18 months

Secondary outcomes

  1. Declaration rate of incident associated with patient injury in both groups

    Time frame: 18 months

  2. Repartition of patient injury in different classes in both groups.

    Time frame: 18 months

  3. Repartition of incidents causes in different classes in both groups.

    Time frame: 18 months

  4. Repartition of preventive actions in different classes in both groups.

    Time frame: 18 months

  5. Repartition of correctives actions in different classes in both groups.

    Time frame: 18 months

  6. 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

  7. Identification of brakes and levers (qualitative assessment) of program implementation in intervention group.

    Time frame: after 18 months

  8. Psychometric analysis of Medical Office Survey on Patient Safety (french translation) for dimensional structuration of the survey.

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PRisM

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2015
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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