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

NCT02403388 | Completed

• 1 other identifier: 69HCL14_0265
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Management; Primary Health Care; Patient Safety

Keywords

Patient safety; Primary care; Incident reporting; Pluridisciplinary care offices; Risk management; Assessment

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (8)

• 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

Study Arms (2)

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

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.

Interventions

PRisM OTHER

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

Multiprofessional primary care offices with PRisM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Voluntary multiprofessional primary care offices
• With at least 10 Full Time Equivalent (FTE)
• With at least general practitioners and 3 different occupations in care

You may not qualify if:

• Monoprofessional primary care offices

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pôle IMER - Hospices Civils de Lyon

Lyon, 69424, France

Location

Related Publications (1)

• Chaneliere M, Buchet-Poyau K, Keriel-Gascou M, Rabilloud M, Colin C, Langlois-Jacques C, Touzet S. A multifaceted risk management program to improve the reporting rate of patient safety incidents in primary care: a cluster-randomised controlled trial. BMC Prim Care. 2024 Jul 6;25(1):244. doi: 10.1186/s12875-024-02476-4.

  PMID: 38971743 DERIVED

Study Officials

• Marc CHANELIERE, MD

  Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: March 31, 2015
• Study Start: March 1, 2016
• Primary Completion: April 9, 2018
• Study Completion: April 9, 2018
• Last Updated: August 12, 2020

Record last verified: 2019-09

Locations

FR (1)