Primary Health Care Clinical Trial
— PRisMOfficial title:
Implementation and Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care : the PRisM Study
NCT number | NCT02403388 |
Other study ID # | 69HCL14_0265 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2016 |
Est. completion date | April 9, 2018 |
Verified date | September 2019 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 9, 2018 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Pôle IMER - Hospices Civils de Lyon | LYON cedex 03 |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annual incident declaration rate by full-time equivalent in both groups. | 18 months | ||
Secondary | Declaration rate of incident associated with patient injury in both groups | 18 months | ||
Secondary | Repartition of patient injury in different classes in both groups. | 18 months | ||
Secondary | Repartition of incidents causes in different classes in both groups. | 18 months | ||
Secondary | Repartition of preventive actions in different classes in both groups. | 18 months | ||
Secondary | Repartition of correctives actions in different classes in both groups. | 18 months | ||
Secondary | 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 | ||
Secondary | Identification of brakes and levers (qualitative assessment) of program implementation in intervention group. | after 18 months | ||
Secondary | Psychometric analysis of Medical Office Survey on Patient Safety (french translation) for dimensional structuration of the survey. | 1 month |
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