Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication
NCT ID: NCT03481439
Last Updated: 2018-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2018-02-13
2018-06-15
Brief Summary
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The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.
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Detailed Description
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b. Assumption (s) and objective (s) The use of a predictive score of ADE in hospitalized patients in orthopedic surgery would make it possible to prioritize clinical pharmacy actions according to the resources allocated. The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department. The secondary objective is to evaluate its superiority over other predictive models such as the age or the Physical Status Score physical status score used by anesthetists.
c. Methodology The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions (NPS) using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.
d. Expected results and prospects The usefulness of clinical pharmacy activities is now demonstrated, however an improvement in their efficiency is needed. The prospects are the integration of the risk score in the dispensing assistance software connected to the computerized patient record as well as extending the score to other types of surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary cohort
Primary cohort : Cohort of patient between January and February 2017
Collection of a Pharmaceutical intervention
collection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort
Secondary cohort
Secondary cohort : Cohort of patient between February and March 2018
Collection of a Pharmaceutical intervention
collection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort
Interventions
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Collection of a Pharmaceutical intervention
collection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort
Eligibility Criteria
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Inclusion Criteria
* Subject hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Pierre RENAUDIN, Pharm D
Role: STUDY_DIRECTOR
University Hospital, Montpellier
Locations
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Uhmontpellier
Montpellier, , France
Countries
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Other Identifiers
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RECHMPL18_0134
Identifier Type: -
Identifier Source: org_study_id
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