Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication

NCT03481439 | Completed

• 1 other identifier: RECHMPL18_0134
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department. 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.

Conditions

Orthopaedic Surgery; Traumatology

Keywords

Pharmacist; Led medication review; Orthopaedic surgery; Traumatology

Outcome Measures

Primary Outcomes (1)

• Major clinical impact pharmaceutical intervention

  Occurrence of a major clinical impact pharmaceutical intervention according to the CLEO scale

  1 day

Secondary Outcomes (1)

• pharmaceutical intervention

  1 day

Study Arms (2)

Primary cohort

Primary cohort : Cohort of patient between January and February 2017

Other: Collection of a Pharmaceutical intervention

Secondary cohort

Secondary cohort : Cohort of patient between February and March 2018

Other: Collection of a Pharmaceutical intervention

Interventions

Collection of a Pharmaceutical intervention OTHER

collection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort

Primary cohort; Secondary cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier

You may qualify if:

• Subject aged over 18 years
• Subject hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier.

You may not qualify if:

• Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of liberty)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Study Officials

• Pierre RENAUDIN, Pharm D

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: February 13, 2018
• Primary Completion: March 13, 2018
• Study Completion: June 15, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-03

Locations

FR (1)