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

Orthopaedic Surgery Clinical Trial

— HiRisP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481439
• Other study ID #: RECHMPL18_0134
• Status: Completed
• Start date: February 13, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: March 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Pharmaceutical means for clinical pharmacy activities and pharmaceutical analysis are limited. Several methods can be used to increase the efficiency of resources allocated to clinical pharmacy activities. We hypothesize that highlighting patients at risk for iatrogenic drug events (ADEs) by applying a predictive score of ADE could be a way to increase the efficiency of clinician pharmacist interventions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 15, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Subject aged over 18 years

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

Exclusion criteria:

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

Related Conditions & MeSH terms

• Orthopaedic Surgery
• Postoperative Complications
• Traumatology

Intervention

Other:
• Collection of a Pharmaceutical intervention
collection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major clinical impact pharmaceutical intervention	Occurrence of a major clinical impact pharmaceutical intervention according to the CLEO scale	1 day
Secondary	pharmaceutical intervention	Occurrence of a pharmaceutical intervention	1 day