Impact of the Intervention of Pharmacists and Geriatrician on Drug Prescription in Elderly Patients in a Surgical ICU

NCT ID: NCT03706092

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-07-01

Brief Summary

In order to optimize drug prescription and to reduce potentially inappropriate medications, a pharmaceutical analysis activity is conducted in our establishment for several years. Medical prescriptions are reviewed daily by pharmacists. This activity is developed in approximatively 84% of the hospital wards of the institution, and especially in the geriatric department. Drug induced adverse effects are frequently encountered in elderly people and ICU environment causes a high risk of iatrogenic events because of the complexity of care and of the severity of illness. The hypothesis of the study is that the intervention of pharmacists and geriatricians could improve the medical prescription in elderly patients by reducing avoidable drug interactions and thus by decreasing the risk of drug induced adverse effects.

The primary objective of this study is to evaluate the impact of the intervention of pharmacists and geriatricians on medical prescription and on iatrogenic risk in elderly critically ill patients admitted in surgical ICU. The secondary objectives are (i) to describe the elderly patients population in surgical ICU, (ii) to analyze the impact of the ICU stay on medical prescription, (iii) to analyze the opportunities suggested by the pharmacists to optimize drug therapies and (iv) to assess the impact of drug prescription in the ICU on long-term disability.

A prospective, observational, before-after study will be conducted from august 1, 2018 to February 1, 2020, in the surgical ICU of the hospital. Patients older than 70 years and admitted to surgical ICU will be eligible. This study will be conducted in 2 successive steps: (1) first step: without any intervention of pharmacists or and geriatricians (Baseline), (2) second step: all drug prescription during the ICU and the hospital stay will be analyzed by a pharmacist and a geriatrician, to decrease drug interaction and risk of drug related adverse effect. During each step, the demographic and medical data will be recorded. Medical prescriptions will be reviewed at ICU admission, at 96 hours after ICU admission and then every 4 days until discharge from the ICU. For each patient, the impact of the intervention on mid-term and long-term disability will be assessed during a geriatric evaluation by using adequate specific scale at hospital discharge and at 3 months after hospital discharge. All iatrogenic events will be collected and analyzed.

Detailed Description

The aim of this study is to evaluate the impact of the intervention of pharmacists and geriatricians on medical prescription and on the iatrogenic risk in elderly critically ill patients admitted in surgical ICU. This study is before-after prospective study, carried out in 2 steps.

Step 1 data collection from August 1, 2018 to February 1, 2019

This step is a prospective analysis without any intervention of the pharmacist and of the geriatrician.

• The sociodemographic, and medical (comorbidities, reason for ICU admission, SAPS II (Simplified Acute Physiology Score) and SOFA (Sepsis-related Organ Failure Assessment) scores, laboratory data, invasive procedures data will be collected from ICU medical record.
• A geriatric evaluation and disability evaluation will be performed by using the ADL (Activity of Daily Living), Charlson, and SEGA (Short Emergency Geriatric Assessment) scales.
• The medical prescriptions will be reviewed at the first day and at 96 hours after admission in the ICU, and every 4 days during ICU stay. The pharmacist will analyse the medical prescriptions by using a standardized tool (Micromedex®, Theriaque®, Vidal®), to identify inappropriate prescription, and to assess the iatrogenic risks. These interventions will be quantified by using the SFPC Scale (French Society of clinical pharmacy).
• Iatrogenic events will be reported and analyzed.
• Drug prescription and patient outcome at discharge from the ICU and at discharge from the hospital will be collected.
• At 3 months from discharge from the hospital, a new geriatric evaluation will be conducted (patient's outcome and medical prescription).

Step 2, from March 1, 2019 to March, 2020.

This step is a prospective analysis with the intervention of the pharmacist and of the geriatrician.

The same data that step 1 will be collected. During this step, the pharmacist carries individualized interventions that will be discuss with the physician in charge of the patient to improve the safety of drug prescription. The physician will be allowed to accept or to refuse these interventions.

At 3 months from discharge from the hospital, a consultation with geriatrician will be proposed to the elderly patient. The geriatric evaluation and disability assessment will be conducted during this consultation.

Conditions

Aged; Critical Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Before

Elderly patients \> = 70 in ICU without any intervention of the pharmacists and of the geriatricians

No interventions assigned to this group

After

Elderly patients \> = 70 in ICU with individualized intervention of the pharmacists and of the geriatricians

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients 70 years or older
• admitted to surgical ICU

Exclusion Criteria

• patients refusing data collection

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Laure CLAIRET

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

CHU de Besançon

Besançon, , France

Countries

France

Other Identifiers

IATROAGE

Identifier Type: -

Identifier Source: org_study_id