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Clinical Trials/NCT03706092
NCT03706092
Completed
Not Applicable

Impact of the Intervention of Pharmacists and Geriatrician on Drug Prescription in Critically Ill Elderly Patients Admitted in Surgical ICU

Centre Hospitalier Universitaire de Besancon1 site in 1 country230 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aged
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
230
Locations
1
Primary Endpoint
Impact of geriatric and pharmacist's intervention
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
July 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients 70 years or older
  • admitted to surgical ICU

Exclusion Criteria

  • patients refusing data collection

Outcomes

Primary Outcomes

Impact of geriatric and pharmacist's intervention

Time Frame: Hospital stay until 3 months after

Difference between iatrogenic risks before/after pharmaceutical intervention on the elderly's prescription. The iatrogenic risk is evaluated with the iatrogenic events rates and the inappropriate prescriptions rates.

Secondary Outcomes

  • Describe the medical characteristics of elderly patients population in surgical intensive care with the Charlson Comorbidities Index (CCI)(During hospital stay up to 3 months after discharge)
  • Describe the medical characteristics of elderly patients population in surgical intensive care(During hospital stay up to 3 months after discharge)
  • Describe the demographic elderly patients population in surgical intensive care(During hospital stay up to 3 months after discharge)
  • Impact of a stay surgical intensive care on medical prescription change(During Hospital stay in ICU (Day 0, 4, 8, 12, 16) and 3 months after discharge)
  • Evaluate the intervention's impact on the disability and geriatric evaluation with ADL scale(3 months after hospital discharge)
  • Evaluate the intervention's impact on the disability and geriatric evaluation with SEGA scale(3 months after hospital discharge)
  • Analyse the opportunities suggested by the pharmacist for optimization of drug therapies(During Hospital stay ICU (Day 0, 4, 8, 12, 16))

Study Sites (1)

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