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

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ClinicalTrials.gov Identifier: NCT03706092
Recruitment Status : Unknown
Verified October 2018 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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 insitution, 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 datas 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.


Condition or disease
Aged Critical Care

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 geriaitrician.

  • The sociodemographic, and medical (comorbidities, reason for ICU admission, SAPS II (Simplified Acute Physiology Score) and SOFA (Sepsis-related Organ Failure Assessment) scores, laboratory datas, invasive procedures datas will be collected from ICU medical record.
  • A geriatric evaluation and disability evaluation will be performed by using the ADL (Activity 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 datas 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Intervention of Pharmacists and Geriatrician on Drug Prescription in Critically Ill Elderly Patients Admitted in Surgical ICU
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Group/Cohort
Before
Elderly patients > = 70 in ICU without any intervention of the pharmacists and of the geriatricians
After
Elderly patients > = 70 in ICU with individualized intervention of the pharmacists and of the geriatricians



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Describe the medical characteristics of elderly patients population in surgical intensive care with the Charlston Comorbidities Index (CCI) [ Time Frame: During hospital stay up to 3 months after discharge ]

    Charlston Comorbidities Index

    Three grades of severity:

    mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; severe, with CCI scores ≥5


  2. Describe the medical characteristics of elderly patients population in surgical intensive care [ Time Frame: During hospital stay up to 3 months after discharge ]
    Rates of hospitalization's causes: surgical emergency causes, elective surgery causes, medical emergency causes, elective medical causes

  3. Describe the demographic elderly patients population in surgical intensive care [ Time Frame: During hospital stay up to 3 months after discharge ]
    age, sex

  4. Impact of a stay surgical intensive care on medical prescription change [ Time Frame: During Hospital stay in ICU (Day 0, 4, 8, 12, 16) and 3 months after discharge ]
    number of new treatment, number of new interaction, number of iatrogenic event, before/after surgical intensive care

  5. Evaluate the intervention's impact on the disability and geriatric evaluation with ADL scale [ Time Frame: 3 months after hospital discharge ]

    Evolution of disability and geriatric evaluation before/after intervention:

    - ADL (Activity Daily Living evolution of the different geriatrics scores) 0 : dependance, 6 autonomy


  6. Evaluate the intervention's impact on the disability and geriatric evaluation with SEGA scale [ Time Frame: 3 months after hospital discharge ]

    Evolution of disability and geriatric evaluation before/after intervention:

    - SEGA (Short Emergency Geriatric Assessment): 0-26 < or = 8 : Low fragility, 9-11: fragility, > or = 12 Very fragile person


  7. Analyse the opportunities suggested by the pharmacist for optimization of drug therapies [ Time Frame: During Hospital stay ICU (Day 0, 4, 8, 12, 16) ]
    rates of kind opportunities suggested by the pharmacist (dosage adjustement, galenic form change, inappropriate medication ...)



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
70 years or older patient admitted to surgical ICU of university affiliated hospital of Besançon
Criteria

Inclusion Criteria:

  • patients 70 years or older
  • admitted to surgical ICU

Exclusion Criteria:

  • patients refusing data collection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706092


Contacts
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Contact: Anne Laure CLAIRET 3 70 63 22 84 ext +33 alclairet@chu-besancon.fr
Contact: Guillaume BESCH 3 81 21 89 58 ext +33 gbesch@chu-besancon.fr

Locations
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France
CHU de Besançon Recruiting
Besançon, France, 25000
Contact: Lucie VETTORETTI       lvettoretti@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Anne Laure CLAIRET CHU de Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03706092    
Other Study ID Numbers: IATROAGE
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
iatrogenic
surgery ICU
quality of life
disability
inappropriate medications