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AgedIATROAGENCT03706092

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

An observational study of Aged and Critical Care, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Aged, Critical Care
How many people
230 participants
Where
1 siteFrance
Study dates
1 Aug 2018to 1 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 70 years or older patient admitted to surgical ICU of university affiliated hospital of Besançon

Who may be able to join

  • patients 70 years or older
  • admitted to surgical ICU

Who cannot join

  • patients refusing data collection

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de Besançon

    Besançon, 25000

Other trials in France

About this study

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

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.

Read the 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
Keywords
iatrogenic, surgery ICU, quality of life, disability, inappropriate medications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03706092
Study groupRoleWhat they receive
BeforeElderly patients > = 70 in ICU without any intervention of the pharmacists and of the geriatricians
AfterElderly patients > = 70 in ICU with individualized intervention of the pharmacists and of the geriatricians

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of geriatric and pharmacist's intervention

    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.

    Measured: Hospital stay until 3 months after

Secondary outcomes (7)
  1. Describe the medical characteristics of elderly patients population in surgical intensive care with the Charlson Comorbidities Index (CCI)

    Charlson 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

    Measured: During hospital stay up to 3 months after discharge

  2. Describe the medical characteristics of elderly patients population in surgical intensive care

    Rates of hospitalization's causes: surgical emergency causes, elective surgery causes, medical emergency causes, elective medical causes

    Measured: During hospital stay up to 3 months after discharge

  3. Describe the demographic elderly patients population in surgical intensive care

    age, sex

    Measured: During hospital stay up to 3 months after discharge

  4. Impact of a stay surgical intensive care on medical prescription change

    number of new treatment, number of new interaction, number of iatrogenic event, before/after surgical intensive care

    Measured: During Hospital stay in ICU (Day 0, 4, 8, 12, 16) and 3 months after discharge

  5. Evaluate the intervention's impact on the disability and geriatric evaluation with ADL scale

    Evolution of disability and geriatric evaluation before/after intervention:

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

    Measured: 3 months after hospital discharge

  6. Evaluate the intervention's impact on the disability and geriatric evaluation with SEGA scale

    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

    Measured: 3 months after hospital discharge

  7. Analyse the opportunities suggested by the pharmacist for optimization of drug therapies

    rates of kind opportunities suggested by the pharmacist (dosage adjustment, galenic form change, inappropriate medication ...)

    Measured: During Hospital stay ICU (Day 0, 4, 8, 12, 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2018
  2. Study start1 Aug 2018
  3. Primary completion23 Mar 2020
  4. Study completion1 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03706092
Sponsor's protocol ID
IATROAGE
Acronym
IATROAGE
Status last verified
Dec 2019
First submitted
16 Aug 2018
Last updated
9 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aged and Critical Care, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of geriatric and pharmacist's intervention (time frame: Hospital stay until 3 months after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.

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