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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
Describe the demographic elderly patients population in surgical intensive care
age, sex
Measured: During hospital stay up to 3 months after discharge
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
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
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
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.
- First posted15 Oct 2018
- Study start1 Aug 2018
- Primary completion23 Mar 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Laure CLAIRET, Principal investigator, CHU de Besançon
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Intervention of Pharmacists and Geriatrician on Drug Prescription in Critically Ill Elderly Patients Admitted in Surgical ICU
- ClinicalTrials.gov ID
- NCT03706092
- Acronym / sponsor ID
- IATROAGE / IATROAGE
- Conditions
- Aged, Critical Care
- Keywords
- iatrogenic, surgery ICU, quality of life, disability, inappropriate medications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 70 years or older patient admitted to surgical ICU of university affiliated hospital of Besançon
Key inclusion criteria (2 listed)
- patients 70 years or older
- admitted to surgical ICU
Key exclusion criteria (1 listed)
- patients refusing data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Describe the medical characteristics of elderly patients population in surgical intensive care with the Charlson Comorbidities Index (CCI)
Time frame: During hospital stay up to 3 months after discharge
Describe the medical characteristics of elderly patients population in surgical intensive care
Time frame: During hospital stay up to 3 months after discharge
Describe the demographic elderly patients population in surgical intensive care
Time frame: During hospital stay up to 3 months after discharge
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
Evaluate the intervention's impact on the disability and geriatric evaluation with ADL scale
Time frame: 3 months after hospital discharge
Evaluate the intervention's impact on the disability and geriatric evaluation with SEGA scale
Time frame: 3 months after hospital discharge
Analyse the opportunities suggested by the pharmacist for optimization of drug therapies
Time frame: During Hospital stay ICU (Day 0, 4, 8, 12, 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Laure CLAIRET principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
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.