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

NCT03706092 | Completed

• 1 other identifier: IATROAGE
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged; Critical Care

Keywords

iatrogenic; surgery ICU; quality of life; disability; inappropriate medications

Outcome Measures

Primary Outcomes (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.

  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)

  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

Study Arms (2)

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patients 70 years or older
• admitted to surgical ICU

You may not qualify if:

• patients refusing data collection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

Study Officials

• Anne Laure CLAIRET

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: October 15, 2018
• Study Start: August 1, 2018
• Primary Completion: March 23, 2020
• Study Completion: July 1, 2020
• Last Updated: March 9, 2021

Record last verified: 2019-12

Locations

FR (1)