Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients (OPMED)

September 27, 2017 updated by: Hospices Civils de Lyon

OPMED STUDY: Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients

Drug prescription is a fundamental component of care for the elderly. Even if drugs are a chance for the older patient, because of changes in pharmacological, pharmacokinetic and pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks associated with drug prescription, particularly those associated with potentially inappropriate medication (PIM), are increased in the elderly.

We suppose that many of hospitalized elderly have at least one prescribed medication without valid indication. Conversely, many diseases are currently undertreated in elderly patients: e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of patients. Moreover, PMI prescription is associated with an increased of morbidity, mortality, risk of drug-related adverse events, utilization of health care system, care costs and impairment of quality of life. Thus, optimization of drug prescription is a major concern for improvement of the quality and safety of care in elderly.

The investigators' hypothesis is that a multidisciplinary program entitled "Optimisation de la Prescription MEDicamenteuse" ("Optimization of drug prescribing") focused on drug prescription optimization including a physician training to the specificity of the drug prescription in the elderly and a checklist allowing an adapted and standardized pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in short-term medical and geriatric care departments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3055

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hospices Civils de Lyon - Hôpital Édouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized elderly patients from 75 years old.

Description

Inclusion Criteria:

  • Male or female subject aged over 75 years hospitalized in one of the participating department
  • Patient agreed to participate

Exclusion Criteria:

  • Patient with a predictive length of stay equal or less than 48 hours
  • Patients admitted in terminal illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Patients of this group are hospitalized in a time frame where the multidisciplinary intervention program is not implemented in the medical department. Drug prescriptions are conducted under usual care in the department.
Intervention group
Patients of this group are hospitalized in a time frame where the multidisciplinary intervention program is implemented in the medical department.
Other: " Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing")

The multidisciplinary intervention program include:

  • Awareness and training of doctors by two experts (a geriatrician and a pharmacist) within participating departments.
  • Implementation of a checklist which aims to conduct an adapted and standardized pharmaceutical analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of potentially inappropriate medications (PIM) prescribed in discharge of hospitalized patients from 75 years old.
Time Frame: at discharge (average 3 weeks)

Proportion of prescribed PIM will be expressed as the ratio of PIM to the total number of medication in discharge prescription sheet.

PIM will be identified by 2 experts (1 doctor and 1 pharmacist) based on criteria from the lists STOPP/START and Laroche.
at discharge (average 3 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Total number of drugs prescribed per discharge prescription sheet
Time Frame: at discharge (average 3 weeks)
at discharge (average 3 weeks)
Number of rehospitalization within 12 months following discharge
Time Frame: 12 months after inclusion
12 months after inclusion
Number of emergency admission within 12 months following hospitalization
Time Frame: 12 months after inclusion
12 months after inclusion
Mortality within 12 months after hospitalization
Time Frame: 12 months after inclusion
12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

June 1, 2017

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (ESTIMATE)

September 20, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D50789

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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