NCT01947270

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,055

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

4.4 years

First QC Date

July 26, 2013

Last Update Submit

September 27, 2017

Conditions

Keywords

Potentially inappropriate medicationsElderlyPreventionMultidisciplinary programChecklistStepped wedge designAGED, 75 AND OVER

Outcome Measures

Primary Outcomes (1)

  • Proportion of potentially inappropriate medications (PIM) prescribed in discharge of hospitalized patients from 75 years old.

    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 Outcomes (4)

  • Total number of drugs prescribed per discharge prescription sheet

    at discharge (average 3 weeks)

  • Number of rehospitalization within 12 months following discharge

    12 months after inclusion

  • Number of emergency admission within 12 months following hospitalization

    12 months after inclusion

  • Mortality within 12 months after hospitalization

    12 months after inclusion

Study Arms (2)

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")

Interventions

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

Intervention group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized elderly patients from 75 years old.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Hôpital Edouard Herriot

Lyon, 69003, France

Location

Study Design

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

Study Record Dates

First Submitted

July 26, 2013

First Posted

September 20, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations