NCT03415113

Brief Summary

The geriatric population is exposed to poly-medication. Furthermore, old people have important pharmacodynamic and pharmacokinetic changes that expose to much drug iatrogenic. Adverse drug effects are a great cause for hospitalization that is why the knowledge of the complete list of medications taken by the patient is necessary. The poly-medication in elderly can lead to extremely serious clinical consequences and significant costs. Reference documents specific to geriatrics guide the doctor in therapeutic choices. On the one hand, the Laroche's criteria lists all PIM of the French pharmacopoeia in elderly. On the other hand, STOPP/START criteria are a tool for detect PIM listing inappropriate drugs and criteria of potentially drug omissions. This has been validated in French language. It is important that any changes proposed by the geriatrician resulting in just prescription is sustainable beyond the hospitalization to prevent the recurrence of adverse effects. Effective community-hospital coordination is essential. Medication reconciliation is defined as the formal process of checking the complete, accurate list of a patient's previous medication - including drug name, dosage, frequency, and route - and comparing it with the prescription after a transition of care (on admission, after transfer to another medical unit, and/or at discharge). Two groups of patients will be created, one for which medication reconciliation at discharge will be practiced and the other a similar process but not standardized. Four to eight weeks after the discharge, the member of the pharmacy team is calling the usual community pharmacy to get the first non-hospital prescription by fax and compare the number of PIM with the prescription before hospitalization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

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

April 14, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

December 27, 2017

Last Update Submit

January 23, 2018

Conditions

Keywords

Medication reconciliation at discharge, potentially inappropriate medications, elderly.

Outcome Measures

Primary Outcomes (1)

  • Quantification of potentially inappropriate medication prescription

    Quantification of potentially inappropriate medication on the first non-hospital

    4 or 8 weeks

Eligibility Criteria

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

Geriatic population

You may qualify if:

  • Male or female, age ≥ 75 years
  • Pharmaceutical interview at the medication reconciliation at admission in Geriatrics Acute Care Unit.
  • ≥ one PIM on the prescription before admission
  • Identification of the usual referent community pharmacist
  • Output of the unit by a return home
  • Affiliation to a social security scheme

You may not qualify if:

  • Patients undergoing a regime of legal protection.
  • Patients unable to cooperate in pharmaceutical interview at the medication reconciliation at admission whatever reason.
  • Refusal to participate in the study.
  • Output of the unit by transfering to another care unit or death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Guillaume DESCHASSE, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 27, 2017

First Posted

January 30, 2018

Study Start

April 14, 2016

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

January 30, 2018

Record last verified: 2018-01