NCT02916836

Brief Summary

The drug iatrogenesis represents an important public health problem. In the Iatromed project, we want to to assess a specific therapeutic drug conciliation sheet (TDC). This multicenter observational study is focus on 750 patients aged over 75 year old with polymedication. The main objective will be to determine if the use of the TDC, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

September 26, 2016

Last Update Submit

February 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • rate of patient who will have used hospital care in emergency

    The use of hospital care in emergency is defined as a consultation in an emergency room and/or an emergency hospitalization. An emergency hospitalization is an hospitalization for which programing was made maximum 48h before the admission in hospital or clinic. The use will be documented by contact with the patient (or the support person if necessary) and his doctor. Here, it should be noted that deaths will be accounted for in the urgently use of to the hospital care regardless of the place of death. This in intended to take into account the possibility that a death may be related to a drug iatrogenic event for which the patient has not had time to resort to the hospital care in emergency.

    at least one time within the two month after their hospital discharge

Study Arms (2)

With TDC sheet

Use of therapeutic drug conciliation sheet (TDC) by the hospital and transmitted to the family practitioner with other usual documentation

Other: therapeutic drug conciliation sheet (TDC)

Without TDC Sheet

transmission of usual documentation only to the family practitioner

Other: No Use of therapeutic drug conciliation sheet (TDC)

Interventions

Use of therapeutic drug conciliation sheet (TDC)

With TDC sheet

Eligibility Criteria

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

Hospitalized patient aged over 75 years old

You may qualify if:

  • age ≥75 years
  • patients with a medical prescription, including at least three different allopathic molecules including at least a treatment in one of the following therapeutic classes:
  • cardiovascular treatment: antiarrhythmics, antihypertensive drugs, anticoagulants and antiplatelet all classes
  • treatment of the central nervous system: analgesics, benzodiazepines, antidepressants, hypnotic, antipsychotic drugs of all classes.
  • family practitioner identified
  • trusted personne identified
  • Hospital output project establishes

You may not qualify if:

  • not speaking french patient
  • short survival time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Olivier GUERIN

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2020

Last Updated

February 19, 2018

Record last verified: 2018-02