- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916836
Effect of the Use of a Therapeutic Conciliation Document at the Outlet of Hospital, on the Emergency Use of Hospital Care in Patient Aged Over 75 Years Old. (IATROMED)
Study Overview
Status
Conditions
Detailed Description
The drug iatrogenesis represents an important public health problem with 5-10% of the grounds of hospitalization after age 65, and more than 20% after 80 years. Based on this observation, the health authority has proposed in 2011 the realization of therapeutic drug conciliation particularly in the elderly with multiple pathologies and multiple drugs. Taking into account the central role of the family practitioner in prescriptions, and the importance of coordination information such as output of hospitalization (vector of many malfunctions), we have achieved a therapeutic drug conciliation sheet (TDC) based primarily on the information needs by family practitioner after hospitalization of their patients. The issue of this study is to assess the interest for the use of a such TDC on the decrease in the rate of rehospitalization in the target population.
To do this, we are proposing a multicenter observational study. Randomization would be across the centres. The study would focus on 750 patients more of 75 with polymedication. The follow-up will last 6 months.
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. The first secondary objective will be identical to the main objective but rated at 6 months and the second secondary objective will be to assess the impact of the use of the TDC on overall mortality at 6 months.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- not speaking french patient
- short survival time
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
With TDC sheet
Use of therapeutic drug conciliation sheet (TDC) by the hospital and transmitted to the family practitioner with other usual documentation
|
Use of therapeutic drug conciliation sheet (TDC)
|
Without TDC Sheet
transmission of usual documentation only to the family practitioner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of patient who will have used hospital care in emergency
Time Frame: at least one time within the two month after their hospital discharge
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Olivier GUERIN, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-PREPS-01
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