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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Iatrogenic Effect
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patient aged over 75 years old

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of patient who will have used hospital care in emergency
timeFrame: at least one time within the two month after their hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Olivier GUERIN
role: PRINCIPAL_INVESTIGATOR
References: