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.

Withdrawn

• Conditions: Iatrogenic Effect
• Interventions: Other: therapeutic drug conciliation sheet (TDC); Other: No Use of therapeutic drug conciliation sheet (TDC)

• Registration Number: NCT02916836
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Study Start: 2017-01
• Primary Completion: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With TDC sheet	therapeutic drug conciliation sheet (TDC)	Use of therapeutic drug conciliation sheet (TDC) by the hospital and transmitted to the family practitioner with other usual documentation
Without TDC Sheet	No Use of therapeutic drug conciliation sheet (TDC)	transmission of usual documentation only to the family practitioner

Primary Outcome Measures

Name	Time	Method
rate of patient who will have used hospital care in emergency	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.