Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization (IATRO'MED)
The hypothesis is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patients and hospital and health care professionals, allows: i) to initiate a therapeutic review during hospitalization, ii) to accompany the patients upon hospital discharge, iii) to maintain, in outpatient care, the drug treatments that have been optimized during hospitalization.
The main objective of the study is to demonstrate that the intervention of an EOPC in surgical departments and then in outpatient care makes it possible to maintain, 45 days after the discharge of the patients aged 65 years and over, the chronic outpatient treatments revised and optimized during the hospital stay.
The secondary objectives are to measure the impacts of EOPC's intervention on:
- unexpected readmissions, emergency use, medical complications and adverse drug reactions;
- patient and health professional satisfactions (community pharmacists and physicians);
- the costs of drug treatments in ambulatory care.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Strasbourg, France, 67098
- Recruiting
- Les Hopitaux Universitaires de Strasbourg
-
Contact:
- Bruno MICHEL
- Phone Number: +33 303 69 55 16 41
- Email: bruno.michel@chru-strasbourg.fr
-
Principal Investigator:
- Bruno MICHEL
-
Sub-Investigator:
- Gabrielle DE GUIO
-
Sub-Investigator:
- Anne-Sophie BELMAS
-
Strasbourg, France, 67000
- Recruiting
- Groupe Hospitalier Saint Vincent
-
Contact:
- Franck COUTURIER
- Phone Number: +33 3 88 45 81 62
- Email: f.couturier@ghsv.org
-
Principal Investigator:
- Franck COUTURIER
-
Sub-Investigator:
- Mélanie NOLL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient (man or woman)
- age ≥ 65 years with more than 3 drugs taken for 3 months, stay in surgery with a duration of ≥ 1 days including urgent surgery;
- affiliated to a social health insurance scheme;
- for whom a return home is possible;
- able to understand the objectives of the research and give informed, dated and signed consent.
Exclusion Criteria:
- Patient (man or woman)
- with as a hospital discharge an entry into a nursing home or long-term care called "important medical and technical care (SMTI);
- with cognitive or other problems preventing consent (at the discretion of the geriatric expertise team);
- under the safeguard of justice;
- under tutorship or curatorship.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: "intervention " group
Patient At D0, the patient receives his discharge drugs prescription and benefits from a pharmaceutical counselling. At D+3, he benefits from a telephone follow-up (good understanding of the methods of taking drugs, collection of difficulties). Community pharmacist At D0, he receives the discharge drugs prescription. At D+3, he is contacted to collect information relating to drugs 'dispensation. The attending physician At D0, he is informed of the patient's discharge and his drugs treatment At D45, the data collection is based on telephone interviews [attending physician, pharmacist and patient (and if applicable the caregiver)]. It makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.). |
The issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists. The scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization. |
|
No Intervention: Control group
At D0, the patient receives his discharge drugs prescription. At D45, the data collection is based on telephone interviews [attending physician, pharmacist and patient (and if applicable the caregiver)]. It makes possible to collect drugs taken by the patient as well as significant events over the period (acute pathologies, re-hospitalizations, etc.). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance of patients' medication intake at 45 days (D45) compared to the discharge prescription (D0): drugs prescribed and taken by patients (chronic disease treatments only)
Time Frame: 45 days
|
Compliance is defined as the absence of discrepancies between D0 and D+45.
Conversely, the presence of a discrepancy is defined as the presence of at least one deviation of drug intake at D+45 from D0.
|
45 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- 7363
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.