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: Recruiting
• Conditions: Chronic Disease; Surgery; Ambulatory Care; Older Adult; Clinical Pharmacy
• Intervention / Treatment: Behavioral: EOPC Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • 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: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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.).	Behavioral: EOPC Intervention; 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)	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

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): July 16, 2019
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Multicenter study; Before-and-after type study; Minimal risks and constraints
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 7363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No