search
Back to results

Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization (IATRO'MED)

Primary Purpose

Older Adult, Chronic Disease, Clinical Pharmacy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOPC Intervention
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Older Adult focused on measuring Multicenter study, Before-and-after type study, Minimal risks and constraints

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Groupe Hospitalier Saint VincentRecruiting
  • Les Hôpitaux Universitaires de StrasbourgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

"intervention " group

Control group

Arm Description

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.).

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.).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2019
Last Updated
February 24, 2022
Sponsor
University Hospital, Strasbourg, France
search

1. Study Identification

Unique Protocol Identification Number
NCT04020692
Brief Title
Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization
Acronym
IATRO'MED
Official Title
Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Older Adult, Chronic Disease, Clinical Pharmacy, Surgery, Ambulatory Care
Keywords
Multicenter study, Before-and-after type study, Minimal risks and constraints

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"intervention " group
Arm Type
Experimental
Arm Description
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.).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.).
Intervention Type
Behavioral
Intervention Name(s)
EOPC Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Groupe Hospitalier Saint Vincent
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck COUTURIER
Phone
+33 3 88 45 81 62
Email
f.couturier@ghsv.org
First Name & Middle Initial & Last Name & Degree
Franck COUTURIER
First Name & Middle Initial & Last Name & Degree
Mélanie NOLL
Facility Name
Les Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno MICHEL
Phone
+33 303 69 55 16 41
Email
bruno.michel@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Bruno MICHEL
First Name & Middle Initial & Last Name & Degree
Gabrielle DE GUIO
First Name & Middle Initial & Last Name & Degree
Anne-Sophie BELMAS

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization

We'll reach out to this number within 24 hrs