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

February 24, 2022 updated by: University Hospital, Strasbourg, France

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
        • Recruiting
        • Les Hopitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Bruno MICHEL
        • Sub-Investigator:
          • Gabrielle DE GUIO
        • Sub-Investigator:
          • Anne-Sophie BELMAS
      • Strasbourg, France, 67000
        • Recruiting
        • Groupe Hospitalier Saint Vincent
        • Contact:
        • Principal Investigator:
          • Franck COUTURIER
        • Sub-Investigator:
          • Mélanie NOLL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

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