Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization

Surgery Clinical Trial

— IATRO'MED  

Official title:

Home Improvement Initiative of the TRaitement Optimisé Medicamenteux After Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04020692
• Other study ID #: 7363
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 31, 2023
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ambulatory Care
• Chronic Disease
• Clinical Pharmacy
• Older Adult
• Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Saint Vincent	Strasbourg
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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