Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home (EFIRAD)

The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.

Study Overview

• Status: Completed
• Conditions: Bone and Joint Infection
• Intervention / Treatment: Other: pharmaceutical interview

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Pharmacy of Ambroise-Paré hospital, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient > or =18 years;
• Informed consent signed;
• French-speaking and reading;
• Affiliated to a social insurance;
• Benefiting from medical and surgical care for an osteoarticular infection;
• Treated with an oral antibiotic therapy on discharge from hospital.
• Indication of the antibiotic therapy osteoarticular infection;
• Return home immediately after discharge.

Exclusion Criteria:

• Refusal to participate
• Protected adult patient, under guardianship or curatorship.
• Minor patient
• Patient benefiting from an AME.
• Pregnant or breastfeeding woman.
• Non-French speaking patient.
• Patient unable to understand the course of the study.
• Patient with a documented history of cognitive or psychiatric disorders.
• Patient treated with oral antibiotic therapy for an indication other than osteoarticular infection.
• Patient treated with parenteral antibiotic therapy.
• Discharge: Institution (EHPAD), rehabilitation or other health establishment.
• Patient systematically using one of the symptomatic treatments proposed in the discharge prescription before hospitalization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with pharmaceutical interview; Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization.	Other: pharmaceutical interview; Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization
No Intervention: Patients without pharmaceutical interview; Control group without interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects self-management measurement	Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree. Proportion of patients with an optimal or non-optimal self-management.	at day 7
Adverse effects self-management measurement	Phone call to evaluate the self-management of adverse effects. Self-management evaluation (optimal choice/non-optimal choice) performs thanks to the use of a standardized decision-tree. Proportion of patients with an optimal or non-optimal self-management.	at day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient knowledge assessment	Questionnaire, 12 points: proportion of patients reaching a score upper than 10; proportion of patients reaching a score between 6 and 9; proportion of patients reaching a score lower than 6	at day 7

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Thomas Tritz, PharmD, Pharmacy of Ambroise-Paré hospital, APHP; Study Chair: Christophe Menigaux, MD, Orthopedic surgery department, Ambroise Paré hospital, APHP; Study Chair: Nathalie Dournon, MD, Infectiology mobile team, Ambroise Paré hospital, APHP; Study Chair: Jessica Berdougo Berdougo, PharmD, Pitié-Salepetrière hospital, APHP

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: antibiotic treatment; adverse event; osteo articular infection; pharmaceutical interview
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: APHP211422; 2021-A02433-38 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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