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

Not Applicable

Completed

• Conditions: Bone and Joint Infection
• Interventions: Other: pharmaceutical interview

• Registration Number: NCT05248490
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Study Start: 2022-03-22
• Primary Completion: 2024-06-05
• Study Completion: 2024-06-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with pharmaceutical interview	pharmaceutical interview	Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization.

Primary Outcome Measures

Name	Time	Method
Adverse effects self-management measurement	at day 14	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.

Secondary Outcome Measures

Name	Time	Method
Patient knowledge assessment	at day 7	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

Trial Locations

Locations (1)

Pharmacy of Ambroise-Paré hospital, APHP; 🇫🇷 Boulogne-Billancourt, France