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

Primary Purpose

Bone and Joint Infection

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pharmaceutical interview
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone and Joint Infection focused on measuring osteo articular infection, adverse event, antibiotic treatment, pharmaceutical interview

Eligibility Criteria

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

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.

Sites / Locations

  • Pharmacy of Ambroise-Paré hospital, APHPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patients with pharmaceutical interview

Patients without pharmaceutical interview

Arm Description

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

Control group without interview

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2022
Last Updated
August 25, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05248490
Brief Title
Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home
Acronym
EFIRAD
Official Title
Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone and Joint Infection
Keywords
osteo articular infection, adverse event, antibiotic treatment, pharmaceutical interview

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients with pharmaceutical interview
Arm Type
Experimental
Arm Description
Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization.
Arm Title
Patients without pharmaceutical interview
Arm Type
No Intervention
Arm Description
Control group without interview
Intervention Type
Other
Intervention Name(s)
pharmaceutical interview
Intervention Description
Pharmaceutical interview with pharmacist: to be informed treatment taken and related SAE informations at the end of hospitalization
Primary Outcome Measure Information:
Title
Adverse effects self-management measurement
Description
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.
Time Frame
at day 7
Title
Adverse effects self-management measurement
Description
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.
Time Frame
at day 14
Secondary Outcome Measure Information:
Title
Patient knowledge assessment
Description
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
Time Frame
at day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Tritz, PharmD
Phone
+ 33 01 49 09 45 23
Email
thomas.tritz@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Deschamps
Phone
+ 33 01 49 09 45 23
Email
manon.deschamps@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Tritz, PharmD
Organizational Affiliation
Pharmacy of Ambroise-Paré hospital, APHP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christophe Menigaux, MD
Organizational Affiliation
Orthopedic surgery department, Ambroise Paré hospital, APHP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nathalie Dournon, MD
Organizational Affiliation
Infectiology mobile team, Ambroise Paré hospital, APHP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jessica Berdougo Berdougo, PharmD
Organizational Affiliation
Pitié-Salepetrière hospital, APHP
Official's Role
Study Chair
Facility Information:
Facility Name
Pharmacy of Ambroise-Paré hospital, APHP
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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