A Randomized Study of Superiority of POSToperative Pharmaceutical Support on Patients' Knowledge of Their IMPlant

NCT ID: NCT04302233

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2021-11-01

Brief Summary

Recently joint and breast prostheses were placed under special post-marketing surveillance in order to prevent new occurrence of serious incidents by agency for medicines and health products safety. Few of french patient are able to identify their prosthesis in the event on health security alert. An usual postoperative pharmaceutical support (UPS) for patients with joint prosthesis has been implemented to prepare them for return home. At the request of surgeons, a new pharmaceutical support (NPS) has been developed to improve the ability of these patients to recall or find information that identify their prosthesis.

Objectives :

The main objective is to demonstrate that the new pharmaceutical support (NPS) increase the ability to memorize then find correct information of their prosthesis 6 months post-implantation

Material and method :

This study, approved by an ethic committee, takes place in the orthopedic and plastic surgery departments. The 236 adult patients included are hospitalized following the scheduled placement of either a breast or a hip or knee prosthesis. They are randomized, either in the NPS group or in the UPS comparator group. In both cases, patients benefit from the same written information: a patient-implant file and an information booklet specific to their prosthesis, validated by specialist surgeons, to prepare for their return home. The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization. In NPS group, pharmacist use specific photo and quiz.

A telephone follow-up at the 6th month of the patients is carried out by a pharmacist to assess the patient's knowledge, using a standardized questionnaire.

Expected results :

Based on retrospective data already published, the main hypothesis is that the NPS is associated with an improvement in patient ability to remember the correct model or manufacturer of their prosthesis, compared to the UPS, 6 months after the operation.Secondary hypotheses are that NPS compared to UPS leads to an improvement in patients ability to preserve and find correct items related to theirs prosthesis at 6 months as well as an improvement in their knowledge of medical device vigilance and patient satisfaction declarations and a decrease in anxiety associated with prosthesis.

Conditions

Joint Prosthesis; Breast Implants; Health Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

New pharmaceutical support (NPS)

An NPS is an interview comprising the following elements:

The delivery of the identification sheet of their implants with:

• a quiz to focus the patient's attention
• a description of the characteristics of their prosthesis using a specific photo of their implant
• a presentation of the medical device vigilance.
• an explanation of the value of the identification sheet for their implant, An in-depth presentation of an information booklet on living at home with their prosthesis and on medical and paramedical monitoring.

For patients in orthopedic surgery: a booklet specific to their prosthesis and the surgical approach For plastic surgery patients, the information sheets published by the French Society of Plastic Reconstructive and Aesthetic Surgery (SOF.CPRE).

A time to answer any questions the patient may have

Group Type: EXPERIMENTAL

New pharmaceutical support (NPS)

Intervention Type: OTHER

The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization.

Usual pharmaceutical support (UPS)

An UPS is an interview comprising the following elements:

• The delivery of the same patient-implant sheet as in arm 1, but without additional oral information.
• The delivery and oral presentation of the same booklet as practiced in the arm 1 (NPS).
• And a time to answer any questions from the patient months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

New pharmaceutical support (NPS)

The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient aged 18 or over
• Patient hospitalized following the scheduled placement of one of the following prostheses: three-compartment knee prostheses or total hip prosthesis or breast implant
• French-speaking or non-French-speaking patient accompanied by a French-speaking support person
• Patient having received complete information and having signed a free and informed consent for the research
• Patient affiliated to a social security scheme (beneficiary or entitled)

Exclusion Criteria

• Patient having been operated on for the installation of an orthopedic prosthesis not programmed within the framework of a trauma emergency.
• Patient suffering from post-operative confusional syndrome;
• Non-French speaking patient unaccompanied or accompanied by a non-French speaking support person
• Patient on state medical aid
• Persons referred to in articles L1121-5, 6 and 8 of the public health code (corresponds to protected persons): pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to legal protection measure, hospitalized for psychiatric disorder.
• Patient who has already had postoperative pharmaceutical support for the placement of the same type of prosthesis on the contralateral limb
• Patient suffering from a known cognitive or memory disorder.
• Patient expressly refusing to participate in the telephone interview

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, , France

Countries

France

Other Identifiers

APHP200083

Identifier Type: -

Identifier Source: org_study_id