Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04302233
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2020-02-26
Brief Title:
A Randomized Study of Superiority of POSToperative Pharmaceutical Support on Patients Knowledge of Their IMPlant
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
A Randomized Controlled Study of the Superiority Between 2 Types of POSToperative Pharmaceutical Support on Patients Knowledge of Their IMPlant Breast or Joint Prostheses
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSTIMP
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 patients 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 operationSecondary 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
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 patients 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 operationSecondary 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None