Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity Retrospective Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity Retrospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOB-MED
Brief Summary:
No drug prescription guidelines for severe obesity BMI35 kgm2 are available leading to non-standardized and or potentially inappropriate drug management
After validation of guidelines by the Delphi method the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses
The investigators will perform a retrospective multicentric study in 2 hospitals The investigators will check the relevance of rules alerts derived from the recommendations identified using the Delphi method
After validation of guidelines by the Delphi method the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses
The investigators will perform a retrospective multicentric study in 2 hospitals The investigators will check the relevance of rules alerts derived from the recommendations identified using the Delphi method
Detailed Description:
No drug prescription guidelines for severe obesity BMI35 kgm2 are available leading to non-standardized and or potentially inappropriate drug management
After validation of guidelines by the Delphi method the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses
The investigators will perform a retrospective multicentric study in 2 hospitals The investigators will check the relevance of rules alerts derived from the recommendations identified using the Delphi method
The sponsor anticipate around 800 patients in the HEGP data warehouse and around 250 patients in the Rennes University Hospital data warehouse
The main outcome will be the number of prescriptions concerned by rules by type of recommendation in patients with severe obesity
Secondary outcomes will be
1 Number of validated recommendations and their level of evidence
2 Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule Sub-group analysis of this rate by type of recommendation
The study will be conducted in 2 steps
Stage 1 secondary endpoint it consists of the final drafting of recommendations and submission to expertsanalysis of feedback This stage is scheduled to last 12 months
Stage 2 primary and secondary judgment criteria it consists of implementing the recommendations and studying the relevance of the rules This stage is scheduled to last 8 months
Around a hundred patients corresponding to this criteria will be extracted from the HEGP data warehouse
After validation of guidelines by the Delphi method the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses
The investigators will perform a retrospective multicentric study in 2 hospitals The investigators will check the relevance of rules alerts derived from the recommendations identified using the Delphi method
The sponsor anticipate around 800 patients in the HEGP data warehouse and around 250 patients in the Rennes University Hospital data warehouse
The main outcome will be the number of prescriptions concerned by rules by type of recommendation in patients with severe obesity
Secondary outcomes will be
1 Number of validated recommendations and their level of evidence
2 Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule Sub-group analysis of this rate by type of recommendation
The study will be conducted in 2 steps
Stage 1 secondary endpoint it consists of the final drafting of recommendations and submission to expertsanalysis of feedback This stage is scheduled to last 12 months
Stage 2 primary and secondary judgment criteria it consists of implementing the recommendations and studying the relevance of the rules This stage is scheduled to last 8 months
Around a hundred patients corresponding to this criteria will be extracted from the HEGP data warehouse
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None