Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-28 @ 7:47 AM
Study NCT ID:
NCT06517303
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-26
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
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:
False
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 (BMI\>35 kg/m2) 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 (BMI\>35 kg/m2) 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 experts/analysis 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 experts/analysis 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PREPS-19-127 | OTHER_GRANT | French ministry of health | View |