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NCT05713071
Body Weight, Body Weight Changes
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT06517303
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
All sexes
Observational
HEGP, Paris, France
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 :
The study will be conducted in 2 steps:
Around a hundred patients corresponding to this criteria will be extracted from the HEGP data warehouse
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients aged 18 to 65 at the time of prescription with a BMI>35 kg/m² present in the clinical data warehouse of the HEGP and CHU Rennes during the study period with at least one hospitalization of more than 24h.
Exclusion criteria
Time frame: 8 months
number of prescriptions concerned by rules, by type of recommendation, in patients with severe obesity.
Time frame: 12 months
Number of validated recommendations and their level of evidence, validated by experts
Time frame: 8 months
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.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: RECOB-MED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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