Clinical trial NCT06517303: Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study
Official title: Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity, Morbid
Drug Use
Keywords: prescription drug guidelines
clinical decision support system
Rule-based Alert System
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Rennes University Hospital
First posted: 2024-07-24
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 18 to 65 at the time of prescription with a BMI\>35 kg/m² present in the clinical data warehouse

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.

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

Eligibility criteria: 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:

* Patients who refused to have their records processed electronically.
* Patients with a history of bariatric surgery (sleeve gastrectomy, gastric band, gastric bypass) prior to hospitalization.

Primary outcomes:
measure: number of prescriptions concerned by rules, by type of recommendation
timeFrame: 8 months
Secondary outcomes:
measure: Number of validated recommendations and their level of evidence
timeFrame: 12 months
measure: Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule.
timeFrame: 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: HEGP
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Brigitte SABATIER, PhD
role: PRINCIPAL_INVESTIGATOR
References: