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Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study

Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06517303
Acronym
RECOB-MED
Enrollment
1050
Registered
2024-07-24
Start date
2023-06-09
Completion date
2026-06-09
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use, Obesity, Morbid

Keywords

prescription drug guidelines, clinical decision support system, Rule-based Alert System

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

Interventions

None listed

Sponsors

Rennes University Hospital
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
number of prescriptions concerned by rules, by type of recommendation8 monthsnumber of prescriptions concerned by rules, by type of recommendation, in patients with severe obesity.

Secondary

MeasureTime frameDescription
Number of validated recommendations and their level of evidence12 monthsNumber of validated recommendations and their level of evidence, validated by experts
Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule.8 monthsRate 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026