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NCT Number: NCT06517303

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HEGP, Paris, France

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About this study

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 :

  • Number of validated recommendations and their level of evidence,
  • 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

Who can participate

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

  • 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.

Treatment and study plan

Primary outcomes

  1. number of prescriptions concerned by rules, by type of recommendation

    Time frame: 8 months

    number of prescriptions concerned by rules, by type of recommendation, in patients with severe obesity.

Secondary outcomes

  1. Number of validated recommendations and their level of evidence

    Time frame: 12 months

    Number of validated recommendations and their level of evidence, validated by experts

  2. Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule.

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Rennes University Hospital

Registry information

Acronym: RECOB-MED

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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