Evaluation of the Implementation of Drug Prescription Recommendations Using Clinical Decision Support in Patients With Severe Obesity: Retrospective Study (RECOB-MED)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Morbid; Drug Use

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

• Study Type: Observational
• Enrollment (Estimated): 1050

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • HEGP
  • Rennes, France, 35000
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
retrospective study; Retrospective study of two data warehouses and the Delphi method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of prescriptions concerned by rules, by type of recommendation	number of prescriptions concerned by rules, by type of recommendation, in patients with severe obesity.	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of validated recommendations and their level of evidence	Number of validated recommendations and their level of evidence, validated by experts	12 months
Rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule.	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.	8 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Rennes University Hospital
• Investigators: Principal Investigator: Brigitte SABATIER, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2023
• Primary Completion (Estimated): June 9, 2025
• Study Completion (Estimated): June 9, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: clinical decision support system; prescription drug guidelines; Rule-based Alert System
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: APHP200049; PREPS-19-127 (Other Grant/Funding Number: French ministry of health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. Data dictionary would be transmitted.
• IPD Sharing Time Frame: two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.

Processing of shared data must comply with European General Data Protection Regulation (GDPR).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No