ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use (TORNADO)

• ClinicalTrials.gov Identifier: NCT05395897
• Recruitment Status: Active, not recruiting
• First Posted: May 27, 2022
• Last Update Posted: April 11, 2024
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Nantes University Hospital

Tracking Information

• First Submitted Date: May 24, 2022
• First Posted Date: May 27, 2022
• Last Update Posted Date: April 11, 2024
• Actual Study Start Date: January 1, 2023
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2022)

Trajectories of healthcare consumption (psychotropic drugs, consultations, hospitalizations) [ Time Frame: 2020-2021 ]

Trajectories will be defined as the succession of healthcare events. Multidimensional trajectories will be constructed taking into account the timing and concomitance of reimbursements

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 24, 2022)

Problematic use of psychotropic drugs [ Time Frame: 2018-2021 ]

The evolution of indicators of problematic use for psychotropic drugs will be studied: doctor shopping, pharmacy shopping, overconsumption

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use
• Official Title: ORiginal meThodology for Assessing the Impact of the Coronavirus Health Crisis on Psychotropic Drug Use

Brief Summary

The health crisis linked to the coronavirus has had a significant impact on the mental health. The question of the repercussion of this crisis on the consumption of psychotropic drugs is crucial. It is all the more true in France, which was already among the countries with the highest consumption of psychotropic drugs before the crisis. Indeed, an increase in the number of reimbursements for anxiolytic, hypnotic and antidepressant drugs has been highlighted in the context of the health crisis, using data from the health insurance database.

To enhance the understanding about the impacts of the health crisis on the use of psychotropic drugs, it is essential to characterize the evolution of the use at the individual level.

The main objective is to assess the impact of the coronavirus-related health crisis on the consumption of psychotropic drugs by studying the trajectories of reimbursements.

The secondary objective of the project is to evaluate the evolution of problematic consumption of psychotropic drugs in the context of the health crisis.

Detailed Description

The project will allow studying the evolution of the use of psychotropics since the coronavirus-related health crisis according to the temporality of consumption (succession and/or concomitance of consumption) or their persistence over time.

This project has two major aims:

• Pharmacosurveillance: evaluation of the impact of psychotropic drug consumption in the context of the health crisis related to the coronavirus. The consumption of psychotropic drugs is a public health issue in France and concerns the entire general population. Even before the crisis, France was one of the countries in the world where the consumption of psychotropic drugs was the highest.
• Scientific: use of an innovative methodology for assessing the impact of pharmaco-epidemiology (trajectories based on reimbursement data).

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: A 10% random sample of the subjects identified in the SNDS, weighted on the region of residence.
• Condition: Psychotropic Drugs
• Intervention: Not Provided

Study Groups/Cohorts

• New users
  Users without any reimbursement for psychotropic drugs before the beginning of the coronavirus crisis.
• Actual or former users
  Users without at least one reimbursement for psychotropic drugs before the beginning of the coronavirus crisis.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 10, 2024): 2772093
• Original Estimated Enrollment (submitted: May 24, 2022): 5000000
• Estimated Study Completion Date: December 13, 2024
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects identified in the French National Healthcare Data System (SNDS) in 2018, 2019, 2020 and 2021 at national level, alive on 01/01/2018, age ≥ 16 years on 01/01/2020.

Exclusion Criteria:

• Institutionalization at least one day in a residential facility for dependent elderly people with an internal pharmacy in 2018, 2019, 2020 or 2021.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05395897
• Other Study ID Numbers: RC21_0409
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Nantes University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Nantes University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Caroline VIGNEAU, Professor; Nantes University Hospital

• PRS Account: Nantes University Hospital
• Verification Date: April 2024