- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379073
Evaluation of a Clinical Support Website for the Management of Common Mental Health Conditions in Primary Care on Compliance With Benzodiazepine Prescribing Recommendations (Psycho-MG)
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Being a general practitioner or a specialist in general medicine.
- Practicing in the Occitanie region.
- Working in private practice.
- Being registered under Sector 1 fee agreements.
- Providing informed consent to participate in the study.
- Having computer equipment in the medical office, available during consultation (desktop, laptop, tablet, or smartphone) with internet access.
Exclusion criteria:
- Physicians who have been practicing for less than two years, as they are unlikely to have sufficient retrospective data on prescription reimbursements for their patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group (trained on PsychoMG website)
Training intervention on benzodiazepine prescribing with access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.
|
Training intervention on benzodiazepine prescribing with access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.
|
|
No Intervention: Control Group
Training intervention on benzodiazepine prescribing without access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance with recommended maximum duration of benzodiazepine prescriptions among new users
Time Frame: 12 months
|
Primary outcome measure: adherence to recommended prescription duration (yes/no) for benzodiazepines A patient is considered to have a prescription duration for benzodiazepines that is either adherent or non-adherent if they had no benzodiazepine exposure in the previous year and their duration of exposure during the first treatment episode:
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Psycho-MG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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