Anxiety Clinical Trial
— BESTOPH-MGOfficial title:
Evaluation of the Effectiveness of a Joint General Practitioner-Pharmacist Intervention on the Implementation of Benzodiazepine Deprescribing in the Elderly (BESTOPH-MG Trial): Protocol for a Cluster-randomized Controlled Trial
Benzodiazepines or related drug (BZDR) are consumed for hypnotic or anxiolytic purposes in most cases. The consequences of BZDR are multiple with an increased risk of daytime sedation, balance disorders leading to falls and fractures, cognitive disorders, road accidents and dementia. Given their comorbidities, physiological changes, and multiple medications, the elderly are more at risk of suffering from BZDR adverse events. Interprofessional collaboration has shown efficacy in improving prescribing appropriateness and may affect patients outcomes positively. Morever, motivational interviews (MI) may reduce the extent of substance abuse compared to no intervention.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | September 15, 2025 |
Est. primary completion date | September 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - outpatients aged 65 and over - followed by the general practitioner and the pharmacist of the GP-PO pair - having a prescription for an anxiolytic or hypnotic BZDR prescribed at least 4 times in the past year - the last prescription being less than 3 months old - having been dispensed monthly during the last 3 months - affiliated to a social security scheme - and having given consent to participate in the research. Exclusion Criteria: - patients living in an institution - participating in a clinical trial - with epilepsy - active depression - uncontrolled mental disorders - unable to participate in an interview or answer a questionnaire (demented, non-French speaking, illiterate, deaf, ...) - under guardianship - with a dystonic syndrome - and patients who are not sufficiently autonomous to carry out the steps inherent in the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital | Université de Nantes |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Appropriateness measured by sociological interviews of patients, general practicioners and pharmacists and pharmacists observations | Four days of observations will be conducted with pharmacists who have just been trained in MI to study, in action, how they conduct their first interviews with the elderly. These same pharmacists will be observed a second time at the end of the study, to see how their approach to MI has evolved. A first wave of ten semi-structured interviews will be conducted with elderly patients who have already been seen by their pharmacist, to see what effects the pharmacist has had on their representations of BZDR and on their consumption. Finally, three focus groups will be carried out, one with CPs, one with GPs and one with pairs. | 3 to 6 months after the beginning of the enrollment period and 12 months after the end of the enrollment period | |
Secondary | Acceptability 1 | Number of clusters included / Number of clusters planned measured by logbooks | 3 months after last inclusion | |
Secondary | Acceptability 2 | Reason for pharmacists and general practitioners' refusal assesed by individual interviews | within 6 months after refusal | |
Secondary | Acceptability 3 | Number of patients included / Number of patients eligible measured by logbooks | 3 months after last inclusion | |
Secondary | Cost-Utility analysis assessed following the Haute Autorité de Santé 2020 recommendations | A Cost-Utility Analysis (CUA) expressed as a cost per Quality Adjusted Life Year (QALY) will be performed from a collective perspective and with a time horizon of 12 months | 12 months after the last inclusion | |
Secondary | Fidelity 1 | Proportion of pairs completing the study measured through a logbook | 12 months after the last inclusion | |
Secondary | Fidelity 2 | Proportion of patients who actually made appointments with the pharmacist measured through a logbook. | 12 months after the last inclusion | |
Secondary | Fidelity 3 | Number of motivational interviews measured through a logbook. | 6 months after the last inclusion | |
Secondary | Fidelity 4 | Number of reporting made by the pharmacist to the GP will be measured through a logbook. | 6 months after the last inclusion | |
Secondary | BZDR consumption | Cessation or reduction of BZDR use at 12 months from inclusion measured using the National Health Data System.
Proportion of patients no longer being dispensed BZDR at 10 months after enrollment, with the last two months (10 to 12 months) |
10 to 12 months after enrollment in the study | |
Secondary | Anxiety | Anxiety measured by General Anxiety Disorder (GAD-7) | 6 and 12 months after enrollment | |
Secondary | Insomnia | Quality of sleep measured by Insomnia Severity Index (ISI) | 6 and 12 months after enrollment | |
Secondary | Attachment to BZDR | Attachment to BZDR measured by Benzodiazepine Cognitive Attachment Scale (ECAB) scale at 6 and 12 months.
Score ranges from 0 to 10. A score = 6 allows |
6 and 12 months after enrollment | |
Secondary | Reported Quality of life of patients | Quality of life measured by EQ-5D-5L questionnaire at 6 and 12 months. A total of 3125 possible health states is defined. Each state is referred to by a 5-digit code. | 6 and 12 months after enrollment | |
Secondary | Autonomy | Autonomy measured by Instrumental Activities of Daily Living (IADL) at 6 and 12 months.
The scale ranges from 0 to 8, with 0 indicating complete dysautonomia and 8 indicating complete autonomy. |
6 and 12 months after enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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