Effectiveness of a Joint General Practitioner-Pharmacist Intervention on Benzodiazepine Deprescribing in the Elderly

NCT05765656 | Unknown

• 1 other identifier: RC21_0357
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Care; Health Plan Implementation; Benzodiazepine Dependence; Elderly; Anxiety; Deprescribing

Keywords

Primary care; collaborative practice; health plan implementation; deprescribing; benzodiazepine; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Acceptability 1

  3 months after last inclusion

• Acceptability 2

  within 6 months after refusal

• Acceptability 3

  3 months after last inclusion

• Cost-Utility analysis assessed following the Haute Autorité de Santé 2020 recommendations

  12 months after the last inclusion

• Fidelity 1

  12 months after the last inclusion

Study Arms (2)

GP - pharmacist collaboration and pharmacist motivational interviewing

EXPERIMENTAL

Once randomized, the patient will have three motivational interviews with their pharmacist. Each time, a report will be sent to the GP.

Behavioral: GP - pharmacist collaboration and pharmacist motivational interviewing

Usual Care

NO INTERVENTION

The patient is handled by his GP and the pharmacist as usual (medical encounter plus medication dispensation)

Interventions

GP - pharmacist collaboration and pharmacist motivational interviewing BEHAVIORAL

1. Patients in the GP-CP clusters randomized to the intervention arm will be offered a joint GP-CP deprescribing intervention by their GP. 2. After the encounter, the patients will go to the pharmacy to get their medication dispensed. They will be given education materials. The pharmacist will plan with the patients 3 Motivational Interviews which will address the risks of using BZDR, and the benefits and modalities of stopping them. The pharmacists will receive a 2-day training course in MI. They will be given guidelines on BZDR deprescribing. If required, the pharmacists will be supported in their first MI. 3. Following each interview, the pharmacist will inform the GP by means of a formalized report of the points discussed. The pharmacist will inform the GP of the patient's choice or not to get involved in a deprescribing process and of the protocol followed. The objective of this exchange is to formalize the joint GP-CP intervention and to secure the deprescribing of BZDR.

GP - pharmacist collaboration and pharmacist motivational interviewing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Université de Nantes: collaborator

Related Publications (1)

• Huon JF, Nizet P, Caillet P, Lecompte H, Victorri-Vigneau C, Fournier JP; BESTOPH-MG consortium. Evaluation of the effectiveness of a joint general practitioner-pharmacist intervention on the implementation of benzodiazepine deprescribing in older adults (BESTOPH-MG trial): protocol for a cluster-randomized controlled trial. Front Med (Lausanne). 2023 Aug 25;10:1228883. doi: 10.3389/fmed.2023.1228883. eCollection 2023.

  PMID: 37711743 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jean-François HUON, Pharm.D PhD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François HUON, Pharm.D PhD

CONTACT

0244768074; jeanfrancois.huon@chu-nantes.fr

Jean-Pascal Fournier, Professor

CONTACT

jean-pascal.fournier@univ-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non applicable
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic cluster-randomized controlled trial

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 13, 2023
• Study Start: March 15, 2023
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 13, 2023

Record last verified: 2023-02