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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNantes University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patients living in an institution

participating in a clinical trial

with epilepsy

active depression

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: GP - pharmacist collaboration and pharmacist motivational interviewingExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
3 to 6 months after the beginning of the enrollment period and 12 months after the end of the enrollment period

Secondary outcomes

1

Acceptability 1

Number of clusters included / Number of clusters planned measured by logbooks

Time frame
3 months after last inclusion
2

Acceptability 2

Reason for pharmacists and general practitioners' refusal assesed by individual interviews

Time frame
within 6 months after refusal
3

Acceptability 3

Number of patients included / Number of patients eligible measured by logbooks

Time frame
3 months after last inclusion
4

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

Time frame
12 months after the last inclusion

Other outcomes

Sponsors and contacts

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Nantes University Hospital

Lead sponsor

Université de Nantes

Collaborator