A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy

University Hospital, Toulouse697 enrolled

Overview

In patients aged 65 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy may be a source of iatrogeny due to pharmacokinetic interactions, enhanced sensitivity of older people to medication, or failure to adhere to the therapy. Since January 2018, French community pharmacists have been allowed by the Health ministry to perform medication reviews for people aged 65 years and over, who are being treated with more than 5 medications a day. the present hypothesis is that medication therapy management performed in collaboration with patients, general practitioners, and community pharmacists will lead to a reduction in medical events and inappropriate prescriptions.

This is a stepped-wedge cluster randomised controlled trial conducted in 9 regions of France. Each region represents one cluster with 7 community pharmacies located around the University Hospital associated with that cluster. In total, 63 community pharmacies will be enrolled, with each pharmacy including 20 patients over a 10 month-period. Over the life-time of the project, a total of 1260 patients will benefit from either the intervention or from a controlled pharmaceutical care according to the period of time they will be enrolled.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

697

Conditions

Medication Therapy Management

Interventions

Medication therapy managementOTHER

The intervention is in the form of a pharmacist-led medication review aimed at detecting potentially inappropriate prescribing. It includes: * A patient-pharmacist interview to collect comorbidities, medication, laboratory results, self-medication, adherence, medication patient's knowledge. * A pharmacist's evaluation of the prescriptions based on the patient's conditions and on the current recommendations for clinical practice. * Detailed feedback to the general practitioner. * An appointment with the patient to explain the modifications made by the general practitioner (GP)

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient aged 65 or older suffering from long-term illness * Patient aged 75 or older * Living at home * Having 5 medications or more per day for more than 6 months * Being a regular patient of the community pharmacy involved in the study * General practitioner of the patient agrees to participate to the study * Patient being mentally and physically able to decide on his own to participate in the study * Patient available by phone throughout the study Exclusion Criteria: * Patient refuses to participate * Patient without a family doctor * Patient whose family doctor refuses to participate in the study * Patient who does not understand French, or dependant on someone else to manage his medication * Resident of a nursing home * Patient placed under guardianship * Uncertainty of the pharmacist about patient reliability * Patient having benefited from a medication review in the previous 12 months * Patient already included in another study

Locations (1)

Toulouse University Hospital

Toulouse, Occitanie, France

Outcomes

Primary Outcomes

Number of patients hospitalised

Number of patients hospitalised for more or less than 24 hours, including emergency department transfers during a 12 month-period follow-up.

Time frame: Month 12

Secondary Outcomes

Number of patients hospitalised (only non-scheduled hospitalisations)

Number of non-scheduled hospitalisations (including emergency department transfers)

Time frame: Month 12

Existence of at least one potentially inappropriate drug per patient

Evolution of potentially inappropriate prescribing

Time frame: Month 0

Existence of at least one potentially inappropriate drug per patient

Evolution of potentially inappropriate prescribing

Time frame: Month 2

Existence of at least one potentially inappropriate drug per patient

Evolution of potentially inappropriate prescribing

Time frame: Month 12

Mean number of medications per patient

Time frame: Month 0

Mean number of medications per patient

Time frame: Month 12

Medication regimen complexity index

Time frame: Month 0

Medication regimen complexity index

Time frame: Month 12

Girerd compliance test score

To evaluate the impact of medication therapy management on Medication adherence. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.

Time frame: Month 0

Girerd compliance test score

To evaluate the impact of medication therapy management on Medication adherence.From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.

Time frame: Month 4

Girerd compliance test score

To evaluate the impact of medication therapy management on Medication adherence. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.

Time frame: Month 8

Girerd compliance test score

To evaluate the impact of medication therapy management on Medication adherence. From 0 to 6 Yes. 0 Yes: Best value. 6 Yes: worst value.

Time frame: Month 12

Quality of life measured with the EuroQol Group 5-level EQ-5D version

To evaluate the impact of medication therapy management on The patients' quality of life: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Time frame: Month 0

Quality of life measured with the EuroQol Group 5-level EQ-5D version

Time frame: Month 4

Quality of life measured with the EuroQol Group 5-level EQ-5D version

Time frame: Month 8

Quality of life measured with the EuroQol Group 5-level EQ-5D version

Time frame: Month 12

Differential cost ratio

To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios

Time frame: Month 4

Differential cost ratio

To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios

Time frame: Month 8

Differential cost ratio

To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios

Time frame: Month 12

Mean number of modifications made by the General Practitioner per patient, following the pharmacist's intervention

To evaluate the modifications made by the general practitioner due to the pharmacists' interventions

Time frame: Month 2

Data from ClinicalTrials.gov

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