A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy

NCT ID: NCT03909035

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 697 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2021-10-25

Brief Summary

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.

Detailed Description

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.

Conditions

Medication Therapy Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Medication therapy management

Medication therapy management by the community pharmacist in collaboration with the General Practitioners to the Optimizations of Prescriptions

Group Type: EXPERIMENTAL

Medication therapy management

Intervention Type: OTHER

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)

Usual pharmaceutical care

Usual pharmaceutical care provided by the community pharmacist (first level pharmaceutical analysis of the prescriptions)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medication therapy management

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cestac

Role: PRINCIPAL_INVESTIGATOR

Toulouse University Hospital / Paul Sabatier University

Locations

Toulouse University Hospital

Toulouse, Occitanie, France

Countries

France

Other Identifiers

17-0277

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2018/A00213/52

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0454

Identifier Type: -

Identifier Source: org_study_id