A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy (BIMEDOC)

Medication Reviews Performed for Elderly Patients: a Collaborative Approach Between Community Pharmacists, Patients and General Practitioners to the Optimizations of Prescriptions

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.

Study Overview

• Status: Completed
• Conditions: Medication Therapy Management
• Intervention / Treatment: Other: Medication therapy management

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.

• Study Type: Interventional
• Enrollment (Actual): 697
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cestac; Phone Number: +33 5 61 77 11 59; Email: cestac.p@chu-toulouse.fr
• Study Contact Backup: Name: McCambridge; Phone Number: +33 5 67 77 10 32; Email: mccambridge.c@chu-toulouse.fr

Study Locations

• France
  • Occitanie
    • Toulouse, Occitanie, France, 31059
      • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medication therapy management; Medication therapy management by the community pharmacist in collaboration with the General Practitioners to the Optimizations of Prescriptions	Other: 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)
No Intervention: Usual pharmaceutical care; Usual pharmaceutical care provided by the community pharmacist (first level pharmaceutical analysis of the prescriptions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients hospitalised (only non-scheduled hospitalisations)	Number of non-scheduled hospitalisations (including emergency department transfers)	Month 12
Existence of at least one potentially inappropriate drug per patient	Evolution of potentially inappropriate prescribing	Month 0
Existence of at least one potentially inappropriate drug per patient	Evolution of potentially inappropriate prescribing	Month 2
Existence of at least one potentially inappropriate drug per patient	Evolution of potentially inappropriate prescribing	Month 12
Mean number of medications per patient	Mean number of medications per patient	Month 0
Mean number of medications per patient	Mean number of medications per patient	Month 12
Medication regimen complexity index	Medication regimen complexity index	Month 0
Medication regimen complexity index	Medication regimen complexity index	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.	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.	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.	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.	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.	Month 0
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.	Month 4
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.	Month 8
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.	Month 12
Differential cost ratio	To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios	Month 4
Differential cost ratio	To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios	Month 8
Differential cost ratio	To evaluate the impact of medication therapy management on The cost-utility and cost-efficacy ratios	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	Month 2

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Cestac, Toulouse University Hospital / Paul Sabatier University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: older people; inappropriate prescribing; clinical pharmacy; Medication review polypharmacy; collaboration
• Other Study ID Numbers: RC31/17/0454; 17-0277 (Other Grant/Funding Number: French Ministry of Health, PREPS 2017); 2018/A00213/52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No