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

T

Toulouse University Hospital

Status

Completed

Conditions

Medication Therapy Management

Treatments

Other: Medication therapy management

Study type

Interventional

Funder types

Other

Identifiers

NCT03909035
RC31/17/0454
2018/A00213/52 (Other Identifier)
17-0277 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

697 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

697 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

McCambridge; Cestac

Data sourced from clinicaltrials.gov

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