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Completed

NCT Number: NCT03909035

A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy

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.

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Key information

Conditions

Medication Therapy Management

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University Hospital

Toulouse, Occitanie, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication therapy management

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)

Primary outcomes

  1. Number of patients hospitalised

    Time frame: Month 12

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

Secondary outcomes

  1. Number of patients hospitalised (only non-scheduled hospitalisations)

    Time frame: Month 12

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

  2. Existence of at least one potentially inappropriate drug per patient

    Time frame: Month 0

    Evolution of potentially inappropriate prescribing

  3. Existence of at least one potentially inappropriate drug per patient

    Time frame: Month 2

    Evolution of potentially inappropriate prescribing

  4. Existence of at least one potentially inappropriate drug per patient

    Time frame: Month 12

    Evolution of potentially inappropriate prescribing

  5. Mean number of medications per patient

    Time frame: Month 0

    Mean number of medications per patient

  6. Mean number of medications per patient

    Time frame: Month 12

    Mean number of medications per patient

  7. Medication regimen complexity index

    Time frame: Month 0

    Medication regimen complexity index

  8. Medication regimen complexity index

    Time frame: Month 12

    Medication regimen complexity index

  9. Girerd compliance test score

    Time frame: Month 0

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

  10. Girerd compliance test score

    Time frame: Month 4

    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.

  11. Girerd compliance test score

    Time frame: Month 8

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

  12. Girerd compliance test score

    Time frame: Month 12

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

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

    Time frame: Month 0

    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.

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

    Time frame: Month 4

    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.

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

    Time frame: Month 8

    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.

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

    Time frame: Month 12

    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.

  17. Differential cost ratio

    Time frame: Month 4

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

  18. Differential cost ratio

    Time frame: Month 8

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

  19. Differential cost ratio

    Time frame: Month 12

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

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

    Time frame: Month 2

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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: BIMEDOC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2019
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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