A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy

NCT03909035 | Completed DMC

• 3 other identifiers: RC31/17/045417-02772018/A00213/52
• Study Type: interventional
• Target: 697
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Therapy Management

Keywords

Medication review polypharmacy; clinical pharmacy; older people; inappropriate prescribing; collaboration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Number of patients hospitalised (only non-scheduled hospitalisations)

  Month 12

• Existence of at least one potentially inappropriate drug per patient

  Month 0

• Existence of at least one potentially inappropriate drug per patient

  Month 2

• Existence of at least one potentially inappropriate drug per patient

  Month 12

• Mean number of medications per patient

  Month 0

Study Arms (2)

Medication therapy management

EXPERIMENTAL

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

Other: Medication therapy management

Usual pharmaceutical care

NO INTERVENTION

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

Interventions

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)

Medication therapy management

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital

Toulouse, Occitanie, 31059, France

Location

MeSH Terms

Interventions

Medication Therapy Management

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Study Officials

• Cestac

  Toulouse University Hospital / Paul Sabatier University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: April 9, 2019
• Study Start: June 3, 2019
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)