Feasibility Study of the Medication Review With Follow up Service for Patients With Polypharmacy in Swiss Community Pharmacies

NCT05348538 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-05-03

No results posted yet for this study

Summary

In Switzerland, it is estimated that 20,000 people are hospitalized each year as a result of drug related problems (DRP). Community pharmacies (CP) are well positioned to identify and manage such DRPs in a timely manner. In Switzerland, no pharmacy service that focus on the management of DRPs is currently recognized and remunerated. A new service, medication review with follow up (MaJ? for the acronym in french), has been developed. It is focused on DRPs related to self-medication and medication management at home and it includes a systematic review of the patient's treatment.

Objective: To evaluate the impact of the MaJ? service for adults with polypharmacy in Swiss CP for the identification and management of DRPs.

A pre-post intervention study will be carried out in CPs in the canton of Vaud for 15 months. Volunteer pharmacists will include adults with a prescription for at least four chronic and systemic drugs since at least three months. Trained pharmacists will conduct structured consultations with a 6-months interval during the study to deliver the service. The primary outcome is the identification and management of DRPs. Secondary outcomes are patients' knowledge about their treatments, number of expired medications and description of pharmaceutical interventions.

The study has been approved and will be supported by Department of Health and Social Affairs in the canton of Vaud and the Cantonal Health Authorities. The Ethics Committee (CER-VD) concluded that the study does not fall under the Human Research Act. It will begin in spring 2022 in 19 to 35 pharmacies that will recruit at least 162 patients after randomization of eligible patients through a sequence of computer-generated random numbers. Ad-hoc tools (medication management plan) and validated tools (PharmDISC tool, patient knowledge tool) will guide pharmacists throughout the consultation. Educational training and support for pharmacists will increase quality of service provision and fidelity of study protocol. A sub analysis will be carried out for those patients included who are 65 years old or over in order to target the intervention to a specific group of patients with higher risk for DRPs.

This study will evaluate the impact of a new service that includes validated, structured and standardized interventions, training and supervision for CP staff, non-prescription medication evaluation and use of home-based patient records. MaJ? is an enhanced service designed to overcome those barriers found in the implementation process of medication review services.

Conditions

Interventions

OTHER

Medication review with follow up or MaJ? for the acronym in french

MaJ? service will involve a pharmacist-patient face-to-face consultation with a 6-months interval during the study, it includes: 1. Educational training: pharmacists will attend a half a day course. They will inform pharmacy technicians of their tasks. They will also have available an online version of the training about the service and data collection. 2. Service provision: before the pharmacist-patient consultation (pharmacy technicians review the medication to identify the prescribed medication included in the treatment plan and to remove expired or medications non taken by the patient), during (pharmacist assess potential drug related problem) and after the consultation (to send a medication management plan to patients and doctors). 3. Practice change facilitation to support pharmacists: pharmacists will be follow-up by the research team during the study (1st, 2nd, 3rd, 6th, 12th and 15th months of the study) to support them through the delivery of the service.

Sponsors & Collaborators

  • Pharmaceutical Society of the Vaud Canton ("SVPh: Société Vaudoise de pharmacie")

    collaborator UNKNOWN
  • Canton of Vaud ("État de Vaud")

    collaborator UNKNOWN
  • Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

    lead OTHER

Principal Investigators

  • Jérôme Berger, PhD · Unisanté

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-06-30
Completion
2024-09-30

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05348538 on ClinicalTrials.gov