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

NCT05348538 | Unknown

• 1 other identifier: MaJ?-Unisanté-2022-v2
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Disease

Keywords

Chronic disease; Prescription drugs

Outcome Measures

Primary Outcomes (2)

• Change in number of drug related problems (DRPs)

  Number of DRPs detected by the pharmacist during the pharmacist-patient consultation. Pharmacists will complete the management plan and PharmDISC tool at all consultations with the patient (three consultations with a 6-months interval). It will be assessed by comparing the differences between the first and second consultations and the first and third consultations. Total number of DRP and mean per patient will be calculated.

  At three points during the study: 1. First pharmacist-patient consultation, 2. Second consultation (6 months after the first one) and 3. Third consultation (12 months after the first one).

• Change in DRPs

  Pharmacists will complete the PharmDISC tool which includes: 1. Therapy choice: no concordance with guidelines, contraindication, interaction, drug not indicated, duplication, adverse effect, incomplete patient documentation. 2. Drug choice: inappropriate dosage form. 3. Dose choice: underdose/overdose, inappropriate monitoring, dose not adjusted to organ function. 4. Drug use: inappropriate timing of frequency of administration, inappropriate use method. 5. Therapy duration: inappropriate therapy duration. 6. Logistics: prescribed drug not available, error in medication process. 7. Patient: insufficient adherence, insufficient knowledge, burden due to therapy. 8. Other PharmDISC tool has also classification related to health problems: treatment effectiveness, untreated indication, safety of treatment, treatment costs, dissatisfaction/problems of the patient. PharmDISC tool has also classification related to type of problem: manifest, potential.

  At three points during the study: 1. First pharmacist-patient consultation, 2. Second pharmacist-patient consultation (6 months after the first one) and 3. Third pharmacist-patient consultation (12 months after the first one)

Secondary Outcomes (4)

• Change in number of medications removed

  At three points during the study: 1. First pharmacist-patient consultation, 2. Second pharmacist-patient consultation (6 months after the first one) and 3. Third pharmacist-patient consultation (12 months after the first one)

• Change in patients' knowledge

  At three points during the study: 1. First pharmacist-patient consultation, 2. Second pharmacist-patient consultation (6 months after the first one) and 3. Third pharmacist-patient consultation (12 months after the first one)

• Change in number of pharmaceutical interventions

  At three points during the study: 1. First pharmacist-patient consultation, 2. Second pharmacist-patient consultation (6 months after the first one) and 3. Third pharmacist-patient consultation (12 months after the first one)

• Change in pharmaceutical interventions

  At three points during the study: 1. First pharmacist-patient consultation, 2. Second pharmacist-patient consultation (6 months after the first one) and 3. Third pharmacist-patient consultation (12 months after the first one)

Study Arms (1)

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

EXPERIMENTAL

All the pharmacists accepting to participate in the study will perform the intervention.

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

Interventions

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

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.

Also known as: Medication review

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with a prescription for at least four chronic and systemic drugs for at least the last three months.

You may not qualify if:

• Patients suffering from dementia, psychiatric disorder, or other health condition that hinders obtaining informed consent and/or conducting the consultations with the pharmacist.
• Patients who disagree meeting the pharmacist for the three consultations during the study with a 6-months interval.
• Patients who are not able to bring all their medication to the community pharmacy.
• Patients who cannot speak and read French.
• Patients who does not allow the pharmacist contacting the general medical practitioner to inform him/her about possible drug related problems.
• Patients who will not consent of participating in the study.

Sponsors & Collaborators

• Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland: lead
• Pharmaceutical Society of the Vaud Canton ("SVPh: Société Vaudoise de pharmacie"): collaborator
• Canton of Vaud ("État de Vaud"): collaborator

Study Sites (1)

Unisanté, Center of Primay Care and Public Health

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

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MeSH Terms

Conditions

Chronic Disease

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Jérôme Berger, PhD

  Unisanté

  STUDY CHAIR

Central Study Contacts

Mathilde Escaith, MPharm

CONTACT

0041 21 3147676; mathilde.escaith@unisante.ch

Noelia Amador-Fernández, PhD

CONTACT

0041 76 2042475; noelia.amador-fernandez@unisante.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 27, 2022
• Study Start: April 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Septembre 2023 - August 2024
• Access Criteria: Contact principal investigator.

Locations

CH (1)