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临床试验/NCT05348538
NCT05348538招募中不适用

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

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
162
试验地点
1
主要终点
Change in number of drug related problems (DRPs)

研究概览

简要总结

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.

详细描述

  1. Background

1.1. Role of the pharmacist: The role of the community pharmacist includes an increasing number of responsibilities. Whereas in the past the aspects related to the manufacture and sale of medicines were predominant, the 2000s saw the emergence of other roles for the pharmacist in Switzerland, primarily in order to control rising health care costs. With the implementation of the remuneration based on services (RBP for the french acronym) in 2001, a step forward was taken in the direction of pharmaceutical services, for example by the remuneration of the pharmaceutical record during the delivery of prescribed medicines. Since 2001, the RBP has been amended several times in order to respond to the health care system needs and the activities of community pharmacists in relation to patients' needs (adherence, poly-medication, etc.).

According to the Federal Council, pharmacists could still take on additional tasks in the field of primary care, as they offer easier access to health advice. Since 2016, the "Grand Conseil du Canton de Vaud" has been supporting the implementation of a shared medication plan concerning "medication safety throughout the care process". The aim is to evaluate the implementation of a collaborative management of patients' treatment based on the e-health platform for the canton of Vaud on poly-medicated patients with multiple carers (general medical practitioners -GP-, community pharmacies -CP- and nursing homes). In this context, new opportunities exist to strengthen the role of the pharmacist in the care process. In addition to prescribed medications, pharmacists also advise patients when they self-medicate. Self-medication is "the selection and use of medication, including herbal and traditional products, by individuals to treat symptoms or diseases that they have identified themselves". Community pharmacists are often the first health professionals to be contacted by patients with minor ailments. In order to ensure responsible self-medication with non-prescription medication, pharmacist advice is necessary.

Therefore, community pharmacists are in a privileged position to have an overview of all the medicines taken by patients (prescription and non-prescription). A study carried out in the Canton of Vaud in 2017 with diabetic patients showed that 79% of them had visited only one pharmacy in the last 12 months (96% two pharmacies maximum).

1.2. Drug-related problems (DRPs): The Pharmaceutical Care Network Europe (PCNE) describes a DRP as "an event or circumstance involving drug therapy that actually or potentially interferes with the expected optimal outcome of medical care". The PCNE has developed a classification of DRPs that has evolved over time and among investigators. Thus, the variation in classifications makes it difficult to standardize this topic, especially on a more accurate description of the clinical and economic burden of DRP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Medication review with follow up or MaJ? for the acronym in french (Other)

结局指标

主要结局

Change in number of drug related problems (DRPs)

时间窗: 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).

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.

Change in DRPs

时间窗: 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)

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.

次要结局

  • 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 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 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))

研究者

发起方
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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