Clinical trial NCT05348538: Feasibility Study of the Medication Review With Follow up Service for Patients With Polypharmacy in Swiss Community Pharmacies
Official title: Feasibility Study of the Medication Review With Follow up Service for Patients With Polypharmacy in Swiss Community Pharmacies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Keywords: Chronic disease
Prescription drugs
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: Pharmaceutical Society of the Vaud Canton ("SVPh: Société Vaudoise de pharmacie")
name: Canton of Vaud ("État de Vaud")
First posted: 2022-04-27
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

   As an example, it has been estimated that the costs of DRP such as non-adherence is approximately 125 billion euro per year in the European Union. In Switzerland, each year, 20,000 hospitalizations result from DRP. DRPs have several causes, whether related to the patient or to the health process. For example, if the patient is not familiar with his/her treatment, he/she will not be motivated to take it, especially if the disease is chronic and the symptoms are not obvious. In this situation, an adherence problem could arise resulting in health care costs (hospitalizations, medical visits, etc.) that could have been avoided.

   Another example of DRP could be a treatment intake error (inadequate posology, etc.) due to a drug package that is misunderstood or missing or due to old medication storage at home. Intake errors could lead to a decrease of treatment effectiveness or to an increase in adverse effects and risks of drug interactions.

   Another example of DRP could be inadequate storage of medicaments. Treatments such as eye drops could lead to eye infections if they are not properly storage. Similarly, improperly stored insulin pens could lose their effectiveness due to a decrease in insulin concentration.

   These sources of DRP can be prevented and managed through pharmaceutical interventions. A pharmaceutical intervention is described as "any action performed by the pharmacist that result in a change in treatment or therapy management". It is well known that pharmaceutical interventions, such as patient counseling, can reduce DRP.

   One way to identify and prevent the occurrence of DRP in a structured manner is to conduct a medication review with the patient.

   To document community pharmacists' clinical activities, including the identification and management of DRPs, a tool was developed and validated in Swiss CPs.

   1.3. Medication Review: Medication review is defined as "a structured evaluation of the patient's medications with the goal of optimizing their use and improving health status", it involves the detection of DRPs and the recommendation of interventions.

   In Switzerland nowadays, the Swiss law details what pharmacists have to do in order to identify and manage DRPs at the time of the delivery of prescription medications to the patient (check for interactions, contraindications, dosage, etc.). However, there is no service that specifically targets the identification and management of DRPs possibly induced by the patients (adherence, wrong conservation, missing or forgotten information, etc.). The Cantonal Health Authorities set up the project (medication review with follow up or MaJ? for the acronym in french) in collaboration with the Center for Primary Care and Public Health of the University of Lausanne (Unisanté) and the Department of Health and Social Affairs in the canton of Vaud. The aim of the MaJ? service is to perform a medication review at the CP to: 1) achieve a decrease in the number of DRPs, 2) improve patients' literacy about their treatments and 3) remove of expired medications for proper elimination by the CPs. This service allows the pharmacists going further than usual prescription validation in terms of detection of DRPs and pharmaceutical interventions. Based on the principles of the "brown bag" (medication review first described in 1982 in the United States) and medication review with follow up, MaJ? includes all the treatments consumed by the patient (prescribed and non-prescribed medication), who brings them to the CP before performing the service. MaJ? is a service that offers several advantages: first, the material aims to guide and facilitate the detection of DRPs through the use of a validated tool and to record pharmaceutical interventions as well as offering information to the prescribing GP. This service also offers patients a review of self-medication (non-prescription medication). MaJ? strengthens the role of pharmacy technicians to perform an initial sorting of the medication brought to the CP to eliminate expired drugs, to allow the pharmacist an optimal use of the time devoted to the consultation. The service is in line with the national objective to reinforce pharmacy technicians' role, their education and to allow them to assist (under supervision) some services.

   1.4. PharmDISC tool: PharmDISC is a standardised classification system of DRPs and pharmaceutical interventions. The tool was validated in 2014 in Swiss CPs (PI) and it was based on a existing hospital system (the Swiss Association of Public Health Administration and Hospital Pharmacists - GSASA). Community pharmacist who tested the system agreed that "documentation should enhance traceability and information flow within team and with other healthcare professionals, improving so the visibility of pharmacists' activities".
2. Objectives The purpose of the study is to evaluate the feasibility and impact of the MaJ? service for adults with polypharmacy in CP in the canton of Vaud (Switzerland).

   Primary objectives To evaluate the impact of MaJ? on the identification and management of DRP. Secondary objectives To assess the impact of MaJ? on the number of expired medications. To assess the impact of MaJ? on patients' knowledge about their treatments. To describe the interventions made by the pharmacists through MaJ?.
3. Method

   3.1. Research design Pre-post intervention study carried out in Swiss CPs from the canton of Vaud. Each CP will be considered a cluster to avoid contamination. The study will take place over 15 months between spring 2022 and summer 2023.

   3.2. Participants enrollment

   3.2.1. Pharmacies and pharmacists The Cantonal Health Authorities and the Department of Health and Social Affairs in the canton of Vaud will provide CPs with the study information via email.

   In order to participate in this study, pharmacies must meet the following criteria:
   * Employ at least one pharmacist who has completed the MaJ? training to perform the service.
   * Name a pharmacist as the contact pharmacist, who agrees to represent the pharmacy for communication purposes with the research team and for submitting study data.
   * To include at least one patient in the study.

   In order to participate in this study, pharmacists must meet the following criteria:
   * Participate in MaJ? training session.
   * Give oral consent to participate in the research study. The same community pharmacist may care for multiple patients but each patient has to be taken care of by the same-trained pharmacist at each consultation. A pharmacist who works in different participating pharmacies will be assigned to the pharmacy where he/she works higher number of hours per week. After initial training, new eligible pharmacists who start working in participant pharmacies will be able to participate if complete the online training.

   Pharmacists will receive a remuneration of 100 Swiss Francs per review (which cannot be financed by the basic health insurance) for the additional time spent on the research during each documented consultation according to the guidelines in the educational training.

   During patient enrollment, pharmacists will be contacted by the research team to keep them informed of recruitment progress and to motivate them to enroll new patients. These contacts will be made by phone and email.

   3.2.2. Patients: inclusion criteria for patients are included below. The CP will send the list of patients in the CP with the inclusion criteria (this list will not include patients' identification but CP codes). In order to avoid selection bias during recruitment, a member of the research team will randomize 50 patients from the list (randomized through a sequence of computer-generated random numbers). The research team will send an inclusion form to the contact pharmacist of each CP with the 50 patients randomized for them to contact the patients by phone or in person in CP and fill it with the information provided by patients. Participating pharmacists will be asked to enroll at least one to ten patients.

   3.2.3. Sample size calculation Primary objective of the study aims to measure the difference in DRPs per patient observed between the first and second consultation with the patient, and the first and third consultation with the patient. Sample size calculation was based on this primary study outcome to detect a difference of 0.5 DRPs per patient at the end of the study. The sample size was calculated with ≥0.8 power, type I error rate of 5%, assuming an intra-cluster correlation of 0.02. Allowing for 15% dropout, the overall sample size is 162 patients, with 19 to 35 pharmacies (1-10 patients per CP).

   3.3. Description of the intervention

   3.3.1. Pharmacy staff training: Pharmacists will attend a half a day course (four hours) that will cover service provision, good practice standards, patients' recruitment, communication skills with patients and other health professionals, data collection and study protocol. The workshop will include a combination of lecture presentations and interactive sessions including role-play scenarios. The training will be evaluated and accredited for pharmacists' continuing professional development. Pharmacists will inform and train pharmacist's technicians for their tasks. They will also have available an online version of the training about the service and data collection.

   3.3.2. Practice change facilitator: Participant pharmacists will be follow-up by the research team via telephone during the study at least six times (1st, 2nd, 3rd, 6th, 12th and 15th months of the study) to support them through the delivery of the service. Pharmacists will also be able of contacting the research team by email throughout the study concerning service provision, data entry, etc. The facilitation process will be explained to pharmacists during the training session. Facilitation process allows ensuring recruitment targets are met, quality of service provision and fidelity to study protocol.

   3.3.3. Medication review with follow up

   Aims of the service: The aim of the service is to perform a medication review at the CP to achieve the following goals:
   * To remove expired medications.
   * To improve patients' knowledge about their treatments.
   * To decrease the number of DRPs.

   An intervention plan (sent to the GP) is developed based on the pharmacy record, treatments reported by the patient and the consultation. Patients are asked to bring all their medication to the pharmacy, where they are sorted by the pharmacy technician. The medication management plan is then reviewed and explained to the patient by the pharmacist. The pharmacist also checks to identify potential DRPs such as adherence issues and propose interventions to solve them.

   Then, the service is provided in three stages:

   Before the pharmacist-patient consultation. During the pharmacist-patient consultation at the CP. After the pharmacist-patient consultation at the pharmacy. The different tasks performed by the pharmacist or pharmacy technician are also differentiated.

   Procedure of MaJ?:

   - Before the pharmacist-patient consultation

   The purpose of this step is to prepare the necessary documents for the service before the appointment with the patient. The pharmacy technician pre-fills the documents with the following information:

   - Medication management plan: Patient data: for patient identification purposes by the pharmacy. Patient Id: pharmacy software codes. Pharmacy stamp. Medication data: treatment and prescriber information (name of drug prescribed, dose, posology and prescriber's name).

   - Removed medication form: Patient data: for patient identification purposes by the pharmacy. Patients' acceptance of the consultation. Eligibility to receive the benefit: determined by being adult, having four or more medications and the patient's agreement, which determines reimbursement. At the moment of the recruitment, eligible patients should still have inclusion criteria at the time of the first pharmacist-patient consultation. If, after the first pharmacist-patient consultation, a patient have any treatment change and inclusion criteria is no longer met, he/she can still be included in the service.

   Potential treatments to be removed: brand name/INN (international non-proprietary names), dose, formulation.

   Time: time spent by the pharmacy technician to prepare the documents. Medication by group: an initial medication review by the pharmacy technician is carried out. This can be accomplished by the patient bringing their own medications prior to the consultation or throughout other arrangements with the CP. The technician separates the patient's medications into two groups: Group I (prescribed-medication that are part of the medication plan), Group II (medication outside the medication plan, this could be over-the-counter drugs or medication not currently prescribed).

   Before patient's arrival, the pharmacist must have at least 30 minutes to review the patient's medications. The purpose of this review is to have the opportunity to assess potential DRPs and to list them using the PharmDISC tool.

   During the pharmacist-patient consultation The purpose of this consultation is to discuss the potential DRPs and to evaluate and improve patient's knowledge of his/her treatment using the patient's medication knowledge evaluation tool. The pharmacist proposes different interventions to the patient to resolve identified DRPs. This is done using the PharmDISC tool. Patient's non-prescription medications are briefly discussed during this encounter to resolve patients' questions. The pharmacist gives advice about the disposal of expired or unused medications. Pharmacists can also add comments to each page of the forms.

   Pharmacists and patients should sign the forms for compensation purposes. After the pharmacist-patient consultation: The purpose of this phase is to inform the GP by providing report of the consultation with the patient and the medication management plan. In case of different GPs prescribing treatments to the patient, this report may improve communication between health care practitioners and patient's management.

   After the consultation, within a maximum of two-day' period, the pharmacist completes the medication management plan, with medicaments from groups I and II, according to that discussed with the patient. If a pharmacy already has a standard practice form, the pharmacist can use it while following instructions given.

   The medication management plan is given to both, patient and GP. However, in case of discrepancies between the medication record and the medication brought in by the patient, the pharmacist can forward the form to the GP for validation before handing it to the patient. In addition, the pharmacist should complete a medication review report, describing the identified DRPs relevant to the GP and the interventions taken to manage and/or resolve them. This report is also sent to the GP. The report should also be sent to the GP within a maximum of two-day' period after the pharmacist-patient consultation.

   Time frame for the intervention: Pharmacists must carry out three different consultations with the patients with a 6-months interval, at the beginning, six months later and 12 months after the first encounter. The first pharmacist-patient consultation will take place after patient recruitment. After anonymizing data, contact pharmacists in each pharmacy will send a copy of the information to the research team (within one month after the first consultation) The second pharmacist-patient consultation will take place 6 months after the first consultation. The intervention will be conducted similarly to the first consultation and using the same forms. Copy of data will be provided to the research team within one month after completing the second consultation. The third pharmacist-patient consultation will take place 12 months after the first one. The intervention will be conducted similarly to the first and second consultation and using the same forms. Copy of data will be provided to the research team within one month after completing the last consultation.

   3.4. Data analysis Continuous variables will be reported using mean and standard deviation, or median and percentiles depending on the distribution of the variable (the Kolmogorov Smirnov test will be used to assess normality). Categorical variables will be reported using frequency and proportion. For the comparison of continuous variables, the T Student's test or the ANOVA test will be carried out if there is a normal distribution, and Kruskal-Wallis otherwise. The comparison of the categorical variables will be carried out using the χ2 test, the Fisher's exact test or Yate's chi-squared test if necessary.

   For each patient under study, differences between consultations will be compared for dependent variables (DRPs, pharmaceutical interventions, pharmaceutical interventions acceptance, patient knowledge, medication removed). A linear regression model will be performed accounting for the cluster effect. Firstly, variables will be considered significant (p-value\<0.2) in a bivariate model to be included in a multivariate model. Secondly, the variables considered significant at a value of p\<0.1 in the multivariate model will be included in the final model. The level of significance will be set at p\<0.05, the software STATA® will be used.

   An analysis with completed cases will be made. In addition, an analysis with the whole sample will be made where, for the management of missing data, initial value will be considered as not been modified (baseline observation carried forward-BOCF). 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.

   3.5. Data handling Participating pharmacists are responsible for keeping all documents in the CP according to current practices and requirements.

   Different forms used during the study will be collected in paper or electronic format (e-mail) through the contact pharmacists. Research team at Unisanté will code data in a database specifically designed for the study. Data will only be accessible by researchers involved in the project and will be hosted on Unisanté's server (backed up electronically). At the end of the study, data will be kept up to 10 years after the last publication.
4. Data confidentiality and ethical aspects According to the Cantonal Commission for Ethics in Human Research (CER-VD), this study does not fall under the Human Research Act (HRA), therefore, this protocol does not need to be submitted for review. Participants will not need to sign a consent form. Patients' signatures will be requested as proof of service provision and, if necessary, for transmission of the medication plan to the GP.

   The information will be coded, anonymized and the data will be referenced by assigned numbers for both the published and non-published information. All the information collected will be stored in the repository of Unisanté, being accessible only to authorized personnel.
5. Medical monitoring and insurance The service is considered to fall under usual practice of CP, the aim of the service proposed is to give structure to this usual practice, therefore there is no need for safety considerations nor additional insurance. Pharmacists will be able to continue to provide routine care to patients about DRP management. Therefore, no special medical supervision is required. Pharmacists are free to contact GPs in agreement with patients as usual.
6. Financial support Public-private partnership Cantonal Health Authorities - Department of Health and Social Affairs in the canton of Vaud provides for a reimbursement of 100 Swiss Francs per pharmacist-patient consultation. There is no compensation for patients included.
7. Conflict of interest No conflicts of interest are declared. However, the investigators are committed to the development of services within their professional competencies. They are committed to handle data in a rigorous and transparent manner to avoid bias in the collecting, interpretation and discussion of the results.
8. Dissemination plan The findings obtained after the study will be disseminated through the usual methods of scientific dissemination, including communications to congresses and publications in scientific journals.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in number of drug related problems (DRPs)
timeFrame: 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).
measure: Change in DRPs
timeFrame: 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:
measure: Change in number of medications removed
timeFrame: 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)
measure: Change in patients' knowledge
timeFrame: 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)
measure: Change in number of pharmaceutical interventions
timeFrame: 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)
measure: Change in pharmaceutical interventions
timeFrame: 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)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Unisanté, Center of Primay Care and Public Health
state: Vaud
Study officials:
affiliation: Unisanté
name: Jérôme Berger, PhD
role: STUDY_CHAIR
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