- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606716
Factors Determining the Rate of Adoption of Pharmaceutical Recommendations by Patients in Primary Care Following a Medication Review by a Pharmacist (REVMedAdopt)
Polypharmacy is a major and growing public health concern, associated with increased risks of adverse drug events, drug interactions, and hospitalizations. Medication reviews (MedRev), defined as structured evaluations of patients' medications aiming to optimize drug use and improve health outcomes, are increasingly promoted to address these challenges. In Belgium, a reimbursed MedRev service has been implemented in community pharmacies since 2023, involving collaboration between community pharmacists (CPs) and general practitioners (GPs).
The RevMedAdopt Pharmacy Study is a national prospective interventional study designed to evaluate the real-world implementation of this service. It focuses specifically on the adoption of pharmaceutical recommendations generated during medication reviews performed by pharmacy students under supervision, within the framework of their clinical training.
The primary objective is to assess the adoption rate of pharmaceutical recommendations, defined as the proportion of recommendations effectively implemented in patients' medication regimens. Adoption is evaluated at 3 months (patient follow-up) and 6 months (GP follow-up) after the medication review, and categorized as fully adopted, partially adopted, not adopted, or unavailable.
Secondary objectives aim to identify and assess contextual factors associated with successful implementation of recommendations. These factors include characteristics related to patients (e.g., demographics, comorbidities, medication burden), pharmacists (e.g., supervision, role as reference pharmacist), general practitioners (e.g., collaboration and communication), medication review processes (e.g., access to clinical data, communication methods), and the recommendations themselves.
The study includes adult patients living at home in Belgium who are polymedicated (≥5 chronic reimbursed medications) and have both a general practitioner and a reference pharmacist. Approximately 120 patients will be recruited in this first phase.
Medication reviews are conducted by final-year pharmacy students during their internships in community pharmacies, following the official Belgian MedRev framework. Students collect baseline medication data, identify drug-related problems, and formulate recommendations validated by their supervising pharmacist. These recommendations are communicated to the GP, typically via an official electronic form.
Follow-up data are collected by the research team through telephone interviews with patients at 3 months and with GPs at 6 months to assess changes in medication regimens and the implementation of recommendations. In addition, qualitative semi-structured interviews with patients, GPs, and pharmacists are conducted to explore perceived barriers and facilitators influencing adoption.
By combining quantitative and qualitative approaches, this study aims to provide a comprehensive understanding of the determinants of implementation of pharmacist-led medication review recommendations in primary care. The results are expected to inform improvements in interprofessional collaboration and optimization of medication review services in Belgium and similar healthcare systems.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Polypharmacy represents a major public health issue, particularly among patients with chronic conditions, and is associated with increased risks of adverse drug events, drug-drug interactions, inappropriate prescribing, and hospitalizations. Medication reviews (MedRev), defined as structured and systematic evaluations of a patient's medication regimen, aim to optimize medication use, improve adherence, and enhance clinical outcomes.
In Belgium, a reimbursed medication review service has been implemented in community pharmacies since April 2023, promoting collaboration between community pharmacists (CPs) and general practitioners (GPs). However, while such interventions generate pharmaceutical recommendations, their real-world implementation remains variable and insufficiently understood. Previous studies suggest that contextual factors, particularly related to interprofessional collaboration and communication, play a key role in determining whether recommendations are effectively adopted.
The RevMedAdopt Pharmacy Study is a national prospective interventional study designed to evaluate the implementation of this MedRev service in real-life conditions. The study is embedded within the clinical training of final-year pharmacy students, who perform medication reviews under the supervision of accredited community pharmacists.
The primary objective is to assess the adoption rate of pharmaceutical recommendations issued following medication reviews. Adoption is defined as the extent to which recommendations are implemented in the patient's medication regimen and is categorized as fully adopted, partially adopted (alternative action taken), not adopted, or unavailable. This outcome is measured at two time points: 3 months after the intervention (via patient follow-up) and 6 months after the intervention (via GP follow-up).
Secondary objectives are to identify and assess contextual factors associated with the successful implementation of recommendations. These factors include patient-related characteristics (e.g., socio-demographic profile, comorbidities, medication burden), pharmacist-related aspects (e.g., supervision, role as reference pharmacist), GP-related aspects (e.g., involvement, collaboration with pharmacists), characteristics of the medication review process (e.g., access to clinical data, communication channels), and characteristics of the recommendations themselves (e.g., type and clinical relevance).
The study population consists of adult patients living at home in Belgium who are polymedicated (defined as the use of five or more chronic reimbursed medications), and who have both a general practitioner and a reference pharmacist. Patients with insufficient language proficiency or without adequate support in case of cognitive impairment are excluded. Approximately 120 participants will be recruited in the first phase, an initial phase involving UCLouvain students. It is possible that we do an extension to other Belgian universities.
The study is conducted in several sequential steps. First, pharmacy students recruit eligible patients, obtain informed consent, and conduct medication reviews, including patient interviews and pharmacotherapeutic analyses. Drug-related problems are identified, and recommendations are formulated and validated by supervising pharmacists. These recommendations are then communicated to the GP, primarily via an official electronic form (eForm), possibly complemented by additional communication methods.
Follow-up is conducted by the research team. At 3 months, patients are contacted by telephone to update their medication list and assess changes. At 6 months, GPs are contacted to confirm medication changes, evaluate recommendation implementation, and collect additional clinical information. These data allow for a pre-post comparison of medication regimens and calculation of adoption rates.
In addition to quantitative data collection, a qualitative component is conducted through semi-structured interviews with a subset of patients, GPs, and pharmacists. These interviews explore experiences, perceptions, barriers, and facilitators related to medication reviews and the implementation of recommendations.
Data are collected using REDCap, ensuring secure and standardized data management in compliance with GDPR regulations. Quantitative analyses will assess adoption rates and their associations with contextual factors, while qualitative analyses will follow a thematic approach to identify key determinants of implementation.
By combining quantitative and qualitative methods, this study aims to provide a comprehensive understanding of the mechanisms underlying the adoption of pharmacist-led medication review recommendations. The findings are expected to inform improvements in the organization, communication, and effectiveness of medication review services, and to support the development of integrated, patient-centered care models in primary care settings.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Woluwe-Saint-Lambert, Belgium, 1200
- Campus Woluwé
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adult patients (≥18 years old), living at home French-speaking patients or patients with a close caregiver able to communicate in French Patients with polypharmacy (defined as the use of five or more reimbursed chronic medications) Patients undergoing an official structured medication review performed by final-year UCLouvain pharmacy students Patients able to provide informed consent Patients with an identified referent general practitioner and a referent pharmacis
Exclusion Criteria:
- Patients not meeting the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RevMedAdopt intervention
Participants receive a structured medication review conducted by last-year pharmacy students, including identification of drug-related problems and communication of recommendations to the treating general practitioner and/or patient.
|
The intervention consists of a structured medication review performed by trained healthcare students. This process includes the systematic identification of drug-related problems (DRPs), such as inappropriate medications, drug-drug interactions, dosing issues, therapeutic duplications, and adherence-related concerns. Based on this assessment, individualized recommendations are formulated to optimize pharmacotherapy. These interventions may include medication discontinuation (deprescribing), dose adjustment, initiation of appropriate therapies, or patient education. Recommendations are communicated to the GP and/or directly to the patient, depending on the nature of the intervention. The implementation and adoption of these recommendations are subsequently evaluated during follow-ups at 3 and 6 months |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adoption rate of medication review recommendations
Time Frame: 3 and 6 months
|
Proportion of medication review recommendations (related to drug-related problems, DRPs) that are implemented by the GP and/or the patient following communication.
|
3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and types of drug-related problems identified
Time Frame: baseline
|
Number of drug-related problems (DRPs) identified during the medication review, categorized by type.
|
baseline
|
|
Number and types of recommendations formulated
Time Frame: Baseline
|
Number of recommendations formulated to address identified DRPs, categorized by type of intervention, such as deprescribing, dose adjustment, treatment initiation, monitoring, or patient education.
|
Baseline
|
|
Patient characteristics
Time Frame: Baseline
|
Description of baseline patient characteristics, including demographic, clinical, and medication-related variables.
|
Baseline
|
|
Intensity and mode of communication between pharmacist and GP
Time Frame: From baseline to 6 months
|
Assessment of the intensity and mode of communication between the pharmacist and the GP, including the number and type of contacts used to discuss medication review recommendations.
|
From baseline to 6 months
|
|
Communication pathway of recommendations
Time Frame: From baseline to 6 months
|
Description of how medication review recommendations are communicated, including communication via the GP, directly to the patient, or other mean.
|
From baseline to 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adoption rate according to recommendation type
Time Frame: 6 months
|
Proportion of recommendations implemented according to their type.
|
6 months
|
|
Adoption rate according to communication pathway
Time Frame: 6 months
|
Proportion of recommendations implemented depending on the communication method (GP-directed, patient-mediated, or other).
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Olivia Dalleur, PhD, Professor, Université Catholique de Louvain
- Principal Investigator: Manon de Montigny, Université Catholique de Louvain
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REVMEDADOPT 2025/03/NOV/450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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