- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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 growing public health concern associated with adverse drug events, drug interactions, and hospitalizations. Medication reviews (MedRev) are structured evaluations of patients' medications aiming to optimize treatment and improve outcomes. In Belgium, a reimbursed MedRev service involving community pharmacists and general practitioners (GPs) has been implemented since 2023.
The RevMedAdopt Pharmacy Study is a national prospective interventional study evaluating the real-world implementation of pharmaceutical recommendations generated during medication reviews performed by supervised final-year pharmacy students.
The primary objective is to assess the adoption rate of pharmaceutical recommendations at 3 and 6 months after the medication review. Recommendations are categorized as fully adopted, partially adopted, not adopted, or unavailable.
Secondary objectives are to identify factors associated with recommendation implementation, including patient characteristics, pharmacist and GP collaboration, medication review processes, and recommendation-related factors.
The study includes adult polymedicated patients living at home in Belgium and followed by both a GP and a reference pharmacist. Approximately 120 patients will be recruited.
Medication reviews are conducted during pharmacy internships following the official Belgian MedRev framework. Recommendations validated by supervising pharmacists are communicated to GPs. Follow-up data are collected through telephone interviews with patients and GPs. Qualitative interviews with patients, pharmacists, and GPs explore barriers and facilitators influencing recommendation adoption.
This mixed-methods study aims to improve understanding of the implementation of pharmacist-led medication review recommendations in primary care and to support optimization of interprofessional collaboration and medication review services.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Woluwe-Saint-Lambert, Bélgica, 1200
- Campus Woluwé
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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 referent pharmacist
Exclusion Criteria:
- Patients not meeting the inclusion criteria
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adoption rate of medication review recommendations
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number and types of drug-related problems identified
Prazo: baseline
|
Number of drug-related problems (DRPs) identified during the medication review, categorized by type.
|
baseline
|
|
Number and types of recommendations formulated
Prazo: 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
Prazo: Baseline
|
Description of baseline patient characteristics, including demographic, clinical, and medication-related variables.
|
Baseline
|
|
Intensity and mode of communication between pharmacist and GP
Prazo: 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
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adoption rate according to recommendation type
Prazo: 6 months
|
Proportion of recommendations implemented according to their type.
|
6 months
|
|
Adoption rate according to communication pathway
Prazo: 6 months
|
Proportion of recommendations implemented depending on the communication method (GP-directed, patient-mediated, or other).
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Olivia Dalleur, PhD, Professor, Université Catholique de Louvain
- Investigador principal: Manon de Montigny, Université Catholique de Louvain
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Atenção Primária
- polifarmácia
- Ciência da Implementação
- Clínicos Gerais
- Desprescrição
- Assistência Farmacêutica
- Farmácia Comunitária
- Problemas Relacionados a Drogas
- Segurança de Medicamentos
- Revisão de Medicação
- Otimização de Medicamentos
- Colaboração Interprofissional
- Pharmacist Interventions
- Adoption of Recommendations
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REVMEDADOPT 2025/03/NOV/450
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .