- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07550478
Impacto da Intervenção Liderada por Farmacêutico em Adultos Oncológicos Ambulatoriais
Impacto da Reconciliação de Medicamentos, Aconselhamento e Acompanhamento Liderados por Farmacêuticos na Adesão à Medicação, Erros de Medicação e Hospitalização Relacionada com Medicamentos em Doentes Oncológicos Ambulatórios Adultos
Background and Rationale: Cancer patients receiving outpatient therapy often manage complex medication regimens that include anticancer agents, supportive care medications, and treatments for chronic comorbidities. This polypharmacy greatly increases the risk of medication discrepancies, potential drug-drug interactions, and unintentional errors. Moreover, because most oncology care is delivered in outpatient settings, patients are primarily responsible for self-administering their medications, making adherence a key determinant of treatment success and patient safety (Lindenmeyer et al., 2022; Alshehri et al., 2024). Medication errors and poor adherence among oncology patients are widely recognized global concerns. Research indicates that nearly half of cancer patients experience at least one medication discrepancy during transitions of care, and nonadherence to oral anticancer therapies can exceed 40%. Such issues can result in reduced treatment efficacy, increased toxicity, avoidable hospitalizations, higher healthcare costs, and poorer quality of life (Weingart et al., 2018; Wu et al., 2020; Patel et al., 2021). Pharmacists, as essential members of the multidisciplinary oncology team, are uniquely positioned to address these medication-related challenges. Their pharmacotherapy expertise and patient-education roles enable them to detect discrepancies, optimize medication use, and enhance patient understanding of treatment regimens. Evidence from various healthcare settings shows that pharmacist-led interventions such as medication reconciliation, individualized counseling, and structured follow-up can improve medication safety and adherence (de Clercq et al., 2021; Boeni et al., 2022). Despite strong evidence supporting each of these interventions individually, few studies have examined the combined effect of pharmacist-led reconciliation, counseling, and follow-up in outpatient oncology practice. Adult cancer patients face additional challenges, including complex dosing schedules, emotional distress, and financial burdens, all of which can impair medication adherence. An integrated pharmacist led program may create a continuous safety net that detects medication discrepancies early, reinforces correct use, and sustains adherence throughout treatment (Gellad et al., 2022; ISPOR Report, 2023). Therefore, this study aims to evaluate the impact of a comprehensive pharmacist-led program encompassing medication reconciliation, individualized counseling, and systematic follow-up on enhancing medication adherence and reducing medication errors among adult outpatient cancer patients. Demonstrating the effectiveness of this integrated care model may provide strong evidence to support the routine inclusion of pharmacists in outpatient oncology services to improve patient outcomes and medication safety (Alshehri et al., 2024; Boeni et al., 2022).
Study Hypothesis: Adult oncology outpatients are frequently prescribed complex medication regimens upon leaving the hospital. Therefore, this study aims to evaluate whether a comprehensive pharmacist-led outpatient program improves medication adherence and reduces medication errors among this population.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Dr
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Cairo, Dr, Egito, 11829
- Badr University in Cairo
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Cairo, Dr, Egito, 11829
- National Cancer Institute, Cairo University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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• Adult medical oncology outpatient at NCI, Cairo University with different diagnoses.
- Receiving ≥5 medication
Exclusion criteria:
- Cognitive impairment,
- Palliative care
- Language barriers
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: PH-LED
Pharmacist led intervention |
Medication Reconciliation, Counseling and Follow-Up |
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Comparador Ativo: ST- CARE
Standard care |
Counselling
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
medication adherence
Prazo: at baseline and after ONE MONTH
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• To measure medication adherence score in both groups using the Morisky (MMAS-8) scale at baseline and after one month to assess improvement in adherence after the pharmacist-led intervention compared to usual care where 8 = High adherence, 6 to <8 = Medium adherence ,<6 = Low adherence |
at baseline and after ONE MONTH
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Detection of medication errors
Prazo: Number of medication errors within ONE MONTH from baseline
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• To identify and detect the number of medication errors in both groups |
Number of medication errors within ONE MONTH from baseline
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- References: Alshehri, M., Althumairi, A., Alharbi, K., & Alharbi, F. (2024). The impact of pharmacist-led medication reconciliation on patient safety outcomes: A systematic review. International Journal of Medical Toxicology and Legal Medicine, 27(2), 87-95. Boeni, F., Spinatsch, M., Suter, K., Hersberger, K. E., & Arnet, I. (2022). Effectiveness of pharmacist-led counseling on medication adherence in cancer outpatients: A systematic review and meta-analysis. Journal of Oncology Pharmacy Practice, 28(5), 1123-1134. de Clercq, L., Van Camp, Y., De Winter, S., & Simoens, S. (2021). Pharmacist-led medication review and reconciliation in oncology: A scoping review. International Journal of Clinical Pharmacy, 43(4), 929-940. Gellad, W. F., Zhao, X., Thorpe, C. T., & Donohue, J. M. (2022). Pharmacist interventions to improve medication use and safety in oncology outpatients. BMC Health Services Research, 22(1), 1147. Hasen G, Negeso B. Patients Satisfaction with Pharmaceutical Care and Associated Factors in the Southwestern Ethiopia. Patient Prefer Adherence. 2021 Sep 21;15:2155-2163. doi: 10.2147/PPA.S332489. PMID: 34584408; PMCID: PMC8464365 ISPOR Report. (2023). Pharmacist-led interventions to improve medication adherence in cancer patients: A systematic review. Value in Health, 26(Suppl 1), S123-S131. Joy AM, UP N, Chand S, Shetty JK, George SM, Chacko CS, Joel JJ. Role of clinical pharmacist in the medication adherence behaviour of cancer patients: An interventional study. Le Pharmacien Hospitalier et Clinicien. 2021; 56:291-297. Lindenmeyer, A., Oliveira, T., Santos, R., & Mendes, E. (2022). Medication discrepancies among oncology patients: The importance of pharmacist involvement. Journal of Hospital Pharmacy Services, 9(3), 55-63. Patel, J., Wong, A., & Clark, C. (2021). Medication errors and patient outcomes in ambulatory oncology. American Journal of Health-System Pharmacy, 78(14), 1275-1282. Weingart, S. N., Brown, E., Bach, P. B., Engelhardt, K. E., Johnson, S
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- HOSPITAL2601-511-149-206
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