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- Ensaio Clínico NCT05167578
Identifying Reasons for Non-adherence in Patients With Multi-morbidity
Identifying Reasons for Non-adherence in Patients With Multi-morbidity: A Protocol for Prospective Observational Study in Primary Care
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study aims to identify patient-reported reasons for medication non-adherence during pharmacist-led medication reconciliation in primary care. The investigators will examine medication discrepancies between physicians' prescription orders and patients' self-reported medication use, which medicines patients most often use against physician's order, and the reasons for the variant use of medicines. Additionally, the investigators will study the correlation between medication discrepancies and the number of medicines the patient uses. The investigators also aim to investigate which medicines can be classified as high-risk medicines for non-adherence.
The research method will contain a pharmacist-conducted medication reconciliation including a patient interview in a 30-minute appointment. Physicians, nurses, and pharmacists identify patients who are eligible for this study. The study will include 250 patients who visit the public health centres in Vantaa, Southern Finland.
Medication reconciliation will take place at the admission to the health centre, usually before physicians' appointments. A pharmacist will go through all medicines physicians have prescribed, over-the-counter medicines (OTC) and food supplements one by one to assess the actual medicine used by the patient. If a pharmacist identifies medication discrepancies between physician's prescriptions and patient's self-reported use of medicine during the medication reconciliation, she/he will find out the patients' reasons for adjusting the medication. Based on this process pharmacist formulates the updated medication list, including clinically appropriate over-the-counter medicines (OTC medicines) in the patient record system Apotti, where the physician will once more make sure that everything is in order. The pharmacist will advise the patient to clarify the possible misunderstandings or concerns toward medications and motivate the patient to use the medication as prescribed. The outcome of the discussion is documented.
The data will be analyzed by descriptive statistical analysis. The patients' reported reasons for medication discrepancies will be analyzed quantitatively, and central themes and subthemes will be classified. The risk ratio will be identified, i.e., the relative risk among the number of medicines and medication discrepancies. The investigators will compare the total number of patients' medicine, including non-prescription medicine, to medicine the patient is using differently as prescribed and calculate the possible comparative risk adjusting the medicine with the number of prescribed medicines. The investigators will also identify the high-risk medications for non-adherence. The investigators will analyze patients' need for information on medicines as the patient receives guidance and encouragement when the pharmacist identifies discrepancies. The data will be analyzed using IBM SPSS Statistics 26 software.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Kirsi MK Kvarnström, MScPharm
- Número de telefone: +358 40 656 9057
- E-mail: kirsi.kvarnstrom@hus.fi
Estude backup de contato
- Nome: Helena Liira, MD
- E-mail: helena.liira@hus.fi
Locais de estudo
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Vantaa, Finlândia, 01030
- Recrutamento
- Vantaa healthcare and social services
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Contato:
- Helena Liira, MD
- E-mail: helena.liira@hus.fi
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Contato:
- Kirsi MK Kvarnström, McPharm
- Número de telefone: +358 40 656 9057
- E-mail: kirsi.kvarnstrom@hus.fi
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients with multimorbidity
- Patients with ≥5 prescription medicines
- Finnish speaking
- Living at home and managing daily life independently
- Willingness to take part and sign the informed consent
Exclusion Criteria:
- Patients not understand Finnish
- Diagnosed Alzheimer or another memory disorder
- Need help to manage daily life
- End of life care
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Patients with multimorbidity
Patients with multimorbidity who visit the public health centres in Vantaa, Southern Finland
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A pharmacist will go through all medicines physicians have prescribed, over-the-counter medicines (OTC) and food supplements one by one to assess the actual medicine used by the patient.
If a pharmacist identifies medication discrepancies between physician's prescriptions and patient's self-reported use of medicine during the medication reconciliation, she/he will find out the patients' reasons for adjusting the medication.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Medication discrepancy
Prazo: Through study completion, an average of 3 months
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Comparison of actual use of medicines versus prescribed medicines
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Through study completion, an average of 3 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The groups of medicines
Prazo: Through study completion, an average of 3 months
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The medicines that are used differently as prescribes are classified in anatomical therapeutic chemical groups
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Through study completion, an average of 3 months
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The reason for non-adherence
Prazo: Through study completion, an average of 3 months
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Patient reported reasons for not taking medicines as prescribed
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Through study completion, an average of 3 months
|
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The effectiveness of medication information
Prazo: Through study completion, an average of 3 months
|
Will the patient consider taking the medication as prescribed after the discussion with the pharmacist
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Through study completion, an average of 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Marja Airaksinen, PhD Pharm
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HUS/1037/2020
- VD/4977/13.00.00/2020 (Outro identificador: The Institutional Review Board Vantaa)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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