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The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge. (HomeCoMe)

22 de fevereiro de 2016 atualizado por: H.T. Ensing, PharmD, MSc

The Effect of a Home-based Community Pharmacist-led Medication Management Program (HomeCoMe-program) Complementary to an In-hospital Medication Reconciliation Program on Drug-related Problems Post-discharge: A Prospective Cohort Study.

the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.

Visão geral do estudo

Descrição detalhada

Inaccuracy of medication histories and lack of knowledge on actual medication use results in confusion about medication regimens and medication mismanagement before- during - and after hospital admission. This phenomenon accounts for many readmissions, longer duration of admission and preventable and serious Adverse Drug Events (ADEs) as a result of Drug Related Problems (DRPs). Several studies show that discharge medication reconciliation (MR) and counseling by a pharmacy employee reduces the amount of discrepancies in the discharge prescription lists. Still, no unequivocal effect of MR on the occurrence of DRPs after discharge has been shown. This is due to a shift in underlying potential harmful discrepancies from mainly patient based (unintended nonadherence) to mainly system based (eg dispensing errors) and might be explained by (1) suboptimal transfer of information (2) an overload of information during a stressful situation and (3) difficulty to implement changes in medication at home. Therefore the reduction of DRPs, improvement of patients' medication knowledge and initial adherence can probably most effectively be addressed in a multifaceted integrated transmural intervention. Repetition of important information is the key to success. Moreover, the first weeks following hospital discharge are most crucial in preventing drug-related problems as patients could slip back in old medication schemes, or new problems may arise, such as emerging ADEs due to medication changes made during hospitalization.

Tipo de estudo

Intervencional

Inscrição (Real)

150

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Flevoland
      • Almere, Flevoland, Holanda, 1315RA
        • Zorgapotheken Flevoland

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • patient uses more than three prescribed systemic drugs intended for chronic use at admission and discharge
  • patient has an expected length of stay of 48 hours or longer

Exclusion Criteria:

  • Patients admitted for scheduled chemotherapy
  • Patients admitted for radiation therapy
  • Patients admitted for transplantation
  • Patients transferred from another hospital
  • Patients transferred from another non-eligible ward within the same hospital
  • No informed consent signed
  • A live expectancy less than 6 months
  • Inability to be counselled (e.g. cognitive dysfunction, language constraints who cannot be solved with an interpreter)
  • Discharge to a nursing home (presuming dependence on medication administration)
  • If patients' community pharmacy is not participating in this study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: HomeCoMe-program group
the arm receiving the pharmacist home visit
A home visit by patients own community pharmacist within seven days after hospital discharge. The community pharmacist will perform a semi-structured interview on (1) use of the prescribed medication, (2) ADEs, (3) adherence issues, by (A) assessing patient's needs and concerns around his pharmacotherapy, (B) identifying and solving obstacles for medicines intake, (C) checking on the need for a compliance aid, (D) collecting spare medication and finally (4) knowledge on medication use, when to take which medicine and why, and medication changes made during the hospitalisation.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge
Prazo: within 7 days post-discharge

The total number of assessed and solved ADEs post-discharge will be measured. Assessing and solving ADEs takes place during the pharmacist home visit.

Using START-STOPP criteria on patients medication records, ADEs will also be compared between the intervention and usual care group.

within 7 days post-discharge

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Improvement of adherence to medication at hospital discharge
Prazo: up to 6 months after discharge
The "medication possession ratio" will be calculated retrospectively from pharmacy dispensing data after 6 months to investigate patient's adherence and compared between the intervention and control group.
up to 6 months after discharge
Patient assessment of medication knowledge at time of home visit
Prazo: within 7 days after discharge
At time of the home visit patients are asked about their knowledge (e.g. indication, dose regime, etc) regarding the medication they are taking. Knowledge is scored and lack of knowledge is solved by teaching the patient.
within 7 days after discharge
Types of interventions made at the pharmacist home visit
Prazo: within 7 days after discharge
The types of intervention the pharmacist works on during the 7 day follow-up home visit are assessed.
within 7 days after discharge
Patient satisfaction with the pharmacist home visit
Prazo: Immediately after receiving the home visit
The satisfaction survey consists of 13 interview questions, where the subject subjectively scores each question on a four-point scale, developed specifically for this study.
Immediately after receiving the home visit
Assessment of patient reported health rating
Prazo: at 14 days after discharge
Patient are asked by telephone to report their health on a scale from 1 (worst imaginable health) to 10 (best imaginable health). Number are compared between the intervention and control group.
at 14 days after discharge
General practitioners satisfaction with the pharmacist home visit
Prazo: Immediately after the home visit is executed
The satisfaction survey consists of 13 interview questions, where the subject subjectively scores each question on a four-point scale, developed specifically for this study.
Immediately after the home visit is executed
Assessment of patient reported health rating
Prazo: at 42 days after discharge
Patient are asked by telephone to report their health on a scale from 1 (worst imaginable health) to 10 (best imaginable health). Number are compared between the intervention and control group.
at 42 days after discharge

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Marcel L Bouvy, Prof, PharmD, PhD, UIPS

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2013

Conclusão Primária (Real)

1 de fevereiro de 2016

Conclusão do estudo (Real)

1 de fevereiro de 2016

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2013

Primeira postagem (Estimativa)

12 de julho de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

23 de fevereiro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de fevereiro de 2016

Última verificação

1 de fevereiro de 2016

Mais Informações

Termos relacionados a este estudo

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