Partnership in Medication Management (PIMM) in Patients With Mood Disorders (PIMM)
17 de novembro de 2015 atualizado por: St. Joseph's Healthcare Hamilton
Partnership in Medication Management (PIMM): The Effects of One-on-one Medication Training on Medication Adherence in Patients With Mood Disorders
Investigators are doing this study to examine if a new personalized education program for patients with mood disorders (depression and bipolar disorders) will help them take their medications as prescribed by doctors.
Investigators will teach patients about how, when and why it is important for them to take their medications as prescribed.
Also, investigators will ask patients why they do not take medications as prescribed.
Furthermore, investigators will examine whether our education program might save money if it prevents problems related to not taking medication.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
The efficacy of anti-depressants or lithium reported in clinical trials differs from clinical experience. Various factors such as non-adherence to treatment and poor tolerability to medications have been related to treatment non-response or treatment failure in mood disorders (major depressive disorder and bipolar disorder). Premature discontinuation of treatment for mood disorders is common. The long treatments, the patients' beliefs about medications, the lack of knowledge about the medication/treatment purpose, benefits, dosage, and side effects and the relationship between patient and healthcare providers affect treatment continuation.
Investigators are proposing a sequential explanatory mixed methods study to investigate a novel program for medication training in persons with mood disorders. The ultimate purpose of the program is to improve medication adherence in these persons. The primary component of the present study will be quantitative, i.e., a randomized controlled trial with 12 months of follow-up to examine the effect of one-on-one medication training, including the use of a checklist system, on medication adherence in patients with mood disorders. The training program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects. The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication. Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications. To the best of the investigators' knowledge, no research has comprehensively examined whether one-on-one medication training, as described above, may improve medication adherence in patients with mood disorders.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
166
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
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Ontario
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Hamilton, Ontario, Canadá, L8N 4K7
- Recrutamento
- Mood Disorders Program, St. Joseph's Healthcare Hamilton
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Contato:
- Carolina Oremus, MD,PhD(c)
- Número de telefone: 36326 +1(905) 522-1155
- E-mail: coremus@stjoes.ca
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Contato:
- Margaret C McKinnon, PhD,C.Psych.
- Número de telefone: 36645 +1(905) 522-1155
- E-mail: mmckinno@stjoes.ca
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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:
- admitted to the inpatient clinic of the Mood Disorders Program, St. Joseph's Healthcare Hamilton
- with a primary diagnosis of bipolar disorder I or II, or major depressive disorder
- able to speak, read, and understand English.
Exclusion Criteria:
- cut off score on Montreal Cognitive Assessment (MOCA; clinical judgement)
- significant suicidal or homicidal risk
- a medical condition/treatment known to affect the brain
- acquired brain injury.
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: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: PIMM/SAM
Partnership in Medication Management (PIMM): The nurse and the attending physician will meet with the patient and ask how s/he administers medication at home (i.e., blister pack).
Initial education session: the nurse will teach the patient about his/her medications, dosage, purpose, when and how to take them.
Nurse and patient will establish reminders to take his/her medication.
Following the education session, patients will be required to notify the nurse when it is time to take their medications, where their medications are, dosage, purpose and side effects.
Self-Administered Medication (SAM): Patients will transition to SAM once the clinical team feels that no further medication changes are required.
SAM is also the model that the participants will follow after discharge.
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The PIMM program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects.
The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication.
Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications.
Outros nomes:
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Sem intervenção: Standard Prescribing Practice(SPP)
Standard prescribing practice (SPP): medication administration will proceed as standard practice.
Patients will not receive a personalized medication training.
The nurse will administer the patient's medications.
However, patients are encouraged to ask any questions regarding his/her medications.Patients will not be provided with any tool to help them to remember when to take their medications.
The nurse will record the patient's knowledge regarding his/her medications.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Medication adherence measured by the Medication Adherence Rating Scale (MARS).
Prazo: Change from baseline in the Medication Adherence Rating Scale at 2 days before discharge and 1 week, 1 month, 3 months, 6 months and 12 months post-discharge
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Medication adherence measured by the Medication Adherence Rating Scale (MARS).
We will measure medication adherence at baseline and each follow up
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Change from baseline in the Medication Adherence Rating Scale at 2 days before discharge and 1 week, 1 month, 3 months, 6 months and 12 months post-discharge
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to re-hospitalization
Prazo: First time re-hospitalization any point during the 12-month follow-up period
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Investigators will compare the time to re-hospitalization between each study group.
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First time re-hospitalization any point during the 12-month follow-up period
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Costs of re-hospitalization
Prazo: First time re-hospitalization any point during the 12-month follow-up period
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Investigators will adopt a healthcare system perspective and compare the costs of first re-hospitalization between each study group.
When a participant is re-hospitalized for the first time at any point during the 12-month follow-up period, investigators will conduct a chart review of the entire re-hospitalization to identify all of the direct and indirect medical resources consumed during this re-hospitalization.
The chart review will cover the entire length of the re-hospitalization, even if this length exceeds the 12-month follow-up period for the participant in question.
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First time re-hospitalization any point during the 12-month follow-up period
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Carolina Oremus, MD, PhD(c), McMaster University
- Investigador principal: Sharon Simmons, RN,BScN,CPMHNc, St. Joseph's Healthcare Hamilton
- Investigador principal: Margaret C McKinnon, PhD,C.Psych., McMaster University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- The World Health Organization.The global burden of disease: 2004 update, Table A2: Burden of disease in DALYs by cause, sex and income group in WHO regions, estimates for 2004. Geneva, Switzerland, 2008 (accessed on: March 6, 2014).
- Health Canada. A Report on Mental Illnesses in Canada. Ottawa: Health Canada, 2002.
- World Health Organization. Adherence to Long- Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization, 2003.
- Rosa AR, Marco M, Fachel JM, Kapczinski F, Stein AT, Barros HM. Correlation between drug treatment adherence and lithium treatment attitudes and knowledge by bipolar patients. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):217-24. doi: 10.1016/j.pnpbp.2006.08.007. Epub 2006 Sep 18.
- Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB. Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14293-6. doi: 10.1073/pnas.2336126100. Epub 2003 Nov 13. Erratum In: Proc Natl Acad Sci U S A. 2005 Nov 8;102(45):16530.
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 janeiro de 2015
Conclusão Primária (Antecipado)
1 de novembro de 2016
Conclusão do estudo (Antecipado)
1 de maio de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
28 de outubro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de novembro de 2014
Primeira postagem (Estimativa)
7 de novembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de novembro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de novembro de 2015
Última verificação
1 de novembro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PIMM MDP
- PIMM Mood Disorders Program (Número de outro subsídio/financiamento: Mood Disorders Program, St. Joseph/s Healthcare Hamilton)
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